(TheNewswire)
Multiple patientswith sustained clinical benefit, including positive fasting serumC-peptide (a biomarker of insulin produced by Sernova’s Cell Pouchislets) 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 therapeuticscompany today announced that its principal investigator, Dr. PiotrWitkowski, presented new preliminary data from Sernova’s ongoingU.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 toassess the safety, tolerability, and efficacy of the Cell Pouch withinsulin-producing islets. In addition to other criteria, prior toentry into the study, the patients must demonstrate long-standing T1Dwith severe hypoglycemic unawareness episodes and noglucose-stimulated C-peptide circulating in their bloodstream.
Dr. Witkowski’s presentation entitled “Islet AllotransplantationInto The Pre-Vascularized Sernova Cell Pouch TM Device - Preliminary Results Of The PhaseI/II Prospective, Open-Label, Single-Arm Study At University ofChicago” highlighted the following keypoints:
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- 6 patients are implanted with Cell Pouches andcontinue to meet the study’s primary safety endpoint;
- 5 patients have now been transplanted with at leastone dose of therapeutic cells (insulin producing islets) and are indifferent stages of the clinical trial; and
- most significantly, positive fasting serum C-peptidehas been detected in the bloodstream of 4 patients so far. C-peptideis a biomarker for insulin produced by the islets in the CellPouch .
In addition to the continued confirmation of ongoingsafety and tolerability in all currently enrolled patients, Dr.Witkowski provided further updates on the longest treated studypatients. These patients continue to show defined clinical benefitassociated with ongoing efficacy indicators including:
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- reduction/elimination in the need for dailyinjectable insulin
- continued improvement, i.e. reduction/elimination, inSevere Hypoglycemic Events (SHE);
- persistent detection of fasting and stimulatedC-peptide in patients’ bloodstream;
- reduction in HbA1c; and
- continued improvement of glucose control determinedthrough patient blinded Continuous Glucose Monitoring (CGM) andmeasured by reduction of Time Above Range (TAR) and increase of Timein Range (TIR).
As previously reported, the most advanced patient inthe study, who had achieved a ‘functional cure’ (requiring noinjectable insulin) and had been insulin independent for 9 months, hasnow been insulin independent for 14 months with optimal glucosecontrol.
“I believe Sernova is the first company in the worldto demonstrate a subcutaneous vascularized device with therapeuticcells able to produce insulin in the bloodstream across multiplepatients with the most severe diabetes. This is a remarkable feat. Asthe study progresses and our patient dataset continues to build, I ammore confident than ever of the potential of Sernova’s regenerativemedicine therapeutic platform,” said Dr.Philip Toleikis, President and CEO of Sernova. “Our vision ofimproving 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 technologiesusing 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 chronicmetabolic diseases such as insulin-dependent diabetes, blood disordersincluding hemophilia, and other diseases treated through replacementof proteins or hormones missing or in short supply within the body.For more information, please visit www.sernova.com .
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