Clinical trial

metaMe Health Receives FDA Clearance for Regulora®, the First FDA-authorized Treatment Specifically for Abdominal Pain Due to Irritable Bowel Syndrome (IBS)

Tuesday, November 30, 2021 - 7:30pm

Treatment of abdominal pain associated with IBS is poised for a fundamental shift in clinical practice.

Key Points: 
  • Treatment of abdominal pain associated with IBS is poised for a fundamental shift in clinical practice.
  • "The FDA's clearance of Regulora, our first PDT, is a major achievement for the company," said Tim Rudolphi, CEO of metaMe Health.
  • Irritable Bowel Syndrome is a chronic condition of the lower gastrointestinal tract that affects 10-15% of adults in the United States.
  • PDTs are developed under rigorous conditions complete with clinical trials, FDA clearance, and availability only through a physician's prescription.

DGAP-News: Abivax's phase 1/2 clinical study results of ABX196 in liver cancer show good tolerability and promising signals of clinical benefit and were selected for presentation at the ASCO GI Cancers Symposium

Tuesday, November 30, 2021 - 5:09pm

These results support the further clinical development of ABX196 in the HCC setting.

Key Points: 
  • These results support the further clinical development of ABX196 in the HCC setting.
  • The ASCO GI Cancers Symposium is one of the most important international conferences to present and discuss the latest, most innovative and promising research advances in the field of gastrointestinal cancer.
  • It is organized every year by the American Society of Clinical Oncology (ASCO), the world's leading organization in cancer research.
  • We are very much looking forward to present and discuss these results with the world's leading oncology experts at the ASCO GI Cancers Symposium."

GreenLight Biosciences (ENVI) partners with IAVI to accelerate COVID-19 vaccine trial in Africa

Tuesday, November 30, 2021 - 3:52pm

NEW YORK, Nov. 30, 2021 /PRNewswire/ -- GreenLight Biosciences has partnered with the non-profit scientific research organization IAVI to work together on a Phase I clinical trial in Africa.

Key Points: 
  • NEW YORK, Nov. 30, 2021 /PRNewswire/ -- GreenLight Biosciences has partnered with the non-profit scientific research organization IAVI to work together on a Phase I clinical trial in Africa.
  • IAVI and its partners were among the first to conduct HIV vaccine clinical trials in Africa, and since then, IAVI has sponsored more than 60 vaccine and biologics clinical trials in 13 countries.
  • GreenLight will provide its vaccine candidate for the trial and will make preparations for large-scale manufacturing of the vaccine.
  • This partnership aims to accelerate the timeline for manufacturing and deployment of GreenLight's COVID-19 vaccine candidate to Africa and potentially for export from Africa.

Parks Associates: Adoption of Connected Medical Devices has Increased to 25% of US Broadband Households in 2021

Tuesday, November 30, 2021 - 2:15pm

The research firm reports that 55% of US broadband households now own a connected health device , while adoption of connected medical devices, which includes smart thermometers, connected blood-pressure cuffs, and wireless CPAP machines, increased from 15% in 2020 to 25% in 2021.

Key Points: 
  • The research firm reports that 55% of US broadband households now own a connected health device , while adoption of connected medical devices, which includes smart thermometers, connected blood-pressure cuffs, and wireless CPAP machines, increased from 15% in 2020 to 25% in 2021.
  • "Consumers recognize value in the ability to share data from their devices or apps," said Kristen Hanich , Sr. Analyst, Parks Associates.
  • "Interoperability is critical for extending the value of connected devices and services in remote patient care."
  • Connected Health Summit: Consumer Engagement and Innovation is a virtual executive conference focused on the impact of connected devices and IoT healthcare solutions on consumers at home.

Worldwide Clinical Trial Equipment & Ancillary Solutions Industry to 2028 - Players Include Ancillare, Thermo Fisher Scientific and IRM Among Others - ResearchAndMarkets.com

Tuesday, November 30, 2021 - 1:30pm

Complex clinical studies are creating new problems throughout the healthcare supply chain.

Key Points: 
  • Complex clinical studies are creating new problems throughout the healthcare supply chain.
  • As a result, the number of challenges that supply chain managers confront while working with clinical trial equipment & ancillaries has increased.
  • Another important decision-making reason is that renting equipment reduces significant upfront expenses and large investments required to furnish licensed clinical trial locations.
  • The COVID-19 pandemic has affected the global market, which resulted in slowing down the supply chain of the equipment & ancillary supplies.

Alzamend Neuro Announces Date for Delivery of Topline Data for Phase 1 First-in-Human Clinical Trial for AL001 for Dementia Related to Alzheimer’s

Tuesday, November 30, 2021 - 1:30pm

AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimers.

Key Points: 
  • AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimers.
  • We are very excited about this important milestone for Alzamend, said Stephan Jackman, Chief Executive Officer of Alzamend.
  • We look forward to utilizing these data to move swiftly into a Phase 2 multiple ascending dose study involving Alzheimers patients in the first quarter of 2022.
  • We have augmented our clinical trial preparations and executions related to the AL002 combined Phase 1/2 study, said Stephan Jackman.

Lineage Reports Fourth Case of Retinal Tissue Restoration With OpRegen®

Tuesday, November 30, 2021 - 1:00pm

After reporting three previous cases of retinal restoration over the course of the last two years, we have been carefully examining the other Cohort 4 patients.

Key Points: 
  • After reporting three previous cases of retinal restoration over the course of the last two years, we have been carefully examining the other Cohort 4 patients.
  • The finding of a fourth case of restoration further supports our goal of showing that atrophic age-related macular degeneration can be responsive to this type of cell therapy.
  • We have treated 24 patients with OpRegen, 12 of which were not legally blind at baseline and represent our intended treatment population.
  • Restoration of retinal tissue using cell therapy represents a paradigm shift compared to conventional approaches, which to date have only shown an unremarkable slowing of progression.

AgeX Therapeutics’ Licensee ImStem Biotechnology Announces First U.S. Multiple Sclerosis Patient Dosed with IMS001

Tuesday, November 30, 2021 - 1:30pm

AgeX Therapeutics, Inc. (AgeX; NYSE American: AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced today that ImStem Biotechnology, Inc. (ImStem), a biopharmaceutical company developing human embryonic stem cell (ESC)-derived mesenchymal stem cells, has dosed the first U.S. multiple sclerosis (MS) patient with ImStems lead investigational drug candidate IMS001 at the Shepherd Center in Atlanta, GA. IMS001 was derived by ImStem from AgeXs pluripotent stem cell line designated ESI-053, under a non-exclusive sublicense from AgeX.

Key Points: 
  • AgeX Therapeutics, Inc. (AgeX; NYSE American: AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced today that ImStem Biotechnology, Inc. (ImStem), a biopharmaceutical company developing human embryonic stem cell (ESC)-derived mesenchymal stem cells, has dosed the first U.S. multiple sclerosis (MS) patient with ImStems lead investigational drug candidate IMS001 at the Shepherd Center in Atlanta, GA. IMS001 was derived by ImStem from AgeXs pluripotent stem cell line designated ESI-053, under a non-exclusive sublicense from AgeX.
  • AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging.
  • AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes.
  • ImStem Biotechnology Inc. is a privately held company headquartered in Farmington, CT. For more information, visit www.imstem.com .

HSS and Rothman Institute/Jefferson University Hospital to Participate in Clinical Trial for Elute's Antibiotic Loaded Bone Void Filler

Tuesday, November 30, 2021 - 1:33pm

HSS and Rothman will join a group of Elute's clinical partners focused on improving patient care and driving clinical value.

Key Points: 
  • HSS and Rothman will join a group of Elute's clinical partners focused on improving patient care and driving clinical value.
  • "Rothman/Jefferson is happy to participate in this important clinical trial that will evaluate the role of an important and innovative product that offers the potential to help patients.
  • Elute's lead product candidate isEP Granules with Tobramycin, a bone void filler that is designed to provide 8-week, delivery of an antibiotic while allowing growth of new bone.
  • The joint replacement surgeons at Rothman Orthopaedics collectively perform over 17,000 hip and knee procedures each year in both an inpatient and outpatient capacity.

Biostage Hires David Green as Chief Executive Officer

Tuesday, November 30, 2021 - 1:30pm

HOLLISTON, Mass., Nov. 30, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a biotechnology company with successful "first-in-human" experience in esophageal cancer and FDA approval to commence a clinical trial of its Biostage Esophageal Implant for esophageal disease, today announced it has hired David Green as its Chief Executive Officer and appointed Mr. Green as Chairman of the Board of Directors (the "Board").

Key Points: 
  • HOLLISTON, Mass., Nov. 30, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a biotechnology company with successful "first-in-human" experience in esophageal cancer and FDA approval to commence a clinical trial of its Biostage Esophageal Implant for esophageal disease, today announced it has hired David Green as its Chief Executive Officer and appointed Mr. Green as Chairman of the Board of Directors (the "Board").
  • Mr. Green resigned from his roles in Biostage in 2015 after he had been involved in a major road accident.
  • The clinical results of the first-in-human use of our Biostage Esophageal Implant, conducted at Mayo Clinic in 2017, were very positive.
  • Because the Biostage Esophageal Implant is made using the patient's own cells, Biostage does not expect rejection of the implant.