Dr. Philip Toleikis reports
SERNOVA ACHIEVES POSITIVE EFFICACY ENDPOINT IN PHASE I/II CLINICAL TRIAL FOR TYPE 1 DIABETES
Sernova Corp.'s first treated patient in its phase 1/2 clinical trial of its Cell Pouch with therapeutic cells for Type 1 diabetes at the University of Chicago has demonstrated survival of
endocrine tissue (insulin-producing islets) in the sentinel Cell Pouch following 90 days transplant.
This efficacy outcome, namely survival of
endocrine tissue in the sentinel Cell Pouch following 90 days transplant,
by positive staining of islets during histological analysis.
According to the independent pathologist who conducted the analysis: "The explanted sentinel pouch shows abundant viable, organized islet cells intimately associated with blood vessels within a collagen matrix after 90 days of transplantation. These surviving islet cells strongly express insulin."
This achievement is important because it is an indicator of transplanted islet health in the therapeutic Cell Pouches remaining in the subject, including the islets' ability to produce insulin into the bloodstream. This has been demonstrated by
the company's previous reported findings of blood levels of both glucose-stimulated and fasting C-peptide, as well as other efficacy indicators in this patient, who had no measurable levels of this biomarker of insulin prior to the Cell Pouch islet transplant.
"We believe these accumulating positive results continue to validate our Cell Pouch technologies as a viable regenerative medicine therapeutic platform for humans in insulin-dependent diabetes and other chronic diseases," commented Dr. Philip Toleikis, president and chief executive officer of Sernova. "With these encouraging results and the positive review and recommendation from the Data Safety and Monitoring Board
(DSMB), we are excited to continue the clinical trial and carry on compiling safety and efficacy data from our current and future treated patients."
About Sernova's clinical trail
Sernova is conducting a phase 1/2 non-randomized, unblinded, single-arm, company-sponsored trial to assess the safety and tolerability of islet transplantation into the company's patented Cell Pouch in participants with diabetes and hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined measures.
About Sernova's Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device designed for the long-term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones, as required, to treat disease.
About Sernova Corp.
Sernova is developing regenerative medicine therapeutic technologies using a medical device and immune-protected therapeutic 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.
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