Kintara Therapeutics has launched a clinical trial for REM-001, focusing on patients with cutaneous metastatic breast cancer (CMBC).
This trial, designed as an open-label study for 15 subjects, aims to evaluate a 0.8mg dose of REM-001, a second-generation photodynamic therapy (PDT) photosensitiser agent.
It will also optimise the study design, before proceeding to a Phase III trial.
The trial’s primary endpoint is the Best Overall Objective Response Rate (bORR), which includes both complete and partial responses of the target therapy fields up to week 24 post-treatment.
Its initiation follows $2m in funding from the US National Institutes of Health (NIH) Small Business Innovation Research (SBIR) granted in June last year, intended to support REM-001’s clinical development in CMBC patients.
The NIH grant is expected to cover the majority of the costs associated with this clinical trial.
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Kintara focuses on developing new cancer therapies for patients who have limited treatment options.
The company’s photodynamic therapy platform is being developed as a potential treatment for localised cutaneous or visceral tumours, among other possible indications.
REM-001 is the lead programme of Kintara and comprises a laser light source, a light delivery device, and the REM-001 drug product.
It has undergone evaluation in four Phase II/III trials involving CMBC patients who had received chemotherapy and/or radiation therapy.
REM-001 has so far demonstrated a clinical efficacy rate of 80% complete responses in evaluable CMBC lesions and has a safety database from nearly 1,100 patients across various indications.
Kintara president and CEO Robert Hoffman said: “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.
“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.”