Press release Communiqué de presse
Press release Communiqué de presse
June 27, 2021 27 June, 2021
Sernova’s Principal Investigator Presents Interim Data and Positive Patient Outcomes of Phase I/II T1D Study at the American Diabetes Association 81st Scientific Sessions
First Patient Successfully Completes Clinical Trial and Shares Study Experiences and Impact
June 28, 2021 6:00 a.m. EDT
LONDON, ONTARIO – June 28, 2021 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a leading clinical-stage regenerative medicine therapeutics company, today announced that its principal investigator, Dr. Piotr Witkowski, and the clinical trial team for Sernova’s US Phase I/II Type I Diabetes (T1D) clinical trial presented interim data and patient observations from the ongoing study at the American Diabetes Association’s (ADA) 81st Scientific Sessions being held June 25-29th, 2021. Sernova’s data were delivered in a poster presentation entitled “Persistent graft function after allotransplantation into pre-vascularized Sernova Cell Pouch™ device: Preliminary results from the University of Chicago.”
The overall objective of Sernova’s Phase I/II clinical trial is to assess the safety, tolerability and efficacy of its proprietary Cell Pouch transplanted with insulin-producing islets. Study patients eligible to participate in the clinical trial must meet stringent eligibility criteria including, but not limited to, long-standing T1D, severe hypoglycemic unawareness episodes and no glucose-stimulated C-peptide circulating in their bloodstream.
In his poster presentation, Dr. Witkowski confirmed continued safety and tolerability in all six enrolled study patients. In addition, the two longest-treated patients continue to demonstrate defined and meaningful clinical benefit in line with previously established key T1D efficacy indicators including reduction in HbA1c, reduction or elimination of severe hypoglycemic events (SHE), reduction or elimination of daily injectable insulin, detection of C-peptide in the patients’ bloodstream, and improvement in glucose control as measured by continuous glucose monitoring (CGM). The remaining patients are advancing through the study at different stages and their progress continues to be evaluated. The study plans to enroll a total of seven patients and is actively screening for the recruitment of the final patient.
Importantly, the most advanced patient showing positive clinical benefit achieved with Cell Pouch and transplanted islets, and then receiving a top up single infusion of islets (via portal vein), has successfully completed the study protocol. Data from this patient support the long-term safety of Sernova’s Cell Pouch and, importantly, the patient has now remained insulin independent (no requirement for injectable insulin) for 14 months with optimal glucose control. The patient recently gave Sernova permission to share the impact and their personal experience of being the first recipient of the Cell Pouch in Sernova’s T1D Phase I/II clinical trial:
“After completing the safety, tolerability and efficacy study of Sernova's Cell Pouch for clinical islet transplantation and as the first transplant candidate, I can easily state how absolutely wonderful life is to be free of always thinking of how to manage my diabetes. After having T1D for 47 years with approximately 21,535 injections of various cow/pig, synthetic insulins, 34,310 finger sticks, 1,460 urine tests, 15 years on the pump, carbohydrate counting, blood tests, low blood sugar reactions, and doctors…doctors and more doctors’ visits, I have now been free of the need for injectable insulin for 14 months. My Sernova team of invaluable scientists, doctors, engineers, and Dr. Witkowski, and the University of Chicago's support staff have done this truly amazing feat right in the middle of a worldwide pandemic! My only wish is that it could have been done sooner.”
Said principal investigator Dr. Witkowski, “As a clinician-scientist and surgeon, success is typically based on objective outcome measures. Although crucial, often what is missing is the perspective of the patients and the impact on their lives, in their own words. I am thrilled with the transformative and meaningful impact that our clinical trial has had and continues to have on the life of our first patient and I would like to extend my congratulations to this individual who successfully completed the Sernova study with the positive outcome of insulin independence. As we continue to optimize conditions within the designed clinical protocol, I am excited and proud to be a part of the evolution of Sernova’s novel cell therapy approach for the treatment of T1D.”
“Sernova’s ultimate goal is to establish a ‘functional cure’ based on our Cell Pouch technologies for all people with T1D”, said Dr. Philip Toleikis, President & CEO of Sernova Corp. “As we advance our clinical program we thank our patients and physicians as well as our participating pharmaceutical and medtech collaborators who have assisted us to advance beyond established, but insufficient, therapies. Good science is a step-by-step process, and each advancement brings us closer to our goal. It is very timely that we celebrate our first trial patient’s success as the world marks the 100th anniversary of the discovery of insulin.”
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 islet transplantation. The secondary objective is to assess efficacy through a series of defined measures. Patients enrolled in Sernova's clinical trial prior to receiving the Cell Pouch and islets 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 Sernova 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.
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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, including results of clinical trials, and are based on information currently available to management on the date such statements were made. It should also be noted that patient views and outcomes within the clinical trial may differ with each patient dependent on multiple factors. 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. 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.