SEOVF - Sernova Announces Peer Reviewed Publication Demonstrating Positive Preclinical Safety and Efficacy Indicators of Its Novel Cell Pouch System(TM) Therapeutic Approach for Treatment of Thyroid Disease
(TheNewswire)
Sernova prepares for clinical trialof new treatment for post-operative hypothyroidism
LONDON, ONTARIO - TheNewswire – January 27, 2022 –Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE/XETRA:PSH), a clinical-stageregenerative medicine and cell therapy therapeutics company developinga potential ‘functional cure’ for chronic diseases including type1 diabetes (T1D) is pleased to announce publication of a peer reviewedpreclinical study demonstrating positive results of a novel Cell PouchSystem™ cell therapy approach to treat hypothyroidism andpotentially avoid lifelong dependence on thyroid medication followingsurgical removal of the thyroid gland.
The journal article entitled “ Subcutaneous transplantation of human thyroid tissue into apre-vascularized Cell Pouch™ device in a Mus musculus model:Evidence of viability and function for thyroidtransplantation ,” by lead author, Dr. Sam M. Wiseman waspublished in the prestigious scientific journal, PLOS ONE , January20, 2022. In this study, thyroid tissue frompatients undergoing surgery for treatment of benign disease wastransplanted into Sernova Cell Pouches that had been previouslyimplanted into laboratory mice. The aim of the study was toinvestigate the long-term survival of human thyroid tissue in the CellPouch and evaluate the ability of these thyroid transplants to releasethyroid hormones into the bloodstream. The study confirmed that thehuman thyroid tissue transplanted into the Cell Pouch survived andreleased human thyroglobulin into the bloodstream, with no adverseeffects for the three-months duration of thestudy. Thyroglobulin was used as a biomarker efficacy measure inthis study as it is the precursor of thyroid hormones.
“I’m very excited about this study because it represents acritical first step towards a future where we can offer our patients atreatment option that allows for preservation of their thyroidfunction with avoidance of postoperative hypothyroidism, its manyassociated morbidities and life-long dependence on thyroidmedication,” commented SamM. Wiseman BSc, MD, FRCSC, FACS.
Dr. Philip Toleikis, President and CEO Sernova Corpstated, “For hypothyroid disease, these datasupport the potential of our Cell Pouch to allow for a recovery of thenatural thyroid hormone feedback system following thyroidectomy,restoring thyroid hormone levels without the risks and side effectsassociated with hormone replacement drugs. This could providelife-changing options for the more than 150,000 patients who undergo athyroidectomy in the US, alone, each year. These preclinical dataare consistent with our findings utilizing the Cell Pouch in thetreatment of T1D and Hemophilia A. We believe the Sernova CellPouch System therapeutic approach could provide a ‘functionalcure’ for millions of patients who suffer from afflictions caused bythe absence of systemic proteins or hormones.”
Sernova Corp., with Dr. Wiseman as clinicalinvestigator, is preparing regulatory documents to proceed with aPhase 1/2 human clinical trial in subjects undergoing thyroid surgery.In this study, the subjects will be implanted with the Cell Pouch tocreate the vascularized tissue environment several weeks prior totransplant of their healthy thyroid tissue. The objective of the studyis to assess the safety and efficacy of the CellPouch transplanted tissue, with efficacy measured as recovery ofthyroid hormone in the bloodstream. The Company expects to submit aclinical trial application within 2022.
The thyroid gland produces hormones that regulatemetabolism within a narrow functional range. Thyroid hormonereplacement drugs are frequently used to treat insufficient or absentthyroid activity. Optimization of thyroid hormone replacementmedications can be difficult with dose adjustments requiring frequentlab tests to reach appropriate levels . Thyroidhormone replacement therapy is associated with several side-effectsincluding impaired cognition, lethargy, and weight gain, leading todiminished quality of life, and incurring significant ongoing costs tothe patient and healthcare system.
ABOUT THYROID DISEASE
Surgical removal of the thyroid gland, orthyroidectomy, is commonly performed for management of thyroidcancers, and for treatment of benign (non-cancerous) diseases thatinclude nodules, goitre, and hyperthyroidism. It is estimated thatabout 150,000 thyroidectomies are performed in the U.S. annually, withmost individuals undergoing thyroid surgery eventually being diagnosedwith benign conditions. Some patients undergoing partial thyroidectomyand all patients undergoing total thyroidectomy require life-long oralpostoperative thyroid hormone replacement treatment.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeuticsolutions using a medical device (Cell Pouch) and immune protectedtherapeutic cells / tissues (i.e. human donor cells, corrected humancells and stem cell-derived cells) to improve the treatment andquality of life of people with chronic metabolic diseases such asinsulin-dependent diabetes, blood disorders including hemophilia,thyroid disease and other diseases treated through cellular productionof proteins or hormones missing or in short supply within the body.For more information, please visit www.sernova.com .
ABOUT SERNOVA’S CELL POUCH SYSTEMPLATFORM
The Cell Pouch, as part of the Cell Pouch System, is anovel, proprietary, scalable, implantable macro- encapsulation devicesolution 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 Cell Pouch, along with therapeutic cells, has beenshown to provide long-term safety and efficacy in small and largeanimal models of diabetes and has been proven to provide abiologically compatible environment for insulin-producing cells inhumans. Sernova is currently conducting a Phase 1/2 study at theUniversity of Chicago. Positive initial results have been presented atseveral international scientific conferences.
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 expresslydisclaims any intention or obligation to update or revise anyforward-looking statements, whether as a result of new information,future events or otherwise.
Copyright (c) 2022 TheNewswire - All rights reserved.