08.04.2019 11:02:00

Clinical Trial Investigates Orbsen Therapeutics' ORBCEL-C™ Immunotherapy as Treatment for Two Autoimmune Liver Diseases

MERLIN is one of four separate clinical trials studying ORBCEL stromal cell immunotherapies designed to treat some of the most challenging diseases

GALWAY, Ireland, April 8, 2019 /PRNewswire/ -- Orbsen Therapeutics, a biotechnology company focused on the development and commercialization of first-in-class stromal cell immunotherapies, announced its second generation immunotherapy ORBCEL-C™ is being administered to patients participating in MERLIN, a multi-site United Kingdom-based clinical trial to determine the therapy's safety and effectiveness in treating two types of chronic autoimmune liver diseases.

"Orbsen's product pipeline featuring ORBCEL immunotherapies has tremendous potential to make a significant impact on illnesses related to diabetes, autoimmunity and inflammation, as well as chronic liver diseases," said Dr. Larry Couture, CEO of Orbsen Therapeutics.

MERLIN is investigating ORBCEL-C's ability to safely and effectively treat individuals with primary sclerosing cholangitis (PSC), a condition characterized by inflammation in the bile ducts, and autoimmune hepatitis (AIH), a disease which causes the body's immune system to attack the liver. If left untreated, both conditions may lead to cirrhosis or liver failure and subsequently require liver transplantation.

The clinical trial, which will follow as many as 56 patients through the treatment process, is under the direction of Chief Investigator Professor Philip Newsome from the University of Birmingham's Institute of Immunology and Immunotherapy. Study sites include Birmingham, Oxford and Nottingham.

"I am very excited about the potential benefits of this treatment for patients with PSC and AIH," said Professor Newsome. "There is good evidence the selected cells within this new immunotherapy can reduce liver inflammation and improve liver function. The study aims to prove the treatment's safety and efficacy, and explore the possibility it may be applied to future clinical trials to address other immune and inflammatory diseases."

Orbsen's proprietary ORBCEL™ technology yields nearly 100 percent pure stromal cells, a significant increase in purity when compared to first generation stromal cell therapies.

"Patients suffering with PSC and AIH have few therapeutic options today, and most patients require liver transplantation," said Dr. Stephen Elliman, Chief Scientific Officer at Orbsen Therapeutics. "We are optimistic taking ORBCEL-C immunotherapy to the clinic as a solution to preserve liver function and slow progression of these autoimmune liver diseases — ultimately reducing the need for liver transplants in these patients."

Orbsen currently is enrolling and treating patients in three additional clinical trials to assess ORBCEL's safety and efficacy in the prevention and treatment of diabetic kidney disease, non-healing diabetic foot ulcers and moderate to severe acute respiratory distress syndrome (ARDS). Another trial is pending 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 or 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 a high-margin, "off the shelf" therapeutic product.

For more information visit: www.orbsentherapeutics.com

Contact: Rand Walton, 804-647-4526, rwalton@waltonstrategic.com

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