On February 12, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the initiation of a REM-001 15-patient clinical trial (NCT05374915) in cutaneous metastatic breast cancer (CMBC) patients (Press release, Kintara Therapeutics, FEB 12, 2024, View Source [SID1234639983]).

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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 million Small 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.

"We are encouraged by the extensive data from prior REM-001 therapy trials supporting its strong efficacy in CMBC patients, providing us with an opportunity to address a significant unmet medical need," said Robert E. Hoffman, President and CEO of Kintara. "With an 80% complete response rate for evaluable lesions in CMBC patients observed in previous late-stage clinical trials and the support of the NIH, along with the FDA’s Fast Track Designation, we are confident in the potential of REM-001 to help CMBC patients."

"CMBC is a devastating disease with limited treatment options for patients," said Alina Markova, M.D., Section Head, General Dermatology and Oncodermatology at Memorial Sloan Kettering Cancer Center and Principal Investigator of the REM-001 15-patient study. "I am looking forward to testing the therapeutic potential of REM-001 in this trial and bringing novel therapies to CMBC patients to improve their quality of life."

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.