LONDON, Ontario and BOSTON, May 17, 2018 (GLOBE NEWSWIRE) — 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, today announced 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) Annual Meeting taking place June 1-5, 2018 in Chicago, Illinois.
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.
About Cotinga Pharmaceuticals Inc.
Cotinga Pharmaceuticals is a clinical-stage pharmaceutical company that uses proprietary artificial intelligence technologies to pursue a targeted and transformational approach to treating cancer and other unmet medical needs. Cotinga’s CHEMSAS® technology is intended to accelerate the discovery and development of novel drug therapies, allowing the Company to build a pipeline of potential drug candidates faster and with a higher probability of success than traditional methods.
The Company’s lead compound, COTI‐2, has a novel p53‐dependent mechanism of action with selective and potent anti‐cancer activity. P53 mutations occur in over 50% of all cancers. COTI‐2 is initially being evaluated for the treatment of gynecologic cancers and HNSCC in a Phase 1 clinical trial at the MD Anderson Cancer Center at the University of Texas and the Lurie Cancer Center at Northwestern University. The Company has secured orphan drug status in the United States for COTI‐2 for the treatment of ovarian cancer. Preclinical data suggests that COTI-2 could dramatically improve the treatment of cancers with mutations in the p53 gene.
The Company’s second lead compound, COTI-219, is a novel oral small molecule compound targeting the mutant forms of KRAS without inhibiting normal KRAS function. KRAS mutations occur in up to 30% of all cancers and represent a tremendous unmet clinical need and a desirable drug target. COTI-219 is undergoing IND-enabling studies to support a regulatory submission.
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|President and CEO|
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. Forward‐looking statements by their nature are not guarantees of future performance and are based upon management’s current expectations, estimates, projections and assumptions. For example, “Pending regulatory approval, the Company expects to implement the protocol amendment mid-calendar 2018” is a forward-looking statement. Cotinga 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 Cotinga 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. Except as required by law, Cotinga assumes no obligation to update forward-looking statements should circumstances or management’s expectations, estimates, projections and assumptions change.