Sernova receives notice of allowance from FDA for its investigational new drug

Clinical-stage company, Sernova has received a notice of allowance from the US Food and Drug Administration (FDA) for its investigational new drug (IND), with which it will initiate a clinical trial of its Cell Pouch System (CPS) in the US.

The company plans to initiate the new clinical trial under this US IND to investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycaemia unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to assess efficacy through a series of defined measures.

Global organisation, JDRF, has previously committed to provide Sernova up to $2.45 million USD to support the clinical trial.

“Hypoglycaemia unawareness is a serious consequence of type 1 diabetes,” said Derek Rapp, president & CEO, JDRF International. “We are excited to see progress in this and other potentially life-saving JDRF-funded research, which could help prevent people with hypoglycaemia unawareness from experiencing dangerous lows, as we strive to achieve our vision of a world without T1D.”

“We are extremely enthusiastic about the promise of Sernova’s regenerative medicine platform to provide a new therapeutic option for diabetes patients with hypoglycaemia unawareness. We believe Sernova’s multiple advancing cell based therapies have the potential to deliver significant improvement in the quality of life of patients suffering from diabetes and other debilitating diseases,” added Dr Philip Toleikis, Sernova’s president & CEO.