Kintara Therapeutics grants FTD from FDA for REM-001

Kintara Therapeutics announced that the United States Food and Drug Administration, FDA, has granted Fast Track Designation, FTD, to Kintara’s REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer, CMBC. REM-001 was studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to-date of 80% complete responses of CMBC evaluable lesion. "The receipt of Fast Track Designation represents an important regulatory milestone for our REM-001 Therapy program," said Robert E. Hoffman, President and CEO of Kintara. "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."