Critical Outcome Technologies Inc. (COTI)

Critical Outcome Technologies Inc. (COTI)

October 30, 2014 09:06 ET

Critical Outcome Technologies Reports Successful Completion of Two-Species Toxicity Testing for COTI-2

Another critical milestone achieved as low toxicity confirmed in pre-IND testing

LONDON, ONTARIO--(Marketwired - Oct. 30, 2014) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE:COT)(OTCQB:COTQF), the biopharmaceutical company that uses machine learning to rapidly develop targeted therapies, announced today that its lead oncology drug candidate, COTI-2, successfully completed two-species repeated dose toxicity studies in anticipation of a United States Food and Drug Administration ("FDA") Investigational New Drug ("IND") filing.

The repeated dose toxicity studies are the principal studies that support the safety profile of a new drug. As such, the FDA and Health Canada require two-species repeated dose toxicity studies prior to filing an IND or Clinical Trial Application ("CTA") respectively in anticipation of a Phase 1 clinical trial. The key highlights of the studies that supported the development of the Company's protocol for Phase 1 were as follows:

  • COTI-2 was able to achieve a No Observed Adverse Effect Level ("NOAEL") determined in both a rodent and non-rodent species using an oral dosing regimen that was both well tolerated at and above levels that have been effective in recent xenograft experiments. This allows for the selection of a starting oral dose in the Phase 1 clinical trial within the dosing parameters established from the toxicity studies;
  • The studies were conducted with a five day on and two day off dosing schedule repeated for a total of 28 days in both species. Achieving an NOAEL for this dosing regimen provides a treatment regime of Monday to Friday dosing with weekends off, which is generally well tolerated from a patient's perspective; and,
  • The range of apparently safe and effective doses for COTI-2 was identified as being quite wide for a cancer drug and is consistent with COTI-2 having a good safety profile.

"The results of these crucial experiments have confirmed the low toxicity of COTI-2 observed during preclinical development," said Dr. Wayne Danter, COTI's President and CEO. "This important positive data will be shared with potential licensing partners who have been waiting on these results and the data have been incorporated into our IND document targeted for filing by the end of the year."

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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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, "this important positive data will be shared with potential licensing partners who have been waiting on these results …" and "… targeted for filing by the end of the year" 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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