Archive for December, 2019

mohammad hassan 3 years and two months Image Credit:

Dubai: The father of a three-year-old boy in Dubai, whose only hope for survival is a bone marrow transplant, is desperately appealing for help.

Hafeez Khan, father of Mohammad Hassan, said the boy who is suffering from acute myeloid leukaemia (AML), needs Rs4.8 million (Pakistani) or Dh114,000 for his treatment, which includes one-two cycles of chemotherapy and a bone marrow transplant, in Pakistan.

Hassan, who has not been able to attend school as he has been in and out of hospitals in Dubai and Pakistan, was first diagnosed with AML when he was only a year and a half. He remained under treatment at a Dubai hospital for nearly a year until October 2018.

After a brief remission, he developed high fever and body pain on October 17 this year. When he did not respond to any regular medications, we took him to a Dubai hospital where his AML relapse was confirmed, said the father.

He said investigations revealed that Hassan had a soft tissue mass in his sinus which was diagnosed as a chloroma, a solid collection of leukemic cells occurring outside the bone marrow.

Khan, who works as a site engineer for a Dubai-based company, said, Hassan is my first born and I will do everything I can to save him. I appeal for any support that I can get towards this effort.

He said the child was earlier scheduled to have a bone marrow transplant in Turkey but due to the prohibitive costs, they were nowconsidering Pakistan. Still, the estimates we have been given are beyond our reach,Khan said, adding that he was praying for a miracle to save his son.

AML is one of the commonest types of leukaemia or blood cancer in children. In AML, the body makes many immature white blood cells. These cells, called myeloid blasts, cant mature into normal white blood cells. Although AML is a serious disease, it can be cured with high intensity chemotherapy and a bone marrow / stem cell transplant at an early stage.

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3-year-old needs bone marrow transplant to survive, says UAE-based father - Gulf News

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didnt take. Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

She has normal T cells now, Judith Shizuru, the Stanford scientist who pioneered the antibody, told Endpoints News. Shes in school.

Its the kind of medical story to launch a biotech around, and thats what Shizuruis doing. Today, her company Jasper Therapeutics is emerging out of stealth-mode with $35 million in Series A funding led by Abingworth and Qiming, a molecule from Amgen, and a Phase I trial set for its first readout on Monday at ASH.

Jasper is broadly aimed at making stem cell transplants safer, more accessible and more effective by using antibodies as conditioning agents. Theseagents clear out bone marrow to make room for the new stem cells to graft onto the body.

Their Phase I uses a naked antibody called JSP191 to help patients with severe combined autoimmune deficiency receive stem cell transplants the only possible cure for the life-threatening disease but such transplants are used in a wide variety of conditions and Jasper has broader aims. Those include other autoimmune diseases, acute myeloid leukemia and cell-directed gene therapy.

Theres a significant amount of progress being made in gene therapy, interim CEO William Lis told Endpoints, but no progress being made in a conditioning agent that will help graft gene therapy.

Shizuru path to the new antibody was long and fortuitous. In 1987, Arl Arzst, the legendary ad executive and president of Proctor and Gamble international flew in on a recruiting trip for Stanford business students. There he visited Shizuru, a young biologyPhD candidate, because he knew her roommate. Arzsts daughter had diabetes and as Shizuru explained the work she was doing on pancreatic islet cell transplants, he told her to come to Europe.

Shizuru had never been to Europe, but there Arszt introduced her to Ken Farber and the other founders of the Juvenile Diabetes Foundation (now the JDRF). The founders struck a years-long correspondence and encouraged Shizuru to go to medical school, where she decided that if scientists were ever going to develop transplants that didnt trigger an immune response, it would be through stem cell work. She continued her work at the Irv Weissman Stanford regenerative lab, where eventually a graduate student made a discovery that piqued her interest.

To put new stem cells in, you have to get the old stem cells out. Thats not always easy. The cells sit inthese pockets in the bone marrow, and theyre pretty comfortable there. Doctors have to force them out, often using chemotherapy or radiation, which damage DNA and cause severe side effects. The costs sometimes outweigh the benefits.

There are diseases were not treating because its too dangerous, Shizuru said. And the kids were treating, theyre so, so fragile.

The grad student had shown in mice that antibodies could be used to deplete the stem cells and potentially eliminate the need for chemotherapy or radiation. Shizuru and her team began looking to see if anyone had developed a human version of the antibody, CD117. It turned out Amgen had already developed a version of this antibody for a different use. It also turned out she had a former postdoc and a former advisor who worked there. They began a collaboration.

We set out to cross the valley of death, Shizuru said, using an industry slang term for the jump from animal models to human uses.

After making a variety of tweaks to the treatment, they published a paper inScience Translational Medicine in 2016showing the antibodies created a 10,000 fold reduction in the number of stem cells in mice.

The same year, they began a clinical trial on 90 SCID patients. These patients had received stem cell transplants when they were very young but hadnt been given chemo or radiation for fear the side effects would be too severe. The original transplants boosted their numberof immune cells, but without chemo or radiation, the stem cells dont graft into those pockets and the body wont continue producing T cells. Without those, they are extraordinarily prone to infection. Many pass away before age 2.

The hope is that the antibodies allowed the stem cells to graft, and the preliminary answer to that question will be out on Monday. For the first girl in the trial, life has improved but questions about how long her body will make immune cells remain. Still, for that girl and others, Shizuru is confident.

We see there is stem cell engraftment, Shurizi said. They are actually making new T cells.

Link:
Jasper Therapeutics launches out of Stanford with new approach to stem cell treatment - Endpoints News

This fall, 21-year-old Jurnee Farrell, a Howard University senior and a member of the universitys volleyball team donated stem cells to a complete stranger.

This fall, 21-year-old Jurnee Farrell, a Howard University senior and a member of the universitys volleyball team, was set to play in the Mid-Eastern Athletic Conference Tournament.

But instead, she was sidelined by a decision she made herself.

Two years ago, she signed up with Be the Match, a nonprofit that registers potential bone marrow and stem cell donors. When she got the call that she was a match for a 57-year-old woman with a form of leukemia, she was surprised.

At first I was like, This isnt real, Farrell recalled, but then said her decision was clear. She would follow through on the commitment she made two years ago when she signed up.

That meant undergoing a series of shots five days before the outpatient procedure, and then undergoing apheresis, a process in which the donor has blood removed through a needle in one arm, blood-forming cells are collected, and then the blood is returned through a needle in the other arm. The session can take up to eight hours.

Farrell said that the actual donation wasnt bad, but that the shots given in a series five days prior proved a little uncomfortable.

Nevertheless, she urges potential donors to sign up.

Its really not that bad, and the person whose life youre saving is probably going through so much more than you are, she said.

And while Farrell missed the tournament last month, shes back on the court already. We are going to the NCAA tournament this weekend, actually, and we play Pitt on Friday, she said. I just started practicing last week!

Farrells decision to register as a donor is one for which the staff at Be the Match is especially grateful.

Lauren Mueller, a public relations specialist with Be the Match, explained that for Caucasian patients waiting for a bone marrow or stem cell donation, the odds of finding a match are roughly 70%. For African-American patients, the odds are much lower, at 23%.

As a result, we are always looking to increase our diversity on the registry, said Mueller, who encourages people to consider registering.

It starts with a cheek swab, and Mueller said its not uncommon for years to go by before a potential donor hears that they might be a match, just as it was in Farrells case.

Your selfless action can help save a life, Mueller said.

Farrell said that shes hopeful her donation will prove successful, and that she would love to meet the recipient one day.

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Howard University athlete makes the call to donate stem cells - WTOP

Last week, a woman namedVictoria Gray became the first person in the U.S. to have her cells edited with CRISPR. The41-year-old patient was sufferingfromsickle cell anemia.

RELATED:FIRST HUMAN TRIAL USING CRISPR GENE-EDITING IN US BEGINS

The condition, caused by a genetic mutation that messes with the shape of red blood cells, causes havoc on patients, and to make things even worse, the options for treatment are very limited and ineffective. The only current treatment for sickle cell anemia patients is a donor transplant that works for just 10% of patients, but all that is about to change.

It was clear that analternative, much more effectivesolutionwas desperately needed. After much consideration, doctors believed that editing cells extracted from a patient's own bone marrow could restore effective red blood cell creation, and this is exactly the operation they attempted on Gray.

The doctors used CRISPR to tweak Gray's bone marrow DNA to turn on a specific protein that would allow proper red blood cell generation. The operation makes Gray the first person in the U.S. to undergo a CRISPR editing procedure and the second globally.

The treatment comes from observations made back in the 1940s.In 1941 a pediatrician named Jane Watson noticed that babies with sickle cell didnt have symptoms until 6 months to 1 year of age, Vivien Sheehan, a hematologist at Baylor University told Popular Science.

The pediatrician also discovered that these infants produced fetal hemoglobin for much longer periods than healthy babies.Following Watson's observations, the research since then has indicated that increasing fetal hemoglobin could provide an effective treatment for the disease.

Now, CRISPR may just make that treatment viable. But before we get too excited, it should be noted that the strategy comes with several risks.

In order for the edited cells to be inserted back into the patients bone marrow, other stem cells need to be deactivated. Otherwise, there is the chance the unedited stem cells may continue to produce sickled red blood cells very fast, outpacing the edited cells' production of healthy cells.

Now researchers say they need to follow Gray's progress for at least 15 years to rule out any other potential dangers of the procedure. Still, for those 90% suffering with sickle cell anemia that don't respond well to current treatment, the procedure, if successful, would offer the much-needed lifeline they've been hoping for.

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Sickle Cell Anemia Patient Becomes First Person in the US to Have Her Genes Edited With CRISPR - Interesting Engineering

WASHINGTON WhenHoward University student athlete Jurnee Farrellsigned up for the Be The Match registry during a Get In The Game campus drive, she didnt know if she would ever be called upon. However, when her phone rang two years later and she discovered she was a match for a 57-year-old woman suffering from acute lymphoblastic leukemia, she did not hesitate to participate.

The football team was hosting a Be The Match booth after Coach London had donated bone marrow to his daughter, recalls Farrell. I filled out a little form and turned it in. When I got the call a few months ago, they asked if I was still interested in donating. I didnt hesitate to say yes because this is somebodys life and there was no way I could say no to that.

Farrell is a senior criminology major from Denver, Colorado, and a member of the Howard University MEAC Championship Volleyball team. Wearing jersey No. 5 as a defensive specialist, Farrell is known for her bubbly personality off the court and her intensity on the court. At senior night, the day before her donation, the entire team rallied behind her in support of her decision. Unfortunately, the timing of the donation process meant that Farrell was not able to participate in this years MEAC playoffs with her teammates, who brought home their fifth MEAC championship on Nov. 24.

Of course, we were sad to miss out on having Jurnee play in the playoffs, but this is such a worthy cause and we were happy to support her all the way, saysHead Volleyball Coach Shaun Kupferberg.What she is doing speaks directly to Howard Universitys mission of truth and service, that each student comes here not only to learn, but to make a difference in the global community. Im extremely proud of her decision.

Thanks to several medical advances, the process to donate stem cells has drastically changed over the years. In addition to bone marrow donations, doctors can also use a stem cell procedure called Peripheral Blood Stem Cell (PBSC) donation through a short 4-hour out-patient procedure where blood is circulated from one arm, into a machine and then back into the donor.

Beth Carrion, account manager for Registry Growth and Development, says individuals like Farrell help to demystify the giving process and raise awareness of the need for a more diverse donor registry. The chances of finding a match for a stem cell transplant is dependent on a persons genetic markers. Outside of a family member, finding a donor within in ones ethnicity is the next viable option. According to Be The Match, each year approximately 14,000 patients are waiting for a transplant from someone outside of their family. The current odds to match a patient with a donor in one out of 430.

Be the Match is truly thankful for our partnership with Howard University because it plays a vital role in helping the African American community have a higher rate of finding a match, says Carrion. A white person in the registry has a 78 percent chance of finding a match. For Hispanics, its 46 percent, but for African Americans, its only a 23 percent chance. We look forward to hosting more events with Howard this spring.

One week after her procedure, Farrell is back at volleyball practice with her fellow teammates, preparing for the Tournament. As she looks to finish out her senior year, she says shes also hopeful that shell get to meet the woman she helped one day.

After the donation, I can have anonymous communication, but I cannot tell my identity. After a year, they will deem the transplant successful and then we can communicate, says Farrell. I for sure want to meet her.

To join the Howard University registry, text Howard to 61474, follow the prompts and a kit will be mailed to you. You may also register online atjoin.bethematch.org/howard.

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Media Contact: Alonda Thomas,Alonda.Thomas@Howard.edu

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Howard University Student Gives a Stranger the Greatest Gift for the Holidays: Life - Howard Newsroom

AUTO1 shows 87% MRD negative complete response in adult patients with r/r ALL, with no severe cytokine release syndrome

Data presented at 61st American Society of Hematology Annual Meeting form basis for advancement of AUTO1 into pivotal clinical trial in adult ALL

Investor call to be held December 9 at 8:30 am ET / 1:30 pm GMT to review data

LONDON, Dec. 07, 2019 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL) announced today new data highlighting progress on its next-generation programmed T cell therapies to treat patients with acute lymphoblastic leukemia (ALL) and adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL). The data were presented in oral presentations at the 61stAmerican Society of Hematology(ASH) Annual Meeting and Exposition inOrlando, FL. Additional data on pediatric patients with ALL will be presented on December 8.

The data on AUTO1 presented at this years ASH meeting demonstrate the favorable safety profile and high level of clinical activity of AUTO1 in both adults and pediatric patients with ALL, and we look forward to initiation of the pivotal program in adult ALL in the first half of 2020, said Dr. Christian Itin, chairman and chief executive officer of Autolus.

Acute Lymphoblastic Leukemia Data Presented

Title: AUTO1 A novel fast off CD19CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL (Abstract # 226)

Updated results for ALLCAR19, the Phase 1 trial evaluating AUTO1 in adults with recurrent/refractory ALL, were presented by Dr. Claire Roddie MB, PhD, FRCPath, honorary senior lecturer,Cancer Institute, University College London (UCL), in an oral presentation. The trial is designed to assess the primary endpoints of safety ( Grade 3 toxicity) and feasibility of product generation, as well as other secondary endpoints, including efficacy. The trial enrolled patients with a high tumor burden (44% had 50% BM blasts), who were considered high-risk for experiencing cytokine release syndrome (CRS). Product was manufactured for 19 patients; product for 13 of those patients was manufactured using a semi-automated closed process, which will be used for commercial supply.

As of the data cut-off date of November 25, 16 patients had received at least one dose of AUTO1. AUTO1 was well tolerated, with no patients experiencing Grade 3 CRS, and 3 of 16 patients (19%), who had high leukemia burden, experiencing Grade 3 neurotoxicity that resolved swiftly with steroids.

Of 15 patients evaluable for efficacy, 13 (87%) achieved MRD negative CR at 1 month and all patients had ongoing CAR T cell persistence at last follow up. CD19-negative relapse occurred in 22% (2 of 15) patients. In the patients dosed with AUTO1 manufactured in the closed process, 9 of 9 (100%) achieved MRD negative CR at 1 month and 6 months event free survival, and overall survival in this cohort was 100%.

Adult ALL patients, who face a median survival of less than one year after their ALL recurs or relapses, have a significant need for a CAR T cell therapy that is highly active, safe and is a standalone therapy not requiring a stem cell transplant, said Dr. Hagop M. Kantarjian, Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center.

The novel CD 19 CAR-T therapy, AUTO1, is potentially transformative as a standalone curative option for patients with r/r ALL, especially in adults, given its favorable safety profile, said Dr. Max Topp associate professor of Internal Medicine, Hematology and Oncology at the University of Wuerzburg.

Title: Therapy of pediatric B-ALL with a lower affinity CD19 CAR leads to enhanced expansion and prolonged CAR T cell persistence in patients with low bone marrow tumor burden, and is associated with a favorable toxicity profile (Abstract # 225)

Dr. Sara Ghorashian, honorary senior lecturer, Great Ormond Street Institute of Child Health, University College London, presented updated data from the phase 1 CARPALL study of AUTO1 in pediatric ALL patients with low bone marrow tumor burden. The trial is intended to assess the primary endpoints of safety and proportion of patients in molecular complete remission at 1 month. The study recruited a total of 25 patients and stratified them into 2 cohorts. Fourteen patients were treated in cohort 1, which utilized a manual manufacturing process; product was unable to be generated in 3 patients. Median follow-up was 27 months in cohort 1. Seven patients were treated in cohort 2, which utilized the semi-automated closed manufacturing process, which will be used for commercial supply. The aim of cohort 2 was to demonstrate feasibility of manufacture at scale. Product was generated for 100% of patients. Median follow-up was 7 months in cohort 2.

AUTO1 was well-tolerated overall, with no patients experiencing Grade 3 CRS and 1 of 21 (5%) experiencing Grade 4 neurotoxicity, which was considered unrelated to CAR T therapy.

Nineteen of 21 treated patients (90%) achieved molecular complete remission at 1 month post infusion. Consistent with pre-clinical data, CAR T cell expansion was excellent and detectable by flow in a number of patients up to 36 months. Persistence was noted in 15 of 21 patients at last follow-up, up to 36 months. In cohort 2, 100% of patients achieved molecular complete remission at 1 month post infusion.

In the 14 patients in cohort 1, the overall survival at 6 months was 86% and at 12 months was 71%; event free survival (EFS) at 6 months was 71% and at 12 months was 54%. The patients in cohort 2 are not yet evaluable for these parameters. Overall, nine patients relapsed; 5 of 8 evaluable relapses were due to loss of CD19 antigen on the tumor cells.

Title: Clonal dynamics of early responder and long-term surviving CAR-T cells in humans (Abstract # 52)

Dr. Luca Biasco, senior research associate at University College London, presented a detailed analysis of CAR T products, and insertion site analysis from the CARPALL phase 1 patients. This analysis revealed highly polyclonal engraftment, even at very late time-points. Dr. Biasco hypothesized that the propensity for high level polyclonal long-term engraftment was due to favorable phenotype of the CAR T product and the binding kinetic of the receptor.

Diffuse Large B-cell Lymphoma Data Presented

Title: Phase 1/2 study of AUTO3, the first bicistronic chimeric antigen receptor (CAR) targeting CD19 and CD22 followed by an anti-PD1 in patients with relapsed/refractory (r/r) Diffuse Large B Cell Lymphoma (DLBCL): Results of cohort 1 and 2 of the ALEXANDER study (Abstract # 246)

Dr. Kirit Ardeshna, consultant hematologist, Department of Hematology, University College London Hospital NHS Foundation Trust, presented updated data from the ALEXANDER Phase 1/2 study of AUTO3, the first bicistronic CAR T targeting CD19 and CD22 followed by an anti-PD1, in diffuse large B cell lymphoma (DLBCL). 16 patients were treated, and fourteen patients were evaluable at one month. AUTO3 was well-tolerated, with no patients experiencing Grade 3 CRS with primary treatment, and 1 of 14 experiencing Grade 3 neurotoxicity that resolved swiftly with steroids. Five of 14 had a complete response, with 4 of 5 complete responses ongoing, the longest at 18 months.

DLBCL is an aggressive and rapidly progressing cancer, and early response is critical to ensuring positive outcomes for these patients. These early data show the promise of AUTO3 in DLBCL, and we expect to advance AUTO3 to a decision point in relapsed/refractory DLBCL by the middle of next year, said Dr. Christian Itin, chairman and chief executive officer of Autolus. In addition, we look forward to presenting the data from the AMELIA trial of AUTO3 in pediatric ALL during poster sessions on Sunday, December 8, 6:00 8:00 PM ET.

Investor call to review data on Monday, December 9

Autolus management will host an investor conference call on Monday, December 9, at 8:30 a.m. EDT/ 1:30pm GMT, to review the data presented at ASH.

To listen to the webcast and view the accompanying slide presentation, please go to:https://www.autolus.com/investor-relations/news-and-events/events.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9796038. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9796038.

About AUTO1

AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells' abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights fromUCL Business plc(UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL.

About AUTO3

AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in pediatric ALL in the AMELIA clinical trial and in diffuse large B cell lymphoma in the ALEXANDER clinical trial.

AboutAutolus Therapeutics plc

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit http://www.autolus.com.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus financial condition and results of operations, as well as statements regarding the anticipated development of Autolus product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates, and the sufficiency of its cash resources. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed on November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Investor and media contact: Silvia TaylorVice President, Corporate Affairs and Communications Autolus+1-240-801-3850s.taylor@autolus.com

UK:Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

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Autolus Therapeutics Announces New Data Showcasing Clinical Progress of Programmed T Cell Therapy Pipeline in Blood Cancers - GlobeNewswire

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data on two investigational CD20-CD3 T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, in people with relapsed or refractory (R/R) B-cell non-Hodgkins lymphoma (NHL). Results from the Phase I/Ib GO29781 study of mosunetuzumab, including data from people previously treated with chimeric antigen receptor (CAR) T-cell therapy, will be presented at the 61st American Society of Hematology (ASH) 2019 Annual Meeting during the Plenary Scientific Session. The Plenary Scientific Session highlights the top six abstracts submitted to the meeting, as determined by the ASH Program Committee. Additionally, results from the Phase I/Ib NP30179 study evaluating CD20-TCB as a combination therapy with Gazyva (obinutuzumab) for people with R/R NHL, will be presented.

Despite recent treatment advancements, slow-growing and aggressive non-Hodgkins lymphomas present increasingly difficult management challenges with each subsequent relapse, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Were encouraged by these early results, which suggest that our novel bispecific cancer immunotherapies may help people with relapsed or treatment-refractory disease who need more options.

The GO29781 study evaluated mosunetuzumab in patients with R/R NHL, including patients who have relapsed following, or are resistant to, CAR T-cell therapy a patient population with limited treatment options. Results from this dose-escalation study showed encouraging efficacy with an objective response rate (ORR) of 62.7 percent (n=42/67) in slow-growing NHL and 37.1 percent (n=46/124) in aggressive NHL. Additionally, data demonstrated a complete response (CR) rate of 43.3 percent (n=29/67) in slow-growing NHL and 19.4 percent (n=24/124) in aggressive NHL. CRs showed durability, with 82.8 percent (n=24/29) of patients with slow-growing NHL remaining in remission up to 26 months off initial treatment and 70.8 percent (n=17/24) of patients with aggressive NHL, remaining in remission up to 16 months off initial treatment. Of the participants who received prior CAR T-cell therapy, the ORR was 38.9 percent (n=7/18), and 22.2 percent (n=4/18) achieved a CR. Adverse reactions included cytokine release syndrome (CRS) in 28.9 percent of patients with 20.0 percent at Grade 1 and 1.1 percent at Grade 3. Grade 3 neurological adverse events occurred in 3.7 percent of patients.

Results from the Phase I/Ib dose-escalation NP30179 study, evaluating CD20-TCB at doses ranging from 0.6 mg to 16 mg plus Gazyva in people with R/R B-cell NHL, showed an ORR of 54 percent (n=15/28) and a CR rate of 46 percent (n=13/28). This included an ORR and CR of 66.7 percent (n=4/6) in people with follicular lymphoma and an ORR of 50.0 percent (n=11/22) and a CR of 40.9 percent (n=9/22) in aggressive NHL. The most frequently observed adverse event across all treatment doses was CRS, occurring in 67.9 percent of patients (n=19/28), with the majority of events being low grade (Grade 1-2).

Both mosunetuzumab and CD20-TCB continue to be evaluated in a robust clinical development program, investigating the treatments as monotherapies and in combination with other therapies, in people with slow-growing and aggressive forms of NHL.

About Genentechs Investigational Bispecifics

Genentech is currently developing two T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patients existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab and CD20-TCB differ in their structures, and both are being developed by Genentech as part of our ongoing strategy to explore multiple bispecific formats, to identify those that maximize potential clinical benefits for patients. The clinical development programs for mosunetuzumab and CD20-TCB include ongoing investigations of these molecules as monotherapies and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkins lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma.

About the GO29781 study

The GO29781 study [NCT02500407] is a Phase I/Ib, multicenter, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkins lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose, and tolerability.

About the NP30179 study

The NP30179 study [NCT03075696] is a Phase I/Ib, multicenter, open-label, dose-escalation study, evaluating the efficacy, safety, tolerability and pharmacokinetics of CD20-TCB. In this study, CD20-TCB is assessed as a single agent and in combination with Gazyva, following pre-treatment with a one-time, fixed dose of Gazyva, in people with relapsed or refractory B-cell non-Hodgkins lymphoma. Outcome measures include overall response rate, complete response rate per Lugano 2014 criteria, maximum tolerated dose, and tolerability.

About Non-Hodgkins Lymphoma

There are two main types of lymphoma: Hodgkins lymphoma and non-Hodgkins lymphoma (NHL). NHL has two subsets, aggressive and indolent (slow-growing).

NHL represents approximately 85 percent of all lymphomas diagnosed. According to the American Cancer Society, it is expected that nearly 74,000 people will be diagnosed with NHL in the United States in 2019, and nearly 20,000 will die from the disease.

Most cases of NHL start in B-lymphocytes, cells that are part of the bodys immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen.

Gazyva Indications

Gazyva (obinutuzumab) is a prescription medicine used:

Important Safety Information

The most important safety information patients should know about Gazyva

Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that can become serious or life threatening, including:

Who should not receive Gazyva:

Patients should NOT receive Gazyva if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past.

Additional possible serious side effects of Gazyva:

Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that may become severe or life threatening, including:

The most common side effects of Gazyva in CLL were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.

The safety of Gazyva was evaluated based on 392 patients with relapsed or refractory NHL, including FL (81 percent), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which Gazyva is not indicated), who did not respond to or progressed within 6 months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of side effects that were seen were consistent with the overall population who had NHL. The most common side effects of Gazyva were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness, and urinary tract infection.

A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of Gazyva as compared to rituximab product in 1,385 patients with previously untreated follicular lymphoma (86 percent) or marginal zone lymphoma (14 percent).The most common side effects of Gazyva were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation and diarrhea.

Before receiving Gazyva, patients should talk to their doctor about:

Patients should tell their doctor about any side effects.

These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.

Gazyva is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Gazyva.com for the Gazyva full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.

About Genentech in Hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, were investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.

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.

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Genentech Announces New Data on Novel Cd20-cd3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas - Business Wire

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Todays approval offers another opportunity to help prolong the lives of people with this type of the disease.

This approval is based on results from the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS] = 18.6 versus 13.9 months; hazard ratio [HR] = 0.80; 95% CI: 0.640.99; p=0.0384) in the intention-to-treat wild-type (ITT-WT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months; HR=0.75; 95% CI: 0.630.91; p=0.0024) in the ITT-WT population.

Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared with 60.3% of people receiving chemotherapy alone.

In lung cancer, Tecentriq is also approved in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq. Tecentriq is also approved in combination with carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Genentech has an extensive development program for Tecentriq, including nine Phase III studies underway across different types of lung cancer, and multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

For those who qualify, Genentech offers patient assistance programs for people taking Tecentriq through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (866) 422-2377. More information is also available at http://www.Genentech-Access.com.

About the IMpower130 study

IMpower130 is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination nab-paclitaxel and carboplatin versus chemotherapy (nab-paclitaxel and carboplatin) alone for chemotherapy-nave patients with stage IV non-squamous NSCLC. The study enrolled 724 people, of whom 681 were in the ITT-WT population and were randomized (2:1) to receive:

During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People in Arm A received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People in Arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until further disease progression.

The co-primary endpoints were:

About lung cancer

According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2019, and NSCLC accounts for 80-85% of all lung cancers. It is estimated that approximately 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.

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.

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of lung cancer called non-small cell lung cancer (NSCLC).

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:

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.

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 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 in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

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.

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FDA Approves Genentech's Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell...

TheCell Therapy Processing marketreport [6 Year Forecast 2016-2022] focuses on Major Leading Industry Players, providing info likeCell Therapy Processing product scope, market overview, market opportunities, market driving force and market risks.Profile the top manufacturers of Cell Therapy Processing, with sales, revenue and globalmarket share ofCell Therapy Processingare analyzed emphatically bylandscape contrastandspeak to info.Upstream raw materials and instrumentation and downstream demand analysis is additionally administrated. The Cell Therapy Processing marketbusiness development trends and selling channelssquare measure analyzed. From a global perspective, It also represents overall Cell Therapy Processing industry size by analyzingqualitative insights and historical data.

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Summary

There are numerous indications that can be cured using cell therapies, and with increased R&D activities for cell therapies, the number of therapeutic uses is anticipated to increase in the near future. Some of the indications under investigation for the treatment using cell therapy are cerebral disorders such as Parkinsons disease and Alzheimers disease, and also cardiovascular disease. Cardiovascular disease could be treated using cell therapies with the aim to restore normal heart functions. Moreover, many studies are undergoing in the attempt to improve the safety and efficacy in treatment of different malignancies. Cell therapy could also be used to cure metabolic disorder such as diabetes mellitus type 1 where there is lack of insulin production in the patient. Researchers are also trying to restore normal liver and kidney function by introducing modified cells of respective origins. Presently, cell therapy could be a promising technique for the treatment of numerous conditions such as orthopedic, oncology, neurological and variety of autoimmune diseases. The increase in the potential of cell therapies in the treatment of diseases associated with lungs using stem cell therapies is anticipated to drive the markets growth in the near future. In addition, improved understanding of the role of stem cells in inducing development of functional lung cells from both embryonic stem cells (ESCs) and induced pluripotent stem (iPS) cells offers lucrative opportunities for the cell therapy processing markets growth. The rising significance of stem cell therapies provides further understanding of lung biology and repair after lung injury, and further a sound scientific basis for therapeutic use of cell therapies and bioengineering approaches in the treatment of lung diseases.

Report Scope:

This research report presents an in-depth analysis of the global cell therapy processing market by offering type, application and geographic regional markets. The report includes key inhibitors that affect various factors that help in growth of cell therapy processing. The report discusses the role of supply chain members from manufacturers to researchers. The report analyzes key companies operating in the global cell therapy processing market. In-depth patent analysis in the report will provide extensive technological trends across years and regions such as North America, Europe, Asia-Pacific and ROW.

The cell therapy processing market is mainly segmented into three major components: offering type, application and region. Based on offering type, the market is segmented into products (cell lines, instruments, among others), services (product design, process design, among others) and software (enabling software). Based on application, the market is categorized into cardiovascular diseases, bone repair, neurological disorders, skeletal muscle repair, cancer and others. The market is segmented by region into North America, Europe, Asia-Pacific and the ROW.

The cell therapy processing market is mainly segmented into three major components: offering type, application and region. Based on offering type, the market is segmented into products (cell lines, instruments, among others), services (product design, process design, among others) and software (enabling software). Based on application, the market is categorized into cardiovascular diseases, bone repair, neurological disorders, skeletal muscle repair, cancer and others. The market is segmented by region into North America, Europe, Asia-Pacific and the ROW.

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Report Includes:

40 data tables and 25 additional tables

An overview of the global market for cell therapy processing technologies

Analyses of global market trends, with data from 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2022

Analysis of the market by technology, application, and region

An outline of the present state of applications of rainwater harvesting

Descriptions of trends in price and price-performance and other factors, including demand in the market

Profiles of key companies in the market, including Biotime Inc., Cell Design Labs., Flodesign Sonics, Lonza Group Ltd. and Sanbio Co. Ltd.

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Global Cell Therapy Processing Market Growth, Demand, Industry Verticals, and Forecast upto 2022 - News Description

Scientists now have the ability to collect massive amounts of data on lifes most fundamental processes, such as the intricate choreography whereby a handful of embryonic stem cells give rise to trillions of specialized cells throughout the human body. But data doesnt always translate into knowledge unless the relationship of recorded data points can be presented in accurate, meaningful and visible ways.

The lab of Yales Smita Krishnaswamy, associate professor of genetics and computer science, has developed a new algorithm called PHATE that overcomes many of the shortcomings of existing data visualization tools, which are more susceptible to noise and distortion in the relationship of data points.

The panel above shows how PHATE visualizes the differentiation of human embryonic stem cells into neuronal cells, neural stem cells, cardiac cells, and endothelial cells, as compared to the visualizations created by three other technologies.A cleaner, more detailed representation is helpful, for example, for generating promising new hypotheses.

The researchers work is described Dec. 3 in the journal Nature Biotechnology.

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PHATED to be: Yale researchers give shape to big data - Yale News

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today presented results from the interim analysis of the Phase III ELEVATE TN trial, showing that CALQUENCE (acalabrutinib) combined with obinutuzumab or as monotherapy significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated chronic lymphocytic leukemia (CLL).

The Independent Review Committee (IRC)-assessed results were presented at the 2019 American Society of Hematology Annual Meeting and Exhibition in Orlando, US. At a median follow-up of 28.3 months, CALQUENCE in combination with obinutuzumab or as a monotherapy significantly reduced the risk of disease progression or death by 90% and 80%, respectively, vs. chlorambucil plus obinutuzumab.

In an exploratory analysis, CALQUENCE in combination or alone demonstrated consistent PFS improvements across most pre-specified subgroups of patients with high-risk disease characteristics, including the unmutated immunoglobulin heavy-chain variable gene (IGHV), del(11q) and complex karyotype. Overall, the safety and tolerability profile of CALQUENCE observed in the ELEVATE TN trial was consistent with its known profile.

Jos Baselga, Executive Vice President, Oncology R&D said: On the heels of approvals in the US, Australia and Canada, these full results provide further evidence that CALQUENCE, as a new treatment option for patients with chronic lymphocytic leukemia, demonstrates remarkable efficacy and a favorable tolerability profile. These results also provide, for the first time, post-hoc analysis data exploring the potential progression-free survival benefit of adding obinutuzumab to a BTK inhibitor versus BTK inhibitor monotherapy in a randomized trial.

Dr. Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE TN trial, said: In the detailed results from the ELEVATE TN trial comparing CALQUENCE to a commonly used chemo-immunotherapy treatment regimen, CALQUENCE demonstrated a clinically meaningful improvement in progression-free survival, while maintaining its known tolerability and safety profile. These are encouraging results for a patient population that is known to face multiple comorbidities, and where tolerability is a critical factor in their treatment.

Summary of key efficacy results as assessed by IRC from the ELEVATE TN trial at median follow-up of 28.3 months:

Efficacy measure

CALQUENCE plusobinutuzumab

N = 179

CALQUENCEmonotherapyN = 179

Chlorambucil plusobinutuzumabN = 177

PFS

Number of events (%)

14 (7.8)

26 (14.5)

93 (52.5)

Median (95% CI), months

NR(NE, NE)

NR(34.2, NE)

22.6(20.2, 27.6)

HR (95% CI)

0.10 (0.06, 0.17)

0.20 (0.13, 0.30)

-

p-value

<0.0001

<0.0001

-

Estimated PFS at 24 months, %

93

87

47

ORR

ORR, n (%)(95% CI)

168 (93.9)(89.3, 96.5)

153 (85.5)(79.6, 89.9)

139 (78.5)(71.9, 83.9)

p-value

<0.0001

=0.0763

-

OS

Number of events (%)

9 (5.0)

11 (6.1)

17 (9.6)

Median (95% CI), months

NR (NE, NE)

NR (NE, NE)

NR (NE, NE)

HR (95% CI)

0.47 (0.21, 1.06)

0.60 (0.28, 1.27)

-

p-value

=0.0577

=0.1556

-

CI, Confidence Interval; NR, Not Reached; NE, Not Evaluable; HR, Hazard Ratio; ORR, Overall Response Rate, OS, Overall Survival

Adverse events (AEs) led to treatment discontinuation in 11.2% of patients treated with CALQUENCE in combination with obinutuzumab and 8.9% of patients treated with CALQUENCE monotherapy versus 14.1% of patients treated with chlorambucil plus obinutuzumab.

With over two years of follow-up, 79% of patients in both the CALQUENCE-containing arms remain on CALQUENCE as a monotherapy. In the CALQUENCE combination arm (n=178), the most common AEs of any grade (30%) included headache (39.9%), diarrhea (38.8%) and neutropenia (31.5%). In the CALQUENCE monotherapy arm (n=179), the most common AEs of any grade (30%) included headache (36.9%) and diarrhea (34.6%). In the chlorambucil plus obinutuzumab arm (n=169), the most common AEs of any grade (30%) included neutropenia (45.0%), infusion-related reaction (39.6%) and nausea (31.4%).

Other AEs of clinical interest (%)1

CALQUENCE plusobinutuzumabN = 178

CALQUENCEmonotherapyN = 179

Chlorambucil plusobinutuzumabN = 169

Any

Grade 3

Any

Grade 3

Any

Grade 3

Atrial fibrillation

3.4%

0.6%

3.9%

0%

0.6%

0%

Major bleeding

2.8%

1.7%

1.7%

1.7%

1.2%

0%

Hypertension

7.3%

2.8%

4.5%

2.2%

3.6%

3.0%

Infection

69.1%

20.8%

65.4%

14.0%

43.8%

8.3%

SPM excluding NMSC

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CALQUENCE Significantly Prolonged the Time Patients Lived Without Disease Progression or Death in Previously Untreated Chronic Lymphocytic Leukemia -...

SOUTH JORDAN, Utah--(BUSINESS WIRE)--Rio Tinto has approved a $1.5 billion investment (100 per cent basis) to continue production at its Kennecott copper operation in the United States. The investment over the next six years will extend operations at Kennecott to 2032.

The investment will further extend strip waste rock mining and support additional infrastructure development in the second phase of the South Wall Pushback project, to allow mining to continue into a new area of the ore body and deliver close to one million tonnes1 of refined copper between 2026 and 2032. It is a world class project that will generate attractive returns, and allow further exploration of the deposit and options for mine life extension.

This additional investment will commence in 2020 and is included in our group capital expenditure guidance of $7.0 billion in 2020 and $6.5 billion in both 2021 and 2022 as development capital. With this project, Rio Tinto has invested more than $5.0 billion in modernisation, environmental stewardship and mine-life extension initiatives since it acquired Kennecott in 1989.

Rio Tinto chief executive J-S Jacques said, This is an attractive, high value and low risk investment that will ensure Kennecott produces copper and other critical materials to at least 2032. The outlook for copper is attractive, with strong growth in demand driven by its use in electric vehicles and renewable power technologies, and declining grades and closures at existing mines impacting supply.

Kennecott is uniquely positioned to meet strong demand in the United States and delivers almost 20 per cent of the countrys copper production. North American manufacturers have relied on high quality products from Kennecott for the past century and this investment means it will continue to be a source of essential materials into the next decade.

Earlier this year, Rio Tinto announced that it would cut the carbon footprint associated with operations at Kennecott by permanently closing its coal fired power plant and sourcing renewable energy certificates.

J-S added, Kennecott will be supplying customers across North America with products that are not only produced in the region but responsibly mined with a significantly reduced carbon footprint.

Notes to Editors

The first phase of the South Wall Pushback, which is expected to be complete in 2021, extended production from 2019 to 2026. $0.3 billion remains to be spent of a $0.9 billion investment.

In addition to copper, Kennecott is one of the largest producers of gold, silver, platinum group metals and molybdenum in North America, and a potential source of critical minerals such as rhenium and tellurium.

The complex operates on Rio Tintos privately owned land and hosts one of the most advanced copper and precious metals smelters in the world. It processes concentrate from Kennecott and third parties, and is one of only three smelters in the United States.

Rio Tinto is a member of the US Department of Energys Critical Materials Institute (CMI) and is jointly investigating with CMI experts ways to extract additional critical minerals from the existing refining and smelting process.

_____________________

1 This production target (stated as payable metal) includes 0.9 million tonnes of refined copper from the second phase of South Wall Pushback and 0.1 million tonnes from first phase of the South Wall Pushback. It is underpinned 60 per cent by Proved Ore Reserves and 40 per cent by Probable Ore Reserves for the years 2026-2032, which have been scheduled from current mine designs by Competent Persons in accordance with the requirements of the Australasian Code for Reporting of Exploration Results, Minerals Resources and Ore Reserves, 2012 Edition.

Reserves referenced were released to the market in the 2018 Rio Tinto Annual Report on 2 March 2019. The Competent Person responsible for reporting of those Ore Reserves was Ed Woods (AusIMM). Rio Tinto is not aware of any new information or data that materially affects the above ore reserve or mineral resource estimates as reported in the 2018 Annual Report, and confirms that all material assumptions and technical parameters underpinning these estimates continue to apply and have not materially changed. The form and context in which each Competent Persons findings are presented have not been materially modified.

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Rio Tinto Invests $1.5 Billion to Continue Production at Kennecott Copper To 2032 - Business Wire

December 5, 2019

SBM Offshore is pleased to announce that it has signed contracts for the construction of the Companys fourth and fifth hulls under its purchase program for Fast4Ward new build multi-purpose hulls. The contracts were signed with Shanghai Waigaoqiao Shipbuilding and Offshore Co., Ltd. (SWS) and China Merchants Industry Holdings (CMIH). Both yards are also progressing the construction of SBM Offshores first three hulls which are already allocated to projects.

Bruno Chabas, CEO of SBM Offshore, commented:

We continue to have good visibility on new awards from active client engagements. This has given the Company the comfort to accelerate the program and commit to two additional Fast4Ward hulls. The Company is currently constructing five hulls simultaneously, a fact which underscores the fundamentals of our market and SBM Offshores competitive position. During this period of increasing demand, SBM Offshore remains disciplined and selective with respect to market opportunities.

Corporate Profile

SBM Offshore N.V. is a listed holding company that is headquartered in Amsterdam. It holds direct and indirect interests in other companies that collectively with SBM Offshore N.V. form the SBM Offshore Group (the Company).

SBM Offshore provides floating production solutions to the offshore energy industry, over the full product lifecycle. The Company is market leading in leased floating production systems delivered to date, with multiple units currently in operation and has unrivalled operational experience in this field. The Companys main activities are the design, supply, installation, operation and the life extension of floating production solutions for the offshore energy industry.

As of December 31, 2018, Group companies employ approximately 4,350 people worldwide, including circa 650 contractors, which are spread over offices in key markets, operational shore bases and the offshore fleet of vessels. Group Companies employ a further 400 people, working for the joint ventures with two construction yards. For further information, please visit our website at http://www.sbmoffshore.com.

The companies in which SBM Offshore N.V. directly and indirectly owns investments are separate entities. In this communication SBM Offshore is sometimes used for convenience where references are made to SBM Offshore N.V. and its subsidiaries in general, or where no useful purpose is served by identifying the particular company or companies.

The Management BoardAmsterdam, the Netherlands, December 5, 2019

For further information, please contact:

Investor RelationsBert-Jaap DijkstraDirector Corporate Finance and IR

Media RelationsVincent KempkesGroup Communications Director

Disclaimer

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Some of the statements contained in this release that are not historical facts are statements of future expectations and other forward-looking statements based on managements current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those in such statements. Such forward-looking statements are subject to various risks and uncertainties, which may cause actual results and performance of the Companys business to differ materially and adversely from the forward-looking statements. Certain such forward-looking statements can be identified by the use of forward-looking terminology such as believes, may, will, should, would be, expects or anticipates or similar expressions, or the negative thereof, or other variations thereof, or comparable terminology, or by discussions of strategy, plans, or intentions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this release as anticipated, believed, or expected. SBM Offshore NV does not intend, and does not assume any obligation, to update any industry information or forward-looking statements set forth in this release to reflect subsequent events or circumstances. Nothing in this press release shall be deemed an offer to sell, or a solicitation of an offer to buy, any securities.

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SBM Offshore orders two additional Fast4Ward hulls, bringing the construction program to a total of five hulls - Financialbuzz.com

Following the initial 60,000-metre resource drilling program initialled in June 2019, the company has now completed 28,868 metres with the latest assays comprising 10,000 metres of drilling.

() has received assays for a further 10,000 metres of the 60,000-metre resource definition drilling program at the San Antonio and Roswell prospects to the south of its Tomingley Gold Operations (TGO) in New South Wales.

A total of 28,868 metres has been drilled to date in order to define an initial inferred resource at the Roswell and San Antonio prospects.

The drilling program is part of an extensive regional exploration program designed to provide additional ore feed either at surface or underground to TGO.

Assays received so far have demonstrated the potential for a material project life extension and show that a return to open-pit mining or underground extension is possible with appropriate resource confirmation, landholder agreement and regulatory approvals.

The latest notable intersections at Roswell include:

First phase drilling at Roswell is now complete with samples being prepared and assayed to form part of an initial resource which is expected in December.

San Antonio assays include:

Difficult drilling conditions in the southern portion of the San Antonio prospect has caused early abandonment of some drill holes which means the initial inferred resource is now expected in February.

Drilling continues in other areas while the company awaits the arrival of the collaring and casing tool, including some of the 20 metre infill lines that were scheduled for later in the program.

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Alkane Resources intersects additional broad high-grade gold up to 139.5 g/t at Tomingley in NSW - Proactive Investors Australia

A corrosion monitoring program provides comprehensive monitoring of all critical components of industrial objects, assets, facilities and plants for signs of corrosion. For reliable operation it is important to identify the location, rate, and underlying causes of corrosion. A corrosion monitoring program identifies any non-conforming alloy components, as these are generally susceptible to accelerated corrosion and can give relatively frequent cause for catastrophic failure.

Corrosion Monitoring can provide significant advantages when integrated into both preventative maintenance and the processes inherent to safety management programs. Based on the results of the Corrosion Monitoring program, informed decisions can be made, not only regarding the remaining life of the object affected by corrosion but also regarding life extension strategies, prospective material selection, and cost-effective methods for remedy of corrosion issues and problems.

This reprot focsues on the instrument market.

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The global Corrosion Monitoring Instrument market is valued at xx million US$ in 2018 is expected to reach xx million US$ by the end of 2025, growing at a CAGR of xx% during 2019-2025.

This report focuses on Corrosion Monitoring Instrument volume and value at global level, regional level and company level. From a global perspective, this report represents overall Corrosion Monitoring Instrument market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan.

Key companies profiled in Corrosion Monitoring Instrument Market report are Honeywell, ClampOn, Emerson, Intertek, Buckleys (UVRAL) Ltd, PT Korosi Specindo, Cosasco, Alabama Specialty Products and more in term of company basic information, Product Introduction, Application, Specification, Production, Revenue, Price and Gross Margin (2014-2019), etc.

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Table of Content

1 Corrosion Monitoring Instrument Market Overview

2 Global Corrosion Monitoring Instrument Market Competition by Manufacturers

3 Global Corrosion Monitoring Instrument Production Market Share by Regions

4 Global Corrosion Monitoring Instrument Consumption by Regions

5 Global Corrosion Monitoring Instrument Production, Revenue, Price Trend by Type

6 Global Corrosion Monitoring Instrument Market Analysis by Applications

7 Company Profiles and Key Figures in Corrosion Monitoring Instrument Business

8 Corrosion Monitoring Instrument Manufacturing Cost Analysis

9 Marketing Channel, Distributors and Customers

10 Market Dynamics

11 Global Corrosion Monitoring Instrument Market Forecast

12 Research Findings and Conclusion

13 Methodology and Data Source

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Latest Research Report to uncover key Factors of Global Corrosion Monitoring Instrument Market - Market Research Base

Most people would be surprised to hear that the most advanced nuclear-tipped cruise missile ever put into operation was retired from service while its predecessor, a less survivable missile it was supposed to replace, soldiers on in U.S. Air Force service to this very day. This topsy-turvy reality is somewhat metaphorical of General Dynamics' AGM-129 Advanced Cruise Missile (ACM) itself. In fact, the AGM-129 could be considered the second stealth aircraft to ever enter production, because that is what it really was, albeit one that was designed upside down, and for good reason.

The origins of the ACM are fairly straightforward. The AGM-86B Air-Launched Cruise Missile (ALCM) entered service in the early 1980s. When it was being designed, and while the non-production AGM-86A was undergoing initial trials, the best way to deliver a nuclear warhead deep inside Soviet airspace by an air-breathing platform was via low-altitude penetration. The AGM-86 was designed exactly for that, to punch through at treetop level using terrain contour matching, terrain-following radar, and inertial navigation to get close enough to a target that the W80 nuclear warhead onboard could do its job successfully.

USAF

Later on, the AGM-86C and D would integrate GPS to deliver pinpoint conventional strikes. You can read all about the AGM-86C/D's capabilities in this recent piece of ours, but the nuclear-armed version of the era had no such accuracy. Regardless, survivability against quickly evolving Soviet air defenses was the most pressing requirement in the Air Force's air-launched cruise missile portfolio as the 1970s gave way to the 1980s.

USAF

AGM-86 being dropped by a B-52 during tests.

The AGM-86B had a few stealthy characteristics, but it was far from a true low observable design. Just as it came into service, the Air Force realized that the days when being able to beat air defenses via low-flying alone were coming to an end. Airborne early warning and control aircraft and advanced fire control radars with look-down-shoot-down capabilities, like those on Russia's 4th generation fighter and interceptor fleets (Su-27 and MiG-31, specifically), would decrease the effectiveness of nap-of-the-earth flying tactics. Something far more survivable was needed, and fast.

Russia MoD

Out of a handful of DARPA initiatives and studies dubbed TEAL DAWN that explored future cruise missile technologies and long-range bomber strategies, it was concluded thatthe new stealth bomber then in development alone wouldn't be survivable against the densest Soviet air defenses. Long-range and survivable standoff weapons would be needed in part to mitigate those defenses. Two requirements were establishedone stealthy missile that could travel around 1,500 miles or more and another that could travel over 5,000 miles. The latter clearly invalidated much of the need for a stealth bomber in the first place and it was thought that at least a decade would be needed to develop such a long-range weapon. As a result, it was jettisoned to concentrate on the shorter-ranged stealthy cruise missile requirement that could be fielded quickly and equip the Air Force's new stealth bomberat least that's what they hoped. With this in mind, a competition to build such a weapon was quietly launched.

Lockheed, Boeing, and General Dynamics ended up squaring off in secret for this new contract. Lockheed's Skunk Works leveraged their work on the F-117 program, which was just spinning up in a very secretive operational state at the time, to produce its F-117-shaped cruise missile, known under the code name SENIOR PROM. The details surrounding Boeing's design remain unclear. General Dynamics' design was a bit more of a traditional configuration, but one that was clean-sheet and packed with very stealthy features arranged in unique ways to maximize its effectiveness and efficiency. SENIOR PROM, which was a test program before competing for the Advanced Cruise Missile contract, was very stealthy, but it would have been troublesome fitting it into a bomber's weapons bay. By 1983, General Dynamics clenched the contract and the AGM-129A Advanced Cruise Missile was officially born.

Public Domain

Lockheed's SENIOR PROM stealth cruise missile based on its still then very secret F-117 Nighthawk design.

General Dynamics' design, which measured nearly 21 feet long and weighed in at 3,700 pounds, was downright wicked looking. A faceted, stiletto-shaped fuselage with a chined, sharp-tip nose area and forward-swept pop-out wings gave it a sinister, almost Klingon-like look. Not just the wings were backward, all the low observable features were oriented towards defeating detection from above, not below. This resulted in an upside-down-looking airframe of sorts.

The vertical stabilizer-rudder pointed down instead of up. It was made up of composite materials, as were the missile's horizontal forward-swept stabilizers, to remain nearly invisible to the most threatening radar bands. The vertical stabilizer was also offset to the left side of the fuselage's centerline.

Semanticscholar.org/USAF

That gas from the missile's two-dimensional exhaust aperture was blown over a platypus-like defuser structure that shielded its signature from, you guessed it, above, instead of below. The exhaust was also mixed with cold air to help further attenuate its infrared signature. Sovietinfrared search and track (IRST) systems were advancing in capability at the time and included on all of Russia's 4th generation fighter/interceptor designs, so infrared signature reduction was weighted heavily alongside radar cross-section reduction during the competition that led to the AGM-129.

USAF

The AGM-129 seen in stowed configuration during climate testing at Eglin AFB.

The low-observable trapezoidal air inlet sat flush on the bottom of the missile instead of the top of it and fed the engine with air through a serpentine duct, thus eliminating any radar return from the engine fan face. Realizing a flush air inlet on something that flies at transonic speeds comes with major design challenges and it's not like any stealthy air inlet configuration is easy to design or produce, to begin with. Beyond its underlying radar-evading structures, the AGM-129 was also covered with radar absorbent material and coatings and given an olive drab color to blend in with the terrain it would roar over just before sparking off a nuclear apocalypse.

USAF

So, if you think the AGM-129 looks like it is flying inverted, that is by very conscious design. Overall, the missile was designed with a particular weight put on stealth from its upper and forward aspects, where it was most vulnerable. From directly to its side, its radar signature was reduced, but more visible than from other angles. This was deemed a non-issue because the pulse-doppler radars that could threaten it from above are unable to detect low-flying targets hiding in ground clutter while flying at perpendicular angles to the radar antenna as they remain inside the radar's "doppler notch." You can read more about this phenomenon and the tactics associated with it here.

Navigation was also innovative. The AGM-129 introduced a laser doppler velocimeter into its navigational suite, which, like the AGM-86, also included inertial navigation and terrain contour matching. This gave it substantially better accuracy over long distances than the AGM-86B, which was designed less than a decade before it.

It also included laser detection and ranging system (LADAR) to aid in low-altitude flight, which further allowed it to fine-tune its endgame attack run down to as accurate as 90 feet according to stated metrics, although the system likely became even more accurate as it matured. Considering it still packed the same W80 variable yield warhead (5kt-150kt) as the AGM-86B, its better accuracy substantially increased its effectiveness, especially against reinforced targets or those that are partially shielded by terrain.

LADAR, as opposed to radar, also allowed the AGM-129 to remain electromagnetically silent, giving off no radio frequency energy when it was most vulnerable and thus making it even harder to detect. There were some tradeoffs though, LADAR could have trouble receiving data against certain surfaces, such as those that were extremely reflective or highly light absorbent. Still, the system was extremely effective and because the missile was so stealthy, it could fly at higher altitudes and in most cases still survive to make it to its target if need be.

FAS.ORG

Still, the system was not perfect. During one test over Dugway Proving Ground in 1997, an AGM-129 was flying so low it impacted some trailers belonging to an observatory. Nobody was hurt in the incident and the missile had been flying for three and a half hours before the accident. It turns out the mission planners had no idea the trailers were there and how the missile got so low was unclear to begin with.

The missile was fast, traveling at just under the speed of sound, and it also packed a very long range. It used a far more fuel-efficient engine, the Williams International F112-WR-100 turbofan, than the one found on the AGM-86, which gave it significantly greater range while retaining similar dimensions and the same payload. Officially, ACM could reach out 2,000 miles to its target , but it seems clear that its real range was actually significantly further, especially when flying a more efficient flight profile during more benign portions of its trip to its target area. As noted earlier, the missile's high degree of stealth meant that it could climb to more efficient altitudes during certain phases of flight and still have a high chance of surviving to complete its horrific task.

Another interesting component of the AGM-129 was its computer system. From how it has been explained to me it used basically one central processor and computing system to run the vast majority of the missile's functions. For early 1980s military technology, this is an amazing feat. Basically, the computer system and the system designed to used it on the missile was absolutely cutting-edge for its time.

USAF

An incredible gathering of 1990s stealth technology, with the AGM-129 in the foreground and the F-117 and B-2 in the background.

It can't be stressed enough how advanced the ACM was for its time. It had many elements that hadn't yet emerged from the classified manned aircraft realm, but was an autonomous system meant to fly thousands of miles to its target without aid and to be built by the hundreds. It was truly a highly sensitive modern marvel of its era.

The first flight test of an AGM-129 occurred in July of 1985, with the first production missiles being delivered two years later, in 1987. It was that year when the program became public, as well. In that sense, it was the first disclosure of a stealth flying machine ever. Still, the program struggled early in its production run. There were technological issues that popped up in flight testing, but the major problems were with building the advanced missiles themselves. Remember, at the time of its first deliveries, no stealth aircraft had even been acknowledged by the Air Force. This wouldn't occur until two years later when the F-117 was officially disclosed to the public. So, the technologies used in its manufacturing were absolutely cutting-edge in nature.

The missile's very aggressive concurrent testing and production schedule concept and major labor issues with the International Association of Machinists began to cripple the program and it quickly became a pariah on Capitol Hill and in certain parts of the Pentagon. By the end of the decade, the AGM-129 was being declared a fiasco. Things got so bad with quality control issues that production was halted between 1989 and 1991.

FAS.ORG

ACMs being manufactured at the General Dynamics plant.

Of course, the timing of this setback couldn't have been worse. The Cold War was ending and the defense budget was set to snap back hard, especially in terms of strategic weaponry. In addition, the B-2 wouldn't fly until 1989 and still would have a long developmental road ahead of it. The B-1B was also having its own troubles and the missile was never designed to fit in its weapons bays, it was too long, and eventually, the B-1B would lose its nuclear role altogether. So, the weapon that was procured at least in part to be paired with the stealth bomber would be relegated to the B-52.

The confluence of these factors, as well as the START treaty which limited these types of weapons, resulted in a drastic reduction of the programmed buy. The nearly 1,500 missiles needed to replace the AGM-86B in full was slashed down to less than half that, and eventually to a final number of just 460 missiles. Unit cost soared partially as a result of the curtailed order, with each missile costing roughly $4.3 million in 1992 dollars. This is extremely expensive for a cruise missile even by today's standards. A decade earlier, the AGM-86Bs cost around $1.3 million each. The ACM had truly entered a Pentagon budgetary 'death spiral' alongside the plane that was supposed to carry it, the B-2.

FAS.org

President Bush underneath an ACM.

Still, they were the most advanced cruise missiles in the world and the truncated force of 460 missiles soldiered on over the next two decades, exclusively equipping the B-52 force. A single B-52 could carry 20 of the missiles at one time. Six on each wing pylon and eight in the jet's cavernous weapons bay on a rotary launcher.

Two other AGM-129 variants were proposed, but never came to fruition. The AGM-129B was a shadowy initiative to equip a revised design with an axial-flow jet engine, new software, and a different nuclear warhead to take on a specialized role that remains classified. This could have been a GPS-equipped, imaging infrared, or otherwise more precise upgrade of the weapon that would also be equipped with a penetrating nuclear warhead of a lower yield to take on heavily fortified bunkers and more hardened structures. Then again, maybe it was something more exotic, we just don't know for absolute certain.

USAF

ACMs loaded onto a B-52.

The other proposed variant was a conventional land attack model similar to the AGM-86C/D Conventional Air-Launched Cruise Missiles (CALCM), but far more survivable and with a lot longer reach. GPS would have been necessary for this weapon, just like it was for its CALCM progenitor. An imaging infrared seeker with imaging matching could have been injected into the design for even better accuracy. In retrospect, this would have been a relatively amazing weapon.

The ACMs that were built may have received a GPS upgrade sometime during the decade and a half or so that followed their introduction into service in 1990, although it remains unclear if this actually happened. It would have given the missiles pinpoint accuracy, but GPS connectivity would not be assured during a nuclear war and it may have been cost-prohibitive to integrate a GPS antenna onto the ACM's stealth airframe. If the upgrade did happen, it would have likely occurred when the missiles were put through a Service Life Extension Program (SLEP) in the early 2000s that would allow them to serve until 2030 and possibly beyond.

Regardless of this life extension program, in 2007, the 17th year of the AGM-129's operational service, it was decided that the entire ACM force would be drawn down and eliminated from service by the end of 2012. A number of factors contributed to this decision, the first being the post 9/11 focus on counter-insurgency operations instead of preparing for peer state conflicts. The U.S. had two raging wars on its hands that were anything but cheap, and the Russian bear remained largely dormant at the time, while China was just on precipice its economic, geopolitical, and technological rise. The AGM-129 program, with its relatively small fleet made up of super high-tech 1980s technology, meant that sustaining the missiles was far from a cheap or easy task. The AGM-86B, although much less survivable, checked a box for much less money and had commonality with its conventionally armed cousin, the AGM-86C/D, which helped significantly in terms of sustainment scalability.

Beyond fiscal matters, the Strategic Offensive Reductions Treaty (SORT) with Russia also meant more warheads would be pulled off the front lines. So, the Air Force moved forward with not just retiring the AGM-129, but destroying the fleet, a task that was completed as planned by the end of 2012.

During its drawdown period, one highly publicized and unfortunate event occurred with what were historically very shy missiles. On August 30th, 2007 a "Bent Spear" incident occurred with a package of 12 ACMs. A B-52H was set to ferry unarmed ACMs from Minot AFB in North Dakota to Barksdale AFB in Louisiana. The missiles were to be decommissioned at Barksdale, so the mission itself wasn't necessarily out of the ordinary. What was not normal is that six of the missiles were actually carrying their W-80 thermonuclear warheads.

The nuclear-armed B-52 sat overnight without a proper security detail and other precautions until the crew showed up for the mission the next day. During pre-flight checks, the crew did not inspect both pylons loaded with missiles. They only inspected the one that held six unarmed ACMs, but logged that both pylons full of missiles were indeed checked and that they were unarmed. The crews then flew across the Midwest not knowing they were carrying six nuclear warheads.

USAF

A B-52H seen with a 'package' of ACMs pre-loaded on their pylon at Minot AFB.

After arriving at Barksdale, the jet sat for another eight hours without standard precautions associated with nuclear-armed aircraft. It was nearly a day and a half after the Minot AFB personnel blew off normal procedures and loaded the hot ACMs on the B-52 that the fact that the plane was actually carrying live warheads was discovered. The incident was the first of its kind in four decades and sent shockwaves through the Air Force and the Pentagon. A subsequent investigation showed horrible disregard for critical nuclear weapons handling protocols and everyone from four unit commanders down to those directly involved were heavily disciplined or removed from duty. All nuclear weapons handling was suspended at Minot AFB. It also resulted in a new set of procedures that were designed to make sure such a breakdown in procedures doesn't happen again.

It was a sad end to the troubled development and career of the world's first stealth cruise missile.

USAF/Public Domain

In retrospect, the decision not just to retire, but fully destroy the AGM-129 cadre seems like a very poor one. Today, the Air Force is working on developing a new stealthy long-range nuclear-tipped cruise missile, the Long-Range Stand-Off (LRSO) weapon, a program that will cost tens of billions of dollars and won't produce an operational missile until at least 2030. Raytheon, which owns the AGM-129 design after it bought Hughes Missile Systems, which bought General Dynamics' missile portfolio prior, is competing with Lockheed for the LRSO contract. In the meantime, the AGM-86B is supposed to remain a viable deterrent even in an era of ever more capable highly integrated air defense systems, ones that now rely on look-down-shoot-down sensors more than they did 35 years ago and that are far more advanced in general than what existed when ACM was conceived. This begs the question, is the AGM-86B really a survivable deterrent at all? The true answer, that we will never officially get, is probably less comforting than we may want to hear.

The truth is, the AGM-129 was way ahead of its time. Today, there are numerous stealthy cruise missiles in production or will be in production soon and they are becoming an extremely sought-after item. The USAF can't get enough of Lockheed's JASSM family of missiles, which continues to rapidly grow in capability, while the Navy is procuring the anti-ship LRASM cousin of JASSM, the stealthy Naval Strike Missile, and a powered version of the JSOW. Multiple foreign militaries have their own stealthy cruise missiles, as well. But these are conventionally armed weapons. It will be at least another decade until a nuclear-armed stealth cruise missile hits the USAF's inventory again. That weapon, the LRSO, will be in many ways the son of AGM-129 and from what we are hearing, it will be absolutely loaded with the latest and greatest technology that will allow it to survive in the most inhospitable of combat environments. It is also meant to equip the USAF's new stealth bomber, the B-21 Raider.

Somehow this all sounds eerily familiar, doesn't it?

Contact the author: Tyler@thedrive.com

Link:
The Saga Of The AGM-129 Cruise Missile That Was Basically A Stealth Jet Designed Upside Down - The Drive

The 338 Mira was estabilished on 24th December 1952. All these years, 338 Sqn has consisted and is still continuing to consist the cornerstone of the structure of the Hellenic Air Force , which guarantees the security of Greece and the territorial integrity.The emblem of the Squadron is rapresented by Aris, the god of war, and it well fit with the milestone of the aviations after the 60s, the F-4E Phantom II. In the emblem there is still the quote H TAN H ENI TAS, the phrase that Spartian woman said to their sons when they handed over the shield to them- come back with it (winner) or over it (dead).

The 338 Fighter Bomber squadron was formed at the Elefsis air base equipped with the F-84G, the first jet of the Hellenic Air Force. In April 1953 the Squadron redeployed from Elefsis air base (112 Combat Wing) to Larissa air base (110 Combat Wing), where it stayd until November 1956, when it returned to the 112CW. The next redeployment took place in May 1958 moving to Souda air base, Crete, with the 115 Combat Wing.

In January 1960 the squadron stopped its operations for four years, and in 1964 it was again operative with the new F-84F. At the airport of Souda, the Squadron stayed until 30th June 1974, when it stopped again its operations and become incorporated in the 340 Squadron.

The pause in operation took place in order to be reformed in the airport of Andravida with the new F-4E Phantom II, which were just delivered to Hellenic Air Force. In a very short time, the pilots, trained in the USA, diffused their knowledge to the rest of the Unit, yielding a fully operational Squadron in May 1975.

In 1981 the Mobile Training Unit of USAF partecipated in the training of the Squadron on new tactics and advanced aerobatic maneuvers. On 1st February 1984, the new Basic Order 3-1/1984 was applied concerning the increase of fighting capability.

Particularly, all the pilots were trained and certified in low apex attacks, low night navigation and advanced maneuvers. There were also carried out a lot of missions for the familiarization of the pilots with the operational environment of the Aegean Sea.

The next milestone in the history of 338 Squadron happened on 5th August 1991, when the replacement of Peace Icarus I and II aircraft by F-4E SRA took places. Since 12th October, flights of the new aircraft were carried out for their operational development. On 18th December 2002, the aircraft, which equipped the squadron since 1st July 1974, returned, having been upgraded structurally as well as electronically, making them the best Phantoms ever flown.

Until today, after 60 years, 338 squadron continues to contribute to the missions of the Hellenic Air Force, having highly trained crew, that in cooperation with an upgraded legendary aircraft, is able to defend the rights and interests of the Hellenic Nation both in Greece as in Cyprus.

Apart from many exercises and training missions outside Hellenic Airspace, Ares Sqn. partecipated in all range of HAF missions like air to ground attacks, interception, Close Air Support, Interdiction, Air to Surface attacks and Electronic Warfare, but the main role of the Squadron is OCA (Offensive Counter Air) and CAS missions.

The training of the pilots is continuous and includes many release of live ordnance such as AIM-9, AGM-65 Maverick, Laser-guided bomb GBU-12, GBU-16 and GBU-24 and Mk 82 and Mk 84. Squadron sorties are also used to train other HAF pilots with JEWCS jamming pods which fit the F-4E and also with releasing flare targets for A/A live ordnance shots.

Due to its primary role in air-to-ground missions, the 338 Sqn was always present and ready to take action for attacking ground or naval targets during all the tensions in the Aegean Sea such as Ocanographic Chora crisis in 1987 or Imia island tensions during 1996. 338M being the last squadron of Polemiki Aeroporia using the Phantom, is even responsable for the training of new pilots assigned to the Phantom.

Actually the Group is training four pilots are complating the basic training to the F-4E, and after aproximately 70 missions, they are ready to be a aircraft leader, and to continue the big History and career of F-4E in Hellenic Air Force. The Squadron keep two aircraft armed with air to ground weapons ready for QRA.

On 11st August 1997, when the contract was signed with the German EADS for the Peace Icarus 2000 upgrade, also known as the Avionics Upgrade Program (AUP), the most important milestone was put for the History of 338 Mira. It was decided to upgrade the initial F-4s in Hellenic service (Peace Icarus I and II) and to apply a service life extension program to the entire F-4E and RF-4E fleet.

The AUP was an ambitious and challenging piece of work carried out to enhance the capabilities of the Phantom and to maintain the effectiveness of the weapon system into the 21st century. The AUP was complex and resulted in an all-new avionic system featuring a core MIL standard 1553 Databus with integration of improved AN/APG 65 GY radar, mission computer, armament central system, navigation system including GPS and INS, communication system, TCAN, radar altimeter (RADALT), data transfer and video recording system, the CPU-143/A central air data computer, Modular Multi-Role Computer (MMRC), laser gyro inertial navigation system with embedded GPS, AN/APX-113 Advanced Identification Friend or Foe (AIFF) and multi-function colour displays.

A comprehensive upgrade of the associated equipment and mission software ensured that the introduction of this all-new avionic suite brought an increased workload for pilots. In order to ease the transition and ensure that the Phantom cockpit become a more ergonomic and logical working environment a redesigned Human Machine Interface was introduced, featuring Hands on Throttle and Stick (HOTAS), multi function colour display, improved Head Up Display and an enhanced audio warning system.

The AUP upgrade allow the Hellenic Phantom to enhance its operative life. Nowadays the date for its retirement is not clear, probably the Phantom will fly in the Hellenic sky for other 5 years, until the budget for a new aircraft will be available. And, until now, it is not known if the new jet will be the F-16V or the new F-35.

Text and images: Andrea Avian

Original post:
Hellenic Air Force 338 Mira "Ares": the last Phantom over the Aegean - Aviation Report

In November 2018, He Jiankui, a researcher in Shenzhen, China, claimed he utilized CRISPR-Cas9 gene editing to alter the DNA of embryos for seven couples. A set of twins, whose names are Lula and Nana, were born. The research was met by global condemnation and calls for a moratorium on this type of gene editing.

However, aside from the public presentations and the resulting controversy and government crackdown on He Jiankui in China, the actual technical results have not been published. This week, the MIT Technology Review announced they had received a copy of Hes unpublished manuscript titled Birth of Twins After Genome Editing for HIV Resistance. They also received a second manuscript that discussed laboratory research on human and animal embryos. The research was apparently reviewed earlier by Nature and JAMA but is as yet unpublished. The MIT group had the papers reviewed by four experts, a legal expert, an IVF physician, an embryologist, and a gene-editing specialist.

MIT Technology Review writes, Their views were damning. Among them: key claims that He and his team made are not supported by the data; the babies parents may have been under pressure to agree to join the experiment; the supposed medical benefits are dubious at best; and the researchers moved forward with creating living human beings before they fully understood the effects of the edits they had made.

The analysis found 13 key problems, but one of the most relevant is that the stated purpose of the researchwhich is also under attackdid not occur. That is to say, He Jiankui and the authors of the research claim that the goal was to modify the CCR5 gene to make the children resistant to HIV. Not only did that not appear to have happened, but its questionable if it was the real reasonthe real, less scientific reason being to be the first scientists to modify human embryos using CRISPR gene that are then born.

One of the reviewers, Fyodor Urnov, a genome-editing specialist at the University of California Berkeley, said, The claim they have reproduced the prevalent CCR5 variant is a blatant misrepresentation of the actual data and can only be described by one term: a deliberate falsehood. The study shows that the research team instead failed to reproduce the prevalent CCR5 variant.

Another of the reviewers, Rita Vassena, scientific direct or the Eugin Group in Spain, noted, Approaching this document, I was hoping to see a reflective and mindful approach to gene editing in human embryos. Unfortunately, it reads more like an experiment in search of a purpose, an attempt to find a defensible reason to use CRISPR/Cas9 technology in human embryos at all costs, rather than a conscientious, carefully thought through, stepwise approach to editing the human genome for generations to come.

Vassena goes on to say, The idea that editing-derived embryos may one day be able to control the HIV epidemic, as the authors claim, is preposterous.

Hank Greely, professor of law at Stanford University, agreed with that assessment, calling it ludicrous. He also noted, We have no, or almost no, independent evidence for anything reported in this paper. Although I believe that the babies probably were DNA-edited and were born, theres very little evidence for that. Given the circumstances of this case, I am not willing to grant He Jiankui the usual presumption of honesty.

There is also significant doubt as to whether the parents involved in the study understood the procedures and the lack of necessity for having it performed. The father was HIV seropositive and it was under control using anti-retroviral therapy. There was little or no risk of HIV being transferred to the children under a normal in vitro fertilization treatment.

Jeanne OBrien, reproductive endocrinologist with Shady Grove Fertility in Atlanta, said, Being HIV-positive in China carries a significant social stigma. In spite of intense familial and societal obligations to have a child, HIV-positive patients have no access to treatment for infertility. The social context in which the clinical study was carried out is problematic and it targeted a vulnerable patient group. Did the study provide a genetic treatment for a social problem? Was this couple free from undue coercion?

Another problem, one of many, is that the gene edits performed were not the same as the mutations that are known to confer natural HIV resistance. The researchers indicated in the papers that they expect the edits to confer HIV resistance, because they are similar but not identical to CCR5 delta 32, the natural mutation that confers resistance. One of the babies only had edits to one of the CCR5 genes, which at best would only provide partial HIV resistance.

Greely said, Successfully is iffy here. None of the embryos got the 32-base-pair deletion to CCR5 that is known in millions of humans. Instead, the embryos/eventual babies got novel variations, whose effects are not clear. As well, what does partial resistance to HIV mean? How partial? And was that enough to justify transferring the embryo, with a CCR5 gene never before seen in humans, to a uterus for possible birth?

There is also significant concern, as there often is with CRISPR, of possible off-target edits. Urnov called it an egregious misrepresentation of the actual data that can, again, only be described as a blatant falsehood. It is technically impossible to determine whether an edited embryo did not show any off-target mutations without destroying that embryo by inspecting every one of its cells. This is a key problem for the entirety of the embryo-editing field, one that the authors sweep under the rug here.

In short, review of He Jiankuis research finds it deeply flawed in terms of rationale, procedures and results, with what can only be described as serious ethical problems and what appears to be a deliberate misrepresentation of the facts.

Originally posted here:
Reviewers of Chinese CRISPR Research: "Ludicrous" and "Dubious At Best" - BioSpace

DUBLIN--(BUSINESS WIRE)--The "Global CRISPR Technology Market 2019-2025" report has been added to ResearchAndMarkets.com's offering.

The global CRISPR technology market is expected to witness a significant growth rate during the forecast period. CRISPR technology enables the alteration of DNA sequences and modifies the gene function. CRISPR technology can be used for various applications such as treatment of diseases, correcting gene, crop modification, bio-fuel manufacturing and many more. Industry giants are working in CRISPR technology development and are investing in the R&D of the technology. Such investments are expected to create an opportunity for the growth of the market in the near future.

The global CRISPR technology market is segmented on the basis of application and end-user. Based on the application, the market is segmented into biomedical applications, agricultural applications, and industrial applications. In fruit crops, CRISPR technology has numerous applications as it improves the important agronomic traits such as biotic and abiotic stress tolerance and fruit quality. Further, on the basis of end-user, the market is segmented into pharmaceutical & biopharmaceutical companies, and academic & research institutes. CRISPR being a really new technology seeks the interest of everyone from doctors to academic & research institutes. CRISPR holds a lot of hidden potentials to cure many rare and incurable diseases that are still to be discovered and is driving the academic & research institutes as an end-user segment to grow with a significant rate in the market.

Geographically, the market is segmented into four major regions: North America, Europe, Asia-Pacific and Rest of the world (RoW). Among these, North America is expected to hold a prominent position in the global CRISPR technology market. The presence of major pharma companies in the region tends to enhance the growth of the global CRISPR market. Further, the report covers the analysis of several players operating in the market.

Some of the players include Thermo Fisher Scientific Inc., Merck KGaA, GenScript Biotech Corp., Horizon Discovery Group PLC, CRISPR Therapeutics AG, and others.

Key Topics Covered:

1. Report Summary

1.1. Research Methods and Tools

1.2. Market Breakdown

1.2.1. By Segments

1.2.2. By Geography

2. Market Overview and Insights

2.1. Scope of the Report

2.2. Analyst Insight & Current Market Trends

2.2.1. Key Findings

2.2.2. Recommendations

2.2.3. Conclusion

2.3. Rules & Regulations

3. Competitive Landscape

3.1. Company Share Analysis

3.2. Key Strategy Analysis

3.3. Key Company Analysis

3.3.1. Thermo Fisher Scientific, Inc.

3.3.1.1. Overview

3.3.1.2. Financial Analysis

3.3.1.3. SWOT Analysis

3.3.1.4. Recent Developments

3.3.2. Merck KGaA

3.3.2.1. Overview

3.3.2.2. Financial Analysis

3.3.2.3. SWOT Analysis

3.3.2.4. Recent Developments

3.3.3. GenScript Biotech Corp.

3.3.3.1. Overview

3.3.3.2. Financial Analysis

3.3.3.3. SWOT Analysis

3.3.3.4. Recent Developments

3.3.4. Horizon Discovery Group PLC

3.3.4.1. Overview

3.3.4.2. Financial Analysis

3.3.4.3. SWOT Analysis

3.3.4.4. Recent Developments

3.3.5. CRISPR Therapeutics AG

3.3.5.1. Overview

3.3.5.2. Financial Analysis

3.3.5.3. SWOT Analysis

3.3.5.4. Recent Developments

4. Market Determinants

4.1. Motivators

4.2. Restraints

4.3. Opportunities

5. Market Segmentation

5.1. CRISPR Technology Market by Application

5.1.1. Biomedical Applications

5.1.2. Agricultural Applications

5.1.3. Industrial Applications

5.2. Global CRISPR Technology Market by End-User

5.2.1. Pharmaceutical and Biopharmaceutical Companies

5.2.2. Academic & Research Institutes

6. Regional Analysis

6.1. North America

6.1.1. United States

6.1.2. Canada

6.2. Europe

6.2.1. UK

6.2.2. Germany

6.2.3. Italy

6.2.4. Spain

6.2.5. France

6.2.6. Rest of Europe

6.3. Asia-Pacific

6.3.1. China

6.3.2. India

6.3.3. Japan

6.3.4. Rest of Asia-Pacific

6.4. Rest of the World

7. Company Profiles

7.1. AstraZeneca PLC

7.2. BASF SE

7.3. Beam Therapeutics Inc.

7.4. Bio-Rad Laboratories, Inc.

7.5. Caribou Bioscience Inc.

7.6. Cellectics SA

7.7. Cibus, Ltd.

7.8. CRISPR Therapeutics AG

7.9. Danaher Corp.

7.10. Editas Medicine

7.11. GeneCopoeia inc.

7.12. GenScript Biotech Corp.

7.13. Horizon Discovery Group PLC

7.14. Intellia Therapeutics Inc.

7.15. Lonza Group Ltd.

7.16. Merck KGaA

7.17. New England Biolabs, Inc.

7.18. Origene Technologies, Inc.

7.19. Pairwise Plants

7.20. Precision Bioscience, Inc.

7.21. Sangamo Therapeutics Inc.

7.22. Thermo Fisher Scientific, Inc.

7.23. Transposagen Biopharmaceuticals, Inc.

See the original post here:
Global CRISPR Technology Market Report 2019-2025 with Analysis of Key Companies - Thermo Fisher Scientific, Merck KGaA, GenScript Biotech, Horizon...

Chinese scientist He Jiankui shocked the world by claiming he had helped make the first gene-edited babies. One year later, mystery surrounds his fate as well as theirs.

He has not been seen publicly since January, his work has not been published and nothing is known about the health of the babies.

Thats the story its all cloaked in secrecy, which is not productive for the advance of understanding, said Stanford bioethicist Dr. William Hurlbut.

..

The report said the twins and people involved in a second pregnancy using a gene-edited embryo would be monitored by government health departments. Nothing has been revealed about the third baby, which should have been born from that second pregnancy in late summer.

Chinese officials have seized the remaining edited embryos and Hes lab records.

A moratorium is no longer strong enough, and regulation is needed, CRISPR pioneer Jennifer Doudna of the University of California, Berkeley recently wrote in acommentaryin the journal Science.

She noted that the World Health Organization has asked regulators in all countries not to allow such experiments, and that a Russian scientist recently proposed one.

Read full, original post: 1 year later, mystery surrounds Chinas gene-edited babies

See more here:
There's still a lot we don't know about China's controversial CRISPR babies, including their health status - Genetic Literacy Project

When Ben Campbell started out with The New York Produce Show and Conference, he was a professor at the University of Connecticut. During the event, Ben and his students participated in ourUniversity Interchangeprogram, which provides a forum for university professors to share cutting-edge research with the trade and thus help fulfill their mission to disseminate knowledge, while also providing an educational and mentorship program for students. He found the program so valuable, that when he moved on to the University of Georgia he asked if we would expand the program. Which we did.

Professor Campbell has presented on a number of important topics, including these:

Setting Producers Free Production Agriculture And The Regulatory Burden:Can States Help Northeast Production Thrive?Are They Inclined To Do So?

Perceptions And Misperceptions: Consumer Attitudes On Organic And Local University Of Connecticut Study To Be Unveiled At New York Produce Show and Conference

Connecticut Professor Ben Campbell Comes Back To The New York Produce Show With Seminal Work On Consumer Reaction To The Marketing Of Locally Grown Produce

We asked Pundit Investigator and Special Projects editor Mira Slott to see what the good professor has in store for attendees this year:

Ben CampbellAssistant Professor,Department of Agricultural andApplied Economics,University of Georgia

New York Produce Show attendees await your thought-provoking consumer research, measuring how different variables influence and impact produce shoppers perceptions and purchasing decisions.

In 2018, you delved into the multitude of ways consumers can access information to understand how various generations are getting information about produce, while also analyzing how these methods are impacting purchasing. You also have presented on organic and local. What do you have planned for this year?

A: This year, my research examines how giving consumers information about GMOs,CRISPR, organic and pesticides impacts their likelihood of purchasing different products.

Q: Thats a hot topic with the new federal and state labeling laws, increased pesticide restrictions, and the influence on retail buying

A: The emphasis is very much the new labeling laws coming into place with GMOs, and new technologies, and a lot of retail policies banning particular production methods. For instance, you seeneonicotinoidsbeing banned in Maryland, and these pollinators being phased out in Home Depot and Lowes of a lot or all of their plant stock. There are new pesticide bans in homes in Ontario, and within school grounds in Connecticut and New York. When looking at produce, there are issues with GMOs and pesticides in the production process as well.

We see bans of products in different areas, and a lot of misinformation about products. People often dont understand GMOs, but they are very much not in favor of them. So, youre against something but you dont know what it is. You see this phenomenon across the board in relation to different chemicals and pesticides too. And even with organic, misinformation abounds. Theres strong lobbying against something or for it and mixed messaging.

Q: How do you set out to understand the impacts of that cacophonous messaging?

A: I was interested in discovering if we gave people fact-based information about what these production methods are, how would that effect their perceptions or influence their potential purchase of these foods, plants and turf, which use these production practices.

Can information impact the role of production practices on the decision to purchase, and more specifically the type of message and source of message.

One of our objectives was the premise that consumer sentiment drives policy changes at the federal, state and local levels, and at retail, and how these decisions could translate into policy implications.

Q: Could you describe the study methodology. What types of production practices were included and what products? What information did you provide participants?

A: We gave participants different treatments and defined the technology of each, looking at three segments: food, plants and turf. The production practices included insecticides, fungicides, herbicides, CRISPR, GMO and organic. Heres the meaning of what this is and the information on how this production practice works.

Q: Were these scientific definitions? How detailed or complex were the descriptions? Were they consumer-friendly?

A: We purposefully adhered to scientific information for the different treatments, though at a level that non-scientists can understand.

Editors note: here are the definitions provided to participants:

*CRISPR:a new biotechnology that allows scientists to directly edit an organisms genetic material (DNA). This does not require transferring DNA from one organism to another.

*Genetically-Modified Organism (GMO):an organism in which the genetic material (DNA) has been altered through the use of modern biotechnologies. The alteration typically involves transferring DNA from one organism to another.

*Insecticide:a pesticide that is used to eliminate or repel insects.

*Fungicide:a pesticide that is used to eliminate or prevent the growth of fungi, molds, and their spores.

*Herbicide:a pesticide that is used to eliminate or prevent the growth of plants

*Organic:the application of a set of cultural, biological, and mechanical practices that support the cycling of on-farm-resources, promote ecological balance, and conserve biodiversity. These include maintaining or enhancing soil and water quality, conserving wetlands, woodlands, and wildlife and forbidding use of synthetic fertilizers, sewage sludge, irradiation and genetic engineering.

Q: These scientific definitions arent really that appealing when talking about food! Did people understand these terms, or want further explanation or context on usage? The GMO and CRISPR definitions dont seem likely to allay a consumers pre-disposed concern about the effect these technologies could have on a food item. Although, I could see the draw of wanting to purchase produce void of insects, fungi and mold

A: Some people got it. Some people didnt. Most people have never heard of CRISPR. We divvied people into groups to determine how likely they would be to buy the product based on the information we provided them on the production practices of that product.

Q: How were the groups formed?

A: Respondents were randomly divided into the treatment groups. After being randomly placed into a treatment group, they were given the information treatment associated with that treatment group.

We had a control group that didnt receive any information, we just said CRISPR or GMO

Q: Who participated in the study, the numbers, demographics, how did you glean peoples preferences, etc.

A: We did an online survey of 2,500 respondents in the spring/summer of 2019. It included Southeastern US residents in nine states with 10-20 percent of participants per state. The average age was 44 and the average income was $50,000. We had 64 percent female and 71 percent Caucasian.

Q: Did you assess the participants knowledge, or perceived knowledge, of each practice going into the study for a relative comparison? Did you break down the sample further to determine, for example, if some consumers were more prone to buy organic

A: Not exactly in that way, but we asked about knowledge level, how knowledgeable are you about organicand I will show the effects of that in our model.

Q: So, this is the knowledge level that is perceived by the participant, not necessarily the correct knowledge?

A: Yes, thats an important point. We know the odds are that consumers are not correct in their knowledge of the production practices, but perception is the reality. We wanted to find out their perceived knowledge of the different production practices. With 0 = No Knowledge; 50 = Somewhat Knowledgeable; and 100 = Extremely Knowledgeable.

Organic was the highest rated. People said they had the most knowledge of it at 64 for food, 62 for plants, and 60 for turf. Organic stood out relative to all the other practices, where there was much less fluctuation. This compared to both GMO and CRISPR at 44 for food, 44 for plants, and 45 for turf. Insecticides 42 for food, 47 for plants and 48 for turf; herbicide 45 for food, 47 for plants, and 48 for turf; and fungicide, 43 for food, 45 for plants and 48 for turf.

Q: What can be learned from this?

A: Interestingly, people indicated they were more knowledgeable about pesticides as they are applied to turf but less knowledgeable as they are applied to their food, though we see moves to eliminate pesticides on food even though people say they are not that knowledgeable. From a produce standpoint, this is informative, first because consumers are not knowledgeable, and second because consumers who are not knowledgeable are making demands on produce production methods or are not able to knowledgably engage with activists in the discussion.

Q: Since youll be presenting this information to executives in the fresh produce industry, what was included in the food category? Did you distinguish between fresh produce and processed items?

A: In looking at the food category as a whole, by and large its going to be an ingredient, a GMO or CRISPR is going to be applied at the production level, so its not directly targeting produce.

Q: The reason I ask,Brad Rickard of Cornell, a veteran like you at our New York Produce Shows, has presented fascinating research related to this topic.In one studyhe conducted, consumer acceptance of GMOs changed based on the food category (grain crop, fruit or beef) and the level of processing. For instance, consumers showed more willingness to buy the GM processed products relative to their GM fresh versions.

A: In our study, were focused on the impact of messaging. So, in this case, if youre more accepting of a treatment in processed food, would knowledge of the treatment push you to be more accepting? Similarly, if youre less accepting of a treatment in fresh produce, will knowledge make you more accepting. Conversely, will more information about insecticides, herbicides, and fungicide usage on conventional produce increase acceptance, and could that lessen acceptance of organic, which restricts that use?

Q: So, the scale of acceptance might change on processedversusfresh, but thats not what youre measuring in this study

A: Were interested to see if our messaging is going to nudge a consumers acceptance and willingness to purchase one way or the other; thats what were focused on in this study.

Q: Thats interesting, because now youre looking at a domino effect of how knowledge of one type of production practice could change acceptance of products in several categories

A: What we found, in fact, is if we showed participants information about pesticides the message that pesticides are used to eliminate insects or fungicides and the growth of fungi, molds, and their spores or herbicides to get rid of the problem plant if you got that message, you rated organic lower.

If its an apple or a processed apple, I dont think the differences will be that big. The result is still moving in the same direction. Receiving the information on pesticides nudges the participants on likeliness to purchase conventional over organic.

Q: How are you defining nudge? Could there be a noticeable change in purchasing choices if consumers received such messaging?

A: Messaging can have marginal impacts. The lesson here is around the messaging and consumer knowledge actually, perceived knowledge. If I think I know more about CRISPR, Im more accepting of buying that product. So, this is about getting the information out there. That information impacts how we view these things.

If someone views pesticides as bad, providing an explanation negates some of the mysteries of pesticides I understand why theyre using it, and Im less likely to buy organic and more likely to buy something produced with insecticides. We see this movement here. This messaging can impact the perceived value of different products, and the effects on each other.

Q: Doesnt it get complicated, though, since there are so many different types of pesticides, and regulations, safe levels of use, etc., and sometimes frightening media reports can lump them all together?

A: Organic is often viewed as less risky for that reason.

Q: If someone is a diehard organic shopper, they might not be as flexible to change

A: Youre not changing people on the endpoints, youre changing people in the middle. Were looking at the average person, not those on the extremes. Youre not changing the person who is diehard organic, or diehard anti-organic. Their minds are set. Youre shifting perceptions of those in the middle.

Q: How important is pricing in this equation? Did you consider this? For example, isnt there a correlation of organic produce purchases increasing when the pricing is more on par with the conventional counterpart?

A: Yes, pricing certainly could have an impact. For this study, we wanted everything else to be constant, to control for what the message was when consumers were considering acceptance of the different treatments. If an herbicide is used or an insecticide is used, what is the effect of that on consumer purchase decisions?

We chose to give participants a scientific definition instead of doing something more general. The reason we did this is, in the marketplace you see a lot of different labels, and best practice claims, both good and bad. We wanted to see if we gave consumers fact-based information, might that affect their views on these foods that have these different characteristics?

Q: Did you consider homing in on particular products, such as an Arctic apple, where the genetically engineered practice prevents browning, and how that quality might change a consumers likelihood of purchasing it? Also, what if you used a more consumer-friendly description of the production process with clever marketing as can be found on theArctic apple website?

A: These variables certainly could play a role We intentionally kept the definitions scientific to alleviate the positive and negative biases.

Q: You note the broad scope of labeling, certifications and product claims vying for consumer attention. Youve done other studies analyzing consumer acceptance and perceptions or misperceptions of these various labels (environmental labeling, local, organic, natural, bee-friendly, etc.). For instance, I remember in one study, you found that some consumers thought that local and organic were interchangeable. Are you taking these types of influences into account when youre conducting your analysis?

A: We touch on them, and will discuss them in our presentation, but by and large, were going to stick with the production processes and focus on the ones coming under threat, like GMO, and CRISPR. Local is not one of those, because its here to stay. With respect to environmentally friendly labels, those are out there, but we can see that insecticides, fungicides, herbicides, GMO, and CRISPR are the ones really on the forefront now of consumer protests and where people have strong opinions.

Q: Based on your study parameters and methodology, what did you learn? What is most illuminating for produce executives?

A: I can give you some examples from the charts Ill be presenting

With no information, the likeliness to purchase organic was 60, but when given information about pesticides, your score for organic went down to 57. Thats a 3 percent drop in your likeliness to purchase a product, so thats what were seeing.

We see that giving consumers information about pesticides had a small effect on their likeliness to purchase organic. When you hear messaging now, you hear that organic is better because no pesticides are used. But we know that consumers indicate they are not knowledgeable about pesticides. When we give them minimal information about pesticides, they move slightly away from organics.

That example was for turf. For food, it went from 64 to 62.

Q: Is that statistically relevant?

A: A two percent shift doesnt sound like a lot, but were seeing these differences here, which could move people in the middle. Though it sounds marginal, we know that for many consumers, production method makes up a small part of their purchasing decision. If you weaken the case for organic, then it will decrease the likelihood of paying a higher price for organic and thereby lower the probability of purchasing organic.

Q: What movement occurs when you introduce CRISPR and GMO information?

A: For CRISPR and GMO, showing CRISPR info moved the rating from 44 (no info) to 46 (CRISPR info); for GMO: 44 (no info) to 42 (CRSPR info); GMO: 44 (no info) to 41 (GMO info). This indicates that providing GMO info hurts GMO purchasing; GMO: 44 ( no info) to 46 (all info) this implies when looking at all the different methods, GMO is not seen as bad; CRISPR: 44 (no info) to 46 (CRISPR info) -providing CRISPR info helps with purchasing; CRISPR: 44 (no info) to 40 (GMO info) GMO info causes a negative reaction to CRISPR.

Q: If you add in other variables of shopping in a grocery store, the changes could be much more significant

A: Thats right. Two years ago, we examined price premiums and how pricing could impact the market. Once you start adding or subtracting premiums or discounts, that makes a difference. Even if youre at a higher price, I can generate or negate that price premium, through messaging impacts.

We had five percent of the group that would not purchase food with insecticides. These were diehards on the endpoints. And when we gave the group the information on insecticides, that 5 percent of diehards dropped to 2 percent that would not purchase the product. We are talking a 3 percent swing, or getting them from, Im not buying, to being open to buying now.

Q: Did you break down the results by demographics?

A: There are things going on demographic-wise. We see with GMOs, older people are less likely to buy GMOs. People in rural areas didnt like GMOs as much, but by and large, the big thing is, the more people perceive they know about these production practices, the more likely they are to consider buying these products with these practices.

Q: But you cant really control peoples perceptions, or whether they grasped the scientific definition you provided The type of information and the way its communicated seems to be very important.

A: Yes. It depends on what you want to do. If youre selling organic, you dont want to give people the scientific information on pesticides. If youre selling something traditional, non-organic, providing information about production practices and why youre doing it can be a way to counter organics.

Its the same with CRISPR and GMO, in terms of how consumers perceive your product, and in turn other products in a different way.

Q: This goes back to all the information out there that is not always scientific and scares people Some of that information can be quite impressionable. One of the issues magnified by vocal GMO opponents is the unknowns, or the long-term potential negative effects of consumption of GMOs Your definition of CRISPR and GMO outlines scientifically how the practice works, but doesnt address the impacts these alterations could have, either positive or negative. For instance, there is no mention of the positive attributes of the Arctic apple non-browning trait.

A: The key is the information you give will be a nudge to the average consumer, more so than those on the endpoints. The information you give can be powerful. It can have a meaningful effect on those people in the middle who may have strong opinions but can be influenced.

Q: To clarify, you just asked consumers about food, in general, without segmenting food categories, like fruits and vegetables, and you didnt give them examples?

A: No, we didnt. The problem is there are so many examples and categories. If the notion is your likeliness to buy a GMO apple is less than a GMO Pop Tart, the nudge to change that likeliness is what were interested in measuring based on receiving information on the production practice of GMO. Youll see that nudge going in the same direction with either one. I can spin it toward produce or food, in general, but the message stays the same; its just the starting point differs, as Brad Rickard showed in his study that you referenced earlier. Could we ask about produce directly, yes, but then you lose the process we set for this study.

Q: Miguel Gmez of Cornell will be revealing his latest peer-reviewed research, which will be hot off the press, at the NYPS, related to potential impacts of new GMO labeling requirements and non-GMO labeling counter-plays. It specifically targets strawberries, potatoes and apples. [Editors note, a sneak preview Q&A piece is here].

A: Im looking forward to seeing his presentation. I have a study, now in review, looking at tomatoes and tomato plants with GMO and non-GMO labels, and no labels, and those differences, and as a plant or as the product you buy at the supermarket to eat. The differences of how consumers perceive these things is there.

Labeling and how you message matters how you message can impact how consumers feel about your products and others products. So, if youre giving people good information about pesticide usage, it could have a positive impact on peoples views of your product if youre using those practices, and a detrimental impact on organic purchases. If you provide information de-mystifying GMO or CRISPR, it could have a negative effect on purchases of non-GMO, or non-CRISPR products. Thats the point Im trying to get across.

This messaging is interdependent. If you put a GMO label on one thing, it could have a detrimental impact on something else.

Q: Are you interested in extending this study in anyway? For instance, taking it from surveys to an actual supermarket setting, or as youve done in other instances, arrange scenarios where youre interviewing consumers in person and presenting them with actual products

A: Thats always the ideal, but its challenging to conduct studies like that. The problem is getting access to stores to do it. Retailers sometimes dont like you telling consumers about the products in the stores and giving them different messages about pesticides, GMOs, and CRISPR. That can be tricky, so a lot of times we stick to the online surveys or conducting our research outside of stores. I would love to go into stores and change prices of organic products and see how demand changes

Where we go from here the next step Im working on a study looking at plants and the media message, whats the source of the information, and how that impacts consumer perceptions. I would love to understand if the information is from a producer versus a retailer versus an association, versus a mass media outlet. What would happen if each of these players told you the same message, how would that influence the different choices? If an ag group told you about GMOs versus a retailer telling you about GMOs, would that impact the message and your purchasing decision?

Q: That research sounds fascinating

A: My hypothesis would be if the information was coming from an activist group, the consumer would take the information more seriously generally people trust universities; they dont trust the government that much. They trust activists, they dont trust retailers as much; they dont trust industry associations as much. You have these different groups that are vying for power and influence, in respect to getting information out.

Q: Its an interesting hypothesis to test. Will consumers be more accepting of a scientific-based, academic study debunking theEWG Dirty Dozenclaims than if they are warned to stay away from produce on the Dirty Dozen list on the Today Show or Dr. Oz? Further, if the messenger of that scientific-based study is theAlliance for Food and Farming, an industry organization, will that influence the consumers perception of its accuracy?Weve been reporting on these issues for many years.

A: At the NYPS, Ill talk about the production-practices messaging study we did, and the next steps

If you put a government GMO label on a product, it may have a detrimental impact on the consumers desire to purchase that product. But what we found in this study was if the GMO label also comes with good information describing what it is, the consumers could be nudged toward that GM product, and affect how they view other products. In the same way, pesticides are not all bad when you tell consumers what they are, and why theyre used. They may move incrementally toward the pesticide group, especially with plants, and away from the organic alternative. When people understand what it is, they are less likely to fear it and thereby say they are more likely to buy it.

Q: Did any of the results surprise you?

A: I expected if you provided pesticide information, it was only going to have an impact on pesticide products. I wasnt expecting to see so much cross effect on the other products, in respect to pesticides impacting organic, and GMOs impacting CRISPR and organic.

Read more here:
The Science of Product Messaging: How Unbiased Information on Pesticides, Fungicides, Herbicides, Organics, GMO and CRISPR Can Affect Consumer Buying...

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Global and Regional CRISPR And CRISPR-Associated (Cas) Genes Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2025 - Breakaway...

In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering -- by editing her genome.

Victoria Gray's recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research -- gene therapy.

"I have hoped for a cure since I was about 11," the 34-year-old told AFP in an email.

"Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency."

Over several weeks, Gray's blood was drawn so doctors could get to the cause of her illness -- stem cells from her bone marrow that were making deformed red blood cells.

The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 -- pronounced "Crisper" -- a new tool informally known as molecular "scissors."

The genetically edited cells were transfused back into Gray's veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary but, theoretically, she has been cured.

"This is one patient. This is early results. We need to see how it works out in other patients," said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville.

"But these results are really exciting."

In Germany, a 19-year-old woman was treated with a similar method for a different blood disease, beta thalassemia. She had previously needed 16 blood transfusions per year.

Nine months later, she is completely free of that burden.

For decades, the DNA of living organisms such as corn and salmon has been modified.

But Crispr, invented in 2012, made gene editing more widely accessible. It is much simpler than preceding technology, cheaper and easy to use in small labs.

The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself.

"It's all developing very quickly," said French geneticist Emmanuelle Charpentier, one of Crispr's inventors and the cofounder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Crispr is the latest breakthrough in a year of great strides in gene therapy, a medical adventure started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy.

Scientists practising the technique insert a normal gene into cells containing a defective gene.

It does the work the original could not -- such as making normal red blood cells, in Victoria's case, or making tumor-killing super white blood cells for a cancer patient.

Crispr goes even further: instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the US and a blood disease in the European Union.

They join several other gene therapies -- bringing the total to eight -- approved in recent years to treat certain cancers and an inherited blindness.

Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution.

"Twenty-five, 30 years, that's the time it had to take," he told AFP from Paris.

"It took a generation for gene therapy to become a reality. Now, it's only going to go faster."

Just outside Washington, at the National Institutes of Health (NIH), researchers are also celebrating a "breakthrough period."

"We have hit an inflection point," said Carrie Wolinetz, NIH's associate director for science policy.

These therapies are exorbitantly expensive, however, costing up to $2 million -- meaning patients face grueling negotiations with their insurance companies.

They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion -- and fighting a general infection.

"You cannot do this in a community hospital close to home," said her doctor.

However, the number of approved gene therapies will increase to about 40 by 2022, according to MIT researchers.

They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who don't necessarily share the medical ethics of Western medicine.

Last year in China, scientist He Jiankui triggered an international scandal -- and his excommunication from the scientific community -- when he used Crispr to create what he called the first gene-edited humans.

The biophysicist said he had altered the DNA of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV, even though there was no specific reason to put them through the process.

"That technology is not safe," said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr "scissors" often cut next to the targeted gene, causing unexpected mutations.

"It's very easy to do if you don't care about the consequences," Musunuru added.

Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability.

There is also the temptation to genetically edit entire animal species -- malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the US.

The researchers in charge of those projects are advancing carefully, however, fully aware of the unpredictability of chain reactions on the ecosystem.

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Charpentier doesn't believe in the more dystopian scenarios predicted for gene therapy, including American "biohackers" injecting themselves with Crispr technology bought online.

"Not everyone is a biologist or scientist," she said.

And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies' crops?

Charpentier thinks that technology generally tends to be used for the better.

"I'm a bacteriologist -- we've been talking about bioterrorism for years," she said. "Nothing has ever happened."

Link:
A #ReUp of 2019: The year when gene therapy, DNA modifications came of age & saved lives - Economic Times

Its said that nothing is certain except death and taxes. But doubt has been cast over the former since the 1970s, when scientists picked at the seams of one of the fundamental mysteries of biology: the molecular reasons we get old and die.

The loose thread they pulled had to do with telomeresmolecular timepieces on the ends of chromosomes that shorten each time a cell divides, in effect giving it a fixed life span. Some tissues (such as the gut lining) renew almost constantly, and it was found that these have high levels of an enzyme called telomerase, which works to rebuild and extend the telomeres so cells can keep dividing.

That was enough to win Elizabeth Blackburn, Carol Greider, and Jack Szostak a Nobel Prize in 2009. The obvious question, then, was whether telomerase could protect any cell from agingand maybe extend the life of entire organisms, too.

While telomere-extending treatments in mice have yielded intriguing results, nobody has demonstrated that tweaking the molecular clocks has benefits for humans. That isnt stopping one US startup from advertising a telomere-boosting genetic therapyat a price.

Libella Gene Therapeutics, based in Manhattan, Kansas, claims it is now offering a gene therapy to repair telomeres at a clinic in Colombia for $1 million a dose. The company announced on November 21 that it was recruiting patients into what it termed a pay-to-play clinical trial.

Buyer beware, though: this trial is for an unproven, untested treatment that might even be harmful to your health.

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The company proposes to inject patients with viruses carrying the genetic instructions cells need to manufacture telomerase reverse transcriptase, a molecule involved in extending the length of telomeres.

The dangers are enormous, says Jerry Shay, a world expert on aging and cancer at the University of Texas Southwestern Medical Center. Theres a risk of activating a pre-cancerous cell thats got all the alterations except telomerase, especially in people 65 and over.

For years now, people involved in the company have made shifting claims about the study, raising uncertainty about who is involved, when it might start, and even where it would occur. Trial listings posted in October to clinicaltrials.gov currently show plans for three linked experiments, each with five patients, targeting critical limb ischemia, Alzheimers, and aging, respectively.

Jeff Mathis, president of Libella, told MIT Technology Review that two patients have already paid the enormous fee to take part in the study: a 90-year-old-woman and a 79-year-old man, both US citizens. He said they could receive the gene therapy by the second week of January 2020.

The decision to charge patients a fortune to participate in the study of an experimental treatment is a red flag, say ethics experts. Whats the moral justification for charging individuals with Alzheimers? asks Leigh Turner, at the University of Minnesotas Center for Bioethics. Why charge those bearing all the risk?

The telomere study is occurring outside the US because it has not been approved by the Food and Drug Administration. Details posted to clincaltrials.gov indicate that the injections would be carried out at the IPS Arcasalud SAS medical clinic in Zipaquir, Colombia, 40 kilometers (25 miles) north of Bogot.

It takes a lot longer, is a lot more expensive, to get anything done in the US in a timely fashion, Mathis says of Libellas choice to go offshore.

To some promoters of anti-aging cures, urgency is justified. Heres the ethical dilemma: Do you run fast and run the risk of low credibility, or move slowly and have more credibility and global acceptancebut meanwhile people have died? says Mike Fossel, the president of Telocyte, a company planning to run a study of telomerase gene therapy in the US if it can win FDA signoff.

Our reporting revealed a number of unanswered questions about the trial. According to the listings, the principal investigatorwhich is to say the doctor in charge--is Jorge Ulloa, a vascular surgeon rather than an expert in gene transfer. I dont see someone with relevant scientific expertise, says Turner.

Furthermore, Bill Andrews, who is listed as Libellas chief scientific officer, says he does not know who Ulloa is, even though on Libellas website, the mens photos appear together on the list of team members. He said he believed that different doctors were leading the trial.

Turner also expressed concerns about the proposed 10-day observation period described in the posting for the overseas study: If someone pays, shows up, has treatment, and doesnt stick around very long, how are follow-up questions taking place? Where are they taking place?

Companies seeking to try the telomere approach often point to the work of Maria Blasco, a Spanish scientist who reported that telomere-lengthening gene therapy benefited mice and did not cause cancer. Blasco, director of the Spanish National Centre for Cancer Research, says she believes many more studies should be done before trying such a gene experiment on a person.

This isnt the first time Libella has announced that its trial would begin imminently. It claimed in late 2017 that human trials of the telomerase therapy would begin in the next few weeks. In 2016, Andrews (then partnered with biotech startup BioViva) claimed that construction of an age reversal clinic on the island nation of Fiji would be complete before the end of the year. Neither came to pass.

Similar questions surround Libellas most recent claims that it has two paying clients. Pedro Fabian Davalos Berdugo, manager of Arcasalud, said three patients were awaiting treatment in December. But Bioaccess, a Colombian contract research organization facilitating the Libella trial, said that no patients had yet been enrolled.

Also unclear is where Libella is obtaining the viruses needed for the treatment. Virovek, a California biotech company identified by several sources as Libellas manufacturer, did not answer questions about whether any treatment had been produced.

See more here:
Buyer beware of this $1 million gene therapy for aging - MIT Technology Review

The transgender pride flag.

A Russian court has sentenced a 53-year-old trans woman to three years in prison, on bogus distribution of pornography depicting minors charges for sharing nude anime drawings on social media.

The case began in the summer of 2018, when Michelle was informed she was under criminal investigation for posts of hentai sexually charged drawings featuring naked characters from Japanese cartoons in 2013 and 2014.

Prior to the trial, which took place in November, the investigators ordered an expert evaluation of the images from the Center for Socio-Cultural Expertise, an organization known to provide damning conclusions in politically motivated criminal cases, including the case of Pussy Riot, the child pornography case against human rights defender Yury Dmitriev, and dozens of extremism cases against Russias Jehovas Witnesses. Their evaluation of the drawings concluded that they included characters younger than 14 years of age. Authorities took Michelle into custody from the courtroom, immediately after the judge handed down the verdict. She remains in a solitary cell in jail pending an appeals hearing in her case.

Michelle, a survivor of bladder cancer who worked as an epidemiologist at a local clinic before she was fired because of the criminal case, has been on hormone therapy for transitioning for about two years. But she is legally recognized as male. She will therefore be forced to serve her sentence in a mens penal colony. Such a blatant disregard for her gender identity leaves Michelle extremely vulnerable to abuse by both male detainees and guards.

Moreover, Maria Chaschilova, a lawyer at the Moscow LGBT Community Center, who was in contact with Michelle before her trial, says Michelle does not have access to hormone therapy in prison and will not have it in penal colony. The World Professional Association for Transgender Health warns that for trans people in detention the consequences of abrupt withdrawal of hormones include a high likelihood of negative outcomes such as surgical self-treatment by autocastration, depressed mood, dysphoria, and/or suicidality.

Michelle is appealing her conviction and sentence, but so long as this case persists Michelles rights to health, identity, expression, liberty, and even to life hang in the balance.

Read the original here:
Russian Trans Woman Sentenced to Three Years in Men's Prison on Bogus Pornography Charges - Human Rights Watch