Critical Outcome Receives Orphan Drug Designation For COTI-2

(RTTNews) - Critical Outcome Technologies Inc. (COT.V), a bioinformatics and accelerated drug discovery company, said the U.S. Food and Drug Administration has granted COTI-2 an Orphan Drug Designation for the treatment of ovarian cancer.

Dr. Wayne Danter, President and CEO, said, "When current first line treatments fail, oncologists have limited treatment options to offer these patients. With its p53 dependent mechanism of action, COTI-2 is a novel compound with the potential to benefit these patients, as more than 95% of serious ovarian cancers have a p53 gene mutation. "

The Orphan Drug Designation may qualify the company for many benefits, including assistance in study design from the FDA, potential for expedited drug development, eligibility for orphan disease development grants, fee reductions, tax credits for clinical trial costs for U.S. based companies, and a seven-year period of orphan drug exclusivity upon product approval.