Company Finalizing Plans to Commence Clinical Trial for COTI-2 in the Second Half of 2015
LONDON, ON--(May 26, 2015) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (COT:CA) (COTQF) , announced today that the U.S. Food and Drug Administration ("FDA") granted investigational new drug status ("IND") for COTI-2, the Company's small molecule activator of misfolded mutant p53 protein, in gynecological cancers.
"The grant of this IND marks the achievement of the second important milestone for COTI-2 in 2015 and builds on the Orphan Drug designation received for ovarian cancer from the FDA in June 2014," said Dr. Wayne Danter, President and CEO. "During preclinical studies, COTI-2 with its novel mechanism of action demonstrated selective and potent anti-cancer p53-dependent activity in many cancers. We look forward to reproducing these encouraging results in a clinical setting and confirming that COTI-2 is a highly promising novel treatment option for women with gynecological cancers having p53 mutations."
The Company plans to commence a Phase 1 clinical trial in the second half of calendar 2015 in partnership with the University of Texas, MD Anderson Cancer Center in Houston.
The grant of this IND triggers the issuance of 715,720 common shares of the Company as final payment of contingent share consideration that arose on the acquisition of DDP Therapeutics in November 2007.
COTI‐2 is a small molecule activator of misfolded mutant p53 protein approved for clinical development. Extensive studies have demonstrated COTI‐2's ability to restore mutant p53 function and thus induce cancer cell death in many common p53 mutations. Mutations of the p53 gene are the most common genetic alterations in human cancers, occurring in a wide range of cancers, including ovarian, lung, colorectal, breast, liver, bladder and other cancers. COTI-2's specific protein target, low toxicity, combination effectiveness with standard agents, and potential for longer term outpatient therapy as an oral agent, supports a dramatic change in the treatment of susceptible cancers.
About Critical Outcome Technologies Inc.
COTI is a biopharmaceutical company using machine learning to rapidly develop targeted therapies. COTI's proprietary artificial intelligence platform, 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 statement, "The Company plans to commence a Phase 1 clinical trial in the second half of calendar 2015" and "We look forward to reproducing these encouraging results in a clinical setting and confirming that COTI-2 is a highly promising novel treatment option for women with gynecological cancers having p53 mutations" 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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For more information, visit www.criticaloutcome.com or contact:
Critical Outcome Technologies Inc.
Dr. Wayne Danter
President & CEO
Investor Relations - Canada
Stonegate Capital Partners
Investor Relations - United States
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