Press release Communiqué de presse
Press release Communiqué de presse
January 15, 2021 15 January, 2021
Sernova Principal Investigator Presents Additional Positive Preliminary Safety and Efficacy Data from Ongoing U.S. Phase I/II Cell Pouch Clinical Trial for Type-1 Diabetes
Sernova’s Cell Pouch System shows sustained clinical benefit in study patients with type 1 diabetes through
multiple efficacy indicators and ongoing safety and tolerability
January 15, 2021 2:05 p.m. EST
LONDON, ONTARIO – January 15, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a leading clinical-stage regenerative medicine therapeutics company today announced that its principal clinical investigator, Dr. Piotr Witkowski, presented additional positive preliminary safety and efficacy data at the 2021 American Society of Transplant Surgeons Winter Symposium. Sernova’s Cell Pouch™ transplanted with insulin producing cells in patients with type 1 diabetes continues to show persistent islet function and clinically meaningful improvement in measures of glucose control.
Dr. Witkowski highlighted the following key points in his presentation:
• 5 of 7 patients are currently enrolled in the study.
o 5 of 7 patients have been implanted with the Cell Pouch
o 3 of 7 patients have received their first/one islet transplant
o 2 of 7 patients have received their first and second islet transplant
o The remaining 2 patients are actively being pre-screened to complete trial enrolment
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.
In his presentation, aside from confirming ongoing safety and tolerability in all currently enrolled patients, Dr. Witkowski focused on the first transplanted patients who are furthest in the study and who have received a second islet transplant. Importantly, these patients are showing defined clinical benefit with a clinically meaningful reduction in daily injectable insulin requirement, along with the following additional ongoing efficacy indicators:
• Absence of life threatening severe hypoglycemic events;
• Sustained blood levels of C-peptide (a biomarker for insulin produced by cells in the Cell Pouch);
• Reduction in HbA1c (a measure of long-term glucose control); and,
• Improvement in overall Continuous Glucose Monitoring (CGM) measured glucose control parameters (e.g., blood glucose ‘Time in Range’).
With the positive clinical benefit achieved in patients with Cell Pouch islets, one patient was later provided a single infusion of islets (portal vein). This top-up to the islets already received in the Cell Pouch contributed to this patient achieving and sustaining insulin independence. This patient has now been insulin free (requiring no injectable insulin) for nine months with optimal glucose control.
“I am pleased with the invitation to present additional positive preliminary clinical trial results to my esteemed peers at the 2021 ASTS meeting,” said Dr. Witkowski. “While we continue to validate the therapeutic potential of Sernova’s Cell Pouch with islets for type 1 diabetes, we also continue to optimize conditions within the designed clinical protocol towards a therapy to provide to diabetic patients, as we observe ongoing safety and efficacy measures in our trial patients. I am excited to be part of this evolution in patient treatment as we advance the Cell Pouch cell therapy approach towards a functional cure for diabetes.”
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 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.