Press release Communiqué de presse
Press release Communiqué de presse
January 27, 2022 27 January, 2022
Sernova Announces Peer Reviewed Publication Demonstrating Positive Preclinical Safety and Efficacy Indicators of Its Novel Cell Pouch System™ Therapeutic Approach for Treatment of Thyroid Disease
Sernova prepares for clinical trial of new treatment for post-operative hypothyroidism
LONDON, ONTARIO – January 27, 2022 – Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage regenerative medicine and cell therapy therapeutics company developing a potential ‘functional cure’ for chronic diseases including type 1 diabetes (T1D) is pleased to announce publication of a peer reviewed preclinical study demonstrating positive results of a novel Cell Pouch System™ cell therapy approach to treat hypothyroidism and potentially avoid lifelong dependence on thyroid medication following surgical removal of the thyroid gland.
The journal article entitled “Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell Pouch™ device in a Mus musculus model: Evidence of viability and function for thyroid transplantation,” by lead author, Dr. Sam M. Wiseman was published in the prestigious scientific journal, PLOS ONE, January 20, 2022. In this study, thyroid tissue from patients undergoing surgery for treatment of benign disease was transplanted into Sernova Cell Pouches that had been previously implanted into laboratory mice. The aim of the study was to investigate the long-term survival of human thyroid tissue in the Cell Pouch and evaluate the ability of these thyroid transplants to release thyroid hormones into the bloodstream. The study confirmed that the human thyroid tissue transplanted into the Cell Pouch survived and released human thyroglobulin into the bloodstream, with no adverse effects for the three-months duration of the study. Thyroglobulin was used as a biomarker efficacy measure in this study as it is the precursor of thyroid hormones.
“I’m very excited about this study because it represents a critical first step towards a future where we can offer our patients a treatment option that allows for preservation of their thyroid function with avoidance of postoperative hypothyroidism, its many associated morbidities and life-long dependence on thyroid medication,” commented Sam M. Wiseman BSc, MD, FRCSC, FACS.
Dr. Philip Toleikis, President and CEO Sernova Corp stated, “For hypothyroid disease, these data support the potential of our Cell Pouch to allow for a recovery of the natural thyroid hormone feedback system following thyroidectomy, restoring thyroid hormone levels without the risks and side effects associated with hormone replacement drugs. This could provide life-changing options for the more than 150,000 patients who undergo a thyroidectomy in the US, alone, each year. These preclinical data are consistent with our findings utilizing the Cell Pouch in the treatment of T1D and Hemophilia A. We believe the Sernova Cell Pouch System therapeutic approach could provide a ‘functional cure’ for millions of patients who suffer from afflictions caused by the absence of systemic proteins or hormones.”
Sernova Corp., with Dr. Wiseman as clinical investigator, is preparing regulatory documents to proceed with a Phase 1/2 human clinical trial in subjects undergoing thyroid surgery. In this study, the subjects will be implanted with the Cell Pouch to create the vascularized tissue environment several weeks prior to transplant of their healthy thyroid tissue. The objective of the study is to assess the safety and efficacy of the Cell Pouch transplanted tissue, with efficacy measured as recovery of thyroid hormone in the bloodstream. The Company expects to submit a clinical trial application within 2022.
The thyroid gland produces hormones that regulate metabolism within a narrow functional range. Thyroid hormone replacement drugs are frequently used to treat insufficient or absent thyroid activity. Optimization of thyroid hormone replacement medications can be difficult with dose adjustments requiring frequent lab tests to reach appropriate levels. Thyroid hormone replacement therapy is associated with several side-effects including impaired cognition, lethargy, and weight gain, leading to diminished quality of life, and incurring significant ongoing costs to the patient and healthcare system.
ABOUT THYROID DISEASE
Surgical removal of the thyroid gland, or thyroidectomy, is commonly performed for management of thyroid cancers, and for treatment of benign (non-cancerous) diseases that include nodules, goitre, and hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the U.S. annually, with most individuals undergoing thyroid surgery eventually being diagnosed with benign conditions. Some patients undergoing partial thyroidectomy and all patients undergoing total thyroidectomy require life-long oral postoperative thyroid hormone replacement treatment.
ABOUT SERNOVA Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell- derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, thyroid disease and other diseases treated through cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM PLATFORM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans. Sernova is currently conducting a Phase 1/2 study at the University of Chicago. Positive initial results have been presented at several international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes VP, Investor Relations Sernova Corp. email@example.com Tel: 519-902-7923 www.sernova.com
Corey Davis, Ph.D. LifeScience Advisors, LLC firstname.lastname@example.org Tel: 212-915-2577
FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they 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 the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with 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. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.