SERNOVA CONCLUDES SUCCESSFUL PRE-IND MEETING WITH FDA
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Posted by Garry on 17:08:52 2008/05/06
Sernova to move onto large animal testing of Sertolin
2008-05-06 09:45 ET - News Release
Mr. Justin Leushner reports
SERNOVA CONCLUDES SUCCESSFUL PRE-IND MEETING WITH FDA
Sernova Corp. has successfully concluded a meeting with the United States 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 preclinical testing data in rodents to date, the FDA specified that the next stage will be a pivotal preclinical trial consisting of a single large animal trial with clear end points, leading to a phase I/II human clinical trial. The pivotal preclinical 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."
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