A Perth-based biotechnology company is close to commercialising a new cancer therapy more than three decades after it was discovered by a company that, after a series of mergers, ended up as part of Pfizer.
ASX-listed Race Oncology (ASX:RAC) is moving closer to bringing Bisantrene to market in countries that allow pre-FDA approved drugs on a compassionate basis.
Bisantrene is used to treat Acute Myeloid Leukaemia (AML). It has been tested in more than 40 clinical trials, with investment of around US$100 million, but has never made it to market.
The therapy was originally discovered by US-based Lederle, a division of American Cyanamid, over three decades ago.
It was studied in a series of trials during the 1980s, including 33 clinical trials at the National Cancer Institute in the US, to assess its efficacy and safety in a wide range of cancers including AML.
Yet according to Race Oncology CEO, Peter Molloy, its development was deprioritised and ultimately shelved following a series of mergers, starting with Wyeth's acquisition of American Cyanamid. The remnants of the company are now with Pfizer following its merger with Wyeth in 2009.
“Global pharmaceutical companies often shelve drug development programs, especially after mergers, when the imperative is to rationalise the R&D portfolio,” said Mr Molloy.
“Our business model is to rescue drugs that have been overlooked by large Big Pharma, often for commercial reasons. As a smaller player we are the right size to manage drugs to treat less common illnesses where there is a clear medical need,” he added.
Race Oncology said it has filed new patents on Bisantrene and been granted an Orphan Drug Destination in the US - giving it seven years of exclusivity in that country from the date of FDA approval.
The company said it is exploring additional cancer uses for Bisantrene, including breast, lung and prostate cancers, via a proposed joint venture with Swiss-based TargImmune Therapeutics.
“TargImmune is using a unique cancer targeting technology to destroy cancer cells. The low cardiotoxicity of Bisantrene makes it an ideal chemotherapy drug to use alongside TargImmune’s treatment,” added Mr Molloy.