ASX Announcement Race files Bisantrene IND with FDA 25 March 2019: Race Oncology Limited (‘RAC’) announced today that it had filed its IND (Investigational New Drug application) for Bisantrene and received receipt from the FDA confirming qualification of the file for submission. Race had previously advised the market of a target filing date of 31 March 2019. “This is a major milestone in the approval pathway for Bisantrene,” said Race CEO, Peter Molloy. The IND is the core regulatory document that will allow Race to undertake a registration clinical trial of Bisantrene in the treatment of adult AML (Acute Myeloid Leukaemia). Once successfully completed, that trial could allow Bisantrene to be approved in the US. “The filing of the IND definitively brands Bisantrene as a Phase III asset,” said Mr Molloy. A standard IND is subject to a 30-day review period by the FDA, after which the proposed trial can proceed, if the FDA has no questions. Because of the large size and scope of the Bisantrene dossier, Race believes that FDA will have a number of questions and that the Q&A process will likely push the start of the trial into the second half of 2019. “This is in line with our timetable for the adult AML trial, which in any case, is subject to our securing funding for the trial, potentially from a licensing partner,” said Mr Molloy. One reason for more extensive discussions with the FDA in this case, is the size of the IND. Most INDs are filed prior to commencement of human trials and tend to be relatively small dossiers that are supplemented progressively as new data emerges. 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. As a result, the IND is around 2,000 pages long, including references and attachments. It also includes hundreds of pages presenting the pre-clinical data on Bisantrene and its extensive clinical history, with 1,800 treated patients.
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