Sernova to Take Its First Regulatory Step Towards Clinical Trials-Granted Formal Pre-IND Meeting With FDA
Posted on: Tuesday, 18 March 2008, 09:01 CDT
Sernova Corp. (TSX VENTURE: SVA) is pleased to announce that the company will be meeting with the United States Food and Drug Administration (FDA) on April 25, 2008 regarding Sertolin, the company's investigational cellular therapy being developed for diabetes treatment. This formal pre-Investigational New Drug (IND) meeting is Sernova's first step in seeking IND approval to initiate clinical trials in humans. The FDA meeting will provide Sernova with the opportunity to present its experimental data on Sertolin, obtain feedback on its pre-clinical data package, and receive the FDA's perspective on its proposed clinical strategy.
Sernova CEO, Justin Leushner, stated, "With our dedicated work and focus on the Sertolin product, we have put ourselves in a good position to move another step towards commercialization by beginning discussions with FDA for launching Sertolin into human clinical trials. We expect to work closely with the FDA in a collaborative effort to ensure optimal opportunity for success for Sertolin."
With the completion of its large-scale animal efficacy study on Sertolin, announced on December 10, 2007, Sernova is now focusing on completing the scale-up and design of the chamber for human application, finalizing arrangements to secure porcine cells for human trials, and continuing to monitor the long-term animal studies.
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 Sertoli 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 of 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
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release.
Contacts: Sernova Corp. Phil Morehouse 1-888-318-7062 (250) 868-8493 (FAX) Email: info@sernovacorp.com Website: www.sernovacorp.com
SOURCE: Sernova Corp.
Source: MARKET WIRE
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