Society for Brain Mapping and Therapeutics (SBMT) president, Dr. Robert Hariri, CEO of Celularity, has received FDA approval for a clinical trial using immunotherapy to treat COVID-19.
From PR Newswire
WARREN, N.J., April 2, 2020 /PRNewswire/ — Celularity Inc. (“Celularity” or the “Company”), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. With this, Celularity will commence a Phase I/II clinical study including up to 86 patients with COVID-19. The Company believes CYNK-001 is the first immunotherapy IND cleared by the FDA to treat COVID-19 infected adults.
“This IND represents a significant step toward a potential treatment of patients infected with COVID-19 virus, which is spreading globally at unanticipated rates,” said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. “With our initial clinical study, we will gain an understanding of the impact CYNK-001 can have on patients recently diagnosed with COVID-19. We are hopeful to contribute to flattening the COVID-19 curve, expanding on the promising early results we’ve seen in our clinical studies in devastating cancers to patients with coronavirus.” Dr. Hariri also thanked the FDA’s Center for Biologics Evaluation and Research (CBER) in his statement, “While most of its work occurs out of the public’s eye, CBER embodies the public service ideal amidst the current crisis. Thanks to the women and men of CBER for their tireless effort to guide us through the IND process.”