Race Oncology is pleased to announce it has executed an agreement with Washington D.C – based advisory firm, NSF Health Sciences, to facilitate its IND1 filing in the US for leukaemia drug Bisantrene.
Under the agreement, NSF Health Sciences (“NSF”) will prepare, review, and submit Race Oncology’s IND in support of Bisantrene’s further clinical development.
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 Agent for Race Oncology with the FDA, serving as Race’s interface with the FDA regarding agency correspondence, IND amendments, protocol amendments, pharmacovigilance and other reporting.
Assuming the IND is accepted by the FDA, it 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).
The IND will be an important milestone for Race.
NSF will help us successfully navigate the process and prepare Race 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 would need be filed by the end of Q1 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).
Race has three important and largely independent value domains: FDA approval for adult AML, a potential PRV after a smaller paediatric study, and revenues from Named Patient Programs outside the US.
NSF will help us add value on two of these important fronts.