Sernova Biotherapeutics Inc. (SVA.TO), a clinical-stage biotechnology company focused on regenerative medicine, announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to autologous islet transplantation (AIT) for the prevention of type 3c diabetes (T3cD) resulting from total pancreatectomy.
Type 3c diabetes, also known as pancreatogenic diabetes, results from pancreatic damage that reduces insulin production and impairs blood glucose regulation. It can develop as a result of chronic pancreatitis, cystic fibrosis, pancreatic cancer, or other diseases that affect pancreatic function.
Sernova's proprietary Cell Pouch Bio-hybrid Organ is designed to support the engraftment and long-term function of transplanted therapeutic cells. The company plans to evaluate autologous islet transplantation using its Cell Pouch Bio-hybrid Organ by placing a patient's own insulin-producing islet cells, isolated from the removed pancreas, into the Cell Pouch and transplanting them back into the patient.
The goal is to eliminate the need for immunosuppression, preserve insulin production, and prevent post-surgical diabetes and its associated co-morbidities.
Jonathan Rigby, Chief Executive Officer of Sernova, said, "This designation provides Sernova with a potential exclusive lead position in preventing type 3c diabetes."
Sernova is currently trading at C$0.17, up 21.43% on the Toronto Stock Exchange.
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