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Beyond Celiac Chosen by 9 Meters Biopharma as Exclusive Patient Organization to Recruit for First-Ever Phase 3 Clinical Trial

Premier Patient Recruiter for Celiac Disease Research, Beyond Celiac Taps Extensive Network to Advance Study

Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3

Philadelphia, PA, Oct. 14, 2020 (GLOBE NEWSWIRE) — Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has been chosen by 9 Meters Biopharma, Inc. (Nasdaq: NMTR) as the exclusive patient organization to recruit for the first-ever Phase 3-stage clinical trial therapeutic for treatment of celiac disease. Beyond Celiac will use its unrivaled connection to the celiac disease community and its powerful online patient database to recruit participants for the study of larazotide acetate, which aims to address leaky gut in celiac disease.

“We really listen to our community’s wants and needs. Because of our extensive connection to the people and commitment to connecting researchers with our community, Beyond Celiac has become the partner of choice for leading biotechnology and pharmaceutical companies such as 9 Meters,” said Beyond Celiac CEO Alice Bast. “This is the furthest a celiac disease clinical trial has gone, and it’s an exciting opportunity for our organization to play a vital role in fulfilling its promise.”

9 Meters Biopharma is evaluating larazotide acetate for celiac disease patients who continue to experience gastrointestinal symptoms while following a gluten-free diet. Designed to tighten junctions between intestinal cells, larazotide acetate would act like shoelaces to help restore leaky junctions to a normal state and would be used in addition to the gluten-free diet. It is being tested at more than 100 clinical sites, with a goal of 525 study participants. Results are expected by the end of 2021.

By partnering with Beyond Celiac for recruitment, 9 Meters Biopharma now has access to the power of Go Beyond Celiac, a secure online patient database with thousands of users who share their celiac disease stories and experiences with researchers and seek to become involved in studies.

“Our conservative estimate is that our celiac disease program is at least two years ahead of everyone else’s,” said John Temperato, president and CEO of 9 Meters Biopharma. “Beyond Celiac is going to help us across the finish line in developing the effective treatments that celiac patients deserve.”

Celiac disease is a serious genetic autoimmune disorder that affects an estimated 1 in 133 Americans, more than half of whom are still undiagnosed. The disease causes damage to the small intestine, resulting in debilitating symptoms, and if left untreated, can lead to serious long-term health problems including infertility and some types of cancer.

 

About Beyond Celiac

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Exclusive: Moderna Vaccine Trial Contractors Fail to Enroll Enough Minorities, Prompting Slowdown | Top News

CHICAGO (Reuters) – Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest along in the U.S. race for a vaccine seen as essential to ending a pandemic that has claimed over a million lives worldwide. It received more than $1 billion in government funding to develop and produce its candidate, and another $1.5

Exclusive: Moderna vaccine trial contractors fail to enroll enough minorities, prompting slowdown

CHICAGO (Reuters) – Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyder/File Photo

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest along in the U.S. race for a vaccine seen as essential

Exclusive: FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine – sources

WASHINGTON (Reuters) – The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.

FILE PHOTO: A test tube labelled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic

AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said.

Effective vaccines are seen as essential to help end a pandemic that has killed more than one million people worldwide.

The administration of President Donald Trump has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the United States. Other leading companies in the U.S. vaccine race include Pfizer Inc, Moderna Inc and Johnson & Johnson.

Regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials there.

The FDA, however, wants to determine whether similar side effects emerged in trials of other vaccines designed by AstraZeneca’s coronavirus vaccine partner, researchers at Oxford University, the sources said. That does not mean the agency believes there were safety issues associated with any of these vaccines, they added.

“It just shows that the FDA is being thorough,” said one of the sources.

Further complicating the situation is that the data requested by FDA is in a different format than what the U.S. regulator requires, two of the sources said.

The FDA declined to comment on discussions involving an experimental product. Oxford did not respond to requests for comment. AstraZeneca, in a statement, said: “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”

VIRAL VECTOR

All of the vaccines it wants to review use a modified adenovirus as vectors to safely deliver genetic material from the target illnesses – flu, Middle East Respiratory Syndrome, and other diseases – into the body to stimulate an immune system response to fight future infection.

While other vaccine developers have used human adenoviruses for such vaccines, the Oxford researchers chose an adenovirus found in chimpanzees. They felt this would reduce the likelihood that an individual’s immune system would attack the vector virus due to prior exposure rather than the intended target.

Reuters reviewed six research papers that detailed safety data of vaccines using the engineered chimpanzee adenovirus called ChAdOx1 for diseases including tuberculosis, prostate cancer and