Press release Communiqué de presse
Press release Communiqué de presse
January 10, 2022 10 January, 2022
The Principal Investigator in Sernova’s Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Independent
LONDON, ONTARIO – January 10, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE / XETRA:PSH), a
clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional
cure’ for type 1 diabetes (T1D) and other chronic diseases, is pleased to provide a progress update on its Phase
1/2 T1D clinical trial in conjunction with Dr. Piotr Witkowski, the clinical trial’s Principal Investigator at the
University of Chicago. Dr. Witkowski was originally scheduled to provide a clinical trial update at the 2022
American Society of Transplant Surgeons (ASTS) Winter Symposium; however, the conference is now
postponed until August 2022 as a result of the ongoing COVID-19 pandemic.
The objective of Sernova’s Phase 1/2 clinical trial is to assess the safety, tolerability and efficacy of its proprietary Cell Pouch™ transplanted with insulin-producing islets in patients with T1D complicated by hypoglycemia unawareness and a history of severe hypoglycemic events. Study patients must meet stringent eligibility criteria including, but not limited to, long-standing T1D, recent episodes of hypoglycemic unawareness and an absence of glucose-stimulated C-peptide detectable in their bloodstream. Study patients are eligible to receive up to three islet cell transplants throughout the study, including two marginal dose transplants into the Cell Pouch and a single, marginal islet supplement transplanted via the portal vein.
Sernova would like to highlight some updated study findings and key points from the ongoing trial:
• the ongoing safety and tolerability of Cell Pouch has been maintained in all study patients; • Islet transplantation to the Cell Pouch resulted in the establishment of new, measurable islet function documented by detectable levels of stimulated C-peptide in the first three patients, who completed the protocol-defined course of transplants. • a supplemental, single intraportal islet transplant was sufficient for the first two patients to achieve and maintain sustained ongoing insulin independence and freedom from severe hypoglycemic events for over 21 and 2 months, respectively. • the third transplanted patient recently completed their course of Cell Pouch transplants and a supplemental intraportal islet infusion, with favorable improvements in glucose control, near-normal levels of C-peptide, an absence of severe hypoglycemic events and reductions in daily insulin use; • the other three enrolled study patients are progressing through the study protocol, as planned. All have received Cell Pouch implants and are at various stages of protocol-defined islet transplants and follow-up; and • a 7th study patient has been identified.
“We are very encouraged by finding detectable serum C-peptide levels after islet transplantation into the Sernova Cell Pouch in the three most advanced study patients. Additionally, we are very excited about the first two patients becoming insulin independent and free from severe hypoglycemic events after a single supplemental intraportal islet infusion,” said Dr. Witkowski. “I look forward to continuing this trial with Sernova as we further optimize our use of the Cell Pouch System and validate its therapeutic potential.”
Dr. Philip Toleikis, President & CEO of Sernova Corp further remarked, “We believe Sernova is the first company to report that its first two transplanted T1D cell therapy study patients achieved sustained insulin independence. We are further reassured that our Cell Pouch System is performing as expected by creating a safe, vascularized, and natural tissue environment inside the human body, allowing the islet cells to thrive and function efficiently following transplantation. As we progress through the trial, under the expert guidance of Dr. Witkowski, we have had several scientific breakthroughs and advancements related to insulin producing cell dynamics and efficacy related to our Cell Pouch technologies. These findings have led to several technical optimizations, including the upcoming introduction of a higher capacity Cell Pouch configuration designed to accommodate the total quantity and distribution of islets that are achieving insulin independence for patients in our clinical trial. This configuration of Cell Pouch has already received regulatory authorization to be used for the remaining trial implants. Sernova is grateful to Dr. Witkowski’s leadership in this trial as we further enhance our therapeutic cell transplantation approach with our goal to achieve a ‘functional cure’ for the patients with complicated T1D.” Sernova has developed its cell therapy platform, the Cell Pouch System, with the vision of treating the millions of patients with T1D and other chronic diseases using immune-protected therapeutic cells, including stem cell- derived technologies. Sernova’s approach is to provide a minimally invasive, retrievable, safe, organ like environment for rapid engraftment and long-term survival of therapeutic cells as well as to avoid blood mediated inflammatory reactions and permit cell retrievability that cannot be achieved with the traditional portal vein transplantation.
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 HYPOGLYCEMIA UNAWARENESS
Hypoglycemia unawareness is a person’s inability to recognize the symptoms of low blood sugar before they become severe or even fatal. It typically occurs when blood glucose levels are below 3.0 mmol/L and is estimated to affect approximately 15% of people with T1D.
Severe symptoms of low blood sugar include confusion, slurred speech, impaired motor coordination and personality changes. Individuals experiencing a severe hypoglycemic event can lose their ability for self-care and self-control, requiring urgent intervention from another person to prevent loss of consciousness, seizure, coma or death. After a person has had a first hypoglycemia unawareness episode, more are likely to occur.
ABOUT SERNOVA Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and immune protected therapeutic cells / tissues (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 cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells, that 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 a Canadian first-in-human study. Sernova is currently conducting a Phase 1/2 clinical trial study at the University of Chicago. Positive initial results have been presented at several international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes VP, Investor Relations Sernova Corp. firstname.lastname@example.org Tel: 519-902-7923 www.sernova.com
Corey Davis, Ph.D. LifeScience Advisors, LLC email@example.com Tel: 212-915-2577
This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. 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.