Archive for October, 2019
Everything You Need To Know About Male Breast Cancer In Black Men – BET
This October, focus and awareness are being placed on a health crisis that affects one in every eight women in the United States.
Breast cancer is the second most common cause of death among women in the U.S. For Black women, its even more severe. With a 31% mortality rate, Black women have the highest risk out of all races in the country.
Its not hard to see why talking about breast cancer, telling stories of survival and learning about how it's treated can be life-saving for women. However, women are not the only ones whose lives are turned upside down by breast cancer.
Earlier this month, music executive Matthew Knowlesrevealed he was diagnosed with breast cancer this past July, which he immediately had a mastectomy to treat. Knowles told Michael Strahan in an exclusive interview with Good Morning Americathat he has the BRCA2 mutation gene, which triggers breast, prostate and pancreatic cancer as well as melanoma.
The rest of my life, I have to be very much aware and conscious and do all of the early detection - constant mammograms, constant prostate exams, constant MRIs, for the rest of my life, he said, impassioned by his new awareness and outlook.
Beyonce and Solanges father isnt the first Black male celebrity to be diagnosed with breast cancer: '90s talk show hostMontell Williamsand legendary actor Richard Roundtree were also diagnosed with breast cancer and had mastectomies as a result.
Breast cancer is widely known as a womens disease but still affects over 2,600 men a year, killing around 500 annually, according to data reported by the American Cancer Society. The data also states that much like Black women, Black men are at a higher risk than white men.
American Cancer Society researchers found that young Black men are 76% more likely to die from breast cancer than white men, again, generally because screenings are overlooked.
Once again, being Black at the doctors office proves to be a dangerous game. With our historically damaged trust of the medical community and gaping disparities for preventable and treatable diseases, Black men have to be as diligently aware of their health status as Black women, even for a disease that seems unlikely.
Along with Black men, and men in general, another often-overlooked affected demographic istransgender women. As more transgender women opt to forgo surgery and instead take gender-confirming hormone therapies, their chance of breast cancer increases as well. Based on a case study of 2,260 transgender women, the rate of breast cancer compared to cisgender men was almost 50% higher.
Not only does breast cancer generally fall below the radar of most men, but it also carries a stigma that could deter them. The pink ribbons and female-focused language could be a barrier when it comes to bringing these difficult topics up. Pulling more men into the conversation is another step in the right direction for our entire community.
Despite the rarity in occurrence, breast cancer should absolutely be added to the list of illnesses that Black men remain diligently aware of, not just for their own health but for the health of the children they have or may one day have.
In his public plea for awareness, Matthew Knowles also said his diagnosis prompted his family members to be screened for the BRCA2 gene mutation that caused his breast cancer.
This is genetics, it also means that my kids have a higher chance, a higher risk. Even my grandkids have a higher risk, Matthew told Strahan during his interview, And they handled it like they should, they went and got the test.
According to the Mayo Clinic, genetic testing can be done to screen for the three leading gene mutations that cause breast cancer, BRCA1, BRCA2 and PALB2.
These tests are covered by most insurance companies and even several state Medicaid programs. But the catch is men have to ask the right questions.
Even young Black men should ask their family members about medical history and check with their doctor about risk factors and whether they need to be screened for gene mutations.
Knowing that our symptoms and pain are often overlooked by color-blind doctors, our first line of defense in surviving breast cancer -- no matter what gender, no matter what age -- is to ask questions and stay informed.
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Everything You Need To Know About Male Breast Cancer In Black Men - BET
There are more male than female specimens in natural history collections – The Natural History Museum
The specimens held in natural history collections around the world represent the wealth, beauty and diversity of our planet. But rather than being an objective picture of life on Earth, these collections have long been the result of curatorial bias.
An example of this bias is that there is often an overrepresentation of mammals and birds in collections, despite the far more numerous and diverse invertebrates and plants. What's more, even within these groups there are certain biases in how they were collected.
By looking at the bird and mammal specimens held by five major natural history collections, including those at the Natural History Museum, researchers have been delving into whether there is an underlying sex bias - in others words, whether there were more male specimens in the collections than female ones.
Natural history galleries are often filled with male specimens that have big, showy characteristics The Trustees of the Natural History Museum, London
Dr Natalie Cooper, a researcher at the Museum, led the study which has been published in the journal Proceedings of the Royal Society B.
'We looked at over two million specimen records from the American Museum of Natural History, the Field Museum, Musum National d'Histoire Naturelle, the Smithsonian and the Natural History Museum London,' says Natalie.
'From that we found - perhaps unsurprisingly - that there was a bias towards male specimens. It is worse in birds than in mammals, with only about 40% of bird specimens being females, but around 48% female in mammals.'
Groups which show a particularly pronounced bias towards males are those which the males have ornamentations such as the birds of paradise, hummingbirds, carnivores andartiodactyls, like deer, antelope and cattle.
The disparity between the number of male and female specimens in the collections is not wholly unsurprising - it is often the males that have big, showy characteristics - but it might be expected that more recent scientific collections would try and redress this balance. The data, however, shows that this has not been the case.
This means that, for studies which have used natural history collections in everything - for example, biogeography, morphology, taxonomy, genetics and even parasitology - there is likely to be an underlying male bias in the data.
Females are often under represented in groups such as antelopes The Trustees of the Natural History Museum, London
Showing that there is a skew in natural history collections is one thing, but figuring out where it comes from is just as important.
'We were then interested in trying to work out why there is this bias, because obviously curators don't just throw away the female specimens,' explains Natalie. 'It must be something to do with how they were collected.
'That could be either passive, so something to do with how male and female animals behave in the field, or it could be active whereby collectors are deliberately choosing to target males.'
Male and female animals can and do behave differently in the wild. In some species, for example, males may range more widely and so could be more likely to fall into traps, or maybe their more conspicuous nature means that males are more likely to be spotted.
'It is really hard to collate data on the passive explanations,' says Natalie. 'Although from what we can tell there are not more males in most natural populations. In fact, even though many wild populations are female-skewed, we still find lots more males in the collections, so it does seem like there is some active choice going on.'
If uncorrected, then sex biases can lead to skews in data further down the line The Trustees of the Natural History Museum, London
The data showed that among mammals, collectors were more likely to select large individuals with some form or ornamentation or weaponry such as horns, antlers, mains or tusks. In birds, size was not as important as colouration, as it was the more brightly feathered individuals that were more likely to be collected.
Where you have birds in which the female is more colourful and bigger than the males, however, there are more females than males in the collections.
On the surface, a slight bias towards males in museum collections might not seem like much of an issue. But there are many aspects of a species' biology and behaviour that are affected by an animal's biological sex.
At a basic level, if a study is looking at the taxonomy of a species and there are significant differences between males and females in their morphology, any bias towards the males could result in it being difficult to identify females down to species levels, as females are underrepresented in collections.
These biases can go even deeper. For example, males can be more susceptible to parasites as testosterone inhibits the immune system. Where collections are sex-biased, research looking into infection and immunity within a species could be skewed.
In groups such as the birds of paradise, males frequently have more colourful, elobrate and conspicuous plumage The Trustees of the Natural History Museum, London
As research is advancing into more technical analyses, these biases can cause significant differences. Stable isotope ecology can use the chemicals found in tissue to figure out where an animal may have been living or migrating based on what they were eating during their lifetime. But some species may have sex-segregated diets, meaning that you cannot draw inferences about a species in general if the underlying data is overrepresented by one sex.
'You'd like to hope that visiting researchers would come to the Museum and are selecting specimens with a mind to getting an equal number of males and females,' says Natalie.
'But often when people are doing big studies, they might not even consider the sex. They are more interested in getting as many species represented as possible, or in some cases they might not have a choice due to a limited number of specimens for some species that are available in the first place.'
In the past, hunters often selected those animals with the biggest antlers and horns The Trustees of the Natural History Museum, London
In these situations, researchers simply need to be aware of the skews and build them into their analyses. This is something that is being seen more and more in science, from how crash test dummies have typically been based on the male body to how bulletproof jackets have been designed for men.
One of the most striking biases is seen when looking at type specimens. These are the individual specimens on which a species description is made, and so seen as a typical example of that particular species.
Of these, only 25% of bird and 39% of mammal type specimens were found to be female.
'This bias was found to be way more extreme,' says Natalie, 'but it is also funny because there is a way of fixing it and people don't seem to have bothered to take that option.
'You can have these things called paratypes, which are specimens collected at the same time as the type but will represent other parts of the species diversity. It would seem obvious to me to take an opposite-sex paratype, but people don't seem to be doing that.'
In groups such as hummingbirds, there is a higher porportion of males than females in collections The Trustees of the Natural History Museum, London
Natalie and her colleagues expected that there would be significant sex biases in the early 1800s as trophy hunters went out and selected the biggest and fiercest males, but the team assumed that it would get better over time. It didn't.
'It's exactly the same,' says Natalie. 'It's the most beautiful flat correlation that I've ever seen. It's glorious.'
Museums as whole, it turns out, are simply really bad at recording the sex of specimens in their collections. Of the two million that were looked at for this study almost half were unsexed, even in species where the sex is obvious. So one of the most basic things that could be done is to actually record the sex of an individual in the first place.
Continued here:
There are more male than female specimens in natural history collections - The Natural History Museum
The family tree for the tree of life and feral cats; In-The-News for Oct. 24 – Airdrie Today
In-The-News is a roundup of stories from The Canadian Press designed to kickstart your day. Here is what's onthe radar of our editorsfor themorning of Oct. 24.
What we are watching in Canada ...
The Alberta government is to table a budget today that will cut program spending by nearly three per cent.
But Premier Jason Kenney, in a TV addresslast night, reiterated that health and education funding will not bereduced and maintaining front-line services is a priority.
"This will be a challenging budget. It willnot be easy," said Kenney, adding the exact reduction figure is 2.8 per cent.
"These are necessary decisions. In fact, I would argue that they are long overdue. We must embrace transformative change to get a smarter government. That's not going to happen overnight."
The budget is the first one by Kenney's United Conservative government since it defeated the NDP in the spring election.
Kenneyhas promisedthe budget will be alandmark spending document that will balance the books in four years andreorient Alberta's economy long after that.
He has pledged to get it done bygetting more value for public money while reducing overall spendingand endinga recent run of multibillion-dollar deficits he says threaten to cripple future generations with unsustainable debt.
Also this ...
A judge in southwestern Nova Scotia is expected to deliver a decision today in the case against aformer police chief accused of sexually assaulting a 17-year-old girl.
John Collyer was the chief of police in Bridgewater, N.S.
He was placed on administrative leave from the Bridgewater Police Service in August 2016 after the province's Serious Incident Response Team confirmed it was investigating the alleged assault.
The 26-year veteran of the force was suspended in May 2017 after the independent police watchdog charged him with one count of sexual assault and two counts of sexual exploitation.
Thecomplainanttestified thatCollyer asked her an inappropriate question while the two were driving in May 2016before puttinghis hand between her legs and assaulting her.
Collyer has denied the accusations.
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ICYMI (In case you missed it) ...
Scientists have written the family tree for the tree of life.
Years of analysis, released in the journal Nature, has allowed researchersto pinpoint a billion years of evolutionary relationships between plants as different as cannabisand cucumbers, orchids and oaks.
"Everything isinterrelated,"says the University of Alberta's Gane Wong, one of the paper's dozens of co-authors.
Science has known for a long time that species with significant differences can be related through a common evolutionary ancestor. In plants, those relationships have been studied mostly through how they look or behave. Do they have trunks? Flowers? How do their seeds form?
Wong and his colleagues nearly 200 of them have been looking at how the links are expressed through genetics.
The team couldn't resolve everything. They couldn't find branches in the tree for about five per cent of species, either because there wasn't enough data or because it dated from so long ago it couldn't be read accurately.
But the work is already yielding concrete benefits. Proteins taken from an obscure algae species studied by the researchers were found to turn certain brain neurons on and off. Those proteins are now being used in clinical trials to treat blindness.
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What we are watching in the U.S. ...
Alberta's oilsands are at the centre of acourt battle in New York this week that legal experts say could affect future climate lawsuits in Canada.
"The evidence that's coming out through this case is absolutely relevant to other lawsuits," said Martin Olszynski, a University of Calgary professor who teaches environmental law.
New York'sattorney general is accusingExxon Mobil of misrepresenting the risks oilsands operations face as governments move to fight climate change.
Inthe case filed a year ago, the state claims Exxon told investors that it was evaluating projects based on a carbon price that was much higher than the oneused in calculations. That led investors to believe they faced a lower risk and alsoinflated evaluations of Exxon's oil reserves.
Exxonhas tried twice to block the case. The company's lawyer, calling the accusations bizarre and twisted,arguedTuesday that Exxon did nothing wrong.
Although the lawsuit deals with a wide array of the multinational's operations, the oilsands feature prominently as Exxon is a major player through its subsidiary Imperial Oil.
"In these parts of its business, Exxon often applied a much lower price per ton to a small percentage of its (greenhouse gas) emissions ... and held those lower costs flat far into the future," court documents say.
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What we are watching in the rest of the world ...
Authorities found 39 people dead in a truck in an industrial park in England and arrested the driver on suspicion of murder in one of Britain's worst human-smuggling tragedies.
Police were reconstructing the final journey of the victims as they tried to piece together where they were from and how they came to be in England.
"To put 39 people into a locked metal container shows a contempt for human life that is evil," said Jackie Doyle-Price, a member of Parliament who represents the area where the truck was found. "The best thing we can do in memory of those victims is to find the perpetrators and bring them to justice."
The truck and the trailer with the people inside apparently took separate circuitous journeys before ending up on the grounds of the Waterglade Industrial Park in Grays, 25 miles (40 kilometres) east of London on the River Thames.
British police said they believe the container went from the port of Zeebrugge in Belgium to Purfleet, England, where it arrived early Wednesday. Police believe the tractor travelled from Northern Ireland to Dublin, where it took a ferry to Holyhead in Wales before picking up the trailer at the dockside in England.
The truck's driver a 25-year-old man from Northern Ireland was arrested on suspicion of murder. He has not been charged and his name has not been released.
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On this day in1990
The RCMP announced it would allowIndigenousofficers to wear their hair in braids while in uniform.
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Weird and wild ...
ST. JOHN'S, N.L. Animallovers in Newfoundland and Labrador are seeking help for dozens of feral cats facing an uncertain futureas the humansinthe small town where they prowl prepare to relocate.
Residents of Little Bay Islands have voted to resettle the community, andthey have until the end of the year to move before services are withdrawn.
Little Bay Islands, off Newfoundland's northern coast,is one of manyruralcommunities in the province faced with a dwindling population. The 2016 census recorded just 71 people living in the town.
Asresidents grapple with theprospect ofleaving their homes behind, the question of what will happen to theferal felines remains.
Resident Carol Hull estimates there are between 35 and 40 "semi-feral" catsliving in the community.
Animal welfare groups in other parts of Newfoundland have become involved in the campaign to domesticate and find homes for some of the animals.
Hullis hoping for abump in funding for animal welfare groups willing to take them in.
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Your health ...
TORONTOAnew report from Young Adult Cancer Canada sheds light on such uniqueissues faced by the 22 young adult Canadians, ages 15-39, who are diagnosed with cancer each day.
The study surveyed 622 diagnosed young adults across Canada to explore the physical, social, financial, and emotional challenges they face as compared to their peers without cancer.
It found cancer in young adulthood can "disrupt an important period of development and identity formation, which tends to have a cascading impact on all areas of life."
Yet there arefew support programs geared tohelping these patients throughdiagnosis and recovery, the report says.
It also found one of the main issues facing young adults with cancer is financial strain. Treatment and recovery affect their ability to work, and not all treatment costs are covered by public health care in Canada.
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The games we play ...
When softball player and Olympic 2022 hopeful Natalie Wideman was handed a$6,000cheque and told the money came from women she did not know, she was speechless.
"I instantly broke down crying," says the 27-year-oldcatcherfrom Mississauga, Ont. "In our generation, there's so much stuff being put on women, comparing each other to each other and judging each other's choices.
"Women helping women is just really, really, special to me."
The money came from Canadian Athletes Now, or Canfund, via a campaign of professional women supporting female athletes.
The 150 Women campaign named for the minimum donation of $150 has cut $6,000 chequesto 109 female athletes in two years. Eight of them have won Olympic gold.
Donors range in age from 18 to 82 with $50,000 the highest single donation so far.
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This report by The Canadian Press was first published Oct. 24, 2019.
The Canadian Press
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The family tree for the tree of life and feral cats; In-The-News for Oct. 24 - Airdrie Today
Bloomington Vet Joins Study For Stem Cell Therapy To Treat Dogs With Arthritis – WGLT News
The Eastland Companion Animal Hospital in Bloomington is asking dog owners if they want to participate in research on using stem cells to treat dogs with arthritis.
Local dogs wouldjoin a double-blind, placebo-controlled studyto show the effectiveness of stem cells in treating large dogs(70 pounds or more) with arthritis in up to two joints of the knee, hip, elbow, or shoulder. The veterinary clinic has partnered with Animal Cell Therapies, who it's worked with before, to bring this study to Bloomington.
Dr. Kathy Petrucci, founder and CEO of Animal Cell Therapies, explained how dogs will receive the treatment.
The dogs that will receive the stem cells will be sedated, Petrucci said. Depending on what joints are affected, they will receive up to two injections in the joint and they will also receive an IV dose of stem cells.
The FDA oversees the cells that are received from donors for the study. Mothers donating these cells are screened for diseases, and cells are tested for any infections to ensure safety.
Stem cell therapy has been controversial, especially related to humans.
I think a lot of the controversy comes from the misunderstanding of the cell types, Petrucci said. The research in stem cells first started centered around embryonic or fetal tissue use. Its controversial to use embryos and fetal tissues for treatment for anything. The fact that we are using a disposable tissue as our cell sources makes it not controversial at all.
Why Umbilical-Derived Cells
Petrucci explained why umbilical-derived cells are more effective in treating arthritis versus other sources.
We looked at fat, bone marrow, embryonic cells, Petrucci said. The embryonic cells are a lot more unpredictable, and the bone marrow cells are more difficult to work with and less predictable. We didnt think the fat cells are as potent as umbilical-derived cells. Umbilical-derived cells are a lot younger and theyre a little bit more predictable. They are more easy to collect. We obtain cells from donors when the tissue would be normally thrown away. Theres no surgery required, no extra biopsies to obtain fat, no bone marrow from research animals. Its a good, ethical source of stem cells.
Umbilical-derived stem cells have proven successful in past studies on treatment for arthritis, according to Petrucci.
We did a study at the University of Florida on elbows only and we had success with that study, Petrucci said. We had good success with dogs under 70 pounds and (less) success with dogs over 70 pounds, so we changed our dose, which is why were testing dogs 70 pounds and over in this study.
Criteria for eligibility includes dogs weighing 70 pounds or more, being one year of age or older, in general good health, no neurologic issues, arthritis in up to two joints of the knee, hip, elbow, or shoulder, and have all four functioning limbs.
Owners must bring their dogs back to the clinic after 30 days to check for progress and complete a questionnaire. About 50 to 100 dogs are expected to participate in the study.
People like you value experienced, knowledgeable and award-winning journalism that covers meaningful stories in Bloomington-Normal. To support more stories and interviews like this one,please consider making a contribution.
Stem Cell Treatment - Excerpt
Stem Cell Research - Full Story
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Bloomington Vet Joins Study For Stem Cell Therapy To Treat Dogs With Arthritis - WGLT News
Ewing sarcoma: Causes, symptoms, and treatment – Medical News Today
Ewing sarcoma is a form of bone cancer that usually affects children and adolescents.
Ewing sarcoma can be very aggressive, but the cells tend to respond well to radiation therapy. Ideally, doctors will diagnose the cancer before it has spread.
According to the National Library of Medicine, an estimated 250 children in the United States receive a diagnosis of Ewing sarcoma each year.
In this article, learn more about Ewing sarcoma, including the symptoms, causes, and treatment options.
Ewing sarcoma is a rare type of cancer that usually starts in the bone typically in the pelvis, chest wall, or legs and occurs mostly in children and teenagers.
Dr. James Ewing first described Ewing sarcoma in 1921. He identified cancer cells that looked different than the cells in osteosarcoma, another type of bone tumor.
Doctors may also refer to this cancer type as the Ewing family of tumors. These tumors have distinct cells that usually respond well to radiation treatments.
This rare cancer type accounts for just 1.5% of all childhood cancers and is the second most common bone cancer type in childhood, after osteosarcoma.
Although researchers are unsure why some people develop Ewing sarcoma, they have identified mutations in certain genes in the tumor cells that cause this cancer.
These include the EWSR1 gene on chromosome 22 and the FLI1 gene on chromosome 11.
These genetic mutations occur spontaneously during a person's lifetime. The individual does not inherit them from a family member.
There are no known risk factors for Ewing sarcoma that make one person more likely than another to develop this cancer.
Ewing sarcoma can cause the following symptoms:
An estimated 87% of Ewing sarcomas are sarcoma of the bone. The other types form in the soft tissues, such as cartilage, that surround the bones.
Ewing sarcoma can spread to other areas of the body. Doctors call this process metastasis.
Areas that the cancer can spread to include other bones, bone marrow, and the lungs.
Doctors categorize Ewing sarcoma as one of three types according to its extent:
Before diagnosing Ewing sarcoma, a doctor will take a person's full medical history and ask them what symptoms they are having, when they noticed them, and what makes them better or worse. They will also perform a thorough physical exam, focusing on the area of concern.
A doctor will usually recommend an imaging study to view the bone or bones. These tests include:
If it looks as though a tumor may be present, a doctor will perform a biopsy, which involves taking a sample of bone tissue. They will send this tissue to a laboratory, where a specialist called a pathologist will check it for the presence of cancerous cells.
A doctor may also order blood tests, a bone marrow biopsy, and other scans when necessary. These tests can help determine whether the cancer has spread to other locations.
A doctor will work with a team of cancer specialists and surgeons to recommend and implement particular treatments.
Possible treatments for Ewing sarcoma include:
Doctors may use a combination of treatments depending on how far the cancer has spread and a person's overall health.
Research into new treatments for Ewing sarcoma is ongoing. Some doctors may inform their patients about clinical trials, which help test new treatments.
Possible complications of Ewing sarcoma include:
If Ewing sarcoma has spread to other areas of the body, it can be life threatening. For this reason, it is vital for a doctor to evaluate any symptoms as quickly as possible.
According to the American Academy of Orthopaedic Surgeons, an estimated two-thirds of people in whom cancer has not spread to other areas of the body survive at least 5 years after their diagnosis.
People who are more likely to have positive outcomes include those who have:
The likelihood of successful treatment is different for every individual, so people should speak to a doctor about their or their child's expected outlook.
Ewing sarcoma is a rare type of cancer that mostly affects young people.
When doctors detect it early enough, the condition usually responds well to treatment.
Anyone who notices signs or symptoms of Ewing sarcoma, such as a bone that breaks for no apparent reason or a painful lump or swelling, should speak to a doctor.
Excerpt from:
Ewing sarcoma: Causes, symptoms, and treatment - Medical News Today
BrainStorm Cell Therapeutics’ President and CEO to be Featured as Keynote Speaker at Cell Series UK 2019 – GlobeNewswire
NEW YORK, Oct. 24, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced, Chaim Lebovits, President and CEO, will serve as a Keynote Speaker at Cell Series UK.Cell Series UK, will be held October 29-30, 2019, at London Novotel West, London, UK. The Conference, organized by Oxford Global, is one of the foremost events in Europe focused on regenerative medicine and cellular innovation.
Ralph Kern MD, MHSc, Chief Operating and Chief Medical Officer of Brainstorm, who will also participate at Cell Series UK stated, We are very pleased to have Chaim Lebovits presenting at this prestigious conference where global leaders in stem cell and regenerative medicine will have the opportunity to learn more about NurOwn and the critical research being conducted by the Company. Mr. Lebovits Keynote Address, Stem Cell Therapeutic Approaches For ALS, will be presented to leading members of the scientific and business community including potential partners and investors.
About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.
AboutBrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.
Safe-Harbor Statements Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
CONTACTS
Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com
Media:Sean LeousWestwicke/ICR PR Phone: +1.646.677.1839sean.leous@icrinc.com
Orchard Therapeutics Presents Data from OTL-200 in Patients with Metachromatic Leukodystrophy Using Cryopreservation – BioSpace
BOSTON and LONDON, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced initial results from a clinical trial with a cryopreserved formulation of OTL-200, a gene therapy in development for the treatment of metachromatic leukodystrophy (MLD) at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy. The initial data show that cellular engraftment with OTL-200 using a cryopreserved formulation is similar to that observed using a fresh formulation with the longest patient having 12 months of follow-up since treatment. The data are being featured this week in a poster session at the European Society of Gene & Cell Therapy (ESGCT) Annual Congress in Barcelona, Spain.
MLD is a devastating and rapidly progressing disease with no standard treatment options. In its most severe forms, patients will not survive beyond their first decade of life.
These data compare the initial results of OTL-200 in the first four MLD patients treated using a cryopreserved formulation to a previously presented integrated analysis of 29 patients treated with a fresh formulation that demonstrated meaningful clinical outcomes. Hematopoietic stem cells are collected, purified and transduced in the same way for both formulations. For the cryopreserved formulation, following transduction, the gene-corrected cells are placed in a specific medium that allows them to be stably frozen. After successful testing and release, the cryopreserved cells are shipped to the site of care where they are thawed and administered to patients who have received conditioning.
Presenting the first supportive data on OTL-200 using a cryopreserved formulation represents a cross-functional effort involving our clinical, CMC and regulatory teams as we prepare for the upcoming European regulatory submission for MLD followed by a BLA in the U.S., said Mark Rothera, president and chief executive officer of Orchard. If approved, a cryopreserved formulation of OTL-200 would more readily facilitate global commercialization and patient access efforts, which are key elements in our mission to deliver potentially curative therapies to patients suffering from often-deadly rare diseases.
Mr. Rothera continued, With over 40 patients now treated using a cryopreserved formulation across our pipeline of six clinical-stage programs, we are confident our approach is supported by a robust set of evidence.
Study Results At the time of the analysis, four early-onset MLD patients (two late infantile and two early juvenile) have been treated with the cryopreserved formulation of OTL-200. All patients are alive and were followed for a minimum of one month, with the longest follow-up out to 12 months in the first patient treated (median follow-up of 0.38 years). The age at the time of treatment ranged from seven months to 42 months.
The initial results in patients receiving the cryopreserved formulation (n=4) demonstrated the following:
Figure 1. Profiles of VCN in bone marrow CD34+ cells: OTL-200 cryopreserved vs. OTL-200 fresh
https://www.globenewswire.com/NewsRoom/AttachmentNg/83f41457-927b-4b1b-9ac2-9d48ac10353a
Figure 2. ARSA activity profile in peripheral blood: OTL-200 cryopreserved vs. OTL-200 fresh
https://www.globenewswire.com/NewsRoom/AttachmentNg/393ca5f0-98ad-47f8-b723-35c5c6c08d8f
c = cryopreserved; f = fresh; Sbj. = subject
We are pleased that these initial data suggest that using gene-corrected cells that have been cryopreserved has a similar impact on clinical biomarkers for early-onset MLD patients as the OTL-200 fresh formulation, said Dr. Valeria Calbi, a hematologist at San Raffaele Scientific Institute and SR-Tiget and an investigator of the study. The four treated patients showed good levels of engraftment of gene-corrected cells and reconstitution of ARSA activity at multiple time points, as well as encouraging early trends in GMFM scores that we look forward to evaluating with additional follow-up. We believe that these data further support the positive benefit / risk profile of OTL-200 as a therapy with potential lifelong benefit for patients with MLD.
Next Steps for OTL-200 Orchard remains on track to submit a marketing authorization application, or MAA, in Europe for MLD in the first half of 2020, as well as a biologics licensing application, or BLA, in the U.S. approximately one year later.
About MLD and OTL-200Metachromatic leukodystrophy (MLD) is a rare and life-threatening inherited disease of the bodys metabolic system occurring in approximately one in every 100,000 live births. MLD is caused by a mutation in the arylsulfatase-A (ARSA) gene that results in the accumulation of sulfatides in the brain and other areas of the body, including the liver, the gallbladder, kidneys, and/or spleen. Over time, the nervous system is damaged and patients with MLD will experience neurological problems such as motor, behavioral and cognitive regression, severe spasticity and seizures, finding it more and more difficult to move, talk, swallow, eat and see. Currently, there are no effective treatments for MLD. In its late infantile form, mortality at 5 years from onset is estimated at 50% and 44% at 10 years for juvenile patients.1 OTL-200 is an ex vivo, autologous, hematopoietic stem cell-based gene therapy being studied for the treatment of MLD. OTL-200 was acquired from GSK in April 2018 and originated from a pioneering collaboration between GSK and the Hospital San Raffaele and Fondazione Telethon, acting through their joint San Raffaele-Telethon Institute for Gene Therapy in Milan, initiated in 2010.
About OrchardOrchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies.
Orchards portfolio of ex vivo, autologous, hematopoietic stem cell (HSC) based gene therapies includes Strimvelis, a gammaretroviral vector-based gene therapy and the first such treatment approved by the European Medicines Agency for severe combined immune deficiency due to adenosine deaminase deficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies are all based on lentiviral vector-based gene modification of autologous HSCs and include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD), transfusion-dependent beta-thalassemia (TDT) and mucopolysaccharidosis type I (MPS-I), as well as an extensive preclinical pipeline. Strimvelis, as well as the programs in MLD, WAS and TDT were acquired by Orchard from GSK in April 2018 and originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy initiated in 2010.
Orchard currently has offices in the U.K. and the U.S., including London, San Francisco and Boston.
Forward-Looking StatementsThis press release contains certain forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as anticipates, believes, expects, intends, projects, and future or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchards expectations regarding the timing of regulatory submissions for approval of its product candidates, including OTL-200 for the treatment of metachromatic leukodystrophy, the timing of interactions with regulators and regulatory submissions related to ongoing and new clinical trials for its product candidates, the timing of announcement of clinical data for its product candidates, including OTL-200, and the likelihood that such data will be positive and support further clinical development and regulatory approval of its product candidates, and the likelihood of approval of such product candidates by the applicable regulatory authorities. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, without limitation: the risk that any one or more of Orchards product candidates, including OTL-200, will not be successfully developed or commercialized, the risk of cessation or delay of any of Orchards ongoing or planned clinical trials, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates, the delay of any of Orchards regulatory submissions, the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates, the receipt of restricted marketing approvals, and the risk of delays in Orchards ability to commercialize its product candidates, if approved. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.
Other risks and uncertainties faced by Orchard include those identified under the heading Risk Factors in Orchards annual report on Form 20-F for the year ended December 31, 2018 as filed with the U.S. Securities and Exchange Commission (SEC) on March 22, 2019, as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
1Mahmood et al. Metachromatic Leukodystrophy: A Case of Triplets with the Late Infantile Variant and a Systematic Review of the Literature. Journal of Child Neurology 2010, DOI: http://doi.org/10.1177/0883073809341669
Contacts
InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com
MediaMolly CameronManager, Corporate Communications+1 978-339-3378media@orchard-tx.com
Figure 1
Profiles of VCN in bone marrow CD34+ cells: OTL-200 cryopreserved vs. OTL-200 fresh
Figure 2
ARSA activity profile in peripheral blood: OTL-200 cryopreserved vs. OTL-200 fresh; c = cryopreserved; f = fresh; Sbj. = subject
‘Hacking the Code of Life’: How gene editing will lead to disease cures and nutritionally enhanced food – Genetic Literacy Project
Across the US,more than 100,000 people are awaiting organ transplants. But there simply arent enough hearts, lungs, livers, and kidneys to meet demand, and 20 people die every day without the organs they need.For decades, scientists have dreamed of using animals to help fill the gap. Theyve been particularly interested in harvesting organs from pigs, whose physiology is similar to our own. Unfortunately, pigs also present some big biological challenges, including the fact that their genomes are chock full of genes that code for what are known as retroviruses, which could pose a serious threat to patients who receive porcine organs.
In 2015, George Church, a geneticist at Harvard University, announced a stunning breakthrough: Working with pig cells, he and his colleagues had managed to disable 62 copies of a retrovirus gene inone fell swoop.This would have been virtually impossible and a logistical nightmare with older forms of genetic modification, writes Nessa Carey in her new book, Hacking the Code of Life: How Gene Editing Will Rewrite Our Futures.But by using the new gene editing technology known as Crispr, the task was a relative cinch.
Its just one example of how gene editing is giving us the power to alter the genome with unprecedented speed and precision. Carey, a biologist with a background in the biotech and pharmaceutical industry, offersa brisk, accessible primer on the fast-moving field, a clear-eyed look at a technology that is already driving major scientific advances and raising complex ethical questions
Its giving every biologist in the world the tools to answer in a few months questions that some scientists have spent half their careers trying to address, Carey writes. Its fueling new ways to tackle problems in fields as diverse as agriculture and cancer treatments. Its a story that began with curiosity, accelerated with ambition, will make some individuals and institutions extraordinarily wealthy, and will touch all our lives.
Though there are several different approaches to gene editing, the most prominent and the one that really supercharged the field is Crispr. The technique, based on an anti-viral defense system thats naturally present in bacteria, requires two pieces of biological material: an enzyme that acts as a pair of minuscule scissors, slicing strands of DNA in two; and a guide molecule that tells the enzyme where to cut.
In bacteria, these guide molecules direct the enzyme to chop up the genomes of invading viruses, preventing them from replicating.
But in 2012 and 2013, two teams of scientists reported that it was possible to hack this system to slice into any strand of DNA, at any complementary location they chose.Researchers could, for instance, create a guide molecule that steered the enzyme to one specific gene in the mouse genome and insert the editing machinery into a mouse cell; the enzyme would then make its cut at that exact spot.
The cell would repair the severed DNA, but it would do so imperfectly, disabling the gene in question.In the years that followed, scientists refined the technique, learning to use it not only to inactivate genes but also to insert new genetic material at specific locations along the genome.
The approach is cheaper, easier, and faster than older methods of genetic engineering, which were first developed in the 1970s. In addition, as Carey explains, it can be used to create smaller modifications to the genome, and leaves fewer extraneous genetic elements. In its most technically exquisite form, gene editing leaves no molecular trace at all. It may just change, in a precisely controlled manner, one letter of the genetic alphabet.
The applications are almost endless.Gene editinghas immense potential for basic research; scientists can learn a lot about what genes do by selectively disabling them. In addition, researchers have used the technology to create a wide variety of organisms that could become valuable agricultural commodities, including mushrooms that dont brown; wheat that produces fewer gluten proteins;drought tolerant, high-yield rice and corn; disease-resistant pigs; and super muscular goats.
How these products will do on the market if they ever reach it remains uncertain.Globally, gene-edited organisms are regulated by a patchwork of conflicting rules. For instance,in 2018, the U.S. Department of Agricultureannouncedthat it would not regulate gene-edited crops that could otherwise have been developed through traditional breeding techniques. A few months later, however, the European Union said that it would subject gene-edited plants to stringent restrictions.
Beyond agriculture, gene editing has enormous potential for medicine. It might, for instance, become a much-needed treatmentfor sickle cell disease. That painful, debilitating disease results from a genetic mutation that causes patients to produce a deformed version of hemoglobin, a protein that helps red blood cells transport oxygen.Ina clinical trial currently underway, scientists are removing stem cells from the bone marrow ofsickle cell patients, using Crispr to edit them, and then infusing the edited cells back into patients.
Even if this trial succeeds, however, gene editing will not be a cure-all.It doesnt always work perfectly and can be challenging to administer directly to living humans (which is why some scientists are instead editing patients cells outside the body). Moreover, many diseases are caused by complex interactions between multiple genes, or genes and the environment. In fact, many of the most common and debilitating conditions arent likely to be good candidates for gene editing any time soon, Carey writes.
And, of course, the ethics of human gene editing can be enormously fraught. Thats especially true when scientists modify sperm cells, egg cells, or early embryos, making tweaks that could be passed down to subsequent generations.This kind of gene editing could theoretically cure some absolutely devastating genetic conditions, but we still have a lot to learn about its safety and effectiveness. It also raises a host of difficult questions about consent (an embryo obviously cannot give it), inequality (who will have access to the technology?), and discrimination(what will the ability to edit a gene related to deafness mean for deaf people, deaf culture, and the disability rights movement more broadly?).
Even in the face of these questions, at least one scientist has already forged ahead. In November 2018, He Jiankui, a researcher then at the Southern University of Science and Technology in China,shocked the worldby announcing that the worlds first gene-edited babies twin girls, who He called Nana and Lulu had already been born. Months earlier, when Nana and Lulu were just embryos, He had edited their CCR5 genes, which code for a protein that allows HIV to infect human cells. By disabling the gene, He hoped to engineer humans who would be protected from HIV infection.
The outcry was swift and harsh. Scientists alleged that Hes science was sloppyand unethical, putting two human beings at unnecessary risk.After all, there are already plenty of ways to prevent HIV transmission, and the CCR5 protein is known to have some benefits, including protecting against the flu.And He had raced ahead of the experts who were still trying to work out careful ethical guidelines for editing human embryos.He Jiankui has shot this measured approach to pieces with his announcement, and now the rest of the scientific community is on the back foot, trying to reassure the public and to create consensus rapidly, Carey writes.
Hacking the Code of Life doesnt break much new ground, and for readers who have been paying attention to Crispr over the past few years, little in the book will come as a surprise. But it does providea broad, even-handed overview of how much has already happened in a field that is less than 10 years old.
Carey swats down the most dystopian dreams about Crispr, like the prospect that criminals might edit their own DNA to evade justice. Shes similarly skeptical that well end up using the technology to create super-beings with enhanced genomes that will make them taller, faster, more attractive.
We actually understand very little about the genetic basis of these traits and what we do know suggests that it will be very difficult to enhance humans in this way, she writes.
But she also acknowledges real risks, including the possibility that the technique could be used to create dangerous bioweapons, that gene-edited organisms could destabilize natural ecosystems,and that our new, hardy crops could prompt us to convert even more of the Earths undeveloped places into farmland.
None of this means that the technology should be abandoned; it hasimmense potential to improve our lives, as the book makes clear.But it does mean we need to proceed with caution. As Carey writes, Ideally, ethics should not be dragged along in the wake of scientific advances; the two should progress together, informing one another.
Emily Anthes, who has written for Undark, The New York Times, The New Yorker, Wired, and Scientific American, among other publications, is the author of the forthcoming book The Great Indoors. Follow her on Twitter @EmilyAnthes
A version of this article was originally published on Undarks website as How Gene Editing Is Changing the World and has been republished here with permission.
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'Hacking the Code of Life': How gene editing will lead to disease cures and nutritionally enhanced food - Genetic Literacy Project
Trends in Cryonics Technology Market Reviewed with 2027 Opportunities in New Research Report – TheLoop21
New York City, NY: October 22, 2019 Published via (Wired Release) Essential Business Strategies Global Cryonics Technology Market provides extensive research and detailed analysis of the present market along with future outlook. The report content includes orientation technology, market, drivers, geographic trends, market statistics, market estimates, producers, and equipment suppliers of cryonics technology industry. It also profiles and analyzes the leading companies and several other prominent companies operating in the Cryonics Technology Market. It also analyzes the industry future trends, risks, and entry barriers, status, development rate, cryonics technology market factors, opportunities and challenges, sales channels, distributors. It helps you understand the technical jargon that offers ease and convenience to you in understanding the report contents. The study provides detailed information on the established Cryonics Technology market with a clear perceptive of global market players and emerging market associations through market research reports.
Complete Analysis of the report contains the current market scenario as well as a market forecast till 2029. The forecast is also supported by the elements affecting the market dynamics for the forecast period. Various applications, product types, geographical regions, and market value are focused in this wide report scope. The study includes all active constraints, restraints, openings, market challenges and also outlines the historical data, current and future momentum of the market. The market is a widening field for top candidates including-Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific, Custom Biogenic Systems, Oregon Cryonics, Alcor Life Extension Foundation, Osiris Cryonics, Sigma-Aldrich, Southern Cryonics.
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Segment 8 Manufacturers Profiles
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CRISPR Therapeutics and Bayer Announce an Update on Casebia Therapeutics – PRNewswire
LEVERKUSEN, Germany and ZUG, Switzerland and CAMBRIDGE, Mass., Oct. 21, 2019 /PRNewswire/ -- CRISPR Therapeuticsand Bayer today announced proposed plans whereby Casebia Therapeutics, a joint venture between CRISPR Therapeutics and Bayer, would operate under the direct management of CRISPR Therapeutics. Upon closing of the transaction, Casebia Therapeutics would focus on the development of its lead programs in hemophilia, ophthalmology and autoimmune diseases, with Bayer having opt-in rights for two products at IND submission.
"The standalone Casebia entity combined the capabilities of CRISPR Therapeutics and Bayer to significantly advance the CRISPR/Cas9 gene-editing platform," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "As Casebia's programs have advanced beyond the discovery stage, we are evolving the operating model to leverage the manufacturing and clinical expertise of CRISPR Therapeutics to further accelerate these programs."
"We remain excited about the potential of cutting-edge CRISPR/Cas9 based therapies, which have the potential to create a whole new class of medicines," said Kemal Malik, Bayer board member for Innovation. "CRISPR Therapeutics has built the capabilities and expertise necessary to advance the Casebia programs to the next phase of development, and we look forward to continuing our collaboration with them."
The transaction is subject to negotiation and execution of definitive agreements as well as certain customary conditions. The companies anticipate the transaction will close in the fourth quarter of 2019.
About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer AG, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in London, United Kingdom. For more information, please visit http://www.crisprtx.com.
About Bayer and Leaps by BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Bayer's products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, Bayer aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Bayer global group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go towww.bayer.com.
Leaps by Bayer, a unit of Bayer is investing into solutions to some of today's biggest problems. Previous Leaps investments into potentially breakthrough technologies include BlueRock Therapeutics (iPSC technology to cure cardiovascular and CNS diseases), Joyn Bio (probiotics for plants to enable for chemical fertilizer-free farming), Khloris (iPSC as cancer vaccination agents for potential prevention or cure), Century Therapeutics (iPSCs for allogeneic cell therapy of cancer), and Pyxis Oncology (antibody-based immunotherapies targeting the tumor microenvironment).
CRISPR Forward-Looking StatementThis press release may contain a number of "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding CRISPR Therapeutics' expectations about any or all of the following: (i) the proposed transaction involving Casebia Therapeutics; (ii) the therapeutic value, development, and commercial potential of CRISPR/Cas-9 gene editing technologies and therapies, including in hemophilia,ophthalmology and for autoimmune diseases; and (iii) CRISPR Therapeutics' ability to leverage manufacturing and clinical expertise to meaningfully advance certain Casebia Therapeutics programs. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects" and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: uncertainties inherent in corporate restructuring, including the expected timing for completion of such restructuring and the possibility that the parties will be unable to consummate any proposed transaction; the possibility that the expected synergies from CRISPR Therapeutics' manufacturing and clinical expertise will not be realized, or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; the initiation and completion of preclinical studies for CRISPR Therapeutics' and/or Casebia Therapeutics' product candidates; availability and timing of results from preclinical studies; whether results from a preclinical trial will be predictive of future results of the future trials; uncertainties about regulatory approvals to conduct trials or to market products; uncertainties regarding the intellectual property protection for CRISPR Therapeutics' technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading "Risk Factors" in CRISPR Therapeutics' most recent annual report on Form 10-K, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
CRISPR Therapeutics Investor Contact:Susan Kimsusan.kim@crisprtx.com
CRISPR Therapeutics Media Contact:Jennifer PaganelliWCG on behalf of CRISPR347-658-8290jpaganelli@wcgworld.com
Bayer Media Contact:Chris Loder(201) 396-4325Christopher.loder@bayer.com
SOURCE Bayer
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CRISPR Therapeutics and Bayer Announce an Update on Casebia Therapeutics - PRNewswire
Crispr’s next frontier is in-human treatment, says co-inventor – The Business Times
Mon, Oct 21, 2019 - 5:50 AM
New York
AS investors await results from the first US clinical trials of the gene-editing system known as Crispr, scientists are focused on finding ways to administer it directly into humans, according to the technology's co-inventor, Jennifer Doudna.
Right now, in studies using Crispr that have treated patients, researchers have had to extract their cells to be able to make edits to faulty DNA before infusing them back into the body for treatment.
Being able to do precise edits directly inside humans, animals or plants could open the door to new applications, Ms Doudna said.
"With advances and delivery techniques, it may be possible to do that kind of very highly efficient targeted genome editing in the patient, without having to remove cells, but actually to just do a treatment in the patient where the delivery vehicle takes the editing molecule to the right cells," she said in an interview before the Welch Foundation Conference on chemical research this week.
"Sounds fantastical today, but I think that's coming."
In essence, Crispr is a gene-editing system that can splice away parts of human DNA that make people susceptible to disease or defects. While it can be used in plants and animals, scientists are working on therapeutic applications that can offer a one-time cure for certain diseases.
Crispr Therapeutics AG was the first company to start a human trial back in February, and is due to report initial results by year-end.
Editas Medicine Inc is leading efforts in "in-vivo", or inside the body, testing and initiated a clinical study in July. Intellia Therapeutics Inc is expected to follow with its own study next year.
A safe delivery of Crispr directly into humans would shorten manufacturing times and offer new opportunities for the companies.
The biggest challenge is to find a way to deliver gene-editing molecules into specific cell types safely and efficiently, Ms Doudna said.
"That's kind of the next frontier," she added. "If we figure that out, it really does open the way to many, many more kinds of applications in genome editing than are possible today."
Crispr and Intellia Therapeutics have licensed their technology from the University of California at Berkeley, Ms Doudna's academic home, while Editas is using inventions from the Broad Institute in Massachusetts.
The two institutions are fighting over who was first to invent breakthrough gene-editing technology. Ms Doudna is a co-founder of Editas and other Crispr startups and is a scientific board member at Intellia.
The gene-editing field, which only recently entered human testing and has been plagued by research raising safety concerns, recently got some encouraging news.
Chinese researchers safely treated a man with leukemia and HIV using gene-edited stem cells, according to a report in the New England Journal of Medicine. While the attempt to cure his HIV failed, his cancer is in remission 19 months after the treatment, and the modified cells integrated into his body.
The case, which is the first detailed report in a major academic journal of how doctors are using Crispr in living patients, is an "important milestone" and suggests that gene editing will be "a safe technology and that the challenge now is to have it be really effective in different disease settings", Ms Doudna noted. BLOOMBERG
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Crispr's next frontier is in-human treatment, says co-inventor - The Business Times
CRISPR Therapeutics to buy JV from Bayer – Life Sciences Intellectual Property Review
A joint venture between gene-editing startup CRISPR Therapeutics and German pharmaceutical company Bayer will come under the control of CRISPR Therapeutics, according to the pairs proposed plans.
In an announcement published yesterday, October 21, CRISPR Therapeutics and Bayer proposed that the joint venture, Casebia Therapeutics, would focus on the development of its lead programmes in haemophilia, ophthalmology and autoimmune diseases.
The companies agreed to form Cambridge, Massachusetts-based Casebia Therapeutics in December 2015, with the aim of discovering, developing and commercialising new breakthrough therapeutics to cure blood disorders, blindness, and congenital heart diseases.
Samarth Kulkarni, CEO of CRISPR Therapeutics, said: As Casebia's programs have advanced beyond the discovery stage, we are evolving the operating model to leverage the manufacturing and clinical expertise of CRISPR Therapeutics to further accelerate these programmes.
Bayer will have opt-in rights for two products at investigational new drug application submissions.
Kemal Malik, Bayer board member for innovation, added: We remain excited about the potential of cutting-edge CRISPR/Cas9 based therapies, which have the potential to create a whole new class of medicines.
The transaction is expected to close in the fourth quarter of 2019.
In September, an alliance of companies that use gene-editing technologies (including CRISPR Therapeutics) released a bioethical framework, as controversy over gene-editing rages on.
The principles agree that the developers do not support germline gene editing (the process by which the genome of an individual is changed so that the change is heritable) in human clinical trials or for human implantation.
Last week, CRISPR Therapeutics announced that it had entered a licence agreement with biotech KSQ Therapeutics, gaining access to KSQs IP for editing certain novel gene targets in its allogeneic oncology cell therapy programmes.
KSQ gained access to CRISPR Therapeutics IP for editing novel gene targets identified by KSQ as part of its current and future cell programmes.
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Bayer, CRISPR Therapeutics, joint venture, CRISPR, gene-editing, haemophilia, ophthalmology, autoimmune diseases
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CRISPR Therapeutics to buy JV from Bayer - Life Sciences Intellectual Property Review
CRISPR scientist wants to edit genes that cause deafness but falls short of permission – International Business Times, Singapore Edition
Russian scientist Denis Rebrikov recently revealed that he has started a gene-editing process that might eventually enable couples carrying the genetic mutation that causes deafness to give birth to children who can hear. The news was shared with Nature on 17 October via an e-mail.
According to Nature, the scientist mentioned in the e-mail that he will soon publish the results of his experiments, which involves testing the ability of CRISPR to repair the gene causing deafness GJB2 in cells taken from people that have the mutation. Rebrikov believes that the result will help to lay the groundwork for the clinical work. Rebrikov also added that he wants to help couples with unimpaired hearing to have a child such as these to have a child with the same mutation.
Rebrikov also mentioned that he has local review board's permission to do the research but it does not allow the transfer of the gene-edited eggs into the womb and pregnancy. The scientist also emphasized that he will not be going ahead without the approval from the Ministry of Health of the Russian Federation. "I will definitely not transfer an edited embryo without the permission of the regulator," he confirmed.
However, the chances of this happening seem to be really low as last week, the ministry released a statement where it mentioned that the production of gene-edited babies is premature. Rebrikov, however, is not ready to lose hope. He says, "it is hard to predict" when he'll get permission for it so till then all the necessary safety checks need to be undertaken.
Rebrikov has previously also announced that he intends to use the CRISPR tool for gene-edited babies resistant to HIV. At that time, the news came as a shock to all international researchers as people feared that he is following the Chinese scientist He Jiankui who previously announced the controversial birth of the world's first gene-edited babies twin girls.
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CRISPR scientist wants to edit genes that cause deafness but falls short of permission - International Business Times, Singapore Edition
2019 CRISPR & CRISPR-associated Genes Market to Emerge with Increasing Demand for Drug Discovery with Top Companies Insights – Thermo Fisher…
The CRISPR and CRISPR-associated (Cas) Genes market is anticipated to grow in the forecast, owing to the factors such as rising adoption of genome editing technique, growing adoption of CRISPR, and increasing prevalence of genetic disorders. Furthermore, increasing demand for drug discovery is likely to pose growth opportunities for the CRISPR and CRISPR-associated (Cas) Genes market to grow.
CRISPR & CRISPR-associated (Cas) Genes Market to 2027 Global Analysis and Forecasts By Product (Vector-based Cas, DNA-free Cas); Application (Genome Engineering, Disease models, Functional Genomics, Knockdown/activation, Others); End User (Biotechnology and Pharmaceutical Companies, Academic and Government Research Institutes, Contract Research Organizations) and Geography
CRISPR and CRISPR-Associated (Cas) Genes is a genome editing tool that enables the researchers to make changes in the DNA. CRISPR-Cas9 stands for clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9. In recent years the CRISPR and CRISPR-Associated (Cas) Genes has gained lot of popularity as it offers it is cheaper, faster, accurate, and more efficient genome editing methods.
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Leading key market players mentioned in the report:-
The Global CRISPR and CRISPR-associated (Cas) Genes market Analysis to 2027 is a specialized and in-depth study of the medical device industry with a special focus on the global market trend analysis. The report aims to provide an overview of CRISPR and CRISPR-associated (Cas) Genes market with detailed market segmentation by product, application, end user and geography. The global CRISPR and CRISPR-associated (Cas) Genes market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading CRISPR and CRISPR-associated (Cas) Genes market players and offers key trends and opportunities in the market.
The global CRISPR and CRISPR-associated (Cas) Genes market is segmented on the basis of product, application, and end user. Based on product the market is segmented into vector-based Cas and DNA-free Cas. Based on application the market is segmented into genome engineering, disease models, functional genomics, knockdown/activation and others. Based on end user the market is segmented into biotechnology and pharmaceutical companies, academic and government research institutes, contract research organizations.
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Attractive Stock of Yesterday : CRISPR Therapeutics AG (CRSP) – WEB NEWS OBSERVER
CRISPR Therapeutics AG (CRSP):
If you are considering getting into the day trading or penny stock market, its a legitimate and profitable method for making a living. Every good investor knows that in order to make money on any investment, you must first understand all aspects of it, so lets look at daily change, stock price movement in some particular time frame, volatility update, performance indicators and technical analysis and analyst rating. Picking a stock is very difficult job. There are many factors to consider before choosing a right stock to invest in it. If picking stock was easy, everyone would be rich right? This piece of financial article provides a short snap of CRISPR Therapeutics AG (CRSP) regarding Tuesday trading session and presents some other indicators that can help you to support yours research about CRISPR Therapeutics AG (CRSP).
CRISPR Therapeutics AG (CRSP) stock Trading Summary:
CRISPR Therapeutics AG (CRSP) stock changed position at -2.62% to closing price of $39 in recent trading session. The last closing price represents the price at which the last trade occurred. The last price is also the price on which most charts are based; the chart updates with each change of the last price. The stock registered Tuesday volume of 666406 shares. Daily volume is the number of shares that are traded during one trading day. High volume is an indication that a stock is actively traded, and low volume is an indication that a stock is less actively traded. Some stocks tend always to have high volume, as they are popular among day traders and investors alike. Other stocks tend always to have low volume, and arent of particular interest to short-term traders. The stock average trading capacity stands with 502.9K shares and relative volume is now at 1.33.
CRISPR Therapeutics AG (CRSP) Stock Price Movement in past 50 Days period and 52-Week period
CRISPR Therapeutics AG (CRSP) stock demonstrated 75.52% move opposition to 12-month low and unveiled a move of -27.64% versus to 12-month high. The recent trading activity has given its price a change of -22.68% to its 50 Day High and 9.98% move versus to its 50 Day Low. Prices of commodities, securities and stocks fluctuate frequently, recording highest and lowest figures at different points of time in the market. A figure recorded as the highest/lowest price of the security, bond or stock over the period of past 52 weeks is generally referred to as its 52-week high/ low. It is an important parameter for investors (as they compare the current trading price of the stocks and bonds to the highest/lowest prices they have reached in the past 52 weeks) in making investment decisions. It also plays an important role in determination of the predicted future prices of the stock.
CRISPR Therapeutics AG (CRSP) Stock Past Performance
CRISPR Therapeutics AG (CRSP) stock revealed -18.24% return for the recent month and disclosed -20.63% return in 3-month period. The stock grabbed 1.11% return over last 6-months and 8.21% return in yearly time period. To measure stock performance since start of the year, it resulted a change of 36.51%. Past performance shows you the funds track record, but do remember that past performance is not an indication of future performance. Read the historical performance of the stock critically and make sure to take into account both long- and short-term performance. Past performance is just one piece of the puzzle when evaluating investments. Understanding how performance fits in with your overall investing strategy and what else should be considered can keep you from developing tunnel vision.
Volatility in Focus:
The stock unfolded volatility at 4.71% during a week and it has been swapped around 5.62% over a month. Volatility is a rate at which the price of a security increases or decreases for a given set of returns. Volatility is measured by calculating the standard deviation of the annualized returns over a given period of time. It shows the range to which the price of a security may increase or decrease. Volatility measures the risk of a security. It is used in option pricing formula to gauge the fluctuations in the returns of the underlying assets. Volatility indicates the pricing behavior of the security and helps estimate the fluctuations that may happen in a short period of time. If the prices of a security fluctuate rapidly in a short time span, it is termed to have high volatility. If the prices of a security fluctuate slowly in a longer time span, it is termed to have low volatility.
The average true range is a volatility indicator. This stocks Average True Range (ATR) is currently standing at 2.06.
Overbought and Oversold levels
The stock has RSI reading of 43.34. RSI gives an indication of the impending reversals or reaction in price of a security. RSI moves in the range of 0 and 100. So an RSI of 0 means that the stock price has fallen in all of the 14 trading days. Similarly, an RSI of 100 means that the stock price has risen in all of the 14 trading days. In technical analysis, an RSI of above 70 is considered an overbought area while an RSI of less than 30 is considered as an oversold area. RSI can be used as a leading indicator as it normally tops and bottoms ahead of the market, thereby indicating an imminent correction in the price of a security. It is pertinent to note that the levels of 70 and 30 needs to be adjusted according to the inherent volatility of the security in question.
Analyst Watch: Analysts have assigned their consensus opinion on this stock with rating of 2.3 on scale of 1 to 5. 1 or 2 =>Buy view 4 or 5 => Sell opinion. 3 =>Hold. Analysts recommendations are the fountainhead of equity research reports and should be used in tangent with proprietary research and investment methodologies in order to make investment decisions.
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Attractive Stock of Yesterday : CRISPR Therapeutics AG (CRSP) - WEB NEWS OBSERVER
At Current Price, Is It Too Late To Buy CRISPR Therapeutics AG (CRSP)? – US Post News
On Monday, shares of CRISPR Therapeutics AG (NASDAQ:CRSP) marked $40.05 per share versus a previous $37.91 closing price. With having a 5.64% gain, an insight into the fundamental values of CRISPR Therapeutics AG, investors would also find a great ally in the technical patterns of the stock movements showed in stock charts. CRSP showed a rise of 40.18% within its YTD performance, with highs and lows between $22.22 $53.90 during the period of 52 weeks, compared to the simple moving average of -1.84% in the period of the last 200 days.
Jefferies equity researchers changed the status of CRISPR Therapeutics AG (NASDAQ: CRSP) shares to a Buy rating in the report published on August 1st, 2019. Other analysts, including Canaccord Genuity, also published their reports on CRSP shares. Canaccord Genuity repeated the rating from the previous report, marking CRSP under Buy rating, in the report published on July 26th, 2019. Additionally, CRSP shares got another Buy rating from ROTH Capital, setting a target price of $50 on the companys shares, according to the report published in June 10th, 2019. On the other hand, William Blair Initiated the Mkt Perform rating for CRSP shares, as published in the report on March 14th, 2019. Goldman seems to be going bullish on the price of CRSP shares, based on the price prediction for CRSP. Another Sell rating came from Citigroup.
The present dividend yield for CRSP owners is set at 0, marking the return investors will get regardless of the companys performance in the upcoming period. In addition, the growth of sales from quarter to quarter is recording -72.70%, hinting the companys progress in the upcoming progress.
In order to gain a clear insight on the performance of CRISPR Therapeutics AG (CRSP) as it may occur in the future, there are more than several well-rounded types of analysis and research techniques, while equity is most certainly one of the more important indicators into the companys growth and performance. In this case, you want to make sure that the return on the present equity of -51.50% is enough for you to make a profit out of your investment. You may also count in the quick ratio of the company, currently set at 14.00 so you would make sure that the company is able to cover the debts it may have, which can be easily seen in annual reports of the company.
Set to affect the volatility of a given stock, the average volume can also be a valuable indicator, while CRSP is currently recording an average of 496.33K in volumes. The volatility of the stock on monthly basis is set at 5.34%, while the weekly volatility levels are marked at 4.30%with 9.19% of gain in the last seven days. Additionally, long-term investors are predicting the target price of $62.13, indicating growth from the present price of $40.05, which can represent yet another valuable research and analysis points that can help you decide whether to invest in CRSP or pass.
CRISPR Therapeutics AG (CRSP) is based in the Switzerland and it represents one of the well-known company operating with Healthcare sector. If you wish to compare CRSP shares with other companies under Electronic Equipment and Consumer Goods, a factor to note is the P/E value of for CRISPR Therapeutics AG, while the value can represent an indicator in the future growth of the company in terms of investors expectations. The later value should have a steady growth rate, increasing and growing gradually, which serves the purpose of reliably showcasing the progress of the company. The value -3.93 is supported by the yearly ESP growth of -101.60%.
Besides from looking into the fundamentals, you should also note the number of people inside the company owning the shares, as the values should be in line with the expectations of investors. In that spirit, the present ownership of stocks inside the company is set at 2.00%, which can provide you with an insight of how involved executives are in owning shares of the company. In oppose to the executives share, the institutional ownership counts 51.10% of shares, carrying an equal significance as an indicator of value, as the presence of large investors may signal a strong company.
It appears that more than several institutional investors and hedge funds decided to increase stakes in CRSP in the recent period. That is how ARK Investment Management LLC now has an increase position in CRSP by 34.67% in the first quarter, owning 2.72 million shares of CRSP stocks, with the value of $111.67 million after the purchase of an additional 701,332 shares during the last quarter. In the meanwhile, Nikko Asset Management Americas, also increased their stake in CRSP shares changed 324.31% in the first quarter, which means that the company now owns 1.87 million shares of company, all valued at $76.71 million after the acquisition of additional 1,430,364 shares during the last quarter.
Waddell & Reed Investment Managem acquired a new position in CRISPR Therapeutics AG during the first quarter, with the value of $41.07 million, and Federated Global Investment Manag increased their stake in the companys shares by 8.82% in the first quarter, now owning 67,400 shares valued at $34.09 million after the acquisition of the additional 831663 shares during the last quarter. In the end, Bellevue Asset Management AG increased their position by during the first quarter, now owning 810462 CRSP shares, now holding the value of $33.22 million in CRSP with the purchase of the additional 810,462 shares during the period of the last quarter. At the present, 51.10% of CRSP shares are in the ownership of institutional investors.
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At Current Price, Is It Too Late To Buy CRISPR Therapeutics AG (CRSP)? - US Post News
5 Biotech and Pharmaceutical Innovation Trends in 2019 – BioSpace
New Detection and Treatment for Cancer
According to the American Cancer Society, the oldest description of cancer dates back to Egypt around 3000 BC. Weve been looking for answers ever since. The good news is that there are new detection and treatments for cancer that are providing the way forward to earlier detection and more targeted therapy.
GRAIL, Inc. has a new blood test in development that screens for numerous types of cancer. Investigators at Dana-Farber Cancer Institute confirmed the test has an overall specificity of 99.4%. Results of the multi-center trial were presented at the European Society for Medical Oncology 2019 Congress on September 18, 2019.
By looking for DNA rather than liquid biopsies, the test is able to focus in on portions of the genome where abnormal methylation patterns are found in cancer cells. The lead author, Geoffrey Oxnard, MD of Dana-Farber, commented that if the test was in wide use, it would increase the number of patients who could receive more effective treatments.
Non-Opioid Chronic Pain Management
With the rise of awareness of the dangers of opioids, doctors and patients are turning to alternative solutions for chronic pain management. Physical therapy, acupuncture, surgery, injections, and nerve blocks are some of those solutions. However, for Richard Hanbury, the solution to his personal chronic pain would not be found in opioids but in the experimentation of relaxation techniques, pulsing lights, and sound. As he tracked the decrease of his own pain, he began to raise seed funding, and in 2018, with the help of Stanford University and the United States Special Operations Command, put the device to the test.
In January, the Smithsonian Magazine identified Hanbury, founder of Sana, as an innovator to watch in 2019. Sana has developed a non-invasive bio-therapeutic to manage chronic pain while reducing health care costs. The company has created a device that--with the push of a button--the combination of deep relaxation with the promotion of hemispheric balance leads to pain relief in 16 minutes. As of July of 2019, the company had completed the engineering and testing required for review for FDA approval. Pending FDA approval, it will first be available for fibromyalgia treatment. Additional clinical studies are underway for Opioid Use Disorder, Severe Pain, Neuropathic Pain, and Oncology Pain. The aim, says Hanbury, is to create less suffering and a better status of care.
Virtual Reality is also being used for pain management. VR provides a safe, effective, drug-free alternative in the aftermath of an opioid epidemic. Its even being used to monitor Alzheimer's disease.
AI Applications
Fast Company identified Arterys as one of the Worlds 50 Most Innovative Companies of 2019 for scanning smartly. With long waiting lists and a shortage of radiology specialists, Arterys saw a need for AI to help doctors quickly detect, measure, and track tumor and lesions in CT scans of the lungs and in MRI and CT scans of the liver. In August, a major French hospital signed a five-year deal to deploy the AI platform. The purpose is not to replace human radiologists, but to let the system do manual tasks, allowing the radiologist to focus more on the patient and the experience.
But Arterys isnt the only company providing AI assistance. Machines are being used to predict, comprehend, learn, and act. From surgery-assisting robots to faster diagnoses, AI has multiple applications in the life science industries. For more read 32 Examples of AI in Healthcare and Would You Trust An Automated Doctor?
Neurological Advancements
By 2050, the cost and diagnosis of neurological disorders is expected to nearly double. The good news is that innovation is happening at a rapid pace as scientists are discovering more about the function of the nervous system on molecular and genetic levels. According to an article in Americas Biopharmaceutical Companies, there are 537 medications currently being developed for the treatment of chronic pain, brain tumors, Alzheimers disease, Parkinsons disease, epilepsy, headaches, and migraines. The article highlights disease-modifying treatments for Alzheimers that have the potential to stop or slow down the progression of the disease.
According to Doug Williamson, chief medical officer and vice president of U.S. drug development at Lundbeck, hope is right around the horizon. Just as cancer has progressed from being a death sentence to often being treatable and in some cases curable, the next few decades will see far more effective treatments for a variety of neurological diseases.
It is not only in medication that we are seeing advancements for neurological diseases, like Alzheimers and Parkinsons disease. Earlier this year The Norman Fixel Institute for Neurological Diseases at the University of Florida Health in Gainesville opened its doors. Neurologists, neurosurgeons, neuropsychologists, physical therapists, occupational therapists, speech and swallowing specialists, nutritionists, psychiatrists and social workers are all working together under one roof, providing comprehensive and advanced care.
We are thinking broadly and establishing a coordinated approach to improvement of clinical care, drug discovery, as well as gene and neuromodulatory therapy, said David R. Nelson, M.D., senior vice president for health affairs at UF and president of UF Health. Our outstanding team of experts will continue to push the boundaries in identifying new, game-changing approaches to treating neurologic disease.
Direct to Consumer Hearing Aids
InnerScope Hearing Technologies Inc.(innd.com) received the Best Hearing Aid Manufacturer 2019 USA & GHP Award for its innovation in direct-to-consumer hearing aid delivery. The company is working to serve 1.2 billion people worldwide who have hearing loss by providing accessible and affordable solutions. There are five hearing aid manufacturers that control 97% of hearing aids sold globally. The company plans to disrupt this existing product with its patented self-fitting hearing aid that will be distributed through global big box retailers. InnerScope is also conducting a 510K FDA clinical trial on treatment for tinnitus. The goal is to provide quality care to people who previously have been unable to afford hearing devices.
2019/ 2020 Potential Jobs and Opportunities
As we finish out 2019 and enter 2020, the future of biotechnology and pharmaceuticals is promising. Innovations, small biotech startups, and clinical tests are advancing towards earlier diagnosis and more effective treatments. As more advances are made in the life sciences, additional opportunities will open. This is good news for those seeking employment, meaning its time to pitch your dream position into markets where they need you, but dont quite know why.You can check out current openings within the life sciences industry here.
Stay ahead of your competitors. Read Creating a Life Sciences Jobs Where One Doesnt Exist. Twenty years ago, would you have thought strapping on a headset would be an effective pain management strategy or that a cure for the HIV infection was possible? Go start tomorrow's innovations today. The future is waiting.
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5 Biotech and Pharmaceutical Innovation Trends in 2019 - BioSpace
The science of sensations – Penn: Office of University Communications
The touch of a feather, the itch of a mosquito bite, the prick of a needle: The body is capable of distinguishing and responding to all of these sensations in a near instantaneous relay, from skin to brain and back again.
Our brain is constantly computing these things, and in healthy people it never gets it wrong, says Ishmail Abdus-Saboor, a biologist in Penns School of Arts and Sciences.
The details that drive these processes are now at the heart of Abdus-Saboors research. Using a variety of techniques and models, he and his labestablished at Penn last yearseek to tease out the nervous system pathways involved in translating sensations to the brain, with a particular focus on acute and chronic pain.
His work has taken on a new significance in light of the opioid epidemic.
As a field we have really struggled in identifying novel pain killers, he says. This is why we have an overreliance on opioids.
Getting to the bottom of basic mechanisms in pain sensation has the potential to uncover new pathways that could be targeted with alternative medications. And with a new technique for applying a measurement to pain itself, Abdus-Saboor has in hand a platform that could be used to screen new drugs or even help clinicians one day evaluate their patients discomfort in a much more rigorous way than is currently available.
Animal behavior and biology got their hooks into Abdus-Saboor when he was a child. Growing up in Philadelphias Germantown neighborhood, he fashioned a laboratory in his home at age 14, winning a citywide science competition for his investigations of crayfish.
He carried that fascination with him through his undergrad years at North Carolina A&T State University, pursuing animal science as a pre-vet student. A summer in a laboratory at Penn refined that interest. The mysteries contained in the molecules and genes of animals began to emerge as the most captivating to Abdus-Saboor.
He wound up pursuing his graduate studies with Meera Sundaram at Penn in the Perelman School of Medicine, focusing on the genetics of the nematode worm Caenorhabditis elegans. But he made a conscious choice to shift gears as he embarked on two postdoctoral fellowships.
Thinking about running my own lab one day, I was considering which area has the biggest growth potential in biomedical research, he recalls. The brain is the last frontier; its the least well-understood organ. I thought that, if I could apply some of the tools that Id been learning in genetics and molecular biology toward the study of the nervous system, then perhaps I could make some important discoveries and look at things from a different vantage point.
First in a postdoctoral fellowship with Benjamin Shykind of Cornell University and in a second position working with Wenqin Luo back at Penn, Abdus-Saboor played catch up in the field of neuroscience.
Basically, every single approach that I worked on was new to me, he says. But I think that navet helped me.
Specifically, Abdus-Saboor started asking questions about the common techniques use to evaluate responses to sensory stimuli in mouse studies and wasnt satisfied with the answers. Certain assays, for example, relied on a binary responseeither the animals responded to a stimulus or they didnta measure that struck Abdus-Saboor as rather crude and possibly biased.
Over the last few years, as he wrapped up his postdoc with Luo and established his own lab at Penn, he set out to create a more refined scale for evaluating these types of responses. His technique relies on the use of a high-speed videography, capable of capturing 1,000 frames per second. In a paper published in August in Cell Reports, he, colleagueNathan Fried, Luo, and others reported the creation of a nuanced mouse pain scale that could effectively differentiate responses to a variety of sensory stimuli.
Taking lessons from other model systems, mainly fruit flies and zebrafish, people have been using high-speed cameras to slow down behaviors that we cant see with the naked eye, says Abdus-Saboor. I had the hypothesis that if we did this, maybe there was a lot more information we could extract that could inform us and teach us about what the animal is experiencing. And that turned out to be the case.
Processing frames from these recordings manually, which is how the researchers initially completed the study, was a tedious task. But working with biostatisticians, computational biologists, and machine-learning specialists, Abdus-Saboor and members of his lab were able to streamline the process, and, in collaboration with departmental colleague Joshua Plotkin, are working to automate the video frame-by-frame analysis.
We want others to easily adopt this technology, and automation would help avoid the potential error and variability of human scoring, he says. There are emerging technologies that are allowing us to do this.
So far, theyve tested the platform using both male and female mice representing a variety genetic types and have gotten consistent results across the board.
As his lab has developed this technology, theyve been working in parallel to more deeply understand the nervous system circuits that produce the sensation of pain, especially in the context of chronic pain. People who suffer from chronic pain become more sensitive to various types of touch, even an otherwise innocuous application of warmth or pressure.
This is the chronic pain we hear a lot about now, in this opioid epidemic era, Abdus-Saboor says.
In his relatively short time as a faculty member, hes already struck up collaborations with researchers working on pain elsewhere in the University to advance the science of treating pain. In the School of Dental Medicine, he and Claire Mitchell have worked together on a study of dental pain. Abdus-Saboor has also had productive conversations with researchers, such as Penn Dental Medicines Elliot Hersh, who are interested in applying his high-speed camera platform in clinical settings to objectively evaluate the patients pain and prescribe painkilling drugs appropriately.
Were not there yet, but these are conversations were starting to have, says Abdus-Saboor. If this technology could evolve into the clinic? That would be a wonderful thing.
Ishmail Abdus-Saboor is the Mitchell and Margo Blutt Presidential Assistant Professor in the Department of Biology at the University of Pennsylvanias School of Arts and Sciences.
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The science of sensations - Penn: Office of University Communications
Weekly genetics review: Production systems the focus in new breed indexes – Beef Central
FOR many producers, the development of breed indexes was a significant step forward in the provision of genetic information.
As the number of EBVs increased with developments in performance recording, combined with new ways to capture genetic information, the complexity of making a purchase decision on a bull also became more challenging.
Breed Indexes offered an effective approach to considering the impact of genetic potential a bull possessed to influence the profitability of his progeny across the industry production chain. For many, this allowed a more focussed decision on bulls without having to individually assess each trait and attempt to consider how that would impact finishing traits of steers, or fertility traits in replacement heifers.
Although the Index was a strong guide, it allowed the opportunity for producers to create a short-list of potential bulls that could then be individually selected if required, based on personal preferences on specific genetic traits.
The development of Breed Indexes comes through world leading technology developed in Australia by AGBU the Australian Genetics Breeding Unit based in Armidale. BreedObject continues to refine and account for new genetic technologies and data, and with the release of Version 6, this has opened the possibility for breeds to reconsider the driving focus behind their breed indexes.
The first of the breed societies to reassess their indexes has been Herefords Australia.
Andrew Donoghue
Andrew Donoghue, the general manager of the Society, explained that the opportunity to provide Indexes that focussed on the production systems that Herefords were used within was an exciting outcome of the new BreedObject software.
We have been looking and talking with our members and across industry about where we as a breed want to head. Logically we know that the expectations for Herefords in Northern systems are very different to those in southern regions, Mr Donoghue said.
In the past the focus of the indexes was on finishing systems. However when we talk about finishing systems, the outcome is more about compliance with a specification effectively, hitting requirements for fatness, carcase weight and marbling.
So while some people choose to use grass finishing as their focus and others grain finishing, we are still effectively heading in the same direction.
As Mr Donoghue explained, the significant difference between production systems in the north and the south revolves largely around the cost of feed during annual feed gaps.
The cost of feed in those periods is significant depending where the cattle are located, he said, and this has a major impact on a production systems profitability.
Choosing bulls that can have a genetic influence on a herds feed efficiency, as well as growth and mature weights will help producers adjust their programs to better meet their environmental constraints in a profitable way, he said.
Click on image for a larger view
For producers, the change in Indexes will be to step away from looking at a finishing system, and ranking bulls according to their value.
Instead, the first step will be to consider their location as either a southern or northern producer. From there, the progression is to select a production system that reflects their operation, before then choosing the most suitable bulls for that program.
The Hereford Indexes to be released this month have all been developed with a focus on maintaining and improving eating quality outcomes. Within the model that creates the ranking, premiums to reflect marbling were included, as well as placing pressure on early growth in order to maintain low levels of ossification.
Once producers have chosen their location and production system, there are four indexes that can be considered. For those in southern production regions these will be:
Andrew Donoghue highlighted the major difference between the Northern and Southern Self-Replacing Index as being a significant difference in feed cost.
While the Index still targets the production of cattle for the domestic market, he said it was envisaged that producers would use this in either straightbred Hereford herds or where Hereford bulls are going into crossbred herds, say over a Bos indicus composite based cow herd.
Finishing weights are slightly higher in the northern systems and the indexes also pick this up in the calculations, he said.
The second Northern focused Index, the Northern Baldy Terminal Index is one that will appeal to producers who are choosing Hereford Bulls to join to Bos indicus infused females (eg Santa Gertrudis) where all progeny (male and female) are destined for slaughter. The finishing systems are calculated with steers and heifers slaughtered at 18-19 months of age; steers producing 340kg carcases with 14mm of P8 fat depth, and heifers producing 300kg carcases with 17mm of P8 fat.
In discussing the new Indexes, Mr Donoghue highlighted the attention focussed on creating a system that more realistically reflects production, and environmental pressures experienced by breeders across the country.
We have really spent a lot of time consulting with our members and across industry ensuring that the new indexes align with the key production and market systems for Hereford cattle, he said.
Alastair Rayner
Alastair Rayner is the Principal of RaynerAg, an agricultural advisory service based in NSW. He regularly attends bull sales to support client purchases and undertakes pre sale selections and classifications. He can be contacted here or through his website http://www.raynerag.com.au
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Weekly genetics review: Production systems the focus in new breed indexes - Beef Central
Common causes of hair loss in men – The Voice Online
HEREDITY, AS well as medical conditions and some medications and supplements, are all common causes of hair loss in men. When determining the key cause of baldness, it is important to understand ones personal genetics and account for any other risk factors and practices that may damage the hair.
We lose approximately 100 hairs a day, a loss that does not cause noticeable bald spots. However, when this loss is aggravated, a baldness pattern will appear or the hair will start falling noticeably more than usual. Some of the common causes include the following:
While genetic baldness is not preventable, you can reduce or mitigate other risk factors by talking to your physician when you start a new medical treatment that lists hair loss among its side effects.
Some of the above mentioned causes may have easy fixes, such as implementing a healthy and balanced diet that will include lots of proteins, iron, and zinc. Removing the causes of stress and paying attention to how you style your hair is also important. You may want to stop using damaging hair products or keeping your hair in a too-tight bun, for those who prefer the man bun.
Identifying the cause of hair loss is the first step towards treating the problem. Once you have determined it, you can talk to a physician. He may recommend hair prescription tablets or a hair transplant as a suitable solution for the genetic causes of hair loss.
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Common causes of hair loss in men - The Voice Online
What Happened When I Found the Right Doctor for My Depression – Yahoo Lifestyle
Everyone handles their mental health in different ways. Some people turn to the gym for stress release and waves ofendorphins. There are people who turn to meditation, mindfulness, spirituality and religion for peace of mind and body. Therapy is another way people find clarity and control over their demons. There are people who take medication to help treat their mental illness, and people who do one or more of the above. Whatever path you choose to find healing is your decision, and it is no one elses job to judge your path. We are all different people and therefore need different things. Healing is not a one-size-fits-all deal, and we should all be encouraged to find what helps us.
I began my healing in 2013 when I first graduated high school and was off to college. I always knew I had depression, but I never saw it for the monster it was. I had been in therapy since I was about 8 years old due to my parents divorce and I felt like I was doing fine. I went to college in the fall and started to experience extreme panic attacks and fell into a deep depression. I dropped out a month later and moved home to solve this hiccup in my path. A few appointments later, I found my way to a new doctor (since I was too old for my pediatrician) and was put on antidepressants for my depression. This continued until 2016 when I found a new physician, since mine was getting me nowhere, and decided to find an adult therapist. I was put on three different medications, went to intensive therapy on and off and found myself at college graduation three years later. Honestly? I was proud I made it that far because during that time I was drowning. I was taking medicine, working out every day, going to therapy but why wasnt I better?
Related: Review: Paul Rudds New Netflix Show 'Living With Yourself' Captures What Its Like to Be Split by Depression
I moved home and began the search for a full-time job. The transition to adulthood is hard and it is very real. My anxiety and depression were still there in full swing, but I was able to get through a few months without a total meltdown. After weeks of interviews, I was offered a job; and two weeks into it, I quit. I spiraled right back into the deep end and immediately ran to my general doctor for a medication change. A year went by, I thought I solved it and was offered a similar position to the one before. Two days after accepting the job offer, I spiraled into a manic episode and crashed. I started my new job and shortly after, almost landed myself in the hospital from violent panic attacks. I quit. I had to start all over, where was I even supposed to begin?
This was me August of 2019. This was me two months ago. In those two months, I have found more answers than I ever have before. Do you want to know how?
Related: How I'm Learning Not to Fear Recovery From Depression
I found a professional in the field.
Not a general doctor.
Not a family therapist.
But rather a psychiatrist who specializes in treating mental illness day in and day out. A therapist who met me where I was and continues to challenge me in ways I can understand.
I share this story because mental illness is no joke. It is not fake, it is not something that people make up. It is real and it is raw. My brain is sick and I had spent the last six years searching for answers from people who were not qualified to give me any. It is vital to find someone who specializes in what you are searching for. Do you want to know how I know?
My psychiatrist spent my first appointment talking to me about my life, then ran a DNA test to see what medications would work with my genetics. It turns out, the five different medications I tried and was rotated on did not work for my genetics. Not one. Chemically, they were not a match. I spent six years spending money and searching for answers in people who did not have the background to help me.
Related: 4 Tips That Help Me Complete Simple Tasks When I'm Depressed
If you want to change your medication, or start taking it, find someone who specializes in it. If you want to start working out and dont know where to start, find a trainer at a nearby gym. If you want to learn meditation, find a class or research it. If you want to delve deeper into spirituality, find a spiritual guide to help you.
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What Happened When I Found the Right Doctor for My Depression - Yahoo Lifestyle
Why Are More Black Women Dying From the Most Common Reproductive Cancer? – Mother Jones
Adrienne Moore knew something was wrong. After being diagnosed and successfully treated for ovarian cancer a decade earlier, she recognized the pain and bleeding she began to experience during intercourse, and the sudden irregularity of her periods, as signs of a potentially serious problem with her reproductive health.
Moore, a 45-year-old respiratory nurse from Atlanta, was terrified that her cancer had returned. But when she sought help from her doctors in 2012, she left her appointments with a series of misdiagnoses: perimenopause, cysts, fibroids. Being in the medical world, I thought I knew how to communicate with my caregivers, she says. But even as she pressed her fears, it felt like no one was listening.
She returned to her doctors repeatedly over the next three years, but her symptoms didnt improve. When her employers switched her health insurance plan, and her monthly premium jumped, Moore became unable to afford specialist care. As the pain grew unbearable, she requested sick leave from work. Instead, she was laid off. Her family paid out of pocket for scans and tests that Moore herself ordered. Still, doctors found nothing wrong.
But growing in Moores pelvic cavity, across her ovaries and into the endometriumthe lining of her wombwas a disease that could kill her.
Endometrial cancer is the most common type of gynecological cancer in the United States. Four times more common than cervical cancer, and the fourth most common cancer in women, its one of the few cancers in the country for which diagnoses and deaths are on the rise. The American Cancer Society estimates that at least 57,000 women will be diagnosed this year, and more than 11,000 will die.
Black women are just as likely to get endometrial cancer as white women, but they are more likely to die from it. Within every age, within every stage of diagnosis, within every tumor type, black women do worse, says Dr. Kemi Doll, a gynecologic oncologist at the University of Washington.
Doll has spent the past seven years researching gynecological cancers and investigating the cause of the disparity. She believes that, as with racial discrepancies in other medical conditions, the difference in the endometrial cancer death rate is the result of how the medical establishment treats black women.
To start, black women are less likely than white women to receive an early diagnosis for the disease. As a result, thousands discover they have the cancer only after it has spread, when they have less chance of survival.
That could be because doctors miss early signs of the disease, or because many black women are more reluctant or less able than their white counterparts to seek help from doctors. For many black women, confidence in the health care system has been undermined by decades of difficult experiences. Studies have found that doctors are more likely to view black patients as medically uncooperative, and that diagnostic and treatment decisions are influenced by patients race. Black patients consistently report higher levels of dissatisfaction with their care and mistrust of their doctors. Doll says that patients she speaks with frequently describe feeling dismissed, ignored, or overwhelmed. If you consider a black woman in the US who has had a lifetime of experiences of subpar reproductive health care, Doll says, it might not be that a couple of drops of postmenopausal bleeding has you running to the doctor.
And even those, like Moore, who seek help early for endometrial cancer receive less aggressive care. A recent study conducted by Dolls team found that black women with health insurance or access to medical care were less likely than white women to receive biopsies that could confirm their cancer earlier. Another found that 40 percent of the black-white mortality gap in endometrial cancer may be due to inequitable surgery rates: research shows that black women are less likely to receive surgery than white women at every stage of the disease, and they are also less likely to receive chemotherapy.
For further proof, Doll points to the racial discrepancies that exist in other diseases. Black women are less likely than white women to be tested for hereditary genetic mutations linked to breast cancer. Black patients with end-stage renal disease are less likely to be considered appropriate candidates for kidney transplants. Compared with white patients, black patients are more likely to die from breast, prostate, and stomach cancer, more likely to develop Alzheimers, and more likely to have a stroke. When it comes to maternal care, black women are almost four times more likely to die a pregnancy-related death than white women, and more likely to experience pregnancy complications like preeclampsia, placental abruptions, and postpartum hemorrhage.
You can either approach it from the standpoint that there is something fundamentally wrong with black womens bodies, or theres something wrong with the way we treat black women and their bodies, Doll says. We are not going to help women, and we are not going to solve this problem, if we dont deal with the problem of race and racism.
Not everyone agrees entirely with Dolls prognosis. Dr. Rodney Rocconi, interim director of the University of South Alabama Mitchell Cancer Institute, believes that biology plays an important part in endometrial cancers mortality disparity. Rocconi points to the fact that black women are more likely to be diagnosed with an aggressive form of endometrial cancer, regardless of how early she is diagnosed.
Rocconis research has found that women with a higher percentage of African ancestry are significantly more likely to have a genetic mutation that allows tumors to grow unchecked. Other research corroborates this idea: certain genetic mechanisms that help suppress tumors are less active in black women. Studies of kidney disease and hypertension suggest that genetics may also play part in increasing black peoples risk of developing the illnesses.
Critics argue that research linking race, genetics, and disease veers troublingly close to endorsing theories of eugenics and promoting pseudo-scientific racism. Rocconi agrees that theres no such thing as a black gene. But identifying a concrete link between black womens genetics and the aggressive tumors they suffer could be the first step in finding a cure. Whats most exciting to me is that we can target the biological cause of the disease, Rocconi says. Once the research is confirmed, we can add a targeted therapy to inhibit that immune pathway, and make patients more likely to respond to therapy.
But progress is hampered by another racial discrepancy, this time in clinical trials. Black enrollment numbers for early-phase endometrial cancer clinical trials, Rocconi notes, are dismal: For even one white person enrolled, 0.04 black people are. That first phase in clinical trials helps set the pipeline for agents that can be used in patients, Rocconi says. We are self-selecting [therapies] that work in the majority white population. This is a widespread problem. A recent ProPublica investigation found that in trials for 18 drugs targeting cancers that occur at least as frequently in black people as white, on average only 4.1 percent of participants were black.
To increase participation, Rocconi says, doctors must find a way to garner black patients trust in medical institutions. In Alabama, where the infamous Tuskegee syphilis experiment remains in living memory, Rocconi has had success enrolling more black patients in cancer treatment trials thanks to a University of South Alabama peer support program that helps patients understand treatment plans and medications and access things like medical insurance, hospital transportation, and community services. These were black women who were talking to people from the same community, Rocconi says. They were advocates for them.
Rocconis and Dolls research converge in another way, too: Both researchers believe epigenetics, the idea that social, economic, and cultural inequalities can alter our DNA, might also have a role in explaining why more black women are dying from endometrial cancer. Since the inequalities black women face persist throughout lifetimes, the resulting epigenetic changes keep accumulatingresulting in poorer health outcomes, including cancer, among certain racial and ethnic groups, a study co-written by Rocconi asserts. In other words, black womens genes may predispose them to aggressive endometrial cancer. But those genes have been influenced by generations of inequality.
This is why Doll believes that her patients experiences are key. The genetic information that youre getting comes from a person who had an experience, she says. And if you dont look at that experience you simply wont ever know how it may be influencing what youre seeing on the genetic level.
Back in Atlanta, Adrienne Moore was determined to find answers to what was ailing her. When she started a new job, a year after being laid off, she used her reinstated health benefits to order a biopsy on one of her cysts. It confirmed what she thought she already knew: She had cancer. But when the oncologist described the disease, she was shocked. She had never heard of endometrial cancer before. Her disease was so advanced, she was diagnosed at Stage 3. She was lucky to survive.
As she finished chemotherapy, Moore joined the Endometrial Cancer Action Network for African-Americans, a national support group founded by Doll. The organization hosts an online community for survivors and an education arm that informs black women about the disease, and its members serve as a research pool for ongoing studies into the cancers causes and treatments. Moore, whose cancer is now in remission, is a patient advisor for ECANA and conducts outreach to black women across Georgia.
Theres such a silence around our reproductive health, says Moore. She feels she had a lucky escape. When black women tell me theyve never heard of endometrial cancer, she says, its probably because weve lost so many to this disease.
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Why Are More Black Women Dying From the Most Common Reproductive Cancer? - Mother Jones
Genentech’s Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular…
Oct. 21, 2019 05:00 UTC
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMbrave150 study, evaluating Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy, met both of its co-primary endpoints demonstrating statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared with standard-of-care sorafenib.
Safety for the combination of Tecentriq and Avastin was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. Data from the IMbrave150 study will be presented at an upcoming medical meeting.
We are very pleased with the results of our study testing the combination of Tecentriq and Avastin, which marks the first treatment in more than a decade to improve overall survival in people with unresectable hepatocellular carcinoma who have not received prior systemic therapy, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. HCC is a major cause of death globally and particularly in Asia, making this study an important step in our mission of addressing unmet medical needs for patients around the world. We will submit these data to global health authorities as soon as possible. Our hope is to bring a new treatment to people with this aggressive disease who currently have limited options.
In July 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial.
Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
About the IMbrave150 study
IMbrave150 is a global Phase III, multicenter, open-label study of 501 people with unresectable HCC who have not received prior systemic therapy. People were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously, 1200 mg on day 1 of each 21-day cycle, and Avastin was administered intravenously, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints were OS and PFS by independent review facility (IRF) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Secondary efficacy endpoints included overall response rate (ORR), time to progression (TTP) and duration of response (DoR), as measured by RECIST v1.1 (investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as patient-reported outcomes (PROs), safety and pharmacokinetics.
About hepatocellular carcinoma
According to the American Cancer Society, it is estimated that more than 42,000 Americans will be diagnosed with liver cancer in 2019. Liver cancer incidence has more than tripled since 1980 and HCC accounts for approximately 75% of all liver cancer cases in the United States. HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B and C) or alcohol consumption, and typically presents at an advanced stage where there are limited treatment options.
About the Tecentriq and Avastin combination
There is a strong scientific rationale to support further investigation of Tecentriq plus Avastin in combination. Avastin, in addition to its anti-angiogenic effects, may further enhance Tecentriqs ability to restore anti-cancer immunity by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumor infiltration and enabling priming and activation of T-cell responses against tumor antigens.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
About Avastin (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumors ability to grow and spread in the body (metastasize).
Tecentriq U.S. Indications
Tecentriq is a prescription medicine used to treat adults with:
A type of bladder and urinary tract cancer called urothelial carcinoma. Tecentriq may be used when your bladder cancer:
The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
A type of breast cancer called triple-negative breast cancer (TNBC).
Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients disease worsened. Continued approval for this use may depend on results of an ongoing study to confirm benefit.
A type of lung cancer called small cell lung cancer (SCLC).
It is not known if Tecentriq is safe and effective in children.
Important Safety Information
What is the most important information about Tecentriq?
Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
Tecentriq can cause serious side effects, including:
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.
Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq when used alone include:
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:
The most common side effects of Tecentriq when used in triple-negative breast cancer with paclitaxel protein-bound include:
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at 1-888-835-2555.
Please visit http://www.Tecentriq.com for the Tecentriq full Prescribing Information for additional Important Safety Information.
Avastin is approved for:
Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments.
Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC)
Possible serious side effects
Everyone reacts differently to Avastin therapy. So, its important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Their doctor will stop treatment if any serious side effects occur. Patients should contact their health care team if there are any signs of these side effects.
Side effects seen most often
In clinical studies across different types of cancer, some patients experienced the following side effects:
Avastin is not for everyone
Patients should talk to their doctor if they are:
Patients should talk with their doctor if they have any questions about their condition or treatment.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at 1-888-835-2555.
For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.
About Genentech in personalized cancer immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, were investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is currently studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191020005095/en/
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Genentech's Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular...
Krygen XL has now become the best priced and best reviewed male enhancement supplement in the UK – I’m Herald
T-levels boosters and sexual performance enhancers usually come at a steep price and you dont even have the guarantee that theyll render good results. The Krygen XL proves that you can have both potent ingredients, and a fair price for reaching your athletic and personal objectives.
This highly anticipated product is formulated with pharmaceutical-grade pro-sexual ingredients, that will boost your sex life into top gear.
The Krygen XLs new and improved formula helps rev your sexual system into its top shape, by helping you achieve harder erections, ramping up your stamina and power in bed, and helping you perform at your peak.
Men with higher levels of the male hormone usually have greater sexual activity. Older men need to secrete more of it for their libido and erectile function to work properly.
Visit the official website and get your hands on the first bottle of the Krygen XL sent out to you for FREE anywhere in the UK!
But its important to note that erectile dysfunction is often due to other conditions or medications rather than low testosterone levels.
Studies show that testosterone therapy can benefit your sexual health and performance. It also shows that there is a maximum level of testosterone before theres no increased response. For men who dont have hypogonadism, increasing your testosterone may not benefit your libido.
So, boiling it down to the basic benefits, The Krygen XL will:
So a formula that makes all of those things possible has become the core interest of the scientific world. This is where the Krygen XL came into play and due to its rapid absorption technology and fast-acting, all-natural formula, it delivers a blend of ingredients that help boost the flow of blood to the penis chambers and expands its holding capacity.
Regular use of the supplement has a positive effect on the size of your male parts, helping you amp up your manhood, both in terms of length and girth.
Krygen XLs extra strength blend helps maximize the attributes mentioned earlier to help you experience a complete transformation of your sexual health, performance, & confidence.
Why choose the Krygen XL and not another testo enhancer?
Disclaimer:
For more information about the Krygen XL offer please visit the official website.
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Krygen XL has now become the best priced and best reviewed male enhancement supplement in the UK - I'm Herald
Testosterone Replacement Therapy Market Growing Demand, Analysis by Key Players-Bayer, Novartis – The Market Journal
HTF MI recently introduced study Global Testosterone Replacement Therapy Market Research Report 2019 with in-depth focused approach on qualitative research, describing product Scope and elaborating industry insights and outlook to 2022. The market Study is putting a lot of emphasis on macro-economic issues, influencing factors and key market trends and drivers gearing up and are changing the dynamics of Global Testosterone Replacement Therapy market.
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TheGlobal Testosterone Replacement Therapy Market research studyis designed especially for business strategists, industry executives, marketing, sales and product managers & consultants highlighting the value drivers that may provides a competitive advantage to a business, giving an upper hand in the industry. What differentiation strategist should bring in its product or services understanding the competitors move and consumer behavior to make it more appealing? The report offers a measurable and verifiable method with in-depth analysis of market concentration, new entrants and the technological advancement and market trends in future. Some of the key vendors driving the market are AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin & Acerus Pharmaceuticals.
Testosterone deficiency, also referred to as hypogonadism, is a common problem among men aged between 40 and 79 years, with some studies stating that nearly 30% of all men worldwide are affected by hypogonadism. As the incidence of testosterone deficiency increases, it is expected that the demand for TRT will also show a simultaneous increase.The global average price of testosterone replacement therapy is in the decreasing trend, from 45.4 USD/Unit in 2012 to 34.9 USD/Unit in 2016. With the situation of global economy, prices will be in decreasing trend in the following five years.The classification of testosterone replacement therapy includes gels, injections, patches and other types, and the proportion of gels in 2016 is about 72%.Testosterone replacement therapy is widely sold in hospitals, clinics and other field. The most proportion of testosterone replacement therapy is sold in clinics, and the consumption proportion is about 43%.North America region is the largest supplier of testosterone replacement therapy, with a production market share nearly 86% in 2016. Europe is the second largest supplier of Testosterone Replacement Therapy, enjoying production market share nearly 9.9% in 2016.North America is the largest consumption place, with a consumption market share nearly 83% in 2016. Following North America, Europe is the second largest consumption place with the consumption market share of 12%. Market competition is intense. AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan)Bayer, etc. are the leaders of the industry. The top five players together held about 80% of the market in the same year and they hold key technologies and patents, with high-end customers; have been formed in the monopoly position in the industry. The global Testosterone Replacement Therapy market is valued at 1820 million US$ in 2018 is expected to reach 1300 million US$ by the end of 2025, growing at a CAGR of -4.1% during 2019-2025. This report focuses on Testosterone Replacement Therapy volume and value at global level, regional level and company level. From a global perspective, this report represents overall Testosterone Replacement Therapy market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan. At company level, this report focuses on the production capacity, ex-factory price, revenue and market share for each manufacturer
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Further to get in-depth view of Market competitive landscape and Size, The Global Testosterone Replacement Therapy market study is segmented by Application/ end users [Hospitals, Clinics & Others], products type [, Gels, Injections, Patches & Other]. Geographically, this report study is segmented into several key Regions such as North America, Europe, China & Japan with revenue, value drivers and growth rate of Testosterone Replacement Therapy to achieve a competitive edge, value proposition and market dominance in lucrative regions across the globe.
Some of the key questions answered in this report: Detailed Overview of Testosterone Replacement Therapy market will help deliver clients and businesses making strategies. Influencing factors that thriving demand and latest trend running in the market What is the market concentration? Is it fragmented or highly concentrated? What trends, challenges and barriers will impact the development and sizing of Global Testosterone Replacement Therapy market SWOT Analysis of each defined key players along with its profile and Porters five forces tool mechanism to compliment the same. What growth momentum or acceleration market carries during the forecast period? Which region may tap highest market share in coming era? Which application/end-user category or Product Type may seek incremental growth prospects? What would be the market share of key countries likeUnited States, France, Germany, UK, China, and Australia & Japan etc.? What focused approach and constraints are holding the Testosterone Replacement Therapy market tight?
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Chapter 1 is related to Executive summary to describe Definition, Specifications and Classification of Global Testosterone Replacement Therapy market, Applications such as Hospitals, Clinics & Others, Market Segment by Regions;Chapter 2, about objective of the report.Chapter 3, to display Research Methodology used for the report, Comprehensive analysis, using market research tools such as Porters and SWOT analysisChapter 4 , to show the Overall Market Analysis, segmentation analysis, characteristics;Chapter 5, 6 and 7, to show the Market size, share and forecast; Five forces analysis (bargaining Power of buyers/suppliers), Threats to new entrants and market condition;Chapter 8 and 9, to show analysis by regional segmentation North America, Europe, China & Japan, comparison, leading countries and opportunities; Regional Marketing Type Analysis, Supply Chain Analysis.Chapter 10, focus on identifying the key industry influencers, consumer behavior, marketing channels, Industry experts and strategic decision makers overview;Chapter 11 and 12, Market Trend Analysis, Drivers, Challenges by consumer behavior and demand.Chapter 13 and 14, describe about the vendor landscape (classification and Market Positioning)Chapter 15, deals with Testosterone Replacement Therapy Market sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.
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About Author:HTF Market Report is a wholly owned brand of HTF market Intelligence Consulting Private Limited. HTF Market Report global research and market intelligence consulting organization is uniquely positioned to not only identify growth opportunities but to also empower and inspire you to create visionary growth strategies for futures, enabled by our extraordinary depth and breadth of thought leadership, research, tools, events and experience that assist you for making goals into a reality. Our understanding of the interplay between industry convergence, Mega Trends, technologies and market trends provides our clients with new business models and expansion opportunities. We are focused on identifying the Accurate Forecast in every industry we cover so our clients can reap the benefits of being early market entrants and can accomplish their Goals & Objectives.Contact US :Craig Francis (PR & Marketing Manager)HTF Market Intelligence Consulting Private LimitedUnit No. 429, Parsonage Road Edison, NJNew Jersey USA 08837Phone: +1 (206) 317 1218sales@htfmarketreport.comConnect with us atLinkedIn|Facebook|Twitter
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Testosterone Replacement Therapy Market Growing Demand, Analysis by Key Players-Bayer, Novartis - The Market Journal