Kintara Therapeutics, Inc. announced the initiation of a REM-001 15-patient clinical trial (NCT05374915) in cutaneous metastatic breast cancer (CMBC) patients. This open label 15-patient study in CMBC patients is evaluating REM-001, a second-generation photodynamic therapy (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 (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24.

In June 2023, Kintara was awarded a $2.0 millionSmall Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001 in CMBC. This grant will cover the majority of the costs to run this clinical study. Cutaneous metastases can develop with any metastatic cancer but are believed to occur most frequently in metastatic breast cancer.

A 2003 meta-analysis of over 20,000 metastatic cancer patients found that 24% of the breast cancer patients included in the analysis had developed cutaneous metastases, which was the highest rate of any cancer type. Based on a 2017 analysis, the current prevalence of metastatic breast cancer in the United States is estimated to be over 168,000. Accordingly, the prevalence of CMBC may be in excess of 40,000 cases annually in the United States.