Sernova Corp
TSX VENTURE : SVA

Sernova Corp

May 06, 2008 09:30 ET

Sernova Concludes Successful Pre-IND Meeting With FDA

LONDON, ONTARIO--(Marketwire - May 6, 2008) - Sernova Corp. (TSX VENTURE:SVA) -

Sernova Corp. today announced the successful conclusion of a meeting with the U.S. Food and Drug Administration (FDA) that established definitive requirements for the filing of an Investigational New Drug (IND) application, which is required to advance Sertolin into human Clinical Trials. Sertolin is the Corporation's proprietary technology for treating insulin-dependent diabetes. After review of Sernova's pre-clinical testing data in rodents to date, the FDA specified that the next stage will be a pivotal pre-clinical trial consisting of a single large animal trial with clear endpoints, leading to a Phase I/II human Clinical Trial. The pivotal pre-clinical trial is expected to take about 18 months to complete and will assess the long-term safety and durable activity of Sertolin.

Justin Leushner, President of Sernova, noted, "This key development reflects the interest of the FDA in diabetes therapies, and creates a definitive path for Sernova to initiate "first in man" Clinical Trials to advance our unique technology through the regulatory process required for human use."

The FDA meetings clarified the details of the development path for Sernova's xenotransplantation approach to treat diabetes, which incorporates co-transplantation of insulin-producing porcine islet cells and Sertoli cells within a small subcutaneous medical device. "Sernova appreciates the positive instruction and interactions we received in our pre-IND meeting with the FDA," said Dr. David White, Lead Scientist for Sernova. "Their clear advice and direction will greatly assist our future IND application as we look toward the crucial Clinical Trials in humans."

About Sernova

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.

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