Orbsen Therapeutics Launches Clinical Trial to Address Leading Cause of Death Among COVID-19 Patients

Orbsen's stromal cell immunotherapy, ORBCEL, may benefit patients with Acute Respiratory Distress Syndrome (ARDS) caused by coronavirus (COVID-19)

GALWAY, Ireland, April 8, 2020 /PRNewswire/ -- Orbsen Therapeutics, a biotechnology company focused on the development and commercialization of best-in-class stromal cell immunotherapies, announced the beginning of a phase 2a clinical trial for the treatment of COVID-19 patients with acute respiratory distress syndrome (ARDS). Nearly 90 percent of deaths caused by COVID-19 are the result of ARDS.

Orbsen's ORBCEL recently completed a successful phase 1 trial in patients with moderate to severe ARDS. In pre-clinical studies, ORBCEL, a next-generation stromal cell immunotherapy, demonstrated the ability to mitigate the devastating effects of ARDS by improving lung oxygenation, lessening inflammation, reducing edema and decreasing bacterial infection.

"The successful completion of ORBCEL's phase 1 clinical trial, intended to assess ORBCEL safety in patients, confirms our belief in the potential of Orbsen's proprietary stromal cell immunotherapy technologies," said Dr. Larry Couture, CEO of Orbsen Therapeutics. "We believe ORBCEL will prove a valuable addition to the arsenal of therapies to combat the effects of COVID-19."

The phase 2a clinical trial, funded by the Wellcome Trust, has been approved by the United Kingdom's Medical Health Regulatory Agency (MHRA). Also, the UK's National Institute of Health Research (NIHR) designated the trial as a National Urgent Public Health Study.

"While more than 100 vaccines and therapies targeting COVID-19 are in development, there are no disease modifying therapies approved for ARDS," said Dr. Steve Elliman, Chief Scientific Officer at Orbsen. "We take seriously NIHR's designation of this trial as an Urgent Public Health Research Study and believe ORBCEL has the potential to be a timely and effective treatment for patients with ARDS."

Patients have already begun enrolling in the study. Five clinical trial sites throughout the UK will host the study led by clinical investigators from Queen's University Belfast. Other trial supporters include the Health and Social Care Research & Development Division and the Belfast Health and Social Care Trust.

ORBCEL is derived from a select and highly purified population of immunomodulatory stromal cells obtained from umbilical cord tissue. Orbsen currently is enrolling and treating patients in additional clinical trials across Europe to assess ORBCEL's safety and efficacy in the prevention and treatment of diabetic kidney disease, auto-immune hepatitis and primary sclerosing cholangitis. Another trial is pending regulatory review in the UK for patients with several auto-immune disorders.

About Orbsen Therapeutics

Orbsen Therapeutics, Ltd. is a leading company in the development of cellular immunotherapies across four immune-mediated inflammatory conditions. Founded in 2006, Orbsen Therapeutics Ltd., is a privately held company led by global leaders in the field of cellular immunotherapy. The company, which spun-out from Ireland's Regenerative Medicine Institute at the National University of Ireland Galway, has developed proprietary technologies that enables the isolation of a well characterized population of pure stromal cells from human tissues which, once isolated, can be expanded and frozen to generate multiple doses of an "off the shelf" therapeutic product.

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