Why this cancer drug was lost for 25 years

At the end of July, a team of clinicians at the Sheba Medical Centre in Israel treated a patient with a drug that had been lost for over 25 years.

The patient, diagnosed with relapsed/refractory Acute Myeloid Leukaemia (AML), is one of 12 to be recruited as part of a clinical trial designed to help return this lost drug to clinical use after such a long time.

Bisantrene, as the drug is known, was rediscovered by specialty pharmaceutical company Race Oncology after its founder’s interest was piqued by the promising data Bisantrene showed.

“There’s so much clinical history on this drug, it’s been in 1,800 patients and 46 phase II trials in various cancers,” Race Oncology CEO Peter Molloy told European Pharmaceutical Manufacturer.

Bisantrene’s history then is one of promise but in the early 1990s, the drug was lost due to a series of pharmaceutical mergers.

“[Bisantrene] got left behind despite the fact it showed quite remarkable effectiveness in treating acute myeloid leukaemia (AML) when everything else had failed,” Molloy says.

This is key to the drug’s clinical use. While AML is a difficult disease to treat, a number of therapies do exist “that are targeted treatments for specific mutations in AML cells and they can target more effectively than the broad spectrum drugs,” Molloy says.

But Bisantrene is intended as a salvage therapy, or in other words, for patients who have exhausted all other means of treatment.

One of the drug’s particularly attractive attributes is its reduced risk of cardiotoxicity when treating children with AML.

“When it comes to children it’s a major issue because you could end up curing the child – and often it’s infants who have this disease – but giving them congestive heart failure; it’s lifelong cardiac damage that current drugs can cause and Bisantrene doesn’t have that attribute,” Molloy explains.

That’s why Race Oncology is now looking for a partner to help fund and run a paediatric clinical trial in the US.

The company has recently secured a new patent for the drug in the United States, enabling Bisantrene to be used in combination with other drugs to treat AML and breast cancer.

And while Race Oncology’s efforts could bring back Bisantrene from the annals of history, the fact it was lost isn’t something that surprises Molloy.

“Frankly, when I worked in big pharma, I would have deprioritised [Bisantrene] as well because from big pharma’s perspective it was never going to be a billion-dollar drug,” Molloy states.

But that hasn’t stopped Race Oncology and the conclusion of the trial taking place at the Sheba Medical Centre should give the company more insight into the efficacy of Bisantrene. Hopefully, the drug’s resurrection will prove successful.

“I sincerely hope it leads to new remissions in patients who wouldn’t otherwise have much hope of survival,” Molloy adds.