Kintara Therapeutics announced the expansion of the inclusion criteria in the open label 15- patient REM-001 study in cutaneous metastatic breast cancer, or CMBC, to include patients receiving pembrolizumab, or KEYTRUDA, for at least three months at screening. CMBC patients are being screened and dosed in the 15-patient study which is evaluating REM-001, a second-generation photodynamic therapy, or PDT, photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate, or bORR, of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the $2.0M Small Business Innovation Research grant Kintara was awarded from the National Institutes of Health.
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