Critical Outcome Technologies Receives Orphan Drug Designation For COTI-2
Designation for treatment of ovarian cancer provides further support for the clinical development of COTI-2
LONDON, ONTARIO--(Marketwired - June 17, 2014) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE:COT)(OTCQB:COTQF), the bioinformatics and accelerated drug discovery company, announced today 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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Notice to Readers
Information contained in this press release may contain certain statements, which constitute "forward- looking statements" within the meaning of the Securities Act (Ontario) and applicable securities laws. For example, the statements: "… COTI-2 is a novel compound with the potential to benefit these patients"; "… 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 the drug candidate's development progresses"; and "… may qualify the Company for a number of benefits under the Orphan Drug Act of 1983 (ODA), as amended" are forward-looking statements. Forward‐looking statements by their nature are not guarantees of future performance and are based upon management's current expectations, estimates, projections, and assumptions. COTI operates in a highly competitive environment that involves significant risks and uncertainties, which could cause actual results to differ materially from those anticipated in these forward‐looking statements. Management of COTI considers the assumptions on which these forward‐looking statements are based to be reasonable, but as a result of the many risk factors, cautions the reader that actual results could differ materially from those expressed or implied in these forward-looking statements. Information in this press release should be considered accurate only as of the date of the release and may be superseded by more recent information disclosed in later press releases, filings with the securities regulatory authorities or otherwise.
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Critical Outcome Technologies Inc.
Dr. Wayne Danter
President & CEO