Critical Outcomes expands Phase I COTI-2 study to HNSCC

Critical Outcome Technologies Inc. (TSX-V:COT; OTCQB:COTQF) expanded an open-label, U.S. Phase I trial evaluating oral COTI-2 in gynecological malignancies to include up to 36 patients with squamous cell carcinoma of the head and neck (SCCHN) with histologically confirmed p53 mutations.

The trial's primary endpoints will evaluate maximum tolerated dose (MTD) and safety. Secondary endpoints include pharmacokinetics, clinical activity and response duration. Patients will receive COTI-2 for 5 consecutive days followed by 2 days off treatment every week in 4-week cycles, starting at a 1 mg/kg dose...