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Investigational New Drug application filed with FDA

Race Oncology has announced the US Food and Drug Administration has received its Investigational New Drug (IND) application for the company’s cancer drug Bisantrene.

The IND application is a major milestone in the approval process for the company’s Acute Myeloid Leukaemia (AML) drug in the United States. The application is a precursor to Race Oncology’s intended 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.

Because Bisantrene is entering the clinical and regulatory process at Phase III, the IND comprises the entire history of Bisantrene’s preclinical and clinical development, along with Phase III 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 Race Oncology CEO Peter Molloy.

The FDA will now take 30 days to review the application, which consists of new chemistry and manufacturing data developed by Race Oncology, 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 forty phase two clinical studies during the 1980s and 1990s. Race has rescued the drug after it was lost in a series of big pharma mergers.

In addition to underpinning the adult AML approval of Bisantrene, the IND will be the core regulatory document and springboard for Race’s planned trial in paediatric AML.

Race has received a Rare Paediatric Disease designation for Bisantrene from the FDA, and upon a successful paediatric trial, could receive a valuable and saleable ‘Priority Review Voucher’ (PRV).

The Company 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,” added Mr Molloy.

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