Press release Communiqué de presse
Press release Communiqué de presse
February 18, 2021 18 February, 2021
Sernova Announces Second Annual Data Safety Monitoring Board Review of its Diabetes Cell Pouch System™ Clinical Trial and Recommendation for Protocol Continuation
Ongoing Safety of Sernova's Clinical Trial Confirmed
February 18, 2021 9:00 a.m. EST
LONDON, ONTARIO – February 18, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical- stage company and leader in regenerative medicine therapeutics, is pleased to announce that the clinical trial independent Data Safety Monitoring Board ("DSMB") has completed the second planned annual review of the ongoing Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation Phase I/II clinical trial in patients with severe hypoglycemia unawareness and inability to produce their own insulin. The DSMB recommended that the Phase I/II clinical study should continue according to the study protocol and any related amendments. In their assessment, the DSMB did not raise any concerns regarding patient safety.
"We are pleased with the second annual independent DSMB review of our Phase I/II clinical trial," said Dr. Philip Toleikis, President & CEO Sernova Corp. "We thank the DSMB for its diligence, guidance and support as Sernova continues progressing the clinical trial."
The DSMB is an independent group of clinical research experts who review the accumulated data to permit a thorough evaluation of patient safety and to ensure the integrity of the study's data and progress towards completion.
ABOUT SERNOVA'S CLINICAL TRIAL
Sernova is conducting a Phase I/II 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 diabetic subjects with hypoglycemia unawareness and an inability to produce their own insulin. The secondary objective is to assess efficacy through a series of defined measures. Eligible subjects are implanted with Cell Pouches. Following development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under strict release criteria, transplanted into the Cell Pouch. A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional safety and efficacy measures for approximately six months. At this point, a decision will be made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow-up. Following this period, eligible patients may be administered a single dose of islets through the portal vein. Patients will be then further followed for one year to assess longer-term safety and efficacy. This study is supported in part by funding from JDRF, the leading global organization funding type 1 diabetes (T1D) research.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details, please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA'S CELL POUCH SYSTEM
The Cell Pouch system including the Cell Pouch, which is a novel, proprietary, scalable, implantable macro- encapsulation device solution 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. The Cell Pouch along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin- producing cells in humans. In early assessments of its ongoing Phase I/II clinical trial, Sernova has shown presence of blood levels of c-peptide both during glucose tolerance tests as well as under fasting conditions. Clinical testing is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing 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 treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information contact:
Tel: (519) 858-5126
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova's management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.