SOURCE: Critical Outcome Technologies Inc. (COTI)

Critical Outcome Technologies Inc. (COTI)

June 06, 2016 08:30 ET

Critical Outcome Activates Second Clinical Trial Site for Its COTI-2 Gynecological Cancer Study

Northwestern University Site Open for Enrollment

LONDON, ON--(Marketwired - June 06, 2016) - Critical Outcome Technologies Inc. (TSX VENTURE: COT)(OTCQB: COTQF) ("COTI" or the "Company") announced today the opening on June 3, 2016, of a second treatment site in its Phase 1 clinical trial of COTI-2 for gynecological cancers. This site, at the Lurie Cancer Center at Northwestern University in Chicago, Illinois will broaden the base of patients who can potentially qualify for the study with the goal of expediting the enrollment of patients into the trial and thus allowing the overall trial to move forward on a timelier basis.

"We are excited to have a second clinical trial site open and to be working with the talented oncology team at Northwestern University," said Dr. Wayne Danter, President & Chief Executive Officer. "In addition to its intended benefit of increasing the enrollment and speed of moving the trial forward, patients may also benefit from this Midwest location that could offer closer proximity, easier access, and lower travel costs to participating in the trial. The team at Northwestern University will be working closely with the MD Anderson Cancer Centre site in Houston and with our internal clinical management staff as part of the overall study team."

The lead investigator at Northwestern University is Dr. Wilberto Nieves-Neira. Dr. Nieves-Neira is an Associate Professor in Obstetrics and Gynecology in the Gynecologic Oncology department at the Northwestern University Feinberg School of Medicine.

About the Lurie Cancer Center at Northwestern University

The Lurie Cancer Center ("LCC") at Northwestern University is one of only 45 NCI-designated Comprehensive Cancer Centers in the United States. The LCC was first established 1974, and is a founding member of both the National Comprehensive Cancer Network (NCCN) and the Big Ten Cancer Research Consortium. The LCC is affiliated with four teaching hospitals in Chicago; Northwestern Memorial Hospital, the Ann & Robert H. Lurie Children's Hospital of Chicago, the Rehabilitation Institute of Chicago, and the Jesse Brown Veteran's Affairs Medical Center, together treating more than 10,000 new cancer cases each year.

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 cancers; treatment of patients in a Phase 1 clinical trial began at MD Anderson Cancer Center in February 2016. 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 upon 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" as such term is defined under applicable securities laws. For example, the statement, "... the goal of expediting the enrollment of patients into the trial and thus allowing the overall study to move forward on a timelier basis ..." 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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