Race submits bisantrene to US FDA

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The US FDA has received an Investigational New Drug (IND) application from Melbourne-based Race Oncology (ASX:RAC) for its cancer drug bisantrene.

Bisantrene is the company's investigational treatment for Acute Myeloid Leukaemia (AML). The FDA application is a precursor to the company’s planned 250-patient clinical trial of Bisantrene for the treatment of adult AML.

“The filing of the IND definitely brands Bisantrene as a Phase III asset,” said Race Oncology CEO Peter Molloy.

Bisantrene is entering the clinical and regulatory process at Phase 3. The IND comprises the entire history of its preclinical and clinical development, along with phase 3 quality manufacturing and other data.

“Race Oncology is well advanced in our push to get FDA approval of Bisantrene in the United States. Our team has been focused on this milestone for the past six months,” said Mr Molloy.

The FDA will now take 30 days to review the application, which consists of new chemistry and manufacturing data developed by the company, as well as the entire history of the pre-clinical and clinical development of Bisantrene over three decades.

Bisantrene is a chemotherapy drug that was the subject of more than 40 phase 2 clinical studies during the 1980s and 1990s. Race gained rights to the drug after its was development was halted following a series of mergers between large pharmaceutical companies.

Race said it also plans a trial of bisantrene in paediatric AML. The company has received a Rare Paediatric Disease designation for bisantrene from the FDA and, upon completion of a successful paediatric trial, could receive a valuable and saleable ‘Priority Review Voucher’ (PRV).

The company said it is now in advanced discussions around the funding and conduct of the paediatric trial.

“The IND is the culmination of nearly three years of manufacturing and development work at Race Oncology, and it now provides the launch pad for a number of value creating programs,” said Mr Molloy. “I regard this IND as our most important achievement to date.”