Race Oncology Ltd (ASX:RAC) will seek to repurpose the chemotherapy drug Bisantrene for acute myeloid leukaemia (AML).
The drug was the subject of more than 40 phase II clinical studies during the 1980s and 1990s and now Race Oncology owns recent patent filings on Bisantrene and has secured Orphan Drug Designation in the U.S.
The drug showed promise in treating AML in 5 phase 2 studies, was approved in France for AML in 1990, and then disappeared after a series of big pharma mergers.
The drug may not have been a focus because AML was considered a smaller market.
The immunotherapy checkpoint inhibitor drugs have not made significant headway with AML.
As a result, the treatment of AML has not changed in 30 years and it remains essentially incurable once the standard of care (SOC) fails.
The SOC is well established so that Bisantrene is unlikely to be adopted as a first line treatment for AML in the near term, but only for relapsed/refractory AML.
Race Oncology is pursuing late stage drug assets that have been overlooked or shelved by large pharmas, but with the potential to be revitalised and brought to market to generate revenues.
Bisantrene is Race Oncology’s first drug asset and the company is considering expanding its portfolio in the future.
The goal for the next year is to file an Investigational New Drug with the FDA and gain the FDA’s assent to complete the development of Bisantrene under 505(b)(2).
Under 505(b)(2), the FDA would allow Race Oncology to use and apply all the available historical clinical and other data on Bisantrene and thereby not have to repeat those studies.
This could provide a window to bring the drug to market quickly to generate revenues far quicker than the traditional biotechnology pathway.
In parallel, the company is preparing to launch Bisantrene in European markets where it is legal to sell orphan drugs that are not yet approved elsewhere in the world – these include France, Italy, Finland and Turkey.
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