Troy, MI, January 20, 2010 --(PR.com
)-- Regulatory Affairs Associates announced today that a contract was signed with Ohio State University to manufacture clinical supplies for a break-through drug to prevent oral cancer. The drug will be tested at multiple clinical sites in the United States during 2010.
The topical gel formulation uses anthocyanins as the active drug component. After harvesting the American-grown black raspberries , the cancer-preventing compounds in the black raspberries are concentrated and freeze dried. Laboratory experiments and pilot human clinical trials have demonstrated patient safety and potential efficacy in the prevention of oral cancer.
The upcoming placebo-controlled multicenter trial will be funded by an NIH Grand Opportunities grant under an IND authorized by the US FDA to evaluate precancerous lesions in 72 patients. Oropharyngeal cancer affects around 34,000 patients annually in the USA and results in significant morbidity and mortality.
Anthocyanins are promising cancer-preventing agents due to their antioxidant and anti-inflammatory properties. Black raspberries have large quantities of these compounds.
Regulatory Affairs Associates is a preeminent FDA consulting company. Stephen Goldner, President said: “We are especially pleased to support the years of effort invested by the Ohio State researchers. The Ohio State oral cancer chemopreventive team of Drs. Gary Stoner, Peter Larsen and Susan Mallery will collaborate with clinician-scientists in other universities for this trial. We are confident that the FDA will look favorably upon the project and allow this trial to proceed smoothly so that the chemopreventive gels can be evaluated in patients with known precancerous oral lesions in a multicenter, placebo-controlled setting.”
Dr. Mallery, OSU Professor of Oral Pathology said: “We could not have initiated this definitive clinical trial without the people at Regulatory Affairs Associates who moved faster than we could have believed possible. Now our companion clinical sites at University of Louisville and University of North Carolina, Chapel Hill will be able to proceed with their patient accrual efforts much sooner than anticipated.”
About Regulatory Affairs Associates
Regulatory Affairs Associates is a full service drug and medical device providing expert FDA consulting services for companies, inventors and universities world wide. Their experts have worked over 35 years to bring many life sustaining drugs and medical devices to the marketplace in the USA and around the world.