Kintara Therapeutics Launches Clinical Trial for REM-001, a Promising Treatment for Cutaneous Metastatic Breast Cancer
Kintara Therapeutics, a leading biopharmaceutical company, has announced the initiation of a clinical trial for REM-001, a groundbreaking treatment for cutaneous metastatic breast cancer (CMBC). This exciting study, which will involve 15 patients, aims to confirm the planned dosage and optimize the study design in preparation for a Phase 3 clinical trial.
The primary objective of this open-label trial is to evaluate the Best Overall Objective Response Rate (bORR) of the target treatment fields within a period of up to 24 weeks post-treatment. REM-001 is a second-generation photodynamic therapy (PDT) photosensitizer agent, and the trial will assess the efficacy of a 0.8 mg dose.
In June 2023, Kintara received a generous $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 substantial grant is expected to cover the majority of the costs associated with the clinical study, marking a significant milestone in the advancement of this transformative therapy.
Robert E. Hoffman, President and CEO of Kintara, expressed his confidence in REM-001’s ability to aid CMBC patients, highlighting an impressive 80% complete response rate for evaluable lesions in CMBC patients observed in previous late-stage clinical trials. Furthermore, REM-001 has received Fast Track Designation from the FDA, further highlighting its potential to revolutionize CMBC treatment.
Dr. Alina Markova, Principal Investigator of the study and Section Head at Memorial Sloan Kettering Cancer Center, emphasized the limited treatment options currently available for CMBC and the urgent need to develop new therapies for these patients. With over 40,000 cases annually in the United States alone, the prevalence of CMBC underscores the significance of this clinical trial and the potential impact of REM-001.
Kintara is dedicated to the development of innovative cancer therapies to address the unmet medical needs of patients. REM-001 Therapy has been extensively studied in four Phase 2/3 clinical trials, and its safety profile is supported by a robust database of approximately 1,100 patients across multiple indications.
This groundbreaking clinical trial represents a major step forward in the fight against CMBC, offering hope to patients and a potential breakthrough in the field of cancer therapy. The information in this article is based on a press release statement from Kintara Therapeutics.
Analyst comment
Positive news. The launch of the clinical trial for REM-001 is a significant step forward in the treatment of cutaneous metastatic breast cancer (CMBC). With promising results from previous trials, the trial aims to confirm the dosage and optimize the study design for a Phase 3 trial. The generous grant received from NIH will cover most of the costs associated with the study. REM-001 has the potential to revolutionize CMBC treatment and provide new options for patients.
