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Sernova Announces Advancements with its Novel Cell Pouch System™ to Preserve Thyroid Function Following Total Thyroidectomy | ||||||||
By: GlobeNewswire - 30 Jan 2023 | Back to overview list |
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LONDON, Ontario, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced advancements in its thyroid cell therapy program – one of three cell therapy development programs utilizing the Company’s proprietary Cell Pouch System™. In a preclinical proof of concept study, the Company demonstrated that auto-transplantation of thyroid tissue into the Cell Pouch can compensate for removal of the thyroid gland (total thyroidectomy), restoring normal thyroid hormone levels in an animal model. The thyroid is a vital hormone-producing gland that is critical for metabolism and regulation of body functions.1 Loss of thyroid function occurs following surgical removal of the gland and is associated with memory impairment, depression, intolerance to cold, chronic fatigue, constipation, weight gain and lethargy.2 It is estimated that more than 150,000 patients in the US undergo thyroidectomies annually3, and subsequently require lifelong thyroid hormone replacement therapy. Despite some benefits, patients on thyroid replacement medications often experience significant impairment in psychological well-being.4 The primary goal of Sernova’s thyroid program is to restore normal thyroid function without life-long medication, and avoid the burden of repeated laboratory testing in patients who have undergone thyroid surgery. Data from Sernova’s preclinical program demonstrates that total thyroidectomy with auto-transplantation into the Cell Pouch allows for reestablishment of production of triiodothyronine (T3) and thyroxine (T4) and the hypothalamic-pituitary-thyroid axis. The study was conducted in a pre-clinical animal model whereby the Cell Pouch was pre-implanted for several weeks prior to each subject undergoing total thyroidectomy. The thyroid gland of each Treatment Group subject was removed, prepared with minimal manipulation, and transplanted into the pre-implanted Cell Pouch. Thyroid hormones were monitored over several months with weekly measurements of circulating thyroid hormones (T3, T4). Following thyroidectomy in the Treatment Group, the T3 and T4 levels fell initially but subsequently recovered to normal or near-normal levels following thyroid transplant into the Cell Pouch. Control Group subjects received the Cell Pouch implant and underwent total thyroidectomy but did not receive a thyroid transplant. In the Control Group, post-thyroidectomy T3 and T4 rapidly decreased and remained below baseline concentrations throughout the experiment. “Along with previously published preclinical data that reported survival and function of human thyroid tissue transplanted into the Cell Pouch5, this preclinical study also supports the viability of Sernova’s Cell Pouch System approach and represents an important step towards establishing an entirely new treatment option for post-thyroidectomy hypothyroidism,” commented Dr. Sam Wiseman, BSc, MD, FRCSC, FACS, Professor of Surgery, Faculty of Medicine at the University of British Columbia and attending surgeon at St. Paul’s Hospital in Vancouver. “These findings demonstrate a further therapeutic application of Sernova’s Cell Pouch System,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “In addition to type 1 diabetes [and hemophilia], this study shows the potential to treat the significant number of patients undergoing removal of their thyroid glands each year. We have already begun to interact with regulatory authorities towards initiating clinical trials with this novel therapy.” Sernova intends to present data from the Company’s thyroid development program at a scientific conference later this year. References
ABOUT SERNOVA’S CELL THERAPY THYROID DISEASE PROGRAM Thyroidectomy is commonly performed for cancer diagnosis or treatment and for treatment of benign (non- cancerous) disease that includes goiter and hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the US yearly. Patients undergoing total thyroidectomy, and many patients undergoing partial thyroidectomy, require life-long thyroid hormone medication. Post-surgical thyroid hormone replacement therapy, if monitored carefully, can be effective; however, patients often suffer from deleterious side-effects including weight gain, depression, headaches, and cardiovascular disease, with resultant negative impact on quality of life, and significant costs to the healthcare system. The development of new therapeutic strategies to overcome hypothyroidism remains an important unmet medical need. ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY FOR FURTHER INFORMATION, PLEASE CONTACT:
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. |
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