(TheNewswire)
First PatientSuccessfully Completes Clinical Trial and Shares Study Experiences andImpact
LONDON, ONTARIO - TheNewswire - June 28, 2021 – Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE/XETRA:PSH), a leading clinical-stage regenerative medicine therapeuticscompany, today announced that its principal investigator, Dr. PiotrWitkowski, and the clinical trial team for Sernova’s US Phase I/IIType I Diabetes (T1D) clinical trial presented interim data andpatient observations from the ongoing study at the American DiabetesAssociation’s (ADA) 81 st Scientific Sessions being held June25-29th, 2021. Sernova’s data were delivered in a posterpresentation entitled “Persistent graft function afterallotransplantation into pre-vascularized Sernova Cell Pouch™device: Preliminary results from the University of Chicago.”
The overall objective of Sernova’s Phase I/IIclinical trial is to assess the safety, tolerability and efficacy ofits proprietary Cell Pouch transplanted with insulin-producing islets.Study patients eligible to participate in the clinical trial must meetstringent eligibility criteria including, but not limited to,long-standing T1D, severe hypoglycemic unawareness episodes and noglucose-stimulated C-peptide circulating in their bloodstream.
In his poster presentation, Dr. Witkowski confirmedcontinued safety and tolerability in all six enrolled study patients.In addition, the two longest-treated patients continue to demonstratedefined and meaningful clinical benefit in line with previouslyestablished key T1D efficacy indicators including reduction in HbA1c,reduction or elimination of severe hypoglycemic events (SHE),reduction or elimination of daily injectable insulin, detection ofC-peptide in the patients’ bloodstream, and improvement in glucosecontrol as measured by continuous glucose monitoring (CGM). Theremaining patients are advancing through the study at different stagesand their progress continues to be evaluated. The study plans toenroll a total of seven patients and is actively screening for therecruitment of the final patient.
Importantly, the most advanced patient showing positiveclinical benefit achieved with Cell Pouch and transplanted islets, andthen receiving a top up single infusion of islets (via portal vein),has successfully completed the study protocol. Data from thispatient support the long-term safety of Sernova’s Cell Pouch and,importantly, the patient has now remained insulin independent (norequirement for injectable insulin) for 14 months with optimal glucosecontrol. The patient recently gave Sernova permission to share theimpact and their personal experience of being the first recipient ofthe Cell Pouch in Sernova’s T1D Phase I/II clinical trial:
“After completing the safety, tolerability andefficacy study of Sernova's Cell Pouch for clinical islettransplantation and as the first transplant candidate, I can easilystate how absolutely wonderful life is to be free of always thinkingof how to manage my diabetes. After having T1D for 47 years withapproximately 21,535 injections of various cow/pig, syntheticinsulins, 34,310 finger sticks, 1,460 urine tests, 15 years on thepump, carbohydrate counting, blood tests, low blood sugar reactions,and doctors…doctors and more doctors’ visits, I have now been freeof the need for injectable insulin for 14 months. My Sernova team ofinvaluable scientists, doctors, engineers, and Dr. Witkowski, and theUniversity of Chicago's support staff have done this truly amazingfeat right in the middle of a worldwide pandemic! My only wish isthat it could have been done sooner.”
Said principal investigator Dr. Witkowski, “As aclinician-scientist and surgeon, success is typically based onobjective outcome measures. Although crucial, often what is missing isthe perspective of the patients and the impact on their lives, intheir own words. I am thrilled with the transformative and meaningfulimpact that our clinical trial has had and continues to have on thelife of our first patient and I would like to extend mycongratulations to this individual who successfully completed theSernova study with the positive outcome of insulin independence. As wecontinue to optimize conditions within the designed clinical protocol,I am excited and proud to be a part of the evolution of Sernova’snovel 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 allpeople with T1D”, said Dr. Philip Toleikis, President & CEO ofSernova Corp. “As we advance our clinical program we thank ourpatients and physicians as well as our participating pharmaceuticaland medtech collaborators who have assisted us to advance beyondestablished, but insufficient, therapies. Good science is astep-by-step process, and each advancement brings us closer to ourgoal. It is very timely that we celebrate our first trial patient’ssuccess as the world marks the 100 th anniversary ofthe 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 safetyand tolerability of islet transplantation into the company's patentedCell Pouch in diabetic subjects with hypoglycemia unawareness. Theprimary objective of the study is to assess the safety of the CellPouch following implantation and islet transplantation. The secondaryobjective is to assess efficacy through a series of defined measures.Patients enrolled in Sernova's clinical trial prior to receiving theCell Pouch and islets are incapable of producing C-peptide, abiomarker for insulin produced by islet cells.
Eligible subjects are implanted with Cell Pouches.Following the development of vascularized tissue chambers within theCell Pouch, subjects are then stabilized on immunosuppression, and adose of purified islets, under strict release criteria, istransplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment ofthe islet transplant. Subjects are followed for additional safety andefficacy measures for approximately six months. At this point, adecision will be made with regards to the transplant of a second isletdose with subsequent safety and efficacy follow-up. Patients will bethen further followed for one year to assess longer-term safety andefficacy.
For more information on the clinical trial, pleasevisit www.clinicaltrials.gov/ct2/show/NCT03513939 .
For more information on enrollment and recruitmentdetails please visit www.pwitkowski.org/sernova .
Sernova is developing regenerative medicine therapeutic technologiesusing 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 chronicmetabolic diseases such as insulin-dependent diabetes, blood disordersincluding hemophilia, and other diseases treated through replacementof proteins or hormones missing or in short supply within the body.For more information, please visit www.sernova.com .
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investor Relations
Sernova Corp.
Tel: (519) 858-5126
investorrelations@sernova.com
www.sernova.com
This release contains statements that, to the extentthey 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 thecompany. Wherever possible, but not always, words such as"expects", "plans", "anticipates","believes", "intends", "estimates","projects", "potential for" and similarexpressions, or that events or conditions "will","would", "may", "could" or"should" occur are used to identify forward-lookingstatements. These statements reflect management’s beliefs withrespect to future events, including results of clinical trials, andare based on information currently available to management on the datesuch statements were made. It should also be noted that patient viewsand outcomes within the clinical trial may differ with each patientdependent on multiple factors. Many factors could cause Sernova’sactual results, performances or achievements to not be as anticipated,estimated or intended or to differ materially from those expressed orimplied by the forward-looking statements contained in this newsrelease. Many of the factors are beyond our control, including thosecaused by, related to, or impacted by the novel coronavirus pandemic.Investors should consult the company’s quarterly and annual filingsavailable on www.sedar.com for additional information on risks anduncertainties relating to the forward-looking statements. Sernovaexpressly disclaims any intention or obligation to update or reviseany forward-looking statements, whether as a result of newinformation, future events or otherwise.
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