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Sernova Confirms Enduring Levels of Fasting C-Peptide in Bloodstream of First Patient in its Phase I/II Clinical Trial for Type-1 Diabetes

Findings further validate Cell Pouch and therapeutic cell performance in Type-1 diabetes

LONDON, ONTARIO - TheNewswire - October 16, 2019 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a clinical-stage regenerative medicine company, is pleased to announce the detection of enduring levels of C-peptide (measured up to 30 days and ongoing), a biomarker of transplanted beta cell insulin production, in the bloodstream of a fasting patient in its ongoing Phase I/II Cell Pouch(TM) US clinical study of type-1 diabetes.

The detection of fasting C-peptide in the bloodstream of our first patient, in addition to Sernova's recent announcement of glucose-stimulated C-peptide and other early efficacy indicators, demonstrate a normalizing response of the Cell Pouch therapeutic cells to the body's varied need for insulin production. This is an important step forward and evidence of ongoing islet engraftment within the Cell Pouch.

"Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide levels in the patient's bloodstream after recent transplant, not only following stimulation with a meal but also when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring islet survival and function within Sernova's Cell Pouch," said Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator. "We look forward to reporting ongoing results in additional patients as the trial progresses."

The entry criteria of Sernova's clinical study require patients to be C-peptide negative upon enrolment. C-peptide measured in the bloodstream is a biomarker of insulin and is widely used as a measure of insulin production by islet cells. C-peptide is typically measured following overnight fasting (fasting C-peptide) and during a glucose tolerance test (glucose-stimulated C-peptide). Together these measures provide an index of the patient's ability to control blood glucose through their production of insulin.

With the goal of improved blood glucose control and stabilization of fluctuating blood sugar levels commonly experienced in people with type-1 diabetes, a normalizing response can also decrease the likelihood of life threatening hypoglycemic unaware events, a key efficacy measure in the Sernova trial.

Sernova's clinical trial is continuing active recruitment and enrollment of study participants and further results will continue to be reported as the study progresses.

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Quelle: www.stockwatch.com
 
aus der Diskussion: Sernova – Patentierte Zelltaschen mit Schutzschild gegen die Immunabwehr !
Autor (Datum des Eintrages): techinvestor69  (16.10.19 15:11:32)
Beitrag: 808 von 8,470 (ID:61705204)
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