Regulatory Affairs Associates (RAA) has signed a contract with Ohio State University to manufacture clinical supplies for a new drug designed to prevent oral cancer. The topical gel formulation uses anthocyanins obtained from black raspberries as the active component. Anthocyanins are promising cancer-preventing agents due to their antioxidant and anti-inflammatory properties.
After harvesting black raspberries, the cancer-preventing compounds in the fruit 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 company said in a press release.
The drug will be tested at multiple clinical sites in the U.S. during 2010, according to RAA. The placebo-controlled multicenter trial will be funded by a National Institutes of Health Grand Opportunities grant to evaluate precancerous lesions in 72 patients. The Ohio State oral cancer chemopreventive team of Drs. Gary Stoner, Peter Larsen, and Susan Mallery will collaborate with clinician-scientists in other universities -- including the University of Louisville, KY, and University of North Carolina -- for this trial, according to RAA President Stephen Goldner said.
"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," he said.
