Press release Communiqué de presse
Press release Communiqué de presse
November 18, 2020 18 November, 2020
Sernova Provides Clinical Update on U.S. Phase I/II Cell Pouch Trial for Type 1 Diabetes
• 5 of 7 study patients implanted with Cell Pouch and cell transplants ongoing; full enrollment on track for
• Treated patients continue to demonstrate enduring safety indicators and blood levels of insulin (C-peptide) produced by cells in the Cell Pouch
November 18, 2020 9:00 a.m. EST
LONDON, ONTARIO – November 18, 2020 – Sernova Corp (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a leading clinical-stage regenerative medicine therapeutics company developing a ‘functional cure’ for insulin-dependent diabetes, hemophilia A, and other diseases, provides an update on its U.S. Phase I/II (safety/efficacy) clinical trial of its Cell Pouch System for type 1 diabetes (T1D) at the University of Chicago.
The overall objective of the study is to assess the safety, tolerability, and efficacy of the Cell Pouch with insulin- producing islets. In addition to other criteria, prior to entry into the study, the patients must demonstrate long- standing type 1 diabetes with severe hypoglycemic unawareness episodes and no glucose-stimulated C- peptide circulating in their bloodstream.
As of this date, 5 of the 7 patients have now been enrolled, implanted with Cell Pouches and are actively advancing through the transplantation phase of the study. Pre-screening is ongoing for the final two patients and full enrollment of the study is anticipated to be completed in the first quarter of 2021.
The primary endpoint of the study is to demonstrate safety and tolerability of islet transplantation into the Cell Pouch. Overall, the following trends have been observed:
SAFETY (Primary Endpoint):
• Following implantation, consistent incorporation of the Cell Pouch with vascularized tissue providing a suitable environment for transplant of islets (insulin-producing cells)
• No incidence of Severe Adverse Events (SAEs) related to the Cell Pouch or islet transplant
“I am pleased that these ongoing safety findings in the treated patients continue to meet the primary endpoint for our study,” said Dr. Piotr Witkowski, study principal investigator and Director of the Pancreatic and Islet Transplant Program at the University of Chicago.
Highlighting some of the trial efficacy findings with focus on clinical benefits to the T1D patients, the following trends have also been observed.
EFFICACY (Secondary Endpoint):
• Ongoing detection of bloodstream levels of C-peptide in treated patients (proof that cells in the Cell Pouch are producing insulin, important for controlling blood sugar levels)
• Reduction in injectable insulin use
• Reduction in levels of HbA1c as a measure of long-term glucose control (the lower the HbA1c, the lesser the risk of developing diabetes-related complications)
• Reduction in severe hypoglycemic episodes (blood sugar levels that are too low may lead to life- threatening events)
“I am encouraged by the fact that, in contrast to previous clinical studies in this field, we are observing persistent evidence of insulin production (C-peptide) by islets transplanted into the Cell Pouch in our patients,” said Dr. Piotr Witkowski. “I look forward to ongoing results in the study and observing improvements in patient quality of life along with efficacy measures as we advance this regenerative medicine treatment.”
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. The primary objective of the study is to assess the safety of the Cell Pouch following implantation and transplantation. The secondary objective is to assess efficacy through a series of defined measures. Patients enrolled in Sernova’s clinical trial are incapable of producing C-peptide, a biomarker for insulin produced by islet cells.
Eligible subjects are implanted with Cell Pouches. Following the 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, is 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. Patients will be then further followed for one year to assess longer-term safety and efficacy.
For more information on the 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 upon implantation 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 in its first treated patient 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 press release contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this press release 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. Forward-looking statements include statements about subsequent clinical activity, including enrolment of patients and continuing results therefrom, and the potential benefits, safety, and efficacy of the Cell Pouch for various indications, including type 1 diabetes. While Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to significant scientific, business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors that could cause Sernova’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained in this press release. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Readers should not place undue reliance on these statements or the scientific data presented and should refer to the risk factors identified in the company’s continuous disclosure filed on SEDAR. 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.