Dr. Philip Toleikis reports
SERNOVA ANNOUNCES POSITIVE DSMB REVIEW AND RECOMMENDATION FOR CONTINUATION OF PHASE I/II DIABETES CLINICAL TRIAL OF CELL POUCH
The independent Data Safety Monitoring Board (DSMB) has completed its first interim analysis of the continuing safety, tolerability and efficacy study of Sernova Corp.'s Cell Pouch for clinical islet transplantation phase 1/2 clinical trial in patients with severe hypoglycemia unawareness.
The DSMB did not raise any concerns regarding safety and recommended the continuation of the study.
"We are very pleased with the recommendation of the DSMB. In light of this positive assessment, Sernova continues the trial as we carry on compiling safety and efficacy results from our treated patients, along with advancing further patient enrolment at the University of Chicago," commented Dr. Philip Toleikis, president and chief executive officer of Sernova. "We thank the DSMB for its diligence, guidance and support as we continue moving forward with our mission to provide people suffering from diabetes and other chronic diseases improved treatment options and a better quality of life."
The DSMB is an independent group of clinical research experts that reviews the accumulated safety data throughout the clinical trial to safeguard the safety and interests of participating patients, while ensuring the scientific validity and integrity of the trial. This interim analysis was the first of three planned DSMB reviews of this clinical trial.
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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