Multiple patients with sustained clinical benefit, including positive fasting serum C-peptide (a biomarker of insulin produced by Sernova’s Cell Pouch islets) detected in their bloodstream
LONDON, ONTARIO – TheNewswire - June 7, 2021 – Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE/XETRA:PSH), a leading clinical-stage regenerative medicine therapeutics company today announced that its principal investigator, Dr. Piotr Witkowski, presented new preliminary data from Sernova’s ongoing U.S. Phase I/II T1D clinical trial at the University of Chicago. Dr. Witkowski’s presented the data at the American Transplant Congress (ATC) 2021 Virtual Connect conference on Saturday June 5, 2021.
The overall objective of the clinical trial is to assess the safety, tolerability, and efficacy of the Cell Pouch with insulin-producing islets. In addition to other criteria, prior to entry into the study, the patients must demonstrate long-standing T1D with severe hypoglycemic unawareness episodes and no glucose-stimulated C-peptide circulating in their bloodstream.
Dr. Witkowski’s presentation entitled “Islet Allotransplantation Into The Pre-Vascularized Sernova Cell PouchTM Device - Preliminary Results Of The Phase I/II Prospective, Open-Label, Single-Arm Study At University of Chicago” highlighted the following key points:
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- 6 patients are implanted with Cell Pouches and continue to meet the study’s primary safety endpoint;
- 5 patients have now been transplanted with at least one dose of therapeutic cells (insulin producing islets) and are in different stages of the clinical trial; and
- most significantly, positive fasting serum C-peptide has been detected in the bloodstream of 4 patients so far. C-peptide is a biomarker for insulin produced by the islets in the Cell Pouch.
In addition to the continued confirmation of ongoing safety and tolerability in all currently enrolled patients, Dr. Witkowski provided further updates on the longest treated study patients. These patients continue to show defined clinical benefit associated with ongoing efficacy indicators including:
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- reduction/elimination in the need for daily injectable insulin
- continued improvement, i.e. reduction/elimination, in Severe Hypoglycemic Events (SHE);
- persistent detection of fasting and stimulated C-peptide in patients’ bloodstream;
- reduction in HbA1c; and
- continued improvement of glucose control determined through patient blinded Continuous Glucose Monitoring (CGM) and measured by reduction of Time Above Range (TAR) and increase of Time in Range (TIR).
As previously reported, the most advanced patient in the study, who had achieved a ‘functional cure’ (requiring no injectable insulin) and had been insulin independent for 9 months, has now been insulin independent for 14 months with optimal glucose control.
“I believe Sernova is the first company in the world to demonstrate a subcutaneous vascularized device with therapeutic cells able to produce insulin in the bloodstream across multiple patients with the most severe diabetes. This is a remarkable feat. As the study progresses and our patient dataset continues to build, I am more confident than ever of the potential of Sernova’s regenerative medicine therapeutic platform,” said Dr. Philip Toleikis, President and CEO of Sernova. “Our vision of improving the lives of people suffering from diabetes with a ‘functional cure’ is another step closer to becoming a reality.”
Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
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