On May 17, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported that the Company and its collaborators from MD Anderson Cancer Center will present data on COTI-2, Cotinga’s lead compound currently in a Phase 1 clinical trial, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5, 2018 in Chicago, Illinois (Press release, Cotinga, MAY 17, 2018, View Source [SID1234533154]).
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Abstract Title: COTI-2, a potent orally available small molecule targeting mutant p53, with promising efficacy as monotherapy and combination treatment in preclinical tumor models
Session Date and Time: Saturday, June 2nd, 2018 1:15 PM – 4:45 PM Central Time
Session Location: McCormick Place South, Hall A, Poster Board 28
Phase 1b/2a Trial of COTI-2
The ongoing Phase 1 trial of COTI-2 is currently evaluating COTI-2 as a monotherapy for the potential treatment of gynecological malignancies and head and neck squamous cell carcinoma ("HNSCC"). In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating COTI-2 was generally safe and well-tolerated. COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy. In March 2018, the Company submitted a protocol amendment to the FDA for to expand the trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacodynamics and various signals of efficacy. Pending regulatory approval, the Company expects to implement the protocol amendment mid-calendar 2018.