- Preclinical proof of concept study demonstrates that thyroid auto-transplantation into the Cell Pouch can restore thyroid hormone production following removal of the thyroid gland
Sernova has engaged with regulatory authorities towards initiating clinical development of a prospective therapy for hypothyroidism
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
“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.
“These findings demonstrate a further therapeutic application of Sernova’s Cell Pouch System,” said Dr.
References
- InformedHealth.org.
Cologne, Germany :Institute for Quality and Efficiency in Health Care; How does the thyroid gland work? 2010 Nov 17 [Updated 2018 Apr 19]. https://www.ncbi.nlm.nih.gov/books/NBK279388/ - Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism.
Lancet . 2017; 390: 1550–1562. https://doi.org/10.1016/S0140-6736(17)30703-1 PMID: 28336049 - Al-Qurayshi Z, Robins R, Hauch A, Randolph GW, Kandil E. Association of Surgeon Volume With
Outcomes and Cost Savings Following Thyroidectomy : A National Forecast. JAMA Otolaryngol Head Neck Surg. 2016;142(1):32–39. doi:10.1001/jamaoto.2015.2503 - Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in patients on 'adequate' doses of l-thyroxine: results of a large, controlled community-based questionnaire study. Clin Endocrinol (Oxf). 2002 Nov;57(5):577-85. doi: 10.1046/j.1365-2265.2002.01654.x. PMID: 12390330.
- Wiseman SM, Memarnejadian A, Boyce GK, Nguyen A, Walker BA, Holmes DT, Welch ID, Mazzuca DM, Toleikis PM. 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. PLoS One. 2022; 17(1): e0262345. https://doi.org/10.1371/journal.pone.0262345
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
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate: | Investors: | Media: |
VP, Investor Relations christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com | cdavis@lifesciadvisors.com Tel: 212-915-2577 | emiller@lifescicomms.com Tel: 646-791-9705 |
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.
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