(TheNewswire)
Ongoing Safety ofSernova's Clinical Trial Confirmed
L ondon, Ontario - TheNewswire- February 18, 2021 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF)(FSE:PSH), a clinical-stage company and leader in regenerativemedicine therapeutics, is pleased to announce that the clinical trialindependent Data Safety Monitoring Board ("DSMB") hascompleted the second planned annual review of the ongoing Safety, Tolerability and Efficacy Study ofSernova's Cell Pouch™ for Clinical Islet Transplantation Phase I/II clinical trial in patients with severe hypoglycemiaunawareness and inability to produce their own insulin.
The DSMB recommended that the Phase I/II clinical study shouldcontinue according to the study protocol and any related amendments.In their assessment, the DSMB did not raise any concerns regardingpatient safety.
"We are pleased with the second annual independent DSMB review ofour Phase I/II clinical trial," said Dr. Philip Toleikis,President & CEO Sernova Corp. "We thank the DSMB for itsdiligence, guidance and support as Sernova continues progressing theclinical trial."
The DSMB is an independent group of clinical research experts whoreview the accumulated data to permit a thorough evaluation of patientsafety and to ensure the integrity of the study's data and progresstowards completion.
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 and aninability to produce their own insulin. The secondary objective is toassess efficacy through a series of defined measures. Eligiblesubjects are implanted with Cell Pouches. Following development ofvascularized tissue chambers within the Cell Pouch, subjects are thenstabilized on immunosuppression and a dose of purified islets, understrict release criteria, transplanted into the Cell Pouch. Asentinel pouch is removed for an early assessment of the islettransplant. Subjects are followed for additional safety and efficacymeasures for approximately six months. At this point, a decision willbe made with regards to the transplant of a second islet dose withsubsequent safety and efficacy follow-up. Following this period,eligible patients may be administered a single dose of islets throughthe portal vein. Patients will be then further followed for one yearto assess longer-term safety and efficacy. This study is supported inpart by funding from JDRF, the leading global organization fundingtype 1 diabetes (T1D) research.
For more information on this clinical trial, pleasevisit www.clinicaltrials.gov/ct2/show/NCT03513939. For moreinformation on enrollment and recruitment details, please visit www.pwitkowski.org/sernova .
ABOUT SERNOVA'S CELL POUCHSYSTEM
The Cell Pouch system including the Cell Pouch, which is a novel,proprietary, scalable, implantable macro-encapsulation device solutiondesigned for the long- term survival and function of therapeuticcells. The device is designed to incorporate with tissue, forminghighly vascularized tissue chambers for the transplantation andfunction of therapeutic cells which then release proteins and hormonesas required to treat disease. The Cell Pouch along with therapeuticcells has been shown to provide long-term safety and efficacy in smalland large animal models of diabetes and has been proven to provide abiologically compatible environment for insulin-producing cells inhumans. In early assessments of its ongoing Phase I/II clinical trial,Sernova has shown presence of blood levels of c-peptide both duringglucose tolerance tests as well as under fasting conditions. Clinicaltesting is ongoing at the University of Chicago.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutictechnologies using a medical device and immune protected therapeuticcells (i.e. human donor cells, corrected human cells and stemcell-derived cells) to improve the treatment and quality of life ofpeople 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 visitwww.sernova.com
For further information contact:
Dominic Gray
Sernova Corp
Tel: (519) 858-5126
FORWARD-LOOKING INFORMATION
This release may contain forward-looking statements. Forward-lookingstatements are statements that are not historical facts and aregenerally, 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 suchforward-looking statements are based on reasonable assumptions, suchstatements are not guarantees of future performance, and actualresults may differ materially from those in forward-lookingstatements. Forward-looking statements are based on the beliefs,estimates, and opinions of Sernova's management on the date suchstatements were made, which include our beliefs about the conduct andoutcome of clinical trials. Sernova expressly disclaims any intentionor obligation to update or revise any forward-looking statementswhether as a result of new information, future events or otherwise.
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