The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Kintara Therapeutics’ late-stage photodynamic therapy (PDT), REM-001, to treat cutaneous metastatic breast cancer (CMBC).
The second-generation PDT photosensitiser drug, REM-001 has undergone late-stage clinical development in previous clinical trials.
The REM-001 therapy includes three parts, a laser light source, a light delivery device and the drug REM-001.
Kintara Therapeutics president and CEO Robert Hoffman said: “The receipt of Fast Track Designation represents an important regulatory milestone for our REM-001 Therapy program.
“We believe this designation is a key component of our future clinical and regulatory strategy as we continue to seek funding, in particular grants, to restart REM-001 clinical development as soon as possible.”
The company stated that REM-001 was evaluated in four Phase II/III clinical trials in CMBC patients who had received chemotherapy and/or failed radiation therapy previously.
In the studies, REM-001 demonstrated 80% clinical efficacy to complete responses of CMBC evaluable lesions and safety database of nearly 1,100 patients across several indications.
The biopharmaceutical company is looking to raise funds to restart a 15-patient study in CMBC patients in advance of a Phase III study.
Kintara Therapeutics chief scientific officer Dennis Brown said: “This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address CMBC.
“We have extensive data in hand to support the advancement of this clinical program and look forward to the continued investigation of our drug candidate in the next study as planned.”