Adler Pollock & Sheehan P.C. (“AP&S”) is pleased to congratulate its client, Sernova Biotherapeutics Inc. on the U.S. Food and Drug Administration’s (FDA) grant of Orphan Drug Designation for autologous islet transplantation (AIT) for the prevention of diabetes resulting from total pancreatectomy.
The designation marks an important milestone in the development of Sernova’s innovative Cell Pouch Bio-hybrid Organ platform, which is designed to support the engraftment and long-term function of transplanted therapeutic cells. The FDA’s recognition underscores the potential of Sernova’s technology to address a significant unmet medical need for patients who undergo total pancreatectomy and face the risk of developing Type 3c diabetes.
Sernova is preparing to initiate a clinical trial involving autologous islet transplantation, a procedure in which a patient’s own insulin-producing islet cells are isolated from the removed pancreas, implanted within the Cell Pouch, and transplanted back into the patient. By utilizing the patient’s own cells, the approach may eliminate the need for immunosuppressive therapy while preserving insulin production and helping prevent post-surgical diabetes.
“On behalf of our Life Science team at Adler Pollock & Sheehan, we extend our congratulations to the Sernova team on this important achievement,” said AP&S Life Science attorney, Mike Morency, Ph.D. “The FDA’s Orphan Drug Designation highlights the promise of Sernova’s regenerative medicine platform and its potential to improve outcomes for patients facing complex pancreatic diseases and diabetes. We are proud to support Sernova as it advances these groundbreaking therapies.”
Orphan Drug Designation is granted by the FDA to encourage the development of therapies for rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation may provide development incentives, including potential market exclusivity upon approval, tax credits for qualified clinical testing, and waiver of certain FDA fees, subject to applicable requirements.
Sernova Biotherapeutics is a clinical-stage regenerative medicine company developing bio-hybrid organ technologies that combine its Cell Pouch with therapeutic cells to create potential functional cures for insulin-dependent diabetes and other chronic diseases.