On March 20, 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 submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2 (Press release, Cotinga, MAR 20, 2018, View Source [SID1234533158]). The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.

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"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.