(TheNewswire)
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- 5 of 7 study patients implantedwith Cell Pouch and cell transplants ongoing; full enrollment on trackfor early 2021
- Treated patients continue to demonstrateenduring safety indicators and blood levels of insulin (C-peptide)produced by cells in the Cell Pouch
LONDON, ONTARIO - TheNewswire - November 18, 2020 - Sernova Corp (TSXV:SVA)(OTC:SEOVF) (FSE:PSH), a leading clinical-stage regenerative medicinetherapeutics company developing a 'functional cure' forinsulin-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 1diabetes (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-producingislets. In addition to other criteria, prior to entry into the study,the patients must demonstrate long-standing type 1 diabetes withsevere hypoglycemic unawareness episodes and no glucose-stimulatedC-peptide circulating in their bloodstream.
As of this date , 5 of the 7 patients have now beenenrolled, implanted with Cell Pouches and are actively advancingthrough the transplantation phase of the study. Pre-screening isongoing for the final two patients and full enrollment of the study isanticipated to be completed in the first quarter of 2021.
The primary endpoint of the study is to demonstrate safety andtolerability of islet transplantation into the Cell Pouch. Overall, the following trends have been observed:
SAFETY (Primary Endpoint):
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- Following implantation, consistent incorporation ofthe Cell Pouch with vascularized tissue providing a suitableenvironment for transplant of islets (insulin-producing cells)
- No incidence of Severe Adverse Events (SAEs) relatedto the Cell Pouch or islet transplant
"I am pleased that these ongoing safety findingsin the treated patients continue to meet the primary endpoint for ourstudy," said Dr. Piotr Witkowski, study principalinvestigator and Director of the Pancreatic and Islet TransplantProgram at the University of Chicago.
Highlighting some of the trial efficacy findings with focus onclinical benefits to the T1D patients, the following trends have alsobeen observed.
EFFICACY (Secondary Endpoint):
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- Ongoing detection of bloodstream levels of C-peptidein treated patients (proof that cells in the Cell Pouch are producinginsulin, important for controlling blood sugar levels)
- Reduction in injectable insulin use
- Reduction in levels of HbA1c as a measure oflong-term glucose control (the lower the HbA1c, the lesser the risk ofdeveloping diabetes-related complications)
- Reduction in severe hypoglycemic episodes (bloodsugar levels that are too low may lead to life-threatening events)
"I am encouraged by the fact that, in contrast toprevious clinical studies in this field, we are observing persistentevidence of insulin production (C-peptide) by islets transplanted intothe Cell Pouch in our patients," said Dr.Piotr Witkowski. "I look forward to ongoing results in the studyand observing improvements in patient quality of life along withefficacy measures as we advance this regenerative medicinetreatment."
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 transplantation. The secondaryobjective is to assess efficacy through a series of defined measures.Patients enrolled in Sernova's clinical trial are incapable ofproducing 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 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 recruitment detailsplease visit www.pwitkowski.org/sernova .
ABOUT SERNOVA'S CELL POUCHSYSTEM
The Cell Pouch System including the Cell Pouch, whichis a novel, proprietary, scalable, implantable macro-encapsulationdevice solution designed for the long- term survival and function oftherapeutic cells. The device upon implantation is designed toincorporate with tissue, forming highly vascularized tissue chambersfor the transplantation and function of therapeutic cells which thenrelease proteins and hormones as required to treat disease. The CellPouch along with therapeutic cells has been shown to provide long-termsafety and efficacy in small and large animal models of diabetes andhas been proven to provide a biologically compatible environment forinsulin-producing cells in humans. In early assessments of its ongoingPhase I/II clinical trial, Sernova has shown in its first treatedpatient presence of blood levels of C-peptide both during glucosetolerance tests as well as under fasting conditions. Clinical testingis ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicinetherapeutic technologies using a medical device and immune protectedtherapeutic cells (i.e. human donor cells, corrected human cells andstem cell-derived cells) to improve the treatment and quality of lifeof people with chronic metabolic diseases such as insulin-dependentdiabetes, blood disorders including hemophilia, and other diseasestreated through replacement of proteins or hormones missing or inshort supply within the body. For more information, please visit www.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
FORWARD-LOOKING INFORMATION
This press release contains forward-looking statementswithin the meaning of applicable Canadian securities laws . Forward-looking statements in thispress release are statements that are nothistorical facts and are generally, but not always, identified by thewords "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 subsequentclinical activity, including enrolment of patients and continuingresults 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 bereasonable, these assumptions are inherently subject to significantscientific, business, economic, competitive, market and socialuncertainties and contingencies. Additionally,there are known and unknown risk factors that could cause Sernova'sactual results , performance or achievements tobe materially different from any future results, performance orachievements expressed or implied by the forward-looking statements contained in this press release. Results in early stage clinical trials may not be indicativeof full results or results from later stage or larger scale clinicaltrials and do not ensure regulatory approval. Readers should not placeundue reliance on these statements or the scientific data presentedand should refer to the risk factors identified in the company'scontinuous disclosure filed on SEDAR. Sernovaexpressly disclaims any intention or obligation to update or reviseany forward-looking statements whether as a result of new information,future events or otherwise.
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