June 17, 2014
Critical Outcome Technologies Inc., the bioinformatics and accelerated drug discovery company, announced that the U.S. Food and Drug Administration (FDA) has granted COTI-2 an Orphan Drug Designation for the treatment of ovarian cancer.
“Receiving the Orphan Drug Designation for COTI-2 speaks to the need for new treatment options for patients with ovarian cancer,” said Dr. Wayne Danter, President and CEO. “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. We continue to believe that COTI-2 could represent a significant therapeutic advantage over treatments currently available for ovarian and other gynecological cancers.”
“This is an important milestone for COTI-2 and brings us one step closer to bringing this exciting compound to ovarian cancer patients,” said John Drake, Chairman of the Board. “We are looking forward to moving COTI-2 into the clinic in early 2015 and the Orphan Drug Designation should prove helpful in our ongoing dialogue with potential licensees as this drug candidate’s development progresses.”
The Orphan Drug Designation may qualify the Company for a number of benefits under the U.S. Orphan Drug Act of 1983 (ODA), as amended. These benefits include assistance in study design from the FDA, potential for expedited drug development, eligibility for orphan disease development grants, fee reductions, significant tax credits for clinical trial costs for U.S. based companies, and a seven-year period of orphan drug exclusivity upon product approval.
About Orphan Drug Designation
Under the ODA, the FDA may grant the Orphan Drug Designation to facilitate drug development for drugs that target conditions affecting fewer than 200,000 patients in the U.S. each year, which potentially provide a significant therapeutic advantage over existing therapies. The first new drug application to receive FDA approval for a particular active ingredient to treat a particular disease with an FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product and for that indication.
About Critical Outcome Technologies Inc.
COTI is a leading-edge bioinformatics company specializing in accelerating the discovery and development of small molecules – dramatically reducing the time and cost to bring new drugs to market. COTI’s proprietary artificial intelligence system, CHEMSAS®, utilizes a series of predictive computer models to identify compounds with a high probability of being successfully developed from disease specific drug discovery through chemical optimization and preclinical testing. These compounds are targeted for a variety of diseases, particularly those for which current treatments are either lacking or ineffective.
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