Kintara Therapeutics, Inc. (Nasdaq: KTRA), a California-based biopharmaceutical company, announced on Wednesday that it has expanded the inclusion criteria in the open label 15-patient REM-001 study in cutaneous metastatic breast cancer (CMBC) to include patients receiving pembrolizumab (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 (PDT) photosensitiser agent, and is designed to test the 0.8 mg dose as well as optimise the study design in advance of a Phase 3 trial initiation.
The study's primary endpoint is Best Overall Objective Response Rate (bORR) (complete response or partial response) 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 USD2.0m Small Business Innovation Research (SBIR) grant Kintara was awarded from the National Institutes of Health (NIH).
Robert E. Hoffman, Kintara's president and chief executive officer, said: "Expanding the inclusion criteria to include CMBC patients on pembrolizumab for at least three months at screening is expected to significantly increase enrolment in our REM-001 study. With a strengthened balance sheet, we continue to evaluate strategic options with the goal of maximising shareholder value."
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