SOURCE: Critical Outcome Technologies Inc. (COTI)

Critical Outcome Technologies Inc. (COTI)

February 16, 2016 08:30 ET

Critical Outcome Treats First Patient in Phase 1 Study of COTI-2 in Gynecologic Cancers

Study Aims to Have a Positive Impact for Women With p53 Mutations

LONDON, ON--(Marketwired - February 16, 2016) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE: COT) (OTCQB: COTQF), announced today that the first patient in the Company's Phase 1 clinical trial of COTI-2 for the treatment of gynecological cancers has commenced treatment at MD Anderson Cancer Center in Houston, TX with the administration of their first dose yesterday.

"We are very pleased to announce that patient enrollment is proceeding and treatment has begun in the Phase 1 trial of COTI-2," said Dr. Wayne Danter, President and CEO. "During preclinical studies, the activity of COTI‐2 in mutant-p53 ovarian cancer models was striking. In those studies, COTI-2 as a single agent either completely halted tumor growth or led to dramatic tumor regression depending on the dose amount and p53 mutation type. Moreover, there was no observable toxicity in those preclinical studies. We are eager to see similar results from this first-in-human study and anticipate that all three women in the first cohort will be receiving treatment by the end of February."

The Phase 1 trial will include up to 46 women with advanced gynecologic cancers who have failed conventional therapy. The primary objectives for the Phase 1 trial are the evaluation of the safety and tolerability of COTI-2 in patients with advanced or recurrent gynecologic malignancies and the identification of a maximum-tolerated dose and recommended Phase 2 dose (RP2D) for oral COTI-2. Secondary objectives include the evaluation of pharmacokinetics at all dose levels, an estimation of clinical efficacy at all dose levels including the RP2D, a determination of the proportion of patients surviving progression-free at six months, and an estimate of the response duration at all dose levels and at the RP2D. Exploratory objectives include determination of any correlation between individual patient's baseline gene mutation types and treatment with COTI-2, and the evaluation of pharmacodynamic markers of COTI-2 activity at the RP2D level in patients.

In June of 2014, COTI‐2 received the Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of ovarian cancer, one of the five main types of gynecological cancers.

Learn more about COTI-2 by visiting our website at http://criticaloutcome.com/coti-2.

About Critical Outcome Technologies Inc. (COTI) 

COTI is a biopharmaceutical company advancing the treatment of cancer through targeted therapeutics. The Company's lead compound, COTI-2, has a novel p53-dependent mechanism of action with selective and potent anti-cancer activity. The initial therapeutic indication is in gynecologic cancers, which includes ovarian, cervical and endometrial cancers. The Company has secured orphan drug status for the ovarian indication in the U.S. and is planning additional studies in other cancer indications such as head & neck, Li-Fraumeni syndrome and AML, based upon more than ten animal xenograft models showing both single and combination agent activity of COTI-2with other leading cancer drugs. Preclinical data provides evidence to suggest a potentially dramatic change in the treatment of cancers with mutations of the p53 gene.

Follow @CriticalOutcome on Twitter at http://twitter.com/CriticalOutcome

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 "We are eager to see similar results from this first-in-human study and anticipate that all three women in the first cohort will be receiving treatment by the end of February" and "… will include up to 46 women with advanced gynecologic cancers who have failed conventional therapy …" 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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