Press release Communiqué de presse
Press release Communiqué de presse
December 10, 2007 10 December, 2007
Successful Completion of Preclinical Sertolin Study: Regulatory Guidance Sought for Clinical Approval
Kelowna, B.C. - Sernova Corp. ("Sernova")
to announce completion of a comprehensive
efficacy animal study for its lead product Sertolin,
a combination of porcine Sertoli cells and
cells for the treatment of diabetes. The benefits
are the ability to replace insulin producing cells
been destroyed in a diabetic patient without the
anti-rejection drugs, and using the unlimited
porcine derived cells. After conferring with its
Advisory Board and regulatory consultants,
believes it has completed the recommended
preclinical studies and is seeking guidance from
regulators in Canada and the US to determine
any, additional data is required prior to applying
approval to begin clinical trials.
"After a lot of hard work and some ground breaking experiments by our research team, we have established positive data using Sertolin to treat diabetes in the recommended animal model," stated Dr. David White, Sernova's principal researcher. "We will now approach the various health regulators and move forward based on their guidance."
Summary of Results to Date: Four Key Outcomes Islet and Sertoli Cell Isolation and Survival - A reliable process to isolate insulinproducing pig islet cells and Sertoli cells has been established by the Company. In 100% of implants into animals, the islets and Sertoli cells have been shown to survive for extended periods with no detectable side effects to the animal and without the use of any anti-rejection drugs. Porcine Insulin Production - In addition to islet survival, porcine insulin is being produced in the test animals, and the amount of insulin released increases when blood sugar levels are elevated by a fasting glucose challenge test. Animal Health - In the diabetic Lewis rats transplanted with Sertolin, the overall health of the animals was maintained compared to diabetic Lewis rats that did not receive Sertolin. This was demonstrated by healthy weight maintenance in the transplanted rats compared to significant diabetes-related weight loss and early death in the untreated animals. Animal Model Validation - In developing a therapeutic for human use, the Company used the Lewis rat animal model as discussed with the USFDA. While animal models are often imperfect representations of human response, they are a necessity for clinical trial approval. Sernova has demonstrated that Sertolin offers a drug free approach to insulin cell replacement for diabetics, and can lower blood sugar levels in the Lewis rat model; however normalization has not been achieved. This is expected, as further investigations have demonstrated that Lewis rats are significantly non-responsive to porcine insulin. Using pharmaceutical grade porcine insulin, regularly used in humans, Sernova researchers demonstrated that even a 40 fold increase in physiological dosage did not normalize blood sugar levels in the Lewis rats, despite the survival of the insulin producing cells. These studies demonstrate the drawbacks of animal models for diabetes and provide data for future human studies. Because porcine insulin is known to be compatible with humans, and was the primary source of injected insulin for most of the last century, this issue is not expected to be a concern in human applications. President & CEO Justin Leushner stated that "The Company has completed preclinical studies agreed to by the USFDA and is preparing for the next phase of clinical development with its Sertolin product. In addition, we have shown the long-term survival and effectiveness of Sertoli cells to protect transplanted cells from immune rejection without harmful anti-rejection drugs. This approach may represent a breakthrough in the treatment of diabetes, and could be applied to other cell-based therapies in the future."
Charles Allard Resigns
Sernova also wishes to announce that Charles Allard has resigned from its Board of Directors. Mr. Allard informed the Board that while he remains very interested in Sernova's research, his other business commitments have become too time consuming to give adequate attention to the Company.
The Board does not have any immediate plans to replace Mr. Allard with a new Director.
Commented Sernova Chair George Adams, "Chuck brought with him a wealth of business experience and an intense desire to see real improvement in diabetes treatment. We are very sorry to see him go, but respect his decision to do so and wish him all the best."
Sernova Corp. is a Canadian-based, health- sciences company focused on commercializing medical technologies and is currently working on a novel treatment for insulin-dependent diabetes using its patented Sertolin cell 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. One out every 8 dollars spent on health care in the United States is spent on treating diabetes and its complications. Worldwide expenditures on insulin alone are estimated to be $25 billion annually.
This news release may contain forward-looking statements. Forward-looking statements address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements.
ON BEHALF OF THE BOARD
Justin Leushner, President
For further information contact: TEL: (888) 318-7062 Phil Morehouse FAX: (250) 868-8493 Sernova Corp. firstname.lastname@example.org www.sernovacorp.com
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