(TheNewswire)
Multiple patients with sustained clinical benefit, including positive fasting serum C-peptide (a biomarker for insulin produced by Sernova’s Cell Pouch islets) detected in their bloodstream
LONDON, ONTARIO – TheNewswire – June 7, 2021 – Sernova Corp. (TSXV: SVA) (OTC: SEOVF) (FWB / XETRA: PSH), A leading clinical stage regenerative medicine company announced today that its principal investigator, Dr. Piotr Witkowski, presented new preliminary data from Sernova’s ongoing Phase I / II T1D clinical trial in the United States at the University of Chicago. Dr. Witkowski presented the data at the Virtual Connect 2021 conference of the American Transplant Congress (ATC) 2021 on Saturday, June 5, 2021.
The overall aim of the clinical study is to evaluate the safety, tolerability and effectiveness of the Cell Pouch with insulin-producing islets. In addition to other criteria, prior to enrollment in the study, patients must have a long history of T1D with severe hypoglycemic episodes of fainting and must not be circulating glucose-stimulated C-peptide.
Lecture by Dr. Witkowski with the title “Islet allograft in the prevascularized Sernova cell bag” TM Device – Preliminary Results of Prospective, Open, Single Arm, Phase I / II Study at the University of Chicago ” highlighted the following key points:
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– 6 patients will receive Cell Pouches and continue to meet the primary safety endpoint of the study;
– 5 patients have now received at least one dose of therapeutic cells (insulin-producing islets) and are in various stages of clinical trials; and
– especially, positive fasting serum C-peptide has so far been detected in the bloodstream of 4 patients. C-peptide is a biomarker for insulin that is produced by the islets in the cell bag .
In addition to the ongoing confirmation of continued safety and tolerability in all currently enrolled patients, Dr. Witkowski further updates on the longest-serving study patients. These patients continue to show a defined clinical benefit associated with ongoing indicators of effectiveness, including:
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– Reducing / eliminating the need for daily injectable insulin
– sustained improvement, ie reduction / elimination, in severe hypoglycemic events (SHE);
– Sustained evidence of fasting and stimulated C-peptide in the patient’s bloodstream;
– lowering of HbA1c; and
– Continuous improvement in glucose control as determined by patient-blinded continuous glucose monitoring (CGM) and measured by reducing the time over range (TAR) and increasing the time in range (TIR).
As previously reported, the most advanced patient in the study who achieved a “functional cure” (no need for 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 will be the first in the world to demonstrate a subcutaneous vascularized device with therapeutic cells capable of producing insulin in the bloodstream in several patients with the most severe diabetes. This is a remarkable achievement. As the study progresses and our patient record continues to grow, I am more confident than ever about 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 diabetics with a ‘functional cure’ is another step towards reality.”
ABOVE SERNOVA
Sernova develops 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 that are treated by replacing proteins or hormones that are missing or becoming scarce in the body. For more information, please visit www.sernova.com .
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