Melbourne-based Race Oncology (ASX:RAC) has executed an agreement with Washington DC–based advisory firm, NSF Health Sciences, to facilitate its regulatory filing in the US for leukaemia drug Bisantrene.
Under the agreement, NSF will prepare, review, and submit Race Oncology’s filing in support of Bisantrene’s further clinical development.
According to the company, this will involve incorporating pre-IND and Type C meeting comments from the FDA, assembling the non-clinical and clinical modules for the IND from previous clinical studies and published literature, in addition to incorporating the proposed clinical trial protocol and investigator’s brochure.
The contracted cost of the NSF program to file the IND is US$69,900.
NSF also will act as the US gent for Race Oncology with the FDA, serving as its interface with the regulator regarding agency correspondence, IND amendments, protocol amendments, pharmacovigilance and other reporting.
If accepted by the FDA, the IND will allow Race to conduct its pivotal trial, which is a key step towards US marketing approval of Bisantrene for the treatment of relapsed/refractory Acute Myeloid Leukaemia (AML).
Race said the goal is to start the adult registration trial in the second half of 2019.
To achieve this, allowing time for FDA discussion on the protocol, the IND will need be filed by the end of the first quarter of 2019.
Once the IND is accepted by the FDA, Race can also submit a clinical trial protocol to conduct a rare childhood AML study under its recently-announced ‘Rare Paediatric Disease’ designation.
If successful, this could lead to a valuable and saleable Priority Review Voucher (PRV).