Insulin-Producing Cells Survive and Function without Anti-Rejection Drugs
Sernova Corp. (TSX-V: SVA), is pleased to announce its preliminary, preclinical animal studies have demonstrated long term survival and functioning of Sertolin, the Company's patented insulin producing cellular replacement therapy. The findings will be presented at the upcoming Canadian Society of Transplantation Annual General Meeting March 16, 2007.
These critical milestones, which are required for regulatory filings, were achieved in two separate studies. In one study, non-diabetic rats showed the predicted, extended survival of functioning, insulin-secreting cells several months after transplant. Importantly, the data shows the insulin producing cells are accepted by the recipient's immune system without using toxic anti-rejection drugs.
In the other preliminary study using diabetic animals treated with Sertolin, the insulin producing cells demonstrated function for several months. When the insulin producing cells and Sertoli cells were later removed, the animals became diabetic again.
"Having the ability to implant foreign cells into a patient without having to use immunosuppressive drugs to prevent rejection is extremely important for the treatment of a whole host of diseases," stated Dr. David White, principal researcher for Sernova. "The ability to implant cells from a different species without harmful immunological side effects could make cellular replacement a routine procedure."
The next stage in the development of Sertolin is to reverse diabetes in a larger number of test animals, improve the efficacy and prove statistical significance. Also included in current pre-clinical studies is the dosage study and optimization of transplant site. Sernova anticipates having these studies completed by the summer of this year, leading to an Investigational New Drug ("IND") filing later in the year.
"We are well on our way to achieving our goal of treating diabetes through this cellular replacement technology," commented Justin Leushner, President of Sernova Corp. "Since we set out to develop this technology we have remained focused on generating data that moves us closer to having this therapy available to the patients that need it. When working with an animal model it takes time to optimize the model itself and because we are dealing with a technology that requires proof of long term efficacy, we have to wait several months for each of these experiments to run its course. Knowing we have clearly defined milestones and a model that works we can now expedite all the necessary experiments required for our IND filing. With that said I am very encouraged by our results to date and excited about the future of this technology."
Sernova's research is focused on compiling pre-clinical data to support an IND application to the United States Food and Drug Administration for Sertolin Diabetes Therapy. The Company owns the exclusive rights to over 20 patents related to the therapeutic use of Sertoli cells.
About Sernova
Sernova Corp. is a Canadian based, health sciences company focused on commercializing medical technologies and currently working to cure insulin dependent diabetes using its patented Sertolin technology. According to the American Diabetes Association approximately 9 million Americans require insulin injections and it is the sixth leading cause of death in the United States. Over $100 billion per year is spent in the US on treating diabetes and its complications, and worldwide expenditures on insulin is estimated to be $25 billion annually.
