A cancer drug that was largely forgotten about in the 1980’s is on its way back into development courtesy of Race Oncology (ASX: RAC).
The pharmaceutical junior listed on the ASX in 2016 with the aim of “rediscovering” a chemotherapy drug called Bisantrene, aiming to treat various cancers including leukaemia.
Bisantrene was the subject of more than 40 phase 2 clinical studies before it was “lost” in a series of pharmaceutical mergers during the 1990s.
However, after filing its own patents and securing what’s known as an Orphan Drug Designation from the FDA in the US, Race Oncology is now ready to manufacture the drug and demonstrate its capabilities in treating leukaemia sufferers.
The company said it intends to focus on two particularly successful case studies to be formally presented at the International Conference on Leukaemia and Hematologic Oncology in Paris on 21 June 2018.
The case studies refer to two girls in France who were successfully treated with Bisantrene in 1984 and 1991. According to a report published by two French doctors, the two individuals remain alive and well today and constitute a successful demonstration of Bisantrene’s capabilities.
Both patients received Bistantrene having relapsed after multiple lines of standard chemotherapy were unsuccessful. They were treated with one 7-day course of Bisantrene, followed by other chemotherapy, and both patients endured a “complete response to the treatment” which was followed up by bone marrow transplants.
Almost 40 years on, both women remain alive and well with multiple children.
The authors of the case study report are Professor Guy Leverger, a leading French haematology oncologist from the Armand Trousseau children’s hospital in Paris, and Professor Yves Bertrand, also a leading haematology-oncologist, from the Institute of Paediatric Hemato-Oncology in Lyon.
Both doctors were involved in the original Bisantrene studies in France, which were published in the 1980s and 1990s and which contributed to the French marketing approval for Bisantrene. Professor Leverger said the findings “support renewed investigation of Bisantrene in AML.”
“The long-term follow-up with these two salvage paediatric patients I treated decades ago provides interesting insight into a novel chemotherapy lost to development, and with potential benefits over classical anthracyclines,” said Professor Leverger.
According to Race Oncology, the novel chemotherapy that was once lost to development will soon be resurrected and potentially offered to patients on a large scale if the drug completes the necessary clinical trials.
However, its orphan drug designation does allow it to be used on a limited basis, especially on patients with very few treatment options remaining.
The doctors responsible for the report concluded that “published efficacy results from prior salvage studies of Bisantrene in adult and paediatric acute myeloid leukaemia and the long-term case reports presented here, support a renewed interest in its clinical development. Bisantrene is therapeutically active, with a unique safety profile that is particularly appropriate for the treatment of paediatric AML.”