(TheNewswire)
Confirms Ongoing Safety andTolerability of Sernova’s Cell Pouch
LONDON, ONTARIO – TheNewswire - March 17, 2022– Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE:PSH), a clinical- stagecompany and leader in regenerative medicine cell therapeutics, ispleased to announce that the Data Safety Monitoring Board("DSMB") has completed the third annual review ofSernova’s ongoing Phase 1/2 clinical study “Safety, Tolerabilityand Efficacy Study of Sernova’s Cell Pouch for Clinical IsletTransplantation” in patients with Type-1 Diabetes (T1D) who sufferfrom hypoglycemia unawareness and severe hypoglycemic events.
In their assessment, the DSMB recommended that the clinical studyshould continue according to the study plan.
The DSMB is an independent committee of clinical experts who reviewthe accumulated trial data to evaluate patient safety and ensure theintegrity of the study data.
“This recommendation from the DSMB affirms our understanding of thesafety of Cell Pouch in this patient population transplanted withhuman donor islets. We look forward to sharing updates from thestudy through upcoming conference presentations by Dr. PiotrWitkowski, the trial Principal Investigator.” said Dr. PhilipToleikis, President & CEO of Sernova Corp.
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 HYPOGLYCEMIA UNAWARENESS
Hypoglycemia unawareness is a person’s inability to recognize thesymptoms of low blood sugar before they become severe enough to beincapacitating or even fatal, which may occur when blood glucoselevels are below 3.0 mmol/L. It is estimated that approximately 15% ofpeople with T1D, or approximately 240,000 people, are affected byhypoglycemia unawareness in the US alone.
Severe symptoms of low blood sugar include confusion, slurred speech,impaired motor coordination and personality changes. Individualsexperiencing a severe hypoglycemic event can lose their ability forself-care and self-control, requiring urgent intervention from anotherperson to prevent loss of consciousness, seizure, coma, or death. After a person has had a first hypoglycemia unawareness episode,more are likely to occur.
ABOUT SERNOVA
Sernova is developing regenerative medicine cell therapeutic solutionsusing a medical device (Cell Pouch) and immune protected therapeuticcells / tissues (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 cellular production of proteins or hormones missing orin short supply within the body. For more information, please visitwww.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEMCELL THERAPY PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel,proprietary, scalable, implantable macro- encapsulation devicesolution designed for the long-term survival and function oftherapeutic cells. After implantation, the device incorporates withtissue, forming highly vascularized, native tissue chambers for thetransplantation and function of therapeutic cells, that releaseproteins and hormones as required to treat disease.
The Cell Pouch, along with therapeutic cells, has been shown toprovide long-term safety and efficacy in small and large animal modelsof diabetes and has been proven to provide a biologically compatibleenvironment for insulin-producing cells in humans in a Canadianfirst-in-human study. Sernova is currently conducting a Phase 1/2clinical trial study at the University of Chicago. Positive initialresults have been presented at several international scientificconferences.
FOR FURTHER INFORMATION, PLEASECONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
Corey Davis, Ph.D.
LifeScience Advisors, LLC
Tel: 212-915-2577
FORWARD-LOOKING INFORMATION
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 and are based on information currentlyavailable to management on the date such statements were made. Manyfactors could cause Sernova’s actual results, performances orachievements to not be as anticipated, estimated or intended or todiffer materially from those expressed or implied by theforward-looking statements contained in this news release. Suchfactors could include, but are not limited to, the company’s abilityto secure additional financing and licensing arrangements onreasonable terms, or at all; ability to conduct all requiredpreclinical and clinical studies for the company’s Cell Pouch Systemand/or related technologies, including the timing and results of thosetrials; ability to obtain all necessary regulatory approvals, or on atimely basis; ability to in-license additional complementarytechnologies; ability to execute its business strategy andsuccessfully compete in the market; and the inherent risks associatedwith the development of biotechnology combination products generally.Many of the factors are beyond our control, including those caused by,related to, or impacted by the novel coronavirus pandemic. Investorsshould consult the company’s quarterly and annual filings availableon www.sedar.com for additional information on risks and uncertaintiesrelating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update orrevise any forward-looking statements, whether as a result of newinformation, future events or otherwise.
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