LONDON, Ontario and WINDHAM COUNTY, Conn., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced new preclinical data for its novel cell therapy platform, the Cell Pouch System, as a potential treatment for post-operative hypothyroidism at the 2023 American Thyroid Association (ATA) Annual Meeting being held in Washington, D.C., from September 27 to October 1, 2023.

Key insights from the poster:

• After total thyroidectomy, re-implantation of thyroid tissue into the pre-vascularized Cell Pouch™ resulted in the restoration of the two main thyroid hormones, i.e., free thyroxine (FT4) and triiodothyronine (T3), to the baseline levels.
• Thyroid stimulating hormone (TSH) levels had a significant peak immediately after thyroidectomy, with a gradual decline observed starting five weeks after the re-implantation of thyroid glands. This pattern underscores the re-establishment of the intrinsic thyroid feedback loop's impact.
• Newly reported radio-isotope uptake imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the Cell Pouch six months following re-implantation.

“Currently, thyroidectomy patients are bound to life-long thyroid hormone replacement therapy. A significant subset of those patients grapple with persistent symptoms of thyroid dysfunction including weight gain, fatigue, depression, memory and cognitive impairment, negatively impacting their quality of life,” said Cynthia Pussinen, Chief Executive Officer at Sernova. “With Sernova’s Cell Pouch System, we aim to improve quality of life with a treatment for post-operative hypothyroidism. These new data replicate a human clinical scenario in which thyroid tissue is reimplanted into the patient, via the Cell Pouch, leading to the restoration of normal thyroid function. Sernova is assessing the commercial opportunity and pathways for accelerated development of the thyroid program.”

Approximately 150,000 thyroidectomies are performed annually in the U.S. alone, representing a significant market opportunity¹. Sernova’s potential first-generation product would utilize healthy tissue from the patient’s own gland removed during thyroidectomy for benign disease. This therapeutic approach would negate the need for immune suppression medication. A second-generation stem cell-derived technology could potentially be used to treat the broader population with hypothyroid disease.

Poster details:

Title: Auto-Transplantation of Rat Thyroid into a Pre-Vascularized Retrievable Cell Pouch™ Device
for the Treatment of Post-Operative Hypothyroidism
Presenter: Dr. Arash Memarnejadian, Senior Research Scientist, Sernova Corp.
Date and Time: September 29 from 9:50 a.m. to 12:40 p.m. Eastern Time
Poster #: 323

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago, with Cell Pouches implanted for periods of more than four years and counting.

Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

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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.sedarplus.ca 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.

¹ Sun, G. H., DeMonner, S., & Davis, M. M. (2013). Epidemiological and economic trends in inpatient and outpatient thyroidectomy in the United States, 1996–2006. Thyroid, 23(6), 727-733.