Race Oncology has announced its Investigational New Drug application (IND) for Bisantrene Phase 2/3 clinical trial is on hold with the Food and Drug Administration pending outstanding questions.
Bisantrene is a cancer chemotherapy drug which has shown significant activity in several cancers most notably in acute myeloid Leukaemia.
It attacks multiplying cancerous cells and has also been known to have immunologic and genomic effects.
In animal test subjects Bisantrene was found to activate immune cells and then attack and destroy tumour cells. It binds to DNA at a site that displaces telomerase binding proteins which force the tumor cells to lose their immortality and die.
Questions from FDA covered a range of topics including safety, pharmacology, manufacturing, and the trial process.
The second phase of the trial cannot start until the outstanding questions are resolved.
“As we have previously stated, the trial cannot start until we have funding from a licensing partner, so the clinical hold has no immediate impact on the timing of the trial,” Race CEO Peter Molloy stated.
Because of the size and information of the document, there were discussions with the FDA to extend the normal 30-day review period.
Professor Borje Andersson hopes the questions will be answered as the drug will benefit a lot of people.
“This is a drug that has a clear role in AML and I sincerely hope we will see it available for use in treating this disease, in both adults and children,” he said.