Sernova Corp. 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. 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.

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 Groupsubject 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.