SOURCE: Critical Outcome Technologies Inc. (COTI)

Critical Outcome Technologies Inc. (COTI)

April 19, 2016 08:30 ET

Critical Outcome Commences Treatment of Second Cohort in Phase 1 Study of COTI-2 in Gynecologic Cancers

Second Cohort Patients Receive Increased Dosage of P53-Dependent Cancer Drug

LONDON, ON--(Marketwired - April 19, 2016) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE: COT) (OTCQB: COTQF), announced today that the Company commenced treating patients in the second cohort of its ongoing Phase 1 clinical trial of COTI-2 for the treatment of gynecological cancers. Treatment of the second cohort will continue to evaluate COTI-2's safety profile at a dosage level twice that of the first cohort. Prior to initiating cohort two, the independent Dose Escalation Committee reviewed the safety data from all patients in the first cohort and unanimously approved moving to dosing the next cohort.

"We are pleased to be moving into the second cohort of the Phase 1 trial of COTI-2 in gynecological cancers," said Dr. Wayne Danter, President and CEO. "Receiving this approval from the independent Dose Escalation Committee is consistent with the low toxicity profile seen in preclinical studies. No adverse events attributable to treatment were identified in the three patients of the first cohort. We eagerly anticipate advancing toward follow-on cohorts and continuing the dose escalation portion of the study to determine the maximum tolerated dose and ultimately the dose of COTI-2 to be used in Phase 2 trials."

As previously announced, treatment of the first cohort commenced on February 15, 2016.

Learn more about COTI-2 by visiting our website at

About Critical Outcome Technologies Inc. 

COTI is a clinical stage 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 cancer; a Phase 1 clinical trial began at MD Anderson Cancer Center in December 2015. 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 and neck, Li-Fraumeni syndrome, and acute myelogenous leukemia, based on more than ten animal xenograft models showing both single and combination agent activity of COTI-2 with 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.

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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 "We eagerly anticipate advancing toward follow-on cohorts and continuing the dose escalation portion of the study to determine the maximum tolerated dose and ultimately the dose of COTI-2 to be used in Phase 2 trials" is a forward-looking statement. 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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