Critical Outcome Technologies Signs Phase 1 Clinical Trial Agreement
LONDON, ON--(December 10, 2015) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE: COT) (OTCQB: COTQF), announced today the signing of a clinical trial agreement ("CTA") to conduct a Phase 1 clinical trial to evaluate COTI-2, the Company's activator of mutant p53 protein, in patients with advanced gynecologic cancers at The University of Texas MD Anderson Cancer Center ("MD Anderson").
"This is a significant milestone for our Company, our lead oncology COTI-2 program, and potentially for the future of patients afflicted with gynecologic and other cancers," said Dr. Wayne Danter, President and CEO. "The CTA provides many benefits to our Company, and to the advancement of COTI-2, not the least of which is the caliber of the team that will help to guide this first-in-humans trial. MD Anderson is world-renowned for its state‐of‐the‐art facilities, technical capabilities, and the expertise to successfully execute our Phase 1 clinical trial." Principal Investigator for the COTI-2 Phase 1 clinical trial, Shannon Westin, MD, MPH, stated, "An agent, such as COTI-2, that successfully leverages the most common molecular abnormality in solid tumors, a p53 mutation, has the potential to advance the current state of gynecologic cancer care."
With the CTA in place, the Company can now commence the clinical trial with COTI‐2 that is planned to include up to 46 women with advanced gynecologic cancers who have failed conventional therapy. The trial will focus on determining the maximum tolerated-dose, pharmacokinetics, and safety of COTI-2. Patient enrollment is anticipated to begin in mid-December following a site visit to MD Anderson with treatment to commence shortly thereafter. The study includes an expansion arm of ten women specifically with ovarian cancer whose test results will be examined for early signals of treatment efficacy once the maximum tolerated dose is determined.
For the purposes of the Phase 1 clinical trial, the term "gynecologic" cancer refers to cancers of the ovary, endometrium, and cervix. Dr. Westin, an Assistant Professor in the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson will work in association with the lab of Gordon B. Mills, MD, Chairman, Department of Systems Biology, Wiess Distinguished University Chair in Cancer Medicine, Co‐Director, Institute for Personalized Cancer Therapy at MD Anderson in conducting the trial.
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 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 indication is in gynecologic cancers (ovarian, cervical and endometrial) that will begin patient dosing in a Phase 1 clinical trial at MD Anderson Cancer Center in late 2015/early 2016. The Company has secured orphan drug status for the ovarian indication in the U.S. and is planning additional studies in other indications such as head & neck, AML and Li-Fraumeni as well as combination therapies with other leading cancer drugs. Pre-clinical 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, "… successfully leverages the most common molecular abnormality in solid tumors, a p53 mutation, has the potential to advance the current state of gynecological cancer care" and "… the Company can now commence the clinical trial with COTI‐2 that is planned to include up to 46 women with advanced gynecologic cancers who have failed conventional therapy" and "… patient enrollment is anticipated to begin in mid-December following a site visit to MD Anderson with treatment to commence shortly thereafter …" and "… an expansion arm of ten women specifically with ovarian cancer whose test results will be examined for any signals of treatment efficacy once the maximum tolerated dose is determined" 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.
For more information, visit www.criticaloutcome.com or contact:
Dr. Wayne Danter
President & CEO
Vice President Investor Relations
Tel: 508-444-6790 / 519-858-5157
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