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Archive for the ‘Male Genetics’ Category

How Im Raising My Black Son to Be Free & Fearless Despite the Killings of Men Like Him – SheKnows

My son is brown. Dark-brown-sugar-left-on-the-stove-to-caramelize brown. He is short and muscular, with a wide back and a high, track booty like his dad. He is deep-voiced despite his mere five years. Hes full of gumption, eye rolls, and head cocks, with a smart mouth and lip smacks. He is expressive.

That really hurts! He yelled at the nurse when he got his shots.

Dont pull on me! He protested when I yanked him in the car.

He doesnt know that all these things about him are what innately, unconsciously, unawarely, put him in danger. They make him endangered. But I know. After all, he is my son.

Mylen. His name means gracious, dear one, or Gift of God. In this country, I know he will only be seen as such to me, his father, and his family. Yet I dont want him to know this unfortunate truth. I dont want him to know the limitations that have been set on his life simply because genetics, ancestry, and my choice in whom to love, preternaturally predetermined for him to be born Black and male. A Black boy who may only be seen as such for a few more years.

But despite all this knowing, all this perception in the face of systemic oppression, I am still raising him to be fearless, and free.

We live in Jacksonville, Florida. The city, where in 2012, 17-year-old Jordan Davis was killed on Black Friday at a gas station after an argument over loud music by a privileged, racist white man. Months earlier, 17-year-old Trayvon Martin was killed in Sanford, a 90-minute drive south of Jacksonville. In April 2020, Ahmaud Arbery was killed in Glynn County, Georgia, a 90-minute drive north of Jacksonville.

I know intimately the unrest that is awakened when a Black body is forced into death. Were seeing it right now across the country and around the world. The gripping fear that takes hold in a mothers soul when she sees the news about the murder of someone elses son, who reminds her of her son my son. There is a saying in the : Mothers pray their sons will make it to the age of 25. The hope is that somehow, alchemy intervenes after the 25th trip around the sun that then, stray bullets, gang confrontations, and the second-class conditions that ghettoize any community where Black people live will no longer be a weapon that prospers.

These would have been my concerns if I still lived in the Southside of Chicago, the neighborhood of my origin. These would be my concerns if I lived in the Black neighborhoods of Jacksonville. But even though, Ive moved on up, the fears I feel regarding the longevity of my sons life have not let up.

Suburban sprawl in a meticulously pre-planned community: Thats where we dwell. We have a neighborhood watch. There are only three other Black families on our block. My son will go to a good school that reaps the benefits of our zip code and our property taxes. In that school, where he will start Kindergarten in the fall, he may be othered, labeled, ostracized, and deemed a problem child. I am not trying to speak negatively of my son; I simply understand the stakes he will face. Yet, against all these odds, I want him to know he can do anything, be anything, go anywhere, and say anything.

At the park, I beam as he climbs the chain-link fence, glowing with pride at his feat. At home, I allow him to express himself as long as he is respectful. I watch with lax eyes as he runs up and down our block training for a race against his imagination. I stand in awe when we play baseball in our backyard and he hits the ball to our roof, or over the neighbors fence.

There is power in his body, curiosity in his mind, swag in his demeanor, love in his heart, affection in his hug, tenderness in his kiss, and joy in his soul. I do not relish the day that we will have the talk about what he is, and what that means to others who dont look like him. I do not look forward to impressing upon him that his very existence is a threat, and that every second he draws breath is grace and mercy from those who can weaponize their false, fresh white tears against him. I do not want to tell him that even though his father wears blue and served in the Marine Corps, this does not keep him safe.

Mylen will live the majority of his life knowing that the essence of who he is will be disregarded because of how he presents in the world. That his Blackness and maleness is an affront to the descendants of colonizers, Columbusers, enslavers, and public liberals/closet Karens. There will be plenty of time for him to get to know the fear associated with passing police cars. He will have all of his life to learn the hurt when a white woman clutches her purse, or a white man sneers the word boy.

For now, this is our time. Before I instill him with fear, I want him to know what it is to be free. This could very well be the last time he knows such a feeling.

Help young kids of color feel seen with these beautiful Black and biracial dolls that are gorgeous and important.

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How Im Raising My Black Son to Be Free & Fearless Despite the Killings of Men Like Him - SheKnows

Inside the minds of incels: Experts seek to short-circuit the spiral from loneliness to loathing to violence – National Post

Almost three hours into his interrogation by Toronto police, the man who purposely crashed a van into pedestrians along a crowded Toronto sidewalk explained his motive, his dogma. Likely meant as a solemn homily, the words instead push the detective to laugh.

The 10 dead and 16 injured left along Yonge Street in 2018 were causalities of an uprising, the driver said, a beta uprising, if you will, against the Chads and the Stacys.

From his interrogator, Det. Rob Thomas, with the behavioural assessment section no less, a snicker slipped.

Who can blame him? Could there be a more absurd manifesto for mass murder?

Thomas forged ahead with a remarkable session over four and a half hours in which Alek Minassian revealed his online radicalization in the emerging incel ideology (short for involuntary celibate) that has become a woman-hating subculture.

Responses to incel ideology are evolving as violence sparked by its dogma continues, and an online community of fellow believers cheer each attack. While its ideas can evoke laughter of disbelief, its impact is deadly serious.

Last week was a milestone in how Canada responds to incel violence in two significant ways not only showing the hammer but extending a hand.

Incel violence was deemed an act of terrorism in Canada for the first time, when charges against a teenager accused of a deadly machete attack against female workers at a Toronto erotic massage parlour were upgraded to include murder terrorist activity.

At the same time, it is being addressed more urgently as a mental health and social issue needing specific intervention.

While police chase danger from incels as part of an ideological group, mental health professionals, social workers and anti-extremist activists focus on the individuals, the self-described lonely and unloved men behind incel culture and its violent ideas.

Efforts moved forward this week to look into the mindset of incels to short circuit a spiral from loneliness to loathing to violence.

There are certain players involved with the problem of violent extremism and terrorism and they have specific roles, said John McCoy, executive director of the Organization for the Prevention of Violence (OPV).

Youve got an intelligence-gathering agency and law enforcement agencies, but there is a gap and that gap is related to prevention.

While counter violent extremism is usually associated with Islamic jihadists and white supremacists, several organizations are now extending outreach to incels.

Counter violent extremist programming is about trying to prevent the escalation of those who are engaged with some kind of ideology that promotes violence from deciding to get up one day and do something about it like Minassian getting into a van, said McCoy.

McCoys Edmonton-based organization released a report this week to guide mental health practitioners, doctors, social workers, mentors and youth workers in dealing with incels.

Individuals who associate with the incel movement appear more likely than the general population to self-report anxiety, depression and other mood disorders, the OPV says.

Incels span a range of behaviour and belief.

While the violent fringe of the incel movement is being recognized as a threat, it is important to acknowledge the majority of incels are not violent and may be at a higher risk of self-harm than the general population, the report says.

Incels, at least online, often revel in an indifference to living; suicide seems an ever-present possibility with frequent references to the rope call or suifuel, which is something that fuels a desire to die.

One large incel forum conducts periodic polls of its members. In a poll this past March, 88 per cent said they were unhappy; 74 per cent had long-lasting anxiety or emotional distress; 77 per cent were not optimistic about the future and 71.5 per cent said they were on the autism spectrum. Its poll last year found 67.5 per cent of members had seriously considered suicide.

It is important to acknowledge the majority of incels are not violent

Moonshot CVE, a British deradicalization company that works with federal governments, is also turning attention to incels in Canada.

Public Safety Canada recently funded Moonshot for a detailed incel study. This week, it released its first report, designed to help frontline practitioners and social services interrupt incel mobilization to violence.

The Toronto van attack in 2018, and the more recent attack in February 2020, have put their capacity for real-world harm beyond doubt, the Moonshot report says.

It is also clear to anyone who spends time in these communities where both suicidal ideation and suicide itself are rampant incels also pose a significant threat to themselves. The first step in understanding how to engage with these at-risk men is to understand how they communicate and share their worldview.

To that end, Moonshots guide to incel symbols and terminology seeks to break down the jargon to allow informed outside engagement.

In an odd way, Minassian did a lot of that work.

During his four-hour interrogation he spoke in granular detail about the destructive incel worldview, such as dividing humanity into categories of betas, Stacys, Chads and normies.

(A beta is an incel, rejected by society and women because of unfair and unchangeable genetics; a Stacy is the archetype for attractive women who shun betas; a Chad is the name for sexually successful men who attract women despite being seen as dumb; normies are the masses with average looks.)

It sounds childish and comical but it is a meme-friendly way of sorting and explaining incel experiences.

Micah Clark, a Moonshot principal currently based in Ottawa, said incels are unique in the world of violent extremists.

Theyre the ones who adopted the concept of incel, theyve taken that on as their own identity, rather than being called something by other people, he said.

It is a community that has a lot of mental health and social heath needs A lot of these folks are at a very high risk of harming themselves and no one else.

While most incels really have a lot of disdain for themselves and a lot of self-hatred, they are also really into themselves

Then you suddenly have the stark terror of violent attacks and that can never be ignored.

Its a trickier movement to work with, said Clark. Its trickier to understand. They are much more self-aware around who they are and much more self-aware of the fact they are being observed.

They are quite fascinated with themselves. While most incels really have a lot of disdain for themselves and a lot of self-hatred, they are also really into themselves.

Clark said Moonshot has worked with many hardened, tough-nosed counter-terrorist types and former extremists.

And incels weird them out to a degree and in a way that no other movement does. Part of whats so disturbing is its so relatable loneliness and sadness and lack of connection. Its a human experience a lot of us feel and they have felt it in a way that is so far beyond what a lot of us have.

You can recognize that empathy without having to have any sympathy. You can recognize the human experience that led them to this place without having any acceptability around the misogyny, and rejecting it fundamentally.

These reports both highlight one obstacle in reaching incels: despite their self-declared needs, they tend to reject assistance.

The reaction of incels when non-incels engage in their forums is often hostile, rejecting any input from normies.

Accepting therapy and psychological intervention means rejecting incel dogma, Moonshots report says. Under incel dogma, physical appearance is all women care about in sex partners, so pro-social intervention is useless, incels counter.

As one incel post says: therapy dont fix your face.

Overcoming these barriers and making support more accessible will be key to preventing further acts of violence, says the OPV report.

Which means overcoming the irony of a community built on loneliness being hostile to outsiders.

Email: ahumphreys@postmedia.com | Twitter:

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Inside the minds of incels: Experts seek to short-circuit the spiral from loneliness to loathing to violence - National Post

LYNPARZA (olaparib) Receives Positive Opinion from EU CHMP for First-Line Maintenance Treatment of Patients with Germline BRCA-Mutated Metastatic…

KENILWORTH, N.J.--(BUSINESS WIRE)--Jun 1, 2020--

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending LYNPARZA for approval as monotherapy for the maintenance treatment of adult patients with germline BRCA 1/2 mutations (g BRCA m) who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

The CHMP based its positive opinion on results from the Phase 3 POLO trial, which were previously published in TheNew England Journal of Medicine.

The trial demonstrated LYNPARZA nearly doubled the time patients with g BRCA m metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo (HR 0.53 [95% CI 0.35-0.82]p=0.004).

The safety and tolerability profile of LYNPARZA in the POLO trial was consistent with previous trials. The most common adverse reactions (ARs) 10% were fatigue/asthenia (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%). The most common Grade 3 ARs were anemia (11%), fatigue/asthenia (5%), decreased appetite (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%). Among patients taking LYNPARZA, dose interruptions due to an AR of any grade occurred in 35% and dose reductions due to an AR occurred in 17%. Discontinuation due to ARs occurred in 6% of patients receiving LYNPARZA.

Dr. Jos Baselga, executive vice president, oncology R&D, AstraZeneca, said, Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to potentially bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, A pancreatic cancer diagnosis is devastating, and we are committed to research that aims to change the prognosis for patients. The POLO trial demonstrated that treatment with LYNPARZA extended time without disease progression in certain patients with advanced pancreatic cancer we are hopeful that we will be able to bring this treatment to patients in the EU soon.

LYNPARZA is approved in the U.S. as a first line maintenance treatment for patients with g BRCA m metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

ADVERSE REACTIONSFirst-Line Maintenance BRCA m Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/ nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONSFirst-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in 10% of patients treated with LYNPARZA/bevacizumab compared to a 5% frequency for placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

ADVERSE REACTIONSMaintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19 ) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONSAdvanced g BRCA m Ovarian Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in clinical trials of

LYNPARZA for advanced g BRCA m ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA for advanced g BRCA m ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONSg BRCA m, HER2-negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in 20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in > 25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONSFirst-Line Maintenance g BRCA m Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONSHRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in 10% of patients in clinical trials of LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in 25% of patients in clinical trials of LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr 30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCA m Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Advanced g BRCA m Ovarian Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline BRCA- mutated (g BRCA m) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

g BRCA m HER2-negative Metastatic Breast Cancer

For the treatment of adult patients with deleterious or suspected deleterious g BRCA m , human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance g BRCA m Metastatic Pancreatic Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious g BRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

About POLO

POLO is a Phase 3 randomized, double-blinded, placebo-controlled, multi-center trial of LYNPARZA tablets (300 mg twice daily) as maintenance monotherapy vs. placebo. The trial randomized 154 patients with g BRCA m metastatic pancreatic cancer whose disease had not progressed on first-line platinum-based chemotherapy. Patients were randomized (3:2) to receive LYNPARZA or placebo until disease progression. The primary endpoint was progression-free survival and key secondary endpoints included overall survival, time to second disease progression, overall response rate and health-related quality of life. Phase 3 POLO results were published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.

About LYNPARZA (olaparib)

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

About Pancreatic Cancer

Pancreatic cancer is the 12th most commonly occurring cancer worldwide and the 7th leading cause of cancer death globally. The disease has the lowest survival rate of the most common cancers, and is the only major cancer with a single-digit five-year survival rate (2-9%) in nearly every country. There were approximately 460,000 new cases worldwide in 2018. As there are often no symptoms, or symptoms may be non-specific in the early stages, it is most commonly diagnosed at an incurable stage. Around 80% of pancreatic cancer patients are diagnosed when the disease has metastasized and for these, the average survival is less than a year. Despite advances in treatment, few improvements have been made in diagnosis and treatment over the decades. Current treatment is surgery (for which approximately only 10-20% of patients are eligible), chemotherapy and radiotherapy, highlighting a critical unmet medical need for more effective treatment options. 12

About BRCA Mutations

BRCA 1 and BRCA 2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

About the AstraZeneca and Merck Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products including LYNPARZA, the worlds first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.

Mercks Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit http://www.merck.com/clinicaltrials.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the worlds most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the companys ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the companys patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2019 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site ( http://www.sec.gov ).

View source version on businesswire.com:https://www.businesswire.com/news/home/20200601005203/en/

CONTACT: Media:

Pamela Eisele

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LYNPARZA (olaparib) Receives Positive Opinion from EU CHMP for First-Line Maintenance Treatment of Patients with Germline BRCA-Mutated Metastatic...

COVID-19 Impact and Recovery Analysis on Male Breast Cancer Treatment Market investigated in the latest research – WhaTech Technology and Markets News

Company analysis of Male Breast Cancer Treatment Market size which showcase a regional manufacturing status, such as volume, Male Breast Cancer Treatment market share, value and price details.

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Report: calibreresearch.com/report/arket-2688 The study report on the world Male Breast Cancer Treatment market has been encompassed the evaluation of distinct parameters that uplift the growth of the global industry.

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COVID-19 Impact and Recovery Analysis on Male Breast Cancer Treatment Market investigated in the latest research - WhaTech Technology and Markets News

What is Autoflowering Hemp and How to Grow It – Lancaster Farming

One of the buzzwords in the hemp space this year is autoflower. But what is it and why would you want to grow it? This episode answers those questions and a whole lot more with a roundtable panel discussion about autoflowering varieties of industrial hemp with Lancaster County farmer Steve Groff, Atlas Seed Co. Breeder Joe Ullman, and Atlas Seed Co. grower Ryan Power.

And heres what we cover:

The differences between autoflower and photoperiod hemp

Is cloning an option

Expected feminization rates

When does the flowering cycle start

Best time to plant

Recommended spacing

Transplanting vs. direct seeding

Optimal feeding plan

Harvesting

Expected yields

Cannabinoid percentages and more.

For more information, check out Atlas Seed (https://atlasseed.com/) and Hemp Innovators (https://www.hempinnovators.com/)

Autoflower FAQ, provided by Atlas Seed Co.

What is the difference between autoflowering genetics and normal clone or full term varieties?

In short, autoflowering varieties, otherwise known as day neutral genetics or Cannabis ruderalis, begin their flowering phase automatically, regardless of changes in light cycles; normal, full term, clonally propagated Cannabis sativa and Cannabis indica varieties flip to their flowering phase when they exposed to 12 hours of darkness.

Can you take cuttings (clones) of autoflowering varieties?

No, autoflowering cannabis does not allow for cuttings to be taken and therefore must be started from seed and be pollinated to further genetic lines.

What can I expect in terms of the feminization rate of Atlas Seed genetics?

The seeds we offer will show between 1 and 1500 to 1 and 2500 male to female ratio in their respective population. That means between 99.93% and 99.96% will female. We also offer lab test certified feminized seed on key lots to verify the quality of our feminization process.

When can I expect my auto plants to begin their flowering cycle?

Roughly speaking (again growing climate and genetically dependant), autoflowering plants finish their vegetative cycle between weeks 3-5, will continue to stack flowering sites between weeks 3-8, and will see their flowering sites bulk up, densify, and finish in weeks 8-12. For those used to full term and yet unaccustomed to autoflowering cannabis, remain calm until the end of the cycle and watch in marvel as plants continue to increase their flowering yield and cannabinoid content up until the day of harvest!

When is the best time to plant autoflowering varieties?

This is highly dependent on your local climatic conditions, but the rule of thumb is that autos prefer long, dry, sunny days. If you are going for one solid, high yielding harvest then planting as soon as summer soil temperatures stabilize is the way to go. If you are planning on 2 harvests, we generally recommend trying to squeeze in a second late one as opposed to an early harvest, as autoflowering genetics are native to Siberia and will finish more reliably in the cold than they will begin in it.

What is the most common plant spacing for autoflowering varieties?

For hemp we are recommending between 8-12k per acre (more or less 1 plant every 4 square feet), and for cannabis we are recommending between 17,500-20k acre (or about 1 every 2 square feet). For example, 1 row on a 30 bed with 12 in-row spacings will come out to roughly 17,424 plants per acre.

Can you transplant autoflowering varieties?

Absolutely, but there is a method that must be applied to ensure yields are not affected. The most common blunder is for farmers to let seedlings go until they are rootbound which is the easiest way to shock ones plants and greatly reduce their overall yield. The best results we have seen is when plants are transplanted between 7-12 days after sowing. The trick here is to use a cell tray that makes it easy to remove small plants without damaging them. Weve seen the best results with Growcoons, but there are certainly other options as well (ellepots, ihort, etc).

Can you direct seed autoflowering varieties?

Yes, but again this must be done with proper parameters in place, i.e., seasonal timing, soil type, equipment, and so on. As of yet we have not seen any yield differences between transplanted plants and direct seeded, but we are in the process of collecting massive amounts of data on this. Also, if one plans to do this and they are a beginner, than you will likely need 2-3x the seed to see the emergence you want.

What is the most optimal feeding plan you recommend for autoflowering plants?

We recommend that seasoned full term cannabis growers continue to follow their intuition and hard won skill sets, with one key difference: Normally when full term plants initiate their flowering stage, one switches immediately from vegetative, nitrogen rich fertilizer, to flowering, phosphorous rich bloom formulas. With autos, it is important to continue using vegetative, nitrogen rich recipes until week 6-7, well after they have begun their flowering phase. This is done in order to maximize the canopy as the plants continue to grow vertically and horizontally even as they are putting on flowering sites and bulking up.

After week 6-7, transition to bloom recipes to maximize flower yield and cannabinoid potential. They will put in the majority of their weight in the final 3-4 weeks. As a general rule of thumb, remember that the entire vegetative and flowering cycles of the plant are happening in a 70-80 day period. Some slow release nutrients growers may customarily use may not be appropriate for autos.

If I plant autoflowering plants right next to my full term plants, will it cause my full terms to initiate early flowering?

No, no, and decidedly no. We have heard anecdotal hearsay on this issue but based on experience and understanding the difference in the flowering mechanisms between these genetic lines (ruderalis vs. indica / sativa), we do not believe this is possible.

How long does it normally take before autoflowering plants can be harvested?

Classic autoflowering plants (as opposed to super autos which take closer to 120 days) can be harvested between 65-90 days depending on the variety and time of year. During peak summer months when the light intensity is higher, autoflowering crops finish faster. During early spring or late fall and especially in a winter greenhouse run, autoflowering plants will take 10-20 days longer to come to full maturity.

What can I expect in terms of biomass yield for each plant?

Between 2-4 ounces, depending on all of the aforementioned factors, i.e., grower skill, genetics, soil health, etc..

What kind of per acre yield can I expect?

This will differ greatly between hemp and cannabis and most markedly depends on your planting densities. For cannabis between 2-5k lbs is common. For hemp between 1-3k lbs. Is common.

How much of my crop can I use as finished, trimmable flower?

This is most probably most dependent on genetics, but anywhere between 25%-100%. Some plants will present uniformly sized buds that are all trimmable throughout the plant, and others will present a variety of different sized buds, some of which will be more appropriately allotted to smalls or else sent off for extraction. Again, your breeder should be able to answer this question based on experience.

What can I expect in terms of total cannabinoid content from autos?

This is potentially the most grower skill dependent variable of all, but most of the best auto cannabis genetics around today are at or exceeding 20% THC, which is miraculous if one considers they are taking half as long to bring to harvest. The auto hemp game is vastly different as state by state standards for hot hemp differ greatly, however the best varieties of compliant auto hemp as a population are hitting around 30:1 CBD to THC ratios while remaining compliant. Experienced breeders will know their varieties well enough to be able to recommend optimal harvest times to remain in compliance.

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What is Autoflowering Hemp and How to Grow It - Lancaster Farming

HealthDay Reports: Lockdown Got You Down? Experts Offer Tips to De-Stress – HealthDay Coronavirus Liveblog

Each week, HealthDay's Physician's Briefing division rounds up the most important COVID-19 developments in the medical field. See this week's edition below for May 25-May 29.

VA Slashes Use of Hydroxychloroquine to Treat COVID-19 Patients

FRIDAY, May 29, 2020 (HealthDay News) -- The VA health system has stopped nearly all use of hydroxychloroquine to treat COVID-19 patients, Veterans Affairs Secretary Robert Wilkie said at a House hearing on Thursday.

Read Full Article

Deferment of Elective Surgeries Due to COVID-19 Will Have Lasting Impact

FRIDAY, May 29, 2020 (HealthDay News) -- At two years after the end of the elective orthopedic surgery deferment related to the COVID-19 pandemic, there will be a cumulative backlog of more than 1 million surgical cases in an optimistic scenario, according to a study published online May 12 in The Journal of Bone and Joint Surgery.

Read Full Article

Remdesivir Use Growing Globally in COVID-19 Patients

FRIDAY, May 29, 2020 (HealthDay News) -- Worldwide more physicians are using remdesivir to treat COVID-19 patients, according to a survey released May 21 by Sermo, a global health care polling company and social platform for physicians.

Read Full Article

Five-Day Course of Remdesivir Beneficial in Severe COVID-19

FRIDAY, May 29, 2020 (HealthDay News) -- There seems to be no significant difference between a five- and 10-day course of remdesivir for patients with severe COVID-19 not requiring mechanical ventilation, according to a study published online May 27 in the New England Journal of Medicine.

Read Full Article

Burden of Severe COVID-19 High in California, Washington State

FRIDAY, May 29, 2020 (HealthDay News) -- For residents of California and Washington with COVID-19, the length of hospital stay and intensive care unit admission are high, according to a study published online May 22 in The BMJ.

Read Full Article

Positive RT-PCR Findings Seen After COVID-19 Discharge

FRIDAY, May 29, 2020 (HealthDay News) -- Some patients with COVID-19 have positive reverse transcriptase polymerase chain reaction results after discharge, according to a research letter published online May 28 in JAMA Network Open.

Read Full Article

CDC: Coronavirus Antibody Tests Still Not Accurate Enough

THURSDAY, May 28, 2020 (HealthDay News) -- Coronavirus antibody test results may not be accurate enough to help guide decisions about whether to allow large groups of people to gather at work, schools, dormitories, correctional facilities, and other locations, the U.S. Centers for Disease Control and Prevention said Wednesday.

Read Full Article

Parents Facing Higher Levels of Stress During Pandemic

THURSDAY, May 28, 2020 (HealthDay News) -- Individuals, particularly parents, are coping with extreme stress related to the COVID-19 pandemic, according to the results of a survey released May 21 by the American Psychological Association.

Read Full Article

CV Toxicity Tied to Azithromycin and/or Hydroxychloroquine

THURSDAY, May 28, 2020 (HealthDay News) -- Hydroxychloroquine and azithromycin may have a serious adverse impact on the cardiovascular system, according to a research letter published online May 22 in Circulation.

Read Full Article

Improving Glycemic Control May Also Aid COVID-19 Outcomes

THURSDAY, May 28, 2020 (HealthDay News) -- Insulin infusion helps achieve glycemic targets and may reduce the risk for poor outcomes in patients with hyperglycemia and COVID-19, according to a study published online May 19 in Diabetes Care.

Read Full Article

Parents Struggling to Provide for Families During Pandemic

WEDNESDAY, May 27, 2020 (HealthDay News) -- The COVID-19 pandemic poses risks to children's health, well-being, and development as parents struggle to provide for their families, according to a survey released by the Urban Institute.

Read Full Article

U.K. Patients Hospitalized With COVID-19 Are More Often Male

WEDNESDAY, May 27, 2020 (HealthDay News) -- Patients hospitalized with COVID-19 are more often male and frequently have comorbidities, according to a study published online May 22 in the The BMJ.

Read Full Article

Neuroimaging Features of COVID-19 Are Variable

WEDNESDAY, May 27, 2020 (HealthDay News) -- Neuroimaging features of COVID-19 are variable among patients with acute neurological symptoms but are dominated by acute ischemic infarcts, according to a research letter published online May 21 in Radiology.

Read Full Article

African-Americans More Likely to Be Hospitalized With COVID-19

WEDNESDAY, May 27, 2020 (HealthDay News) -- African-American patients have an increased likelihood of hospitalization for COVID-19, according to a report published online May 21 in Health Affairs.

Read Full Article

WHO Suspends Testing of Hydroxychloroquine in COVID-19 Patients

TUESDAY, May 26, 2020 (HealthDay News) -- The World Health Organization has suspended use of the antimalarial drug hydroxychloroquine in a clinical trial of treatments of COVID-19 after a study revealed that patients taking the drug are at increased risk for death and serious heart problems.

Read Full Article

Remdesivir Beats Placebo for Time to COVID-19 Recovery

TUESDAY, May 26, 2020 (HealthDay News) -- For adults hospitalized with COVID-19 with lower respiratory tract infection, time to recovery is shorter with remdesivir than placebo, according to a study published online May 22 in the New England Journal of Medicine.

Read Full Article

Hydroxychloroquine Plus Macrolides No Benefit in COVID-19

TUESDAY, May 26, 2020 (HealthDay News) -- For patients with COVID-19 requiring hospitalization, there is no evidence of benefit for use of hydroxychloroquine or chloroquine with or without a macrolide, according to a study published online May 22 in The Lancet.

Read Full Article

Adenovirus Type-5 Vectored COVID-19 Vaccine Shows Promise

TUESDAY, May 26, 2020 (HealthDay News) -- A recombinant adenovirus type-5 vectored COVID-19 vaccine is safe, tolerable, and immunogenic, according to a study published online May 22 in The Lancet.

Read Full Article

Placental Injury Seen in Pregnant Women With SARS-CoV-2

TUESDAY, May 26, 2020 (HealthDay News) -- Higher rates of decidual arteriopathy and other maternal vascular malperfusion features are seen in placentas of women with severe acute respiratory syndrome coronavirus 2, according to a study published online May 22 in the American Journal of Clinical Pathology.

Read Full Article

Right Ventricular Dilation Linked to Mortality in COVID-19

TUESDAY, May 26, 2020 (HealthDay News) -- Right ventricular dilation is associated with in-hospital mortality among patients hospitalized with COVID-19, according to a study published online May 15 in JACC: Cardiovascular Imaging.

Read Full Article

Original post:
HealthDay Reports: Lockdown Got You Down? Experts Offer Tips to De-Stress - HealthDay Coronavirus Liveblog

Extra proteins alter microglia and behavior in mice – Spectrum

Surplus protein: Male mice that overproduce proteins in microglia have enlarged microglia and more synapses (right) than controls do (left).

The overproduction of proteins in brain cells called microglia causes social impairments, cognitive deficits and repetitive behavior in male mice, a new study has found.1 These behavioral differences are not present in female mice, or in mice that produce excess protein in other brain cells, including neurons or star-shaped support cells known as astrocytes.

Microglia help eliminate excess synapses connections between brain cells that form early in life; this pruning process is crucial to healthy brain development. But male mice that have been engineered to overproduce proteins in these cells have enlarged microglia. That, in turn, lowers the cells mobility and may prevent them from migrating to synapses that need eliminating.

In support of that idea, the mice have too many synapses, the researchers found a result that mirrors evidence that certain brain regions may be overconnected in people with autism.

Increased protein synthesis in microglia is sufficient to cause autism phenotypes in mice, says lead investigator Baoji Xu, professor of neuroscience at the Scripps Research Institute in Jupiter, Florida. Problems in microglia could be an important pathological mechanism for autism.

The researchers studied mice that produce excess levels of EIF4E, a protein that facilitates the synthesis of other proteins. Mutations in several genes linked to autism including TSC1, TSC2, PTEN and FMR1 are associated with elevated levels of an active form of EIF4E and, as a result, many other proteins in the brain. Mice that overproduce EIF4E also display autism-like behavior, researchers have previously found.

These findings have led researchers to theorize that increased protein production in the brain may underlie autism and several related disorders. But the precise link has remained unclear at least until the new work.

By looking at different cells within the mouse brain, they were able to demonstrate the mechanism, says Zosia Miedzybrodzka, professor of medical genetics at the University of Aberdeen in Scotland, who was not involved in the research. Understanding if these same mechanisms are at work in humans is key.

Xus team engineered mice that overproduce EIF4E in specific brain cells: microglia, astrocytes and neurons. Then they put the mice through a battery of behavioral tests. They found that male mice that make extra ElF4E in their microglia are less social, have problems with learning and memory, and overgroom traits considered analogous to those seen in autistic people.

Although female mice also produced excess protein in their microglia, they did not display the same behavioral changes. Nor did mice that overproduced EIF4E in astrocytes or in neurons, although the latter displayed signs of anxiety. The study was published in April in Nature Communications.

Male mice with excess microglial EIF4E have more and larger microglia than control mice do, but their cells are less mobile, and the animals have more synapses.

Although the microglia are bigger, they arent able to migrate, Xu says.

Together, the findings suggest that in male mice, protein overproduction impairs the ability of microglia to travel to synapses that need pruning, altering the animals brain circuitry and behavior in ways that resemble autism in people.

The research provides convincing evidence that the overproduction of proteins in microglia can cause autism-like features, says Eric Klann, director of the Center for Neural Science at New York University, who was not involved in the research.

But Klann says he is not ready to rule out the possibility that elevated protein levels in neurons may play a role, too; ramping up protein production in all of the brains neurons may have masked an effect in certain sub-populations of the cells.

It would be interesting if they had done this manipulation looking at specific subtypes of neurons, Klann says.

It is also not yet clear why none of the microglial abnormalities appeared in female mice, Xu says, but the finding is especially intriguing given that autism is more common in boys than girls.

You have a mechanism that points to why there might be a sex bias in autistic spectrum disorder, which has thus far been elusive, Miedzybrodzka says. Drugs that target microglia might be developed to treat autism and related conditions, she says.

Xu and his colleagues are trying to figure out why female mice seem to be protected from the consequences of protein overproduction in microglia, and to identify specific proteins that might cause the abnormalities in the cells.

Read more here:
Extra proteins alter microglia and behavior in mice - Spectrum

HealthDay Reports: UK Patients Hospitalized With COVID-19 Are More Often Male – HealthDay Coronavirus Liveblog

Each week, HealthDay's Physician's Briefing division rounds up the most important COVID-19 developments in the medical field. See this week's edition below for May 25-May 29.

VA Slashes Use of Hydroxychloroquine to Treat COVID-19 Patients

FRIDAY, May 29, 2020 (HealthDay News) -- The VA health system has stopped nearly all use of hydroxychloroquine to treat COVID-19 patients, Veterans Affairs Secretary Robert Wilkie said at a House hearing on Thursday.

Read Full Article

Deferment of Elective Surgeries Due to COVID-19 Will Have Lasting Impact

FRIDAY, May 29, 2020 (HealthDay News) -- At two years after the end of the elective orthopedic surgery deferment related to the COVID-19 pandemic, there will be a cumulative backlog of more than 1 million surgical cases in an optimistic scenario, according to a study published online May 12 in The Journal of Bone and Joint Surgery.

Read Full Article

Remdesivir Use Growing Globally in COVID-19 Patients

FRIDAY, May 29, 2020 (HealthDay News) -- Worldwide more physicians are using remdesivir to treat COVID-19 patients, according to a survey released May 21 by Sermo, a global health care polling company and social platform for physicians.

Read Full Article

Five-Day Course of Remdesivir Beneficial in Severe COVID-19

FRIDAY, May 29, 2020 (HealthDay News) -- There seems to be no significant difference between a five- and 10-day course of remdesivir for patients with severe COVID-19 not requiring mechanical ventilation, according to a study published online May 27 in the New England Journal of Medicine.

Read Full Article

Burden of Severe COVID-19 High in California, Washington State

FRIDAY, May 29, 2020 (HealthDay News) -- For residents of California and Washington with COVID-19, the length of hospital stay and intensive care unit admission are high, according to a study published online May 22 in The BMJ.

Read Full Article

Positive RT-PCR Findings Seen After COVID-19 Discharge

FRIDAY, May 29, 2020 (HealthDay News) -- Some patients with COVID-19 have positive reverse transcriptase polymerase chain reaction results after discharge, according to a research letter published online May 28 in JAMA Network Open.

Read Full Article

CDC: Coronavirus Antibody Tests Still Not Accurate Enough

THURSDAY, May 28, 2020 (HealthDay News) -- Coronavirus antibody test results may not be accurate enough to help guide decisions about whether to allow large groups of people to gather at work, schools, dormitories, correctional facilities, and other locations, the U.S. Centers for Disease Control and Prevention said Wednesday.

Read Full Article

Parents Facing Higher Levels of Stress During Pandemic

THURSDAY, May 28, 2020 (HealthDay News) -- Individuals, particularly parents, are coping with extreme stress related to the COVID-19 pandemic, according to the results of a survey released May 21 by the American Psychological Association.

Read Full Article

CV Toxicity Tied to Azithromycin and/or Hydroxychloroquine

THURSDAY, May 28, 2020 (HealthDay News) -- Hydroxychloroquine and azithromycin may have a serious adverse impact on the cardiovascular system, according to a research letter published online May 22 in Circulation.

Read Full Article

Improving Glycemic Control May Also Aid COVID-19 Outcomes

THURSDAY, May 28, 2020 (HealthDay News) -- Insulin infusion helps achieve glycemic targets and may reduce the risk for poor outcomes in patients with hyperglycemia and COVID-19, according to a study published online May 19 in Diabetes Care.

Read Full Article

Parents Struggling to Provide for Families During Pandemic

WEDNESDAY, May 27, 2020 (HealthDay News) -- The COVID-19 pandemic poses risks to children's health, well-being, and development as parents struggle to provide for their families, according to a survey released by the Urban Institute.

Read Full Article

U.K. Patients Hospitalized With COVID-19 Are More Often Male

WEDNESDAY, May 27, 2020 (HealthDay News) -- Patients hospitalized with COVID-19 are more often male and frequently have comorbidities, according to a study published online May 22 in the The BMJ.

Read Full Article

Neuroimaging Features of COVID-19 Are Variable

WEDNESDAY, May 27, 2020 (HealthDay News) -- Neuroimaging features of COVID-19 are variable among patients with acute neurological symptoms but are dominated by acute ischemic infarcts, according to a research letter published online May 21 in Radiology.

Read Full Article

African-Americans More Likely to Be Hospitalized With COVID-19

WEDNESDAY, May 27, 2020 (HealthDay News) -- African-American patients have an increased likelihood of hospitalization for COVID-19, according to a report published online May 21 in Health Affairs.

Read Full Article

WHO Suspends Testing of Hydroxychloroquine in COVID-19 Patients

TUESDAY, May 26, 2020 (HealthDay News) -- The World Health Organization has suspended use of the antimalarial drug hydroxychloroquine in a clinical trial of treatments of COVID-19 after a study revealed that patients taking the drug are at increased risk for death and serious heart problems.

Read Full Article

Remdesivir Beats Placebo for Time to COVID-19 Recovery

TUESDAY, May 26, 2020 (HealthDay News) -- For adults hospitalized with COVID-19 with lower respiratory tract infection, time to recovery is shorter with remdesivir than placebo, according to a study published online May 22 in the New England Journal of Medicine.

Read Full Article

Hydroxychloroquine Plus Macrolides No Benefit in COVID-19

TUESDAY, May 26, 2020 (HealthDay News) -- For patients with COVID-19 requiring hospitalization, there is no evidence of benefit for use of hydroxychloroquine or chloroquine with or without a macrolide, according to a study published online May 22 in The Lancet.

Read Full Article

Adenovirus Type-5 Vectored COVID-19 Vaccine Shows Promise

TUESDAY, May 26, 2020 (HealthDay News) -- A recombinant adenovirus type-5 vectored COVID-19 vaccine is safe, tolerable, and immunogenic, according to a study published online May 22 in The Lancet.

Read Full Article

Placental Injury Seen in Pregnant Women With SARS-CoV-2

TUESDAY, May 26, 2020 (HealthDay News) -- Higher rates of decidual arteriopathy and other maternal vascular malperfusion features are seen in placentas of women with severe acute respiratory syndrome coronavirus 2, according to a study published online May 22 in the American Journal of Clinical Pathology.

Read Full Article

Right Ventricular Dilation Linked to Mortality in COVID-19

TUESDAY, May 26, 2020 (HealthDay News) -- Right ventricular dilation is associated with in-hospital mortality among patients hospitalized with COVID-19, according to a study published online May 15 in JACC: Cardiovascular Imaging.

Read Full Article

Read the rest here:
HealthDay Reports: UK Patients Hospitalized With COVID-19 Are More Often Male - HealthDay Coronavirus Liveblog

Lessons we can learn from the honeybees – Advocate Media

Did you know that male honey bees dont have a father? A novel aspect of honey bee reproduction is that they get their genetics straight from the queen, and they have a grandfather but not a father.

That tidbit was enough to intrigue Ryan Giesecke to get interested in the honey bee game. A beekeeper had talked his ear off at a barbecue after a bee had peacefully landed on Giesecke.

I turned and kind of gently tried to blow her off of my shoulder, he says. The guy I was talking to said, Wow, thats a really good reaction. Youre not scared of bees. You should be a beekeeper.

Six months later, his new friend called him and said, Remember how you wanted to be a beekeeper? Suddenly, he had his first two hives. At first, he thought it was going to be a two-hive hobby, but his experience with ladders and power tools resulted in him removing bees from the walls at his aunts, uncles and parents homes. Next, he founded Honey Bee Relocation Services. Here are his thoughts on what we can learn from the hobby:

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Lessons we can learn from the honeybees - Advocate Media

Seattle Genetics Announces Positive Results from Exploratory Analyses of HER2CLIMB for TUKYSA (tucatinib) in Brain Metastases Patients With…

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc.. today announced positive results from exploratory analyses of intracranial efficacy, including survival, in patients with HER2-positive metastatic breast cancer (MBC) who had stable or active brain metastases in the HER2CLIMB pivotal trial of TUKYSA (tucatinib). HER2CLIMB compared TUKYSA in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with unresectable, locally advanced or metastatic HER2-positive breast cancer with or without brain metastases. Of the patients enrolled in the trial, 48 percent had a presence or history of brain metastases. Results demonstrated that the addition of TUKYSA to trastuzumab and capecitabine in patients with brain metastases delayed progression in the brain, doubled the intracranial response rate (tumor shrinkage in the brain) and reduced the overall risk of death by nearly half. The data were consistent across patients who had either stable or active brain metastases. Results were presented in an oral presentation in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the Journal of Clinical Oncology.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200529005149/en/

(Photo: Business Wire)

TUKYSA in combination with trastuzumab and capecitabine was approved by the U.S. Food and Drug Administration (FDA) in April 2020 for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Primary results from HER2CLIMB were first presented at the San Antonio Breast Cancer Symposium in December 2019 and published in the New England Journal of Medicine.

It is immensely gratifying to see for the first time, results for patients with stable or active brain metastases who are not typically included in clinical trials, especially when you consider that nearly half of patients with HER2-positive metastatic breast cancer experience disease progression to the brain, said Nancy U. Lin, M.D., director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Womens Cancers at Dana-Farber in Boston, MA. These additional analyses provide further evidence that TUKYSA improves survival and delays cancer progression in the brain for patients with HER2-positive metastatic breast cancer who have brain metastases.

These additional analyses, together with the primary analysis of HER2CLIMB, show TUKYSA is active for patients with and without disease that has spread to the brain, said Roger Dansey, M.D., Chief Medical Officer of Seattle Genetics. We continue to be encouraged by the remarkable clinical activity of TUKYSA in combination with trastuzumab and capecitabine and look forward to evaluating its potential in additional treatment settings and tumor types through our ongoing clinical program.

The new data that further examine TUKYSAs effect in the brain include exploratory analyses for central nervous system progression-free survival (CNS-PFS), overall survival (OS), intracranial objective response rate (ORR-IC) and duration of response in HER2-positive metastatic breast cancer patients whose disease had spread to the brain.

The exploratory analyses demonstrated that patients with brain metastases who received the TUKYSA combination versus trastuzumab and capecitabine alone had:

Endpoint

TUKYSA Arm (TUKYSA + trastuzumab + capecitabine)

Control Arm (Placebo + trastuzumab + capecitabine)

OS Benefit in All Patients with Brain Metastases

N=198

N=93

Risk Reduction

42% (Hazard Ratio [HR]=0.58 [95% Confidence Interval (CI): 0.40, 0.85]; p=0.005)

One-Year OS

70.1% (95% CI: 62.1, 76.7)

46.7% (95% CI: 33.9, 58.4)

Median OS

18.1 months (95% CI: 15.5, not estimable)

12 months (95% CI: 11.2, 15.2)

CNS-PFS Benefit in All Patients with Brain Metastases

N=198

N=93

Risk Reduction

68% (HR=0.32 [95% CI: 0.22, 0.48]; p<0.0001)

One-year CNS-PFS

40.2% (95% CI: 29.5, 50.6)

0%

Median CNS-PFS

9.9 months (95% CI: 8.0, 13.9)

4.2 months (95% CI: 3.6, 5.7)

Intracranial Objective Response Rate (ORR-IC) in Patients with Active Brain Metastases and Measurable Intracranial Lesions at Baseline

N=55

N=20

Complete Response (CR)

3 (5.5%)

1 (5.0%)

Partial Response (PR)

23 (41.8%)

3 (15.0%)

Stable Disease

24 (43.6%)

16 (80.0%)

Progressive Disease

2 (3.6%)

0

Not Available

3 (5.5%)

0

ORR-IC (CR+PR)

26 (47%) (95% CI: 34, 61)

4 (20%) (95% CI: 6, 44)

Duration of Response-IC

6.8 months (95% CI: 5.5, 16.4)

3 months (95% CI: 3.0, 10.3)

About HER2CLIMB

HER2CLIMB is a multinational randomized (2:1), double-blind, placebo-controlled, active comparator, pivotal clinical trial comparing TUKYSA in combination with trastuzumab and capecitabine compared with trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab and T-DM1. The primary endpoint of the trial was PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by blinded independent central review (BICR) in the first 480 patients enrolled in the trial. HER2CLIMB enrolled a total of 612 patients to support the analyses of key secondary endpoints, including OS, PFS per BICR in patients with brain metastases at baseline and confirmed ORR.1

Results of Primary Analysis of HER2CLIMB

Control Arm (Placebo + trastuzumab + capecitabine)

PFS by BICR in the first 480 patients

46% reduction in risk of progression or death (HR=0.54 [95% CI: 0.42, 0.71]; p<0.00001; N=480)

OS

34% reduction in risk of death (HR=0.66 [95% CI: 0.50, 0.87]; p=0.0048; N=612)

PFS* by BICR in patients with brain metastases

52% reduction in risk of progression or death (HR=0.48 [95% CI: 0.34, 0.69]; p<.0.00001; N=291)

One-Year PFS

25% (95% CI: 17, 34)

0%

Median PFS

7.6 months (95% CI: 6.2, 9.5)

5.4 months (95% CI: 4.1, 5.7)

*standard RECIST, includes brain and body

In HER2CLIMB, serious adverse reactions occurred in 26 percent of patients who received TUKYSA. Serious adverse reactions occurring in 2 percent or more of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea, abdominal pain, and seizure (2% each). The most common adverse reactions occurring in 20 percent or more of patients who received TUKYSA were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash. Adverse reactions leading to treatment discontinuation occurred in 6 percent of patients who received TUKYSA; adverse reactions leading to treatment discontinuation of TUKYSA (in 1 percent or more of patients) were hepatotoxicity (1.5%) and diarrhea (1%).1

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. An estimated 279,100 new cases of breast cancer will be diagnosed in the U.S. in 2020.2 Between 15 and 20 percent of breast cancer cases are HER2-positive.3 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.3,4,5 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time. 6,7,8

About TUKYSA (tucatinib)

TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,9 In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.1

Important Safety Information

Warnings and Precautions

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in 2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Use in Specific Populations

For more information, please see the full Prescribing Information for TUKYSA here.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in peoples lives. The company is headquartered in the Seattle, Washington area, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of TUKYSA including its efficacy, safety and therapeutic uses, including its use in combination with trastuzumab and capecitabine to treat patients with HER2-positive metastatic breast cancer with brain metastases who have received one or more previous anti-HER2 therapies, and its potential use in additional treatment settings and tumor types. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty and uncertainty of pharmaceutical product development; the possibility that adverse events or safety signals may occur; that utilization and adoption of TUKYSA by prescribing physicians may be limited due to impacts related to the COVID-19 pandemic, availability and extent of reimbursement or other factors; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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Seattle Genetics Announces Positive Results from Exploratory Analyses of HER2CLIMB for TUKYSA (tucatinib) in Brain Metastases Patients With...

Poll Finds Many Teachers and Students May Not Return to Schools Even as They Reopen – HealthDay Coronavirus Liveblog

Each week, HealthDay's Physician's Briefing division rounds up the most important COVID-19 developments in the medical field. See this week's edition below for May 25-May 29.

VA Slashes Use of Hydroxychloroquine to Treat COVID-19 Patients

FRIDAY, May 29, 2020 (HealthDay News) -- The VA health system has stopped nearly all use of hydroxychloroquine to treat COVID-19 patients, Veterans Affairs Secretary Robert Wilkie said at a House hearing on Thursday.

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Deferment of Elective Surgeries Due to COVID-19 Will Have Lasting Impact

FRIDAY, May 29, 2020 (HealthDay News) -- At two years after the end of the elective orthopedic surgery deferment related to the COVID-19 pandemic, there will be a cumulative backlog of more than 1 million surgical cases in an optimistic scenario, according to a study published online May 12 in The Journal of Bone and Joint Surgery.

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Remdesivir Use Growing Globally in COVID-19 Patients

FRIDAY, May 29, 2020 (HealthDay News) -- Worldwide more physicians are using remdesivir to treat COVID-19 patients, according to a survey released May 21 by Sermo, a global health care polling company and social platform for physicians.

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Five-Day Course of Remdesivir Beneficial in Severe COVID-19

FRIDAY, May 29, 2020 (HealthDay News) -- There seems to be no significant difference between a five- and 10-day course of remdesivir for patients with severe COVID-19 not requiring mechanical ventilation, according to a study published online May 27 in the New England Journal of Medicine.

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Burden of Severe COVID-19 High in California, Washington State

FRIDAY, May 29, 2020 (HealthDay News) -- For residents of California and Washington with COVID-19, the length of hospital stay and intensive care unit admission are high, according to a study published online May 22 in The BMJ.

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Positive RT-PCR Findings Seen After COVID-19 Discharge

FRIDAY, May 29, 2020 (HealthDay News) -- Some patients with COVID-19 have positive reverse transcriptase polymerase chain reaction results after discharge, according to a research letter published online May 28 in JAMA Network Open.

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CDC: Coronavirus Antibody Tests Still Not Accurate Enough

THURSDAY, May 28, 2020 (HealthDay News) -- Coronavirus antibody test results may not be accurate enough to help guide decisions about whether to allow large groups of people to gather at work, schools, dormitories, correctional facilities, and other locations, the U.S. Centers for Disease Control and Prevention said Wednesday.

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Parents Facing Higher Levels of Stress During Pandemic

THURSDAY, May 28, 2020 (HealthDay News) -- Individuals, particularly parents, are coping with extreme stress related to the COVID-19 pandemic, according to the results of a survey released May 21 by the American Psychological Association.

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CV Toxicity Tied to Azithromycin and/or Hydroxychloroquine

THURSDAY, May 28, 2020 (HealthDay News) -- Hydroxychloroquine and azithromycin may have a serious adverse impact on the cardiovascular system, according to a research letter published online May 22 in Circulation.

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Improving Glycemic Control May Also Aid COVID-19 Outcomes

THURSDAY, May 28, 2020 (HealthDay News) -- Insulin infusion helps achieve glycemic targets and may reduce the risk for poor outcomes in patients with hyperglycemia and COVID-19, according to a study published online May 19 in Diabetes Care.

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Parents Struggling to Provide for Families During Pandemic

WEDNESDAY, May 27, 2020 (HealthDay News) -- The COVID-19 pandemic poses risks to children's health, well-being, and development as parents struggle to provide for their families, according to a survey released by the Urban Institute.

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U.K. Patients Hospitalized With COVID-19 Are More Often Male

WEDNESDAY, May 27, 2020 (HealthDay News) -- Patients hospitalized with COVID-19 are more often male and frequently have comorbidities, according to a study published online May 22 in the The BMJ.

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Neuroimaging Features of COVID-19 Are Variable

WEDNESDAY, May 27, 2020 (HealthDay News) -- Neuroimaging features of COVID-19 are variable among patients with acute neurological symptoms but are dominated by acute ischemic infarcts, according to a research letter published online May 21 in Radiology.

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African-Americans More Likely to Be Hospitalized With COVID-19

WEDNESDAY, May 27, 2020 (HealthDay News) -- African-American patients have an increased likelihood of hospitalization for COVID-19, according to a report published online May 21 in Health Affairs.

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WHO Suspends Testing of Hydroxychloroquine in COVID-19 Patients

TUESDAY, May 26, 2020 (HealthDay News) -- The World Health Organization has suspended use of the antimalarial drug hydroxychloroquine in a clinical trial of treatments of COVID-19 after a study revealed that patients taking the drug are at increased risk for death and serious heart problems.

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Remdesivir Beats Placebo for Time to COVID-19 Recovery

TUESDAY, May 26, 2020 (HealthDay News) -- For adults hospitalized with COVID-19 with lower respiratory tract infection, time to recovery is shorter with remdesivir than placebo, according to a study published online May 22 in the New England Journal of Medicine.

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Hydroxychloroquine Plus Macrolides No Benefit in COVID-19

TUESDAY, May 26, 2020 (HealthDay News) -- For patients with COVID-19 requiring hospitalization, there is no evidence of benefit for use of hydroxychloroquine or chloroquine with or without a macrolide, according to a study published online May 22 in The Lancet.

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Adenovirus Type-5 Vectored COVID-19 Vaccine Shows Promise

TUESDAY, May 26, 2020 (HealthDay News) -- A recombinant adenovirus type-5 vectored COVID-19 vaccine is safe, tolerable, and immunogenic, according to a study published online May 22 in The Lancet.

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Placental Injury Seen in Pregnant Women With SARS-CoV-2

TUESDAY, May 26, 2020 (HealthDay News) -- Higher rates of decidual arteriopathy and other maternal vascular malperfusion features are seen in placentas of women with severe acute respiratory syndrome coronavirus 2, according to a study published online May 22 in the American Journal of Clinical Pathology.

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Right Ventricular Dilation Linked to Mortality in COVID-19

TUESDAY, May 26, 2020 (HealthDay News) -- Right ventricular dilation is associated with in-hospital mortality among patients hospitalized with COVID-19, according to a study published online May 15 in JACC: Cardiovascular Imaging.

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Poll Finds Many Teachers and Students May Not Return to Schools Even as They Reopen - HealthDay Coronavirus Liveblog

What One Monkey Mother Could Teach Humans About Themselves – The Wire

Some rhesus macaques in Agra. Photo: Thomas Schoch/Wikimedia Commons, CC BY-SA 3.0.

In the first week of May, two videos had social media agog. Both involved monkeys, one robbing a Delhi ATM and the other riding by on a bike. At first glance, these videos seem to offer brief moments of amusement in an otherwise grim time. But why bother with such trivia now? Isnt this fiddling while Rome burns?

Well, a post-coronavirus scenario will certainly require a radical reassessment of the deep, conflicted relationship between human societies and their environment, between us and them, between our habitats and theirs. That is why the monkey tricks we saw captured on video earlier this month dont just offer fleeting moments of shock or levity. They are a guide to our past and to our uncertain future.

Indians relationship with simians is the stuff of legend. Millions venerate the monkey-god Hanuman. Myths such as one about the vanara sena1 that helped King Ram build a bridge to Sri Lanka abound. Temples across the country shelter astonishingly large troupes of monkeys; Haridwar literally gods gateway in Hindi is just the most famous of these sites.

Research in the biological sciences around the world also includes substantial focus on primates. That humans share more than 90% of their DNA with the great apes implies that we share several traits with them. For this reason, vaccine trials, not excluding present ones for the coronavirus, are often conducted on primates. Even without knowing it, then, primates greatly contribute to our well being sometimes at great cost to their own.

These issues of human interaction with simians and other species have been around at least since Charles Darwins work, The Expression of the Emotions in Man and Animals (1872). In this book, Darwin examines the sphere of culture and emotion. He reports on the findings of a questionnaire that he sent to 34 countries, including India, asking how 16 different emotions are expressed across cultures. Through this exercise, Darwin sought evidence for his view that all humans share basic emotions with animals owing to a common evolutionary ancestry. Few will deny that we are witnessing such emotions come to the fore in a heightened manner during the present crisis.

In our research at IIT Delhi, based partly on Darwins insights in the Emotions volume, we investigated the feelings that humans, especially children and their caregivers, experienced as they navigated the seas of social survival. The video below documents a small part of what we discovered, by focusing on a mature female monkey, specifically a rhesus macaque (Macaca mulatta).

As viewers will notice, the baby that the monkey mother is holding is actually a puppy. She kisses and fondles it, runs away when she thinks her child is in danger, takes shelter with her partner and another male, possibly her brother, who support her decision to adopt this baby. We observe emotions such as love, trust, bravery, fear, panic, anxiety, anticipation and so on throughout the video.

It happens that this particular simian mother cant have children of her own because male monkeys in the area have been clinically neutered. So she steals a puppy from the locality and attempts to bring it up as her own. In our footage, she hardly lets go of her baby for an instant, bolting as fast as her heavy and precious burden will allow, especially when the alpha male is nearby.

We also hear local villagers talk about how they have witnessed this strange behaviour for some time and how the current pup is in fact one of a series, since the adopted pup always dies. This is because the simian mother treats the puppy just as she would a monkey-baby, feeding it grass and carrying it with her as she leaps from height to height. It is no surprise that the pup eventually dies from injuries and starvation.

This clip teaches us three things at a minimum.

First, it reminds us that animals and humans have shared common spaces for millennia. If we interfere with these spaces, for example by neutering male monkeys, it can have unforeseen, even dangerous, consequences. In this film, the interacting species are humans animatedly discussing the actions of monkeys; the simian troupe that have to assimilate a dog into the everyday routine of their lives; and the small pup at the still centre of this cross-species drama.

Today, we need to understand and respect these relationships (with bats, rats, tigers, bees, bacteria, viruses and plants) more than ever because they determine who we are.

The fact is that we are beings designed by nature for touch-contact with each other as well as with several animal species. Physical distancing may work as an excellent temporary survival strategy. We will, however, have to develop far more innovative ideas in proxemics studies, and invest in understanding technologies of desire and the political economy of inter- and intra-species inequality before humans manage to overcome, even in part, their ancient, touchy feely emotional coding.

Forgetfulness is biological but memorialisation cultural. Both shape us but the evidence thus far indicates that people always return to their old, bad ways after pandemics, however harrowing. It could be the triumph of hope over experience to think that the reset button will be so easy to press this time round.

Second, the video teaches us that there can be individual differences between monkeys as there are among humans. Not all monkeys choose to rear puppies as their own offspring. Not all ride bikes or investigate ATMs.

This insight is important because it tells us that our own human cultures are simultaneously composed of individuals and collectives. Both concepts have great power and potential as we move into an age in which we will have to make increasingly difficult ethical and intellectual choices about our common environment.

Third, the video shows us that humans can learn from their mistakes in a way that other species cannot. The monkey mother in the video repeatedly picks up puppies even though they die on her, remaining a prisoner of her biological instincts. That is her tragedy. Ours is different: that even though we can reflect deeply on our emotions and instincts through language, even though we have the mental capacity to acknowledge our mistakes, we fail to do so. Our greatest gift to argue passionately about something we call the truth can then become our greatest failing, making us prisoners not of our instincts but of our prejudices. That is our tragic flaw.

So it was wonderful to listen to the vociferous debate my students engaged in when I showed them our film. Some thought the macaque mother in question profoundly selfish, others that she was remarkably altruistic. Since the world recently celebrated Mothers Day, the students also debated whether a generic recognition of baby-like characteristics in pets and other creatures might help species survive by triggering a generalised protective circuitry that induces compassionate emotions.

In the 19th century, Darwin knew little about genetics but I imagine he wouldnt have been at all surprised to learn about the current virus that spilled over from bats to humans nor would he have contested the pivotal role empathy can play in preventing humans from self- and others destruction. Towards the end of The Origin of the Species, he wrote presciently:

In the distant future I see open fields for far more important researches. Psychology will be based on a new foundation.

The COVID-19 crisis has shown that we may be at the threshold of that distant future.

Rukmini Bhaya Nair is a cognitive linguist and writer. She teaches at IIT Delhi.

The author is very grateful for the funding received for the Language, Culture and Emotion project from the Department of Science and Technology (DST), 2010-2014. She was Principal Investigator; her co-PIs were Purnima Singh and C.A. Tomy. She also wishes to profusely thank the filmmaker, Muneesh Tarsem, for his work on the rhesus macaque troupe in Himachal Pradesh.

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What One Monkey Mother Could Teach Humans About Themselves - The Wire

Scientists Found New Baldness Cure that Could Trigger Regrowth in Just 4 Months! – Science Times

Researchers discovered that stem cells taken from fat tissues have growth hormones that can work on hair. They used those stem cells to create a new solution that triggers hair regrowth among people with male-pattern baldness.

Androgenetic alopecia or also known as male-pattern baldness or female-pattern baldness is caused by genetics, and hormonal and environmental factors. According to the researchers from Pusan National University Yangsan Hospital in South Korea, it affects about 50% of all men and a similar percentage among women over 50 years old.

The researchers recruited 29 male and nine women patients or 38 people with common baldness to participate in their study. The participants rubbed the new solution into their scalp two times a day. After 16 weeks, they found a significant increase in hair count.

Male-pattern baldness is not a life-threatening condition. However, it can lower one's self-esteem and psychological wellbeing in people with the condition. Some FDA approved medications in the United States to treat hair loss though proven effective, can have side effects like the loss of libido and erectile dysfunction.

Daily Mail reported that scientists discovered the new medication when they found connective tissue let off growth hormones that help cells develop. They examined the stem cells in detail and found that they could activate numerous growth factors that increase the size of the hair follicles.

Researcher Professor Sang Yeoup said that recent studies have shown that the newly developed solution can promote hair growth in both men and women with Androgenetic alopecia. "However, no randomized, placebo-controlled trial in humans has explored the effects and safety of adipose-derived stem cell constituent extract (ADSC-CE) in male pattern baldness," he added.

The participants of their study were middle-aged people with alopecia to identify whether ADSC-CE solutions could work to cure their condition.

Half of the 38 patients being studied were given ADSC-CE solution, and the other half is the placebo solution without the growth hormones. The participants applied a solution- either the experimental or placebo- to their scalps with their fingers. They did it twice a day for 16 weeks.

"At the end of 16 weeks, the group that received the ADSC-CEs had a significant increase in both hair count and follicle diameter," said Young Jin Tak, the senior author of the study. The researchers published their study in the journal Stem Cells Translational Medicine.

Read Also: David Beckham's Case of Missing Hair Sparks Questions on the Best Hair Loss Treatment

Their findings suggest that the ADSC-CE solution can have 'enormous potential' as an alternative to other hair growth solutions currently available as they increase hair density and thickness. The researchers recommend conducting another study with a large and diverse population to confirm the benefits of ADSC-CE on hair growth and explain how mechanisms responsible for the action of ADSC-CE in humans.

According to Anthony Atala, editor-in-chief of STEM CELLS translational medicine and director of the Wake Forest Institute for Regenerative Medicine, the new solution created from adipose tissue cells proves to be both safe and effective. Also, it offers hope to those people suffering from the pattern baldness condition.

Read More: Femininity and Attractiveness: Why Women Feel the Need to Go Hairless

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Scientists Found New Baldness Cure that Could Trigger Regrowth in Just 4 Months! - Science Times

Eldridge, Walker Named McWhorter Scholar-Athlete of the Year Nominees – KAGSTV.com

COLLEGE STATION, Texas SeniorsRaenaEldridge and Benjamin Walker of the Texas A&M womens and mens swimming & diving programs have been nominated for the H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship.The H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship has been presented by the Southeastern Conference since 1986 to the league's top male and female scholar-athletes. The SEC will name the 2020 recipients, chosen by a committee of Faculty Athletics Representatives from the 14 SEC institutions, in late May.Eldridge recently earned her degrees from A&M, majoring in animal science and genetics. The Rockwall, Texas, native has garnered CSCAA Scholar All-America honors every year of her career, while also being named to the SEC Academic Honor Roll each season. For the second straight year, Eldridge was awarded Bill Erwin Scholar-Athlete of the Year honors, recognizing the top male and female student-athletes at Texas A&M who balance athletics and academics while maintaining above a 3.25 GPA, at the recent Building Champions Awards. Eldridge has served as a project leader for the Aggie Research Scholars Program and as a Student Technician of the Genetics Research Lab. Eldridge captained the womens squad as a junior and senior, and earned CSCAA All-America honors twice, while helping her team to three straight SEC Championships.Walker recently earned his degree in accounting from the Mays Business School. He was a two-timeCSCAAScholar All-American and has earned a spot on the SEC Academic Honor Roll in each year of his career. Walker, who hails from The Woodlands, Texas, made A&M history as a junior when he became the program's first individual swimming SEC Champion, winning the 200 Breast. He again claimed gold in the event with a school-record time of 1:51.92, while helping both medley relay teams to podium finishes at the 2020 SEC Championships. The three-timeCSCAAAll-American also holds the Texas A&M all-time school record in the 100 Breast, and was part of the record-holding 200 and 400 medley relay teams, both setting a new program mark at this year's SEC Championships. A team captain in his final season, Walker helped A&M move up the dual meet rankings, rising as high as fourth for the team's highest ranking since the 2001 season.The SEC provides the league's male and female McWhorter Scholar-Athlete of the Year Post-Graduate Scholarship recipients with a $20,000 post-graduate scholarship. The 26 remaining male and female finalists for the award will also receive a $10,000 post-graduate scholarship.

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Eldridge, Walker Named McWhorter Scholar-Athlete of the Year Nominees - KAGSTV.com

Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting – Stockhouse

- Data to be Presented Underscore Progress in Addressing Unmet Needs Across Multiple Tumor Types -

- Additional Results for Recently FDA-Approved TUKYSA(tucatinib) to be Featured in Oral Presentation -

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the presentation of new data from its expanding pipeline of marketed and investigational therapies in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on May 29-31. Thirteen abstracts including an oral presentation of new data from patients with brain metastases who were part of the pivotal HER2CLIMB trial of TUKYSA (tucatinib) in patients with previously treated HER2-positive metastatic breast cancer will highlight the company’s continued progress in advancing research in cancers that have a significant unmet need.

Over the past six months, we have been able to deliver on our promise of bringing important new medicines to certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer through two U.S. FDA approvals,” said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. We look forward to sharing data in the ASCO virtual scientific program that reinforce our ability to rapidly advance novel targeted agents across multiple tumor types.”

An Expanding Portfolio of Marketed Therapies

Key data presentations will showcase progress for certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer as well as for patients with classical Hodgkin lymphoma (HL). Highlights include:

TUKYSA Update in Patients with Brain Metastases

Results for TUKYSA in combination with trastuzumab and capecitabine in patients with brain metastases from the HER2CLIMB pivotal trial of previously treated patients with HER2-positive metastatic breast cancer will be featured in an oral session (Abstract #1005). Data will be presented from these exploratory analyses on findings from the TUKYSA arm of the study on reduction in the risk of death (OS), reduction in the risk of intracranial progression or death (CNS-PFS) and improvement of the intracranial confirmed objective response rate (ORR-IC) compared to trastuzumab and capecitabine. Data will be presented by Nancy U. Lin, Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber in Boston, MA, during an oral presentation available on demand at 8:00 a.m. ET on May 29, 2020. A separate analysis of adverse events (AE) from the same trial will be presented (Abstract #1043; poster presentation).

PADCEV (enfortumab vedotin-ejfv) in Combination and in Other Solid Tumors

Additional results and durability data from the phase 1b EV-103 trial of PADCEV plus pembrolizumab in first-line metastatic urothelial cancer will be presented (Abstract #5044), and a separate Trials-in-Progress poster will provide details about a new randomized cohort added to the EV-103 study, Cohort K, which is evaluating PADCEV as monotherapy or in combination with pembrolizumab (#TPS5092). Both presentations will be featured in the Genitourinary CancerKidney and Bladder session. Data from the Cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States.

Additionally, information about the phase 2 EV-202 trial, which is studying PADCEV in six different types of locally advanced and metastatic solid tumors (HR-positive/HER2-negative and triple-negative breast cancers, squamous and non-squamous non-small cell lung cancers, head and neck cancer and gastroesophageal cancers), will be discussed in a Trials-in-Progress poster during the Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology Poster Session (Abstracts #TPS3647).

ADCETRIS® (brentuximab vedotin) Continues to Advance

Data to be presented on ADCETRIS will demonstrate the company’s progress in efforts to continue expanding clinical research on combination regimens and monotherapy in a variety of HL and peripheral T-cell lymphoma (PTCL) patient populations, including in both older and younger disease settings. A poster presentation will highlight the potential of ADCETRIS in combination with nivolumab or dacarbazine and as a monotherapy for previously untreated older HL patients who typically have poorer outcomes than younger patients due to comorbidities and toxicities related to standard first-line chemotherapy (Abstract #8032). The primary analysis from an ongoing clinical trial evaluating ADCETRIS plus nivolumab in children, adolescents and young adults with standard-risk relapsed or refractory classical HL will also be presented (Abstract #8013; poster discussion). Lastly, two Trials-in-Progress poster presentations will highlight ongoing clinical trials evaluating ADCETRIS as a monotherapy in frontline older HL or CD30-expressing PTCL patients and in a combination regimen in frontline advanced-stage HL patients (Abstracts #TPS8069 and #TPS8068).

A Strong, Diverse Pipeline of Investigational Therapies

An additional four Trials-in-Progress posters for investigational therapies will showcase the company’s continued clinical development of pipeline candidates in first-line cervical cancer (Abstract #TPS6095), metastatic breast cancer (Abstract #TPS1104), metastatic pancreatic ductal adenocarcinoma (PDAC) (Abstract #TPS4671) and other solid tumors (Abstract #TPS3652).

The abstracts published in advance of the ASCO meeting were made available today on the ASCO website. All data presentations will be available on-demand on May 29, 2020.

Details of Key Seattle Genetics Presentations at ASCO20 Virtual:

Abstract Title

Abstract #

Presentation Type

Presenter

ADCETRIS® (brentuximab vedotin)

Nivolumab and brentuximab vedotin (BV)-based, response‐adapted treatment in children, adolescents, and young adults (CAYA) with standard-risk relapsed/refractory classical Hodgkin lymphoma (R/R cHL): Primary analysis

8013

Poster discussion

P. Cole

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

8032

Poster presentation

C. Yasenchak

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma

5044

Poster presentation

J. Rosenberg

TUKYSA (tucatinib)

Tucatinib vs Placebo Added to Trastuzumab and Capecitabine for Patients with Previously Treated HER2+ Metastatic Breast Cancer with Brain Metastases (HER2CLIMB)

1005

Oral presentation

N. Lin

Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB)

1043

Poster presentation

A. Okines

Trials-in-Progress

ADCETRIS® (brentuximab vedotin)

Frontline brentuximab vedotin in Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma for older patients and those with comorbidities

TPS8069

Poster presentation

C. Yasenchak

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma

TPS8068

Poster presentation

J. Friedman

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab for locally advanced or metastatic urothelial carcinoma

TPS5092

Poster presentation

N. Mar

EV-202: A Phase 2 Study of Enfortumab Vedotin in Patients With Select Previously Treated Locally Advanced or Metastatic Solid Tumors

TPS3647

Poster presentation

J. Bruce

Investigational Therapies

Phase 1b/2 trial of tisotumab vedotin (TV) ± bevacizumab (BEV), pembrolizumab (PEM), or carboplatin (CBP) in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024)

TPS6095

Poster presentation

I. Vergote

SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer

TPS1104

Poster presentation

H. Beckwith

SGN228-001: A phase 1 open-label dose escalation and expansion study of SGN-CD228A in select advanced solid tumors

TPS3652

Poster presentation

A. Patnik

Phase 1 study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC)

TPS4671

Poster presentation

A. Coveler

About ADCETRIS (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. Seattle Genetics and Takeda are jointly developing ADCETRIS.

About PADCEV (enfortumab vedotin-ejfv)

PADCEV is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). PADCEV is co-developed by Seattle Genetics and Astellas.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Most Common (20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

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Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting - Stockhouse

Is there a genetic predisposition to suffer from COVID-19? | Present – Explica

Since the outbreak of the COVID-19 pandemic a few months ago, doctors and researchers have been wondering about the causes behind the disparate effects of the infection, whose spectrum ranges from the absolute absence of symptoms to extremely serious symptoms such as , for example, acute respiratory distress syndrome, which cause death on more than a few occasions. What explains such variability? Does the answer reside in our genes?

TLR receivers

Coronaviruses have raised such questions for more than 15 years. In a first study of the severe acute respiratory syndrome (SARS) outbreak in 2003, Ralph Baric and colleagues at the University of North Carolina at Chapel Hill found that inactivation of a gene caused by a mutation turned mice into highly sensitive to SARS-CoV, the disease-causing coronavirus. The gene in question, TICAM2, encodes a helper protein that is involved in the activation of a family of receptors, that of the toll-like receptors (TLR). These are involved in the mechanisms of innate immunity, which constitutes the first line of defense against pathogenic microbes.

Now the focus has shifted to SARS-CoV-2, the new coronavirus responsible for COVID-19, but TLRs have garnered interest again, this time following attempts to explain the marked prevalence of sex. male among people with a serious infection.

According to a national epidemiological study carried out in France and published on April 23, up to 73 percent of those admitted by COVID-19 in intensive care units in that country were men. Differences in habits and hormonal nature would partially explain this preponderance, but genes would have something to do with the situation as well. Unlike men, women have two X chromosomes, so they have twice as many copies of the TLR7 gene, an essential detector of viral activity that enhances the immune response capacity.

Blood groups

The genetics of blood groups also seems to provide clues to a persons risk of severe coronavirus infection. In late March, Peng George Wang of the Southern China University of Science and Technology released the results of a study by his team, not yet externally reviewed, comparing the distribution of blood groups in 2,173 COVID-19 patients treated at three hospitals in the cities of Wuhan and Shenzhen with that of other uninfected citizens in those areas. Blood group A would be associated with a higher risk of contracting the virus, in contrast to type O, which would confer more protection for reasons that are still unknown.

The SARS outbreak of the past decade offers lessons. ABO blood groups are based on two types of carbohydrates (or sugars) present on the surface of red blood cells. The first corresponds to type A and the second to type B. Each sugar molecule is synthesized by an enzyme whose gene is present in two forms (one is responsible for type A and the other is responsible for type B). A third encodes an inactive version of the enzyme: type O (from the German ohne, without). The person carrying the two active enzyme variants, A and B, has type AB blood.

Both carbohydrates, A and B, act as antigens, that is, they trigger the production of antibodies that recognize the antigens that the individual lacks, which is why precautions must be taken in blood transfusions. In the ABO system, type O blood is the richest in antibodies, since it contains both anti-A and anti-B antibodies, while type AB blood does not have any.

In 2008 Jacques Le Pendu of the University of Nantes and his collaborators investigated an in vitro model of SARS-CoV. They found that the anti-A antibody neutralizes the binding of the viruss protein S to the ACE2 receptor (angiotensin-converting enzyme), a necessary step for the infection of the cell to be consumed (as soon as to anti-B antibody, data not yet available).

ACE1 versus ACE2

Another protein very close to ACE2 involved in the control of blood pressure is the angiotensin converting enzyme type 1 (ACE1). The ACE1 gene of the latter is polymorphic, that is, there are several variants (or alleles) thereof, of which D is associated with a reduced expression of the related ACE2 gene. As a result, cells carrying the ACE1 D gene have fewer receptors that serve as a gateway for the SARS-CoV virus. The frequency of the ACE1 D variant is not the same in all countries, especially in Europe, which raises the question of whether the geographical distribution of this variant could not be interrelated with the prevalence of COVID-19. Would this reflect the epidemiology of infection on a global scale? The investigations of the team led by Marc De Buyzere, at the University of Ghent, point in that direction.

Using data from 25 countries (from Portugal to Estonia and from Turkey to Finland), Belgian researchers have calculated that 38 percent of the variability in the prevalence of the disease is explained by the frequency of the D allele of ACE1. Furthermore, a similar correlation is observed in mortality statistics. They also highlight that the D allele is rare in the population of two Asian countries that have been severely affected by SARS-CoV-2.

Another genetic component that could explain vulnerability to the new coronavirus is the genes that encode human leukocyte antigens (HLA), a set of proteins that prevent the immune system from attacking the body itself. These proteins constitute the main histocompatibility complex (MHC), which marks all the cells and tissues of their own and differentiates them from everything that is not. Reid Thompson and colleagues at the Oregon Health and Science University in Portland have discovered a link between certain HLA genes and the severity of COVID-19.

People with the HLA-B * 46: 01 variant appear to be especially vulnerable to SARS-CoV-2, as was previously demonstrated with SARS-CoV. In contrast, the HLA-B * 15: 03 variant would confer a certain degree of protection. Determining a persons HLA gene envelope, using quick and inexpensive analysis, would help better predict the severity of the infection and detect those in whom vaccination would be a priority, according to the researchers.

Major projects

To learn more about the genetic variants that influence SARS-CoV-2 infection, a multitude of projects are underway. In one of them, Andrea Ganna, from the University of Helsinki, has launched the COVID-19 Host Genetics Initiative, which aims to unite the efforts of the international community of geneticists working on this issue. For his part, Jean-Laurent Casanova, from the Parisian Necker Pediatric Hospital and Rockefeller University in New York, coordinates a similar project that seeks to discover the genetic variants that favor the most serious forms of COVID-19 in minors. 50 years.

There is no doubt that we are not equal to SARS-CoV-2, but if we discover what causes such differences, perhaps we can alleviate them.

Loc Mangin

Find here all the contents of Research and Science on the COVID-19 pandemic. You can also access articles published by Scientific American and other international editions through this web.

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Is there a genetic predisposition to suffer from COVID-19? | Present - Explica

Eldridge, Walker Named McWhorter Scholar-Athlete of the Year Nominees – KBTX

BIRMINGHAM, Ala. Seniors Raena Eldridge and Benjamin Walker of the Texas A&M womens and mens swimming & diving programs have been nominated for the H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship.

The H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship has been presented by the Southeastern Conference since 1986 to the league's top male and female scholar-athletes. The SEC will name the 2020 recipients, chosen by a committee of Faculty Athletics Representatives from the 14 SEC institutions, in late May.

Eldridge recently earned her degrees from A&M, majoring in animal science and genetics. The Rockwall, Texas, native has garnered CSCAA Scholar All-America honors every year of her career, while also being named to the SEC Academic Honor Roll each season. For the second straight year, Eldridge was awarded Bill Erwin Scholar-Athlete of the Year honors, recognizing the top male and female student-athletes at Texas A&M who balance athletics and academics while maintaining above a 3.25 GPA, at the recent Building Champions Awards. Eldridge has served as a project leader for the Aggie Research Scholars Program and as a Student Technician of the Genetics Research Lab. Eldridge captained the womens squad as a junior and senior, and earned CSCAA All-America honors twice, while helping her team to three straight SEC Championships.

Walker recently earned his degree in accounting from the Mays Business School. He was a two-time CSCAA Scholar All-American and has earned a spot on the SEC Academic Honor Roll in each year of his career. Walker, who hails from The Woodlands, Texas, made A&M history as a junior when he became the program's first individual swimming SEC Champion, winning the 200 Breast. He again claimed gold in the event with a school-record time of 1:51.92, while helping both medley relay teams to podium finishes at the 2020 SEC Championships. The three-time CSCAA All-American also holds the Texas A&M all-time school record in the 100 Breast, and was part of the record-holding 200 and 400 medley relay teams, both setting a new program mark at this year's SEC Championships. A team captain in his final season, Walker helped A&M move up the dual meet rankings, rising as high as fourth for the team's highest ranking since the 2001 season.

The SEC provides the league's male and female McWhorter Scholar-Athlete of the Year Post-Graduate Scholarship recipients with a $20,000 post-graduate scholarship. The 26 remaining male and female finalists for the award will also receive a $10,000 post-graduate scholarship.

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Eldridge, Walker Named McWhorter Scholar-Athlete of the Year Nominees - KBTX

The Cassowary Is the World’s Most Dangerous Bird – HowStuffWorks

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This massive, flightless emu-like creature has been called "the most dangerous bird in the world." The reason is that this exotic bird can seriously injure or kill a human or dog in an instant with its deadly claws. In fact, cassowaries are listed as Class II animals (along with alligators and wild cats) in Florida due to the risk they pose, which means anyone who wishes to own one must pass numerous tests and get a special permit from local authorities. And even then, tragedies still can occur, as happened to the 75-year-old Florida man who was attacked by at least one of the birds he rears on his properties and later succumbed to his injuries in the hospital.

So, what exactly is a cassowary? Like their cousins the emu, they are ratites, or birds that have flat breastbones and are unable to fly, native to tropical forests of Australia and Southeast Asia. As far as this striking bird's appearance, it boasts bristly feathers, a vivid blue face, a duo of red flaps of skin, known as wattles, hanging from its neck and a prominent helmet (or casque) atop its head. Although size varies across the three different species of cassowaries the Southern, Northern and Dwarf they can stand up to 6 feet, 6 inches (2 meters) tall and weigh as much as 132 pounds (60 kilograms). For a comparison, you can think of one as being the equivalent of six swans.

The portion of their body that makes them so dangerous? Muscular legs with three claw-tipped toes that can pack a pretty powerful punch, including lethal wounds to internal organs and severe bleeding. "The claw on the inner toe of each foot is what is so impressive," says Rick Schwartz, a global ambassador for California's San Diego Zoo, which currently houses several Southern cassowaries in its Safari Park, in an email interview. "Between the three species, that claw is very sharp, and can range from 3 to 5 inches (7 to 12 centimeters) long. The cassowary will use these sharp claws and their powerful kick to defend themselves. It is often stated that they can eviscerate a human in a single kick, though there is no record of this happening."

The good news, according to Guinness World Records, is that you're far more likely to suffer a snake bite or even an infection transmitted by a dog than you are injury by one of these birds. In fact, the most dangerous animal of all is no bigger than a thumb nail. By transmitting disease-causing pathogens, mosquitoes are estimated to be responsible for between 725,000 and 1 million human deaths per year, making them far and away the most lethal animal on Earth.

Now that you know you probably shouldn't provoke a cassowary or a mosquito, for that matter here are 10 other interesting facts about this unusual bird.

While a cassowary is not an emu, both emus and cassowaries can be considered related in taxonomy (the science of classification of living and extinct species), according to Schwartz. "They share the same scientific order [Casuariiformes]," he explains. "But, within that order, they are in different scientific families."

"Cassowaries are the heaviest bird in Australia, and the Southern cassowary is the second-heaviest in the world (the world's heaviest bird is the ostrich)," says Schwartz. "With that in mind, they also have very small wings. When stretched out, their wings extend less than a foot (0.3 meters) from their body." According to Schwartz, Southern cassowary females can weigh up to 170 pounds (79 kilograms) and males up to 125 pounds (56 kilograms); Northern females can weigh up to 128 pounds (58 kilograms) and males up to 80 pounds (36 kilograms); and Dwarf females can weigh up to 55 pounds (24 kilograms) and males up to 40 pounds (18 kilograms).

A cassowary has dense, black feathers that are long and thin compared with the wide and shapely feathers of a flighted bird, according to Schwartz. "From a distance, some people even say the feathers of the cassowary look more like hair," he adds. "The cassowary's feathers are not suitable for flight, but they work very well for a ground-dwelling bird living in a forest ecosystem. The longer, thinner feathers help direct water away from the body, and also protect the bird's body from low branches, sharp twigs and thorns."

It's made of keratin, the same protein that the bird's feathers, nails and beak are made of, according to Schwartz. "The outer covering is thick and hard, but the inside is very porous. The purpose of the casque is not completely understood, but several theories exist including that it can help amplify vocalizations, serve as head protection as the bird pushes headfirst through the dense forest, or it may be another way for the birds to display age and vitality."

"Of the three species of cassowaries, only the Northern and Southern cassowaries have wattles," says Schwartz. As with the casque, there are a few theories on the purpose of the brightly colored wattles, he adds. Among them: "It is thought that they can help communicate the bird's current demeanor; indicate an individual bird's vitality to other cassowaries; or give other cues and communications only known by cassowaries at this time," says Schwartz.

That means they feed on fruits, which makes them very important to their surrounding ecosystem, according to Schwartz. "As they eat fruit, they walk around and pass the seeds through their digestive tract," he explains. "Thus, their droppings deposit seeds that are surrounded in natural fertilizer, helping to spread the diversity of plants in their region."

"With their excellent hearing, they will hear you coming long before you even know they are there, and they will most likely disappear into the forest to avoid you," says Schwartz. "However, should you ever come across one in the wild, it is best to give them plenty of room and not approach them or try to feed them."

In several species of animals, the male participates in incubation and care for the young after the eggs are laid, according to Schwartz. "The female returns to her solitary life, and does not participate in incubating the eggs or caring for the young," he says. "This may be a way to allow her to have several clutches of eggs in one breeding season with different males, thus diversifying her genetics into the next generation."

The most impressive, according to Schwartz? "A deep, low-frequency booming sound," he says. "It's the lowest known call of any bird, and it's so low that it borders on being inaudible to the human ear. If you are nearby when it does this call, you can feel the vibrations in your chest."

Per the International Union for Conservation of Nature (IUCN) Red List of Threatened Species (the world's most comprehensive inventory of the global conservation status of plant and animal species), all three species are listed as either Vulnerable or Near Threatened. "Like many species, their biggest challenges are the loss of habitat due human population growth; roads being built (causing car strikes); and human-introduced species of animals raiding nests," says Schwartz. "The good news is that the governments of the countries cassowaries call home are stepping up their conservation efforts."

There are less than 1,000 cassowaries left in the wild, according to Rainforest Rescue. Toward that end, the Australian-based group works to protect and restore the cassowary's habitat, as well as to create safe passage for these and other rainforest creatures via strategic buy-back of rainforest properties and regenerating damaged rainforest.

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The Cassowary Is the World's Most Dangerous Bird - HowStuffWorks

Leopard Slugs Mate In The Most Beautifully Bizarre Way, And Nobody Knows Why – Gizmodo Australia

Under the cover of night, two large leopard slugs begin to court, circling each other, before climbing single-file up a tree or onto a rock. They lower themselves on a mucus rope, while entwining their bodies in a strictly anti-clockwise fashion.

Both slugs then push out and entwine two overly-sized penises from openings on the side of their head, before exchanging sperm that may later fertilise each of their eggs. Or, perhaps be eaten. Eventually, one slug crawls off and the other follows, eating the mucus trapeze as it goes.

The astonishing sex lives of leopard slugs, or Limax maximus, have long been recognised by naturalists and frequently feature in wildlife documentaries. But while their carnal dance has mesmerised millions, nobody knows why they mate in this most bizarre way.

This is because slug sex science has rarely attracted anything other than observational study. Fortunately for our curiosity, there are a few noble individuals who have taken time to understand the mating habits of snails and slugs, and whose research can give us some valuable clues.

Its well known that leopard slugs, like the majority of land-based snails and slugs, are hermaphrodites meaning that both sexual organs are contained in the same individual. Yet, self-fertilisation is generally not the preferred option. This is likely because natural selection favours mating with another individual to avoid the loss of health, fertility and fitness associated with inbreeding.

Even though they can choose whether to mate as male or female, most slugs and snails mate as male and female at the same time. They can also store sperm for months and even years, and so dont always need to receive sperm if they have previously mated with a better partner. They can have the best of both worlds by choosing to eat and digest most of the sperm, while retaining just enough to fertilise their eggs.

We also know why leopard slugs turn anti-clockwise when mating. Just like human hearts are nearly always to the left hand side in our bodies, a slugs body is also asymmetric. This is most obvious during mating, when the genitals emerge from the right side of the head. This asymmetry makes leopard slugs turn anti-clockwise in synchrony during courting and mating and is also what made rare left-coiling snail Jeremy a media sensation in his/her search for love.

The rest of their elaborate mating behaviour is less well understood. It might be that that communication and cooperation are important aspects of sexual behaviour in the mollusc world, beginning with the head-to-tail trail-following. The long mucus trapeze could be an example of sexual evolution going into overdrive to signify commitment to whats to come, making sure that any mating efforts wont be wasted. The spiral entwinement between mating slugs may also facilitate close physical contact and commitment, minimising the risk of sudden withdrawal.

But this behaviour is also more sinister than it first appears. Some slugs and snails engage in hormone warfare or sexual conflict to increase their chances of fertilising their mate. For example, as artistically interpreted by Isabella Rossellini, many snails (including the common garden variety) stab each with love-darts, transferring hormones to improve the chances that sperm are used for fertilisation. The field slug Deroceras, seen below, flicks and strokes its partner with what looks like a sticky slug blanket for the same reason.

The leopard slugs beautiful entwinement could be another manifestation of this sexual coercion, maximising surface area for hormone transfer. The long penises which can be 60 to 90cm long in one Italian version of the leopard slug may also be another extreme result of an evolutionary arms race to improve the prospects of fertilisation.

Why they intertwine so intricately is another matter. It could be that the beautiful complexity makes it more difficult for one slug to cheat by giving sperm and then not receiving some in return.

In the absence of direct study, the above explanations can only be considered speculation. The truth is that science doesnt yet have a firm handle on the fascinating sex rituals of leopard slugs.

Scientists are not just being voyeuristic when we say wed like to unravel the mysteries of slug sex. Aside from just understanding the wonder and beauty of the behaviour, there are potential benefits.

Some species of slugs are farm and garden pests, eating holes in leaves, stems, flowers, tubers and bulbs and causing particular damage to new growth. With the pending ban of key pesticides for agricultural use in some countries, including the active ingredient in slug pellets, there is growing pressure to find other ways to control their spread. One way could be to identify otherwise harmless chemicals that interfere with their sex lives. A contraceptive sheath for slugs, so to speak.

Another approach could be to question why some of the slugs that cause the most agricultural nuisance forgo sex completely, especially in northern latitudes. Lack of sex reduces genetic variation, which causes crops such as potatoes and bananas to suffer from disease outbreaks. Studying the self-contained reproductive habits of slugs may reveal a similar vulnerability that could be exploited to control their numbers.

There may of course also be benefits which we cant anticipate. So just as people champion trees, bees and butterflies, we need more slug enthusiasts of all kinds to help unravel their mucosal mysteries, including backyard explorers who can contribute to citizen science studies.

Of course, if you are already a convert, then how about a leopard slug sex ornament for the Christmas tree?

Angus Davison, Associate Professor and Reader in Evolutionary Genetics, University of Nottingham

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting – BioSpace

Over the past six months, we have been able to deliver on our promise of bringing important new medicines to certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer through two U.S. FDA approvals, said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. We look forward to sharing data in the ASCO virtual scientific program that reinforce our ability to rapidly advance novel targeted agents across multiple tumor types.

An Expanding Portfolio of Marketed Therapies

Key data presentations will showcase progress for certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer as well as for patients with classical Hodgkin lymphoma (HL). Highlights include:

TUKYSA Update in Patients with Brain Metastases

Results for TUKYSA in combination with trastuzumab and capecitabine in patients with brain metastases from the HER2CLIMB pivotal trial of previously treated patients with HER2-positive metastatic breast cancer will be featured in an oral session (Abstract #1005). Data will be presented from these exploratory analyses on findings from the TUKYSA arm of the study on reduction in the risk of death (OS), reduction in the risk of intracranial progression or death (CNS-PFS) and improvement of the intracranial confirmed objective response rate (ORR-IC) compared to trastuzumab and capecitabine. Data will be presented by Nancy U. Lin, Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Womens Cancers at Dana-Farber in Boston, MA, during an oral presentation available on demand at 8:00 a.m. ET on May 29, 2020. A separate analysis of adverse events (AE) from the same trial will be presented (Abstract #1043; poster presentation).

PADCEV (enfortumab vedotin-ejfv) in Combination and in Other Solid Tumors

Additional results and durability data from the phase 1b EV-103 trial of PADCEV plus pembrolizumab in first-line metastatic urothelial cancer will be presented (Abstract #5044), and a separate Trials-in-Progress poster will provide details about a new randomized cohort added to the EV-103 study, Cohort K, which is evaluating PADCEV as monotherapy or in combination with pembrolizumab (#TPS5092). Both presentations will be featured in the Genitourinary CancerKidney and Bladder session. Data from the Cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States.

Additionally, information about the phase 2 EV-202 trial, which is studying PADCEV in six different types of locally advanced and metastatic solid tumors (HR-positive/HER2-negative and triple-negative breast cancers, squamous and non-squamous non-small cell lung cancers, head and neck cancer and gastroesophageal cancers), will be discussed in a Trials-in-Progress poster during the Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology Poster Session (Abstracts #TPS3647).

ADCETRIS (brentuximab vedotin) Continues to Advance

Data to be presented on ADCETRIS will demonstrate the companys progress in efforts to continue expanding clinical research on combination regimens and monotherapy in a variety of HL and peripheral T-cell lymphoma (PTCL) patient populations, including in both older and younger disease settings. A poster presentation will highlight the potential of ADCETRIS in combination with nivolumab or dacarbazine and as a monotherapy for previously untreated older HL patients who typically have poorer outcomes than younger patients due to comorbidities and toxicities related to standard first-line chemotherapy (Abstract #8032). The primary analysis from an ongoing clinical trial evaluating ADCETRIS plus nivolumab in children, adolescents and young adults with standard-risk relapsed or refractory classical HL will also be presented (Abstract #8013; poster discussion). Lastly, two Trials-in-Progress poster presentations will highlight ongoing clinical trials evaluating ADCETRIS as a monotherapy in frontline older HL or CD30-expressing PTCL patients and in a combination regimen in frontline advanced-stage HL patients (Abstracts #TPS8069 and #TPS8068).

A Strong, Diverse Pipeline of Investigational Therapies

An additional four Trials-in-Progress posters for investigational therapies will showcase the companys continued clinical development of pipeline candidates in first-line cervical cancer (Abstract #TPS6095), metastatic breast cancer (Abstract #TPS1104), metastatic pancreatic ductal adenocarcinoma (PDAC) (Abstract #TPS4671) and other solid tumors (Abstract #TPS3652).

The abstracts published in advance of the ASCO meeting were made available today on the ASCO website. All data presentations will be available on-demand on May 29, 2020.

Details of Key Seattle Genetics Presentations at ASCO20 Virtual:

Abstract Title

Abstract #

Presentation Type

Presenter

ADCETRIS (brentuximab vedotin)

Nivolumab and brentuximab vedotin (BV)-based, responseadapted treatment in children, adolescents, and young adults (CAYA) with standard-risk relapsed/refractory classical Hodgkin lymphoma (R/R cHL): Primary analysis

8013

Poster discussion

P. Cole

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

8032

Poster presentation

C. Yasenchak

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma

5044

Poster presentation

J. Rosenberg

TUKYSA (tucatinib)

Tucatinib vs Placebo Added to Trastuzumab and Capecitabine for Patients with Previously Treated HER2+ Metastatic Breast Cancer with Brain Metastases (HER2CLIMB)

1005

Oral presentation

N. Lin

Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB)

1043

Poster presentation

A. Okines

Trials-in-Progress

ADCETRIS (brentuximab vedotin)

Frontline brentuximab vedotin in Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma for older patients and those with comorbidities

TPS8069

Poster presentation

C. Yasenchak

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma

TPS8068

Poster presentation

J. Friedman

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab for locally advanced or metastatic urothelial carcinoma

TPS5092

Poster presentation

N. Mar

EV-202: A Phase 2 Study of Enfortumab Vedotin in Patients With Select Previously Treated Locally Advanced or Metastatic Solid Tumors

TPS3647

Poster presentation

J. Bruce

Investigational Therapies

Phase 1b/2 trial of tisotumab vedotin (TV) bevacizumab (BEV), pembrolizumab (PEM), or carboplatin (CBP) in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024)

TPS6095

Poster presentation

I. Vergote

SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer

TPS1104

Poster presentation

H. Beckwith

SGN228-001: A phase 1 open-label dose escalation and expansion study of SGN-CD228A in select advanced solid tumors

TPS3652

Poster presentation

A. Patnik

Phase 1 study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC)

TPS4671

Poster presentation

A. Coveler

About ADCETRIS (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. Seattle Genetics and Takeda are jointly developing ADCETRIS.

About PADCEV (enfortumab vedotin-ejfv)

PADCEV is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). PADCEV is co-developed by Seattle Genetics and Astellas.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Most Common (20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

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Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting - BioSpace

Rates of Testicular Cancer are Rising Among Racial/Ethnic Minorities – Cancer Health Treatment News

Between 2001 and 2016 in the United States, Asian/Pacific Islander men experienced the greatest increase in the incidence of testicular germ cell tumors (TGCT), followed by Hispanics and American Indians/Alaska Natives, according to a study published inCancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

TGCT is the predominant form oftesticular cancer, which is the most frequently occurring cancer among men between the ages of 15 and 44 years in the U.S. The incidence of TGCT has been increasing since the mid-20thcentury, but the underlying reasons for the increase remain unclear. While risk factors are not well understood, TGCT is known to be associated with other male reproductive disorders. As such, increases in incidence can be indicative of problems in male reproductive health, explainedArmen Ghazarian, PhD, MPH, first author on the study and a program director in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI) at the National Institutes of Health.

TGCT is most common among men of Northern European ancestry; however, a previousstudyfrom Ghazarian and colleagues revealed that rates increased among Hispanic men between 1998 and 2011. We have long known of the risk among men of Northern European ancestry, but the results of our previous study highlighted that rates were increasing among other racial/ethnic groups as well, said Ghazarian. The latest study builds on this work.

We expanded our analysis to include data from across the U.S., notedKatherine McGlynn, PhD, MPH, senior author on the study and a senior investigator in the Division of Cancer Epidemiology and Genetics at NCI. The goal was to determine if similar trends persisted in the more recent data. Monitoring trends is critical to building a better understanding of potential risk factors.

In this study, Ghazarian and McGlynn examined TGCT incidence data from the United States Cancer Statistics public use databases. The analysis included data on TGCT cases reported between 2001 and 2016 from registries in all 50 states and the District of Columbia.

The authors found that the incidence of TGCT was highest among non-Hispanic white men, followed by Hispanics, American Indians/Alaska Natives, Asians/Pacific Islanders, and non-Hispanic Black men.

While theincidence of TGCT increased across all racial/ethnic groups duringthis period, the authors found that Asian/Pacific Islander men experienced the greatest increase, with anannual percent change(APC) of 2.47, meaning that the incidence increased by 2.47 percent each year. All other racial/ethnic groups experienced annual rate increases as well: Hispanics APC = 2.10, American Indians/Alaska Natives APC = 1.71, non-Hispanic blacks APC = 1.28, and non-Hispanic whites APC = 0.41.

The authors also examined differences in TGCT incidence by geographic region as defined by the U.S. Census Bureau. They found that Asian/Pacific Islander, Hispanic, and American Indian/American Native men had the highest incidence of TGCT in the West, while non-Hispanic Black and non-Hispanic white men had the highest incidence in the Northeast.

While significant increases in incidence among Hispanic men were observed in all geographic regions, significant increases in incidence were observed for Asian/Pacific Islander men in the West, non-Hispanic Black men in the South, and non-Hispanic white men in the Northeast and Midwest. However, Ghazarian cautioned that these results may partially reflect the distribution of different racial/ethnic groups across the country.

A previousstudyexamining global trends did not find similar increases in TGCT incidence in Asian countries. Given the differences in trends, it would be interesting to examine U.S. trends using data on the birthplace of Asian/Pacific Islander men, as there could be an interplay between genetic and environmental risk factors, noted McGlynn. In her ongoing work, she aims to understand the contribution of environmental exposures, such as endocrine-disrupting chemicals, on TGCT risk.

I hope the results from this study will increase awareness of TGCT among men of all racial/ethnic groups, said McGlynn. While incidence remains highest among non-Hispanic white men, it is becoming increasingly clear that this disease does not just affect men of European ancestry.

A limitation of the study was that all Asian/Pacific Islanders were examined as a single group rather than by individual ancestry. This was also the case for Hispanic men. These groupings prevented the examination of whether risk was specific to men of certain ancestries. Another limitation was the lack of data regarding birthplace; incidence trends could be different for men who emigrated to the U.S. compared to men of the same racial/ethnic group who were born in the U.S.

The study was supported by the National Cancer Institute. Ghazarian and McGlynn declare no conflicts of interest.

This announcement was originally published on May 8, 2020, by the American Association for Cancer Research. It is republished with permission.

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Rates of Testicular Cancer are Rising Among Racial/Ethnic Minorities - Cancer Health Treatment News

Asian Men Grapple With What it Means to be Bald as Hairlines are Receding Faster than Ever – News18

Despite his father having an "m-shaped" hairline, Alex Han from northeast China never thought he'd experience hair loss in his 20s.

While studies have suggested almost all Caucasian men will eventually face some degree of male pattern baldness -- and around half can expect to lose their hair by middle age -- Asian men, and East Asians in particular, have historically experienced the lowest incidence of hair loss in the world.

A 2010 study from six Chinese cities found that fewer than 3% of men aged 18-29, and just over 13% of those in their 30s, experienced male pattern baldness. Earlier research from South Korea suggested that only 14.1% of the entire male population was affected, while Japanese men were found to develop male pattern baldness approximately a decade later than their European counterparts.

But as Han, now 34, later discovered, genetics isn't everything. Stress, poor diet, lack of sleep and smoking can all contribute to hair loss. And with lifestyles in China changing dramatically in recent decades, so too are the country's hairlines.

"I was prepping my masters entrance examinations and there was a lot of pressure, so I probably didn't sleep very well," Han said in a phone interview. "At that time, (my receding hairline) was under control, but after three years in Beijing getting my masters, I moved to Germany for PHD study ... and not only me, but other Asian students there, had a problem with hair loss."

It's an issue faced by many in Han's generation, and younger. A 50,000-person survey by the China Association of Health Promotion and Education reportedly found that the country's 30-somethings were going bald faster than any other group. Almost a third of respondents who were born in or after 1990 reported thinning hair, according to Chinese state media. A similar poll by Beijing's prestigious Tsinghua University reportedly found that an astonishing 60% of students had experienced some degree of hair loss.

Chinese state broadcaster CGTN went so far as to describe hair loss among the young as an "epidemic." But lifestyle changes have been accompanied by transformations in both technology and disposable income. Hair transplants are a viable solution for a growing number of men, and the Chinese market for the procedure is expected to hit 20.8 billion yuan ($2.9 billion) in 2020, more than four times what it was four years ago, according to market research firm Statistica.

Han opted to travel to Thailand for the transplant, which sees thousands of hair follicles grafted from other parts of the body -- such as the chest, or back of the neck -- onto the head. The eight- to 10-hour procedure cost him around $9,000, though he found clinics in China quoting "a sixth of that." The transplant may take months to take effect, though Han expressed hope that he will "see the results and see my hair return to normal in the next two or three months," adding, "then I'll behave as if nothing has happened."

Navigating Stigmas

Han's fears mirror those experienced by men with receding hairlines around the world, namely the impact on his confidence, professional prospects and first impressions. "Hairstyles, for me, are critically important for men's first impressions," he said.

But losing your hair may be especially difficult in countries where it's less common. The male beauty standards in East Asian popular culture -- from Korean K-pop to Hong Kong's movie industry -- often favor big hair and boyish looks. "In Asian cultures the younger generation really like idols like (Chinese pop band) TFBoys," Han said, adding that standards for white or black men are often different.

For 37-year-old David Ko, a Seoul-based reporter who has previously written about his experience of hair loss, the lack of visibility of hairless men in South Korea "certainly plays a role in people feeling uncomfortable about going bald."

"Whenever there is a precedent, people tend to feel (more confident) to follow," he said in an email interview.

A Korean study in the International Journal of Dermatology found that balding men were considered older and less attractive by 90% of non-bald respondents. In 2018, National Human Rights Commission of Korea had to urge employers not to discriminate against hairless men, after a building management company was accused of asking a job applicant to wear a wig during his interview and rejecting him on account of his bald head, according to the Yonhap News Agency. (The unnamed company denied doing so).

Chinese American entrepreneur Saul Trejo, who has lived in various cities around Asia since 2011, began losing his hair while studying in Beijing. The 30-year-old said he "definitely noticed" the lower proportion of bald men in the city, compared to the US, and "it probably bothered me, but I tried to not let it." He also found that people were more comfortable than those in the West to pass comment -- even if in an entirely observational way.

"People will tell you straight out," he said in a phone interview from Taipei, recounting instances when his loss of hair was casually pointed out to him. "Normally when they're saying it they're not trying to be mean, they're just commenting, so I can't be mad. But you remember.

"I tried to shave my head, but I didn't think it was suitable for my head and body shape," he added, naming Dwayne "The Rock" Johnson and actor Jason Statham as non-Asians who can pull off the look. "I think Asian people, including myself, tend to be a little slimmer, so if I had to choose between bald and slim versus bald and athletic, or even muscular, then I think it looks better with the more size you have."

In 2018, Trejo underwent a hair transplant in Bangkok, where he was based at the time. While it took almost a year to see the final results, Trejo said his new hairline is "a major blessing," that "massively improved my dating life." Before-and-after images shared with CNN show a remarkable amount of hair restoration at the top and sides of his head.

The doctor behind Trejo's procedure, Damkerng Pathomvanich, is a leading researcher into hair loss. He said that the number of hair transplant clinics in Asia is "skyrocketing," and that business among Chinese patients at his clinic is "booming."

"We published data (in 2002) showing an alarming increase in male pattern baldness in Asians," he said over the phone, naming diet as a key driver for the change. "I had a lot of Caucasian patients saying to me, 'You Asians don't go bald,' but it's not true."

Alternative approaches

There are cheaper and less invasive treatments on the market. Chinese e-commerce giant Alibaba stocks thousands of restorative shampoos, serums and sprays, and has reported that more than 70% of customers buying anti-hair-loss products were born after 1980, according to the South China Morning Post (a newspaper owned by Alibaba).

Drugs like minoxidil and finasteride, available in the US since the 1980s and 1990s respectively, appear to be gaining traction in the region too. Sales of the former, which is commonly traded as Rogaine, are expected to grow 5% per year in Asia Pacific from 2018 to 2024, according to an industry report by Global Market Insights.

Then there are also purported natural remedies. In traditional Chinese medicine, for instance, various herbs and plant extracts have long been touted as solutions to hair loss, though their effectiveness remains a matter of debate (one of them, polygonum multiflorum, or tuber fleeceflower, can even induce hepatitis if over-consumed).

Why Women Feel Pressured to Shave

In Korea, meanwhile, houttuynia cordata -- also known as fish mint, or chameleon plant -- can be brewed into a black liquid that is applied to the scalp, according to the journalist, David Ko, who received some from his concerned mother-in-law.

"I used it like a shampoo whenever I washed my hair," he said. "After wetting my hair, I poured a handful of the plant-steeped water on my scalp, finger-massaged my scalp for about one minute, then rinsed it off with fresh water.

"But as time went by without seeing any clear sign of improvement, I got so tired of the remedy that I dumped more of (it) on my hair each time to finish the jar faster and get the practice over with." He then tried other suggested home remedies. "My wife also nudged me to sprinkle some sea salts over my scalp instead of the plant water, and one of my co-workers told me her balding father benefitted from eating lots of black sesame seeds as a snack."

A ground-breaking Japanese study, published last year, grew hair follicles from scratch using stem cells. They were then successfully transplanted onto the backs of mice, though any resulting therapies remain a long way from ever being approved for humans (and in many countries, stem cell treatments are either highly restricted or completely outlawed).

Other novel responses to hair loss are now available in Asia. Scalp micropigmentation, for instance, involves tattooing thousands of tiny dots on patients' heads to give the illusion of shaved hair. A South Korean study in the peer-reviewed International Journal of Dermatology described the process as "one of the most effective treatment methods" for hair loss, reporting an average satisfaction rate of 4.8 out of 5 among the 80 patients interviewed.

Like 'a Triad'

But, still, Asia poses unique challenges for receding men. Undergoing the scalp tattoo procedure requires patients to permanently sport a shaved-head look, which, as the Korean study suggested, may be "stereotyped in Asian cultures as (being like) a gangster or criminal." According to Ko, however, such labels are a thing of the past.

"Back in the day, when young males shaved their heads, seniors would mildly chide them with a totally unproven and absurd hypothesis," he said, suggesting that elders once saw a skinhead as a sign that someone was a rebel, or had "a problem with society."

"Nowadays (these attitudes) almost never exist, but it is still true people look at bald males with a certain awe."

Eric But of Synergy Model Management, which has offices in Hong Kong and Guangzhou, said that clients are still often looking for Asian models to be "cute (with) long hair -- that Korean drama, perfect boyfriend kind of look." But while he distinguishes between shaved and bald heads, the modeling agent said that the rise of street fashion is gradually normalizing the skinhead look in Asia.

"For our parents' generation, a skinhead in Asia is kind of like a gangster -- if you want to be a triad, or if you go to prison, you have to shave your head," he said over the phone. "But now, for people born in the '90s or later, they see having a skinhead as a streetwear trend. And streetwear is massive in Asia."

Even in the home of coiffed K-pop, visibility may be growing gradually. Ko cited restaurateur Hong Seok-cheon (below), rapper Gill and actor Kim Kwang-kyu as examples of a slowly-growing number of high-profile bald celebrities in South Korea.

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Asian Men Grapple With What it Means to be Bald as Hairlines are Receding Faster than Ever - News18

Hair loss treatment: Expert reveals what you should be taking to help stimulate hair – Express

Hair loss is not something usually for one to worry about, however, it can be upsetting for some. At times, hair loss can be only temporary and can be caused by an illness, genetics, stress, weight loss or an iron deficiency. In others, hair loss is a normal part of getting older but what can be done to help halt the process?Dr Earim Chaudryspoke exclusively toExpress.co.ukto discuss all thingshair-relatedand what are some of the best supplements one can take to help with hair loss.

Dr Chaudry said: Approximately 30percentof men by the age of 30 and 70percentby the age of 70 are affected by Male Pattern Baldness (MPB) but it can appear as early as teenage years, particularly if there is a strong family history of early baldness.

First, a little background on male pattern baldness and how it happens.

Androgen hormones communicate to hair follicles through specific androgen receptors located at the root of the hair follicle. Interestingly, these receptors are only present on hair follicles located at the front and crown of the scalp.

They are not present on the back and sides which is why these areas are not normally affected by the process of MPB.

Genetic factors determine how active these receptors are and therefore how sensitive the hair follicles are to the effect of androgens. The gene that codes for the androgen receptor (AR) has been confirmed to play a role in MPB.

The androgen receptor (AR) gene is located on the X chromosome, which in men is inherited from the mother.

This explains the common belief that MPB is inherited from the maternal side of the family. New research supports that there are far more genetic factors, which can come from one or both parents that contribute to the overall risk of MPB.

Equally, early-onset MPB has been independently linked to metabolic syndrome and other risk factors for heart disease.

When asked what happens during the hair loss process, Dr Chaudry replied: MPBis the most common form of hair loss, caused by your genetics primarily.

It accounts for 95percentof male hair loss and is treatable. In MPB hair follicles gradually shrink, your hair becomes thinner and sheds more quickly.

At the hair follicle, there is an enzyme called 5-alpha-reductase (5AR) which changes testosterone into DHT (a more potent hormone). Hair follicles susceptible to MPB are more sensitive to DHT, and it causes them to shrink.

The hair at the back of the head is more resistant to the effects of DHT and because of receding hairlines and the crown usually are the areas of MPB."

When it comes to the best supplements one can take to help with hair loss, Dr Chaudry recommends: Part of the B family, biotin is one of several vitamins that convert nutrients from food into energy.

It plays an important role in the healthiness of your hair, as well as your skin and nails, and is one of the only natural remedies for hair loss that is backed by science.

Biotin deficiency is extremely rare, so the chances are it will not be the root cause of your hair.

However, some studies have shown that taking biotin helps speed up and increase the rate of hair growth in certainindividuals."

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Hair loss treatment: Expert reveals what you should be taking to help stimulate hair - Express

Death penalty, chewing gum, a property in Jamaica: Lawuits run the gamut – HempToday

Back in autumn 2018, investors began piling into U.S.-based India Globalization Capital, Inc., (IGC) which had announced in September of that year the startup of a CBD beverage called Nitro G. The company had been touting a distribution deal with a partner in Malaysia that would make the business go. IGC eventually raised $30 million in a secondary offering on the New York Stock Exchange.

Due diligence: By October 29 of that year the NYSE had delisted IGCs common stock, flagging the company for promoting ventures the success of which is problematical after analysts pointed to a flaw in the companys plans. As a class action lawsuit filed against IGC in November 2018 described the strategic weakness: Plaintiffs alleged that the company failed to disclose to investors that cannabis was illegal and punishable by death in Malaysia.

Thats only one of the more colorful among pending federal class action lawsuits against cannabis enterprises in U.S. courts in which investors are crying over the money they lost blindly chasing risky stocks.

Meanwhile, as the hemp industry wobbles like any other toddler, everybody from independent farmers to big, loud public companies find themselves before the judge these days.

The claims such as those against IGC are standard fare in the public markets, particularly those companies traded as penny stocks. They generally fall into the made materially false and misleading statements category, with companies and their executives sued for allegedly lying about this or that, or forgetting to disclose some fundamental problem, causing stock prices to drop. Here are some other legal cases in the hemp and CBD sectors, most of which continue to wind their way through federal courts under U.S. securities laws:

Chewing gum conundrum: Plaintiffs allege U.S. CBD maker CV Sciences made misleading public statements about the status of a patent application for a CBD chewing gum. The patent was later rejected, hitting CVs share price. (Filed August 2018)

Some property in Jamaica: Investors allege Canada-based Aphria, Inc. paid C$193 million (US$137 million) for a bundle of assets in Jamaica, Argentina and Colombia that have virtually zero worth. Plaintiffs say the deals real purpose was to help executives siphon money from the company through a web of other deals. (Filed December 2018)

Pumpin it: Plaintiffs allege 22nd Century Group, which says it makes low-THC cannabis products, used an aggressive promotional campaign to push the companys stock price while failing to pursue U.S. Food & Drug Administration approval for any new products. The companys shares plummeted after 22nd Centurys CEO resigned amid rumors about the alleged price-pumping scheme. (Filed January 2019)

What licenses? A plaintiff group is seeking up to $4 million from cannabis producer Sundial Growers, Inc. of Canada through a lawsuit alleging the company misled them regarding the potential for CBD sales through its acquisition of Bridge Farm, a UK-based ag firm. The plaintiffs say Sundial claimed the British company held hemp farming and export licenses when in fact it did not. Sundial is also facing a number of suits in the marijuana space.

Puff puff-ery: Greenlane Holdings, Inc. has been targeted with a lawsuit for allegedly failing to disclose that the city of San Francisco was planning to ban e-cigarettes, after touting its relationship with JUUL, a San Francisco-based e-cigarette maker, causing a drop in Greenlanes share price. (Filed September 2019)

Ka-ching! Paragon Coin, Inc. of the U.S, which says it is incorporating blockchain technology into the cannabis industry, is alleged to have sold tokens that were not registered as securities. The lawsuit is yet unsettled, but SEC has in the meantime settled other charges against Paragon over its initial coin offerings, imposing a $250,000 fine and ordering investors compensated. (Filed January 2018)

How do you feel now?: Investors allege that Zynerba Pharmaceuticals, a CBD maker, mischaracterized the results of clinical trials of a transdermal CBD gel, Zygel, causing shares to suffer. Plaintiffs claim the company reported that the gel was well-tolerated among subjects who participated in the trial, while in truth nearly all patients in the trial reported mild to serious adverse effects, and eight patients discontinued the trial altogether. (Filed October 2019)

Authentic losses: Petitioners say Canadian cannabis giant Tilray violated federal securities laws by inflating the potential of a revenue sharing agreement signed with Authentic Brands Group (ABG) in March 2019. The plaintiffs say Q4 2019 results later showed charges of $112.1 million related to impairment of the ABG agreement. Tilray reported net 2019 losses of $321.2 million, or $3.20 per share. (Filed April 2020)

Gelatinous: Shareholders say Canopy Growth, also of Canada, misled them on the potential for a line of soft gels and oils, saying on a conference call that demand for the products was strong as late as November 2019. That eventually led to a restructuring charge of CA$32.7 million (US$23.2 million) due to poor sales, excessive returns and a bloated inventory. (Filed November 2019)

A marathon 5 years running: Hemp Inc. is the target of an ongoing federal case by the U.S. Securities & Exchange Commission (SEC) in which it is charged with violating securities laws. The original 2016 SEC complaint against the company and three executives charges them with committing a long-running fraud and running an illegal scheme to sell unregistered stock. A Nevada federal judge in April 2020 upheld sanctions against the three executives.

While public companies had their share of legal troubles, private enterprises also are finding themselves the subjects of claims by stakeholders as litigation in the cannabis, CBD and hemp sectors proliferates. The cases reflect the wide range of potential pitfalls at this formative stage of the industry:

Is that mold? Nevada-based Industrial Hemp Manufacturing LLC (a subsidiary of Hemp Inc. see above) sued American Hemp Seed Genetics LLC (AHSG), an Oregon company for $700,000 over a seed contract signed in April 2018, claiming that an initial shipment for which it paid $70,000 contained dead and moldy seeds, while others had a germination rate of only 24%. IHM was to sell $700,000 worth of American Hemp Seed Genetics seed under an arrangement between the two companies. AHSG in March 2020 lost an appeal to dismiss the lawsuit on jurisdictional grounds, so the case continues.

Up in smoke again: Oregonized Hemp Co. LLC and owner Justin Pitts filed a $2.5 million lawsuit against Josephine and Jackson counties in Oregon, alleging that police seized more than two tons of legal industrial hemp from his warehouse, then later destroyed the crop thinking it was marijuana. At least 5,000 pounds of plant material was seized from the greenhouse during the raid, which Pitts said was legal industrial hemp with THC concentrations at or below 0.3 percent. The lawsuit, filed in April 2020, charges civil rights and due process violations.

Pet supplies: CBD supplier Sage Fulfillment sued the pet product distributor Earth Animal Ventures in Connecticut for allegedly reneging on a purchase agreement, claiming revenue losses of $4.8 million in a total $5.95 million deal. In the suit, filed in April 2020, Sage claims Earth Animal failed to live up to its commitment to buy a minimum of 400,000 units of its CBD gel and applicator after purchasing only 75,000 units.

Facing down the Sheriff: Licensed California hemp grower Apothio LLC filed a federal lawsuit against Kern County Sheriff Donny Youngblood, California Department of Fish and Wildlife Director Charles Bonham, their agencies and other county and state officials over the destruction of nearly 500 acres of hemp plants the grower says are worth $1 billion, according to the lawsuit. The federal suit, filed in April, called authorities actions one the largest wholesale destruction of personal property by government entities in the history of the United States.

Troubles in Kentucky: Bankrupt hemp processor GenCanna faces a number of lawsuits after the Kentucky company collapsed late last year:

Integrity/Architecture, Lexington, Kentucky; general contractors Pinnacle Inc., Benton, Kentucky; and Crawford Sales, a door maker based in Evansville, Indiana, say GenCanna owes them a combined $50,000..

Lexington Certified Public Accounting firm Dean Dorton claims GenCanna owes it more than $500,000.

Agro firm Furnwood Farms is in arbitration with GenCanna after filing a lawsuit seeking $5 million last October due to losses resulting from the late delivery, and questionable quality, of cultivation seeds as well as changes in the wording of agreements made by GenCanna.

A group of construction and other contractors filed liens against property owned by the Industrial Authority of Mayfield-Graves County which is under lease to GenCanna. The contractors claim in their lawsuit, filed in October 2019, that GenCanna owes them $13 million related to a processing plant construction project in Mayfield, Kentucky.

Seed deal fails to sprout: Wisconsin hemp seed seller Legacy Hemp LLC is suing Canadian hemp firm Terramax after it tried to terminate a distribution deal for industrial hemp seed in the U.S., claiming Terramax is trying to move distribution rights to another hemp company. The conflict involves questions over which states Legacy was granted rights for distribution of Terramax X-59 hemp seeds. The suit was filed in March 2020.

Organizational matter: In another case in Kentucky, a group of farmers in April filed a $69 million class action lawsuit in U.S. federal courts, alleging Bluegrass Bio-Extracts, Owensboro, Kentucky, and owners Gerald Edds and Bruce Peters, committed fraud and violated the U.S. Racketeer Influenced Corrupt Organizations (RICO) Act by breaching a contract to buy their 2019 hemp crops.

Slanderous affair: American cannabis research firm New Frontier Data sued UK research group Prohibition Partners (PP Intelligence Ltd) and cannabis investor Andy Defrancesco in 2019 for assault libel and slander in a dispute involving rights to research and written analysis in a report on cannabis investments. The case is reported closed, but no details are publicly available.

Problem from the start: GX Farms of California sued H.E.M.P. Group of Colorado for $17 million in January 2020 over a batch of hemp seeds that failed to germinate as promised. GX said it paid $364,000 for 520,000 seeds in spring 2019. According to the suit, GX Farms paid another $25,000 to a broker who promised a germination rate of 99%. GX Farms alleges it lost $3.5 million to $17 million in potential income.

And one at the end: Oregon agri-company Jefferson State Farms has sued a cooperative for $11 million, claiming the group failed to harvest its crops as promised. Jefferson State alleges unlawful trade practices and breach of contract against Palex Enterprises, Hemp Warehouse and Great Horizons LLC, and four individuals. The farm company said it paid the co-op $136,000 as a down payment to schedule its hemp harvest, which never happened. Jefferson State claims $86,000 of that down payment has yet to be returned.

Plow it under: CBD maker Elemental Processing of Kentucky filed a $44 million lawsuit against HP Farms of Oregon, claiming HP sold it a batch of 6 million seeds that were mostly male, causing a massive crop failure in 2019 as farmers to whom Elemental distributed the seeds had to plow their hemp fields under. Elemental says it paid about $352,000 in advance for the seeds and had agreed to pay $3.5 million more or 15% of its profits from the harvested flowers. (Filed September 2019).

Heavy metal: A group of plaintiffs are seeking class action against American Shaman LLC of Missouri, claiming CBD they purchased from the company contained lead and other contaminants. The complaint accuses American Shaman of falsely advertising its CBD products as being free of heavy metals and insecticides. (Filed May 2020)

SOURCES: Goodwin Procter, Law 360, Reuters, Bloomberg Law

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Death penalty, chewing gum, a property in Jamaica: Lawuits run the gamut - HempToday

The Motherland of Mammoths: Can the woolly beasts still be found alive in Siberia? – Russia Beyond

The majority of the worlds mammoth remains is discovered in Russia every year. Yet, some people prefer to believe that we dont even need them as evidence because these animals are still very much alive and well.

In one of the most remote parts of Russia, in the vast Siberian taiga, one can go a hundred miles without meeting a fellow traveler. Could these territories harbor living mammoths to this day?

Some people in Russia believe its possible. Some TV programs devoted to the unknown run investigations into this question, while locals continue to occasionally circulate stories of mammoth sightings. According to one rumor from the 1940s, military pilots flew over the dense taiga in Yakutia and spotted a small herd of animals, very similar to wooly mammoths. In 1978, a similar story happened to a group of people on the Indigirka river in Yakutia. They claimed that one early morning, they woke up to about a dozen mammoths, calmly drinking from the river.

Some Russians believe that mammoths can still be found living in dense Siberian taiga.

These accounts, however, are nothing more than urban legends, like the Yeti or the Loch Ness monster, thinks Nikita Zimov, Russian ecologist and director of the Pleistocene Park in Yakutia, a project that aims to revive the natural habitat of mammoths - the northern subarctic steppe grassland ecosystem, which existed here thousands of years ago. The ultimate dream is to see mammoths walk the Earth again. (So, it stands to reason that Zimov would gladly have supported a living mammoth theory, had he really thought it possible.)

This is complete nonsense. Mammoths in the mainland of Eurasia became extinct, or rather were wiped out (by people), 9,000 years ago. The last mammoths lived on Wrangel Island until 3,380 years ago, he argues. Plus, there is no such thing as unexplored Siberian taiga anymore - over the past 200-300 years, people traversed it many times over.

If one wants to find uniquely preserved mammoth fossils, Russia is the place to go!

Why is that? Well, the permafrost in the northernmost parts of Russia is uniquely suited to the task (as if a mammoth died just yesterday), and when it melts away, the erosion of river banks or other natural factors end up exposing these remains, first for locals, and then scientists, to see.

According to the Mammoth Museum in Yakutsk, 75 percent of the world's known mammoth and related graves with preserved soft tissue were found in Yakutia.

The presentation of a stuffed young mammoth male in St. Petersburg. The remains of a 15-year-old teenage mammoth were discovered in August 2012 at the mouth of the Yenisei River in Taimyr and are estimated to be about 30,000 years old.

Mammoths used to live in the area spanning from modern Spain to Canada [there was a natural bridge that connected Eurasia to North America back then]. Where it emerged as a species I cant say, but a major part of its habitat was on the territory of todays Russia - therefore, it wouldnt be an exaggeration to call Russia a sort of a motherland of mammoths, thinks Zimov.

Yet, according to him, the number of remains found in Russia isnt a telltale sign that it harbored the largest population on the planet. It only indicates that their remains have been much better preserved here thanks to permafrost. The density of the mammoth population could have been higher on the territory of modern Spain, for example, the expert believes.

The mummified remains of mammoth "Yuka" on display in Vladivostok. Yuka, the best preserved Siberian woolly mammoth to be found so far, was discovered in the permafrost of Ust-Yana Ulus in Russia's Yakutia in 2010.

The idea of bringing the beast back from the dead seems tempting, but it looks like Russian scientists are not too involved in this area of genetic research, despite so much frozen DNA being unearthed in the country.

According to Zimov, there are three main teams who are most preoccupied with this question right now - one headed by George Church from Harvard, and two from Japan and South Korea. They have all been researching the problem since the mid-90s.

75 percent of the world's known mammoth and related graves with preserved soft tissue were found in Yakutia.

Our scientists from the Mammoth Museum in Yakutsk are also participating in this research, but their work is mostly about finding the genetic material and transporting it to labs in Japan or Korea, Zimov explains, adding that Russian genetics as a science hasnt been developing as fast as it has in other countries.

He notes that there is much more talk in the media about mammoth cloning than there is evidence to its potential effectiveness. Id personally be very happy if we saw mammoths in our Pleistocene Park. But for now, this is more like waiting for a miracle, he concludes.

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