LONDON, Ontario and BOSTON, March 20, 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 submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2. The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.
“Based on the strength of encouraging interim data from our ongoing Phase 1 trial, as well as preclinical studies demonstrating that COTI-2 was efficacious and synergistic when administered alongside standard of care chemotherapeutics, we are excited to push forward the development of COTI-2 as part of a combination therapy regimen,” said Alison Silva, President and Chief Executive Officer. “After close consultation with our academic collaborators and investigators, we submitted a substantially updated regulatory package to the FDA seeking approval to evaluate COTI-2 as a combination therapy in our ongoing trial. In addition to evaluating our lead asset as a combination therapy for gynecological malignancies and head and neck squamous cell carcinoma (HNSCC), the protocol amendment will also broaden the trial to include other solid tumors. We look forward to implementing this amendment and dosing the first patient with a combination therapy regimen in the months ahead.”
Phase 1 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 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.
The protocol amendment submitted by the Company in March 2018 aims to expand the ongoing Phase 1 trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. The current gynecological malignancies arm will be expanded to evaluate COTI-2 in combination with bevacizumab and paclitaxel/doxorubicin. The current dose-escalation HNSCC arm will be expanded to evaluate COTI-2 in combination with cisplatin in HNSCC and other solid tumors. 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 and subject to sufficient financing, the Company expects to implement this protocol amendment for the ongoing Phase 1 trial of COTI-2 in May 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 accelerates 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 head and neck squamous cell carcinoma 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 in 2018.
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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 “We look forward to implementing this amendment and dosing the first patient with a combination therapy regimen in the months ahead” 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. Except as required by law, COTI assumes no obligation to update forward-looking statements should circumstances or management's expectations, estimates, projections and assumptions change.