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  • Cancer pharmaceutical company Race Oncology (RAC) is reporting impressive results from a phase two clinical trial in acute myeloid leukaemia
  • The small trial returned a 40 per cent response rate in patients with relapsed or refractory acute myeloid leukaemia
  • While the trial cohort consisted of just 10 subjects, the results are still significant given the patients had been unresponsive to three prior therapies on average
  • The research team at Israel’s Sheba Medical Centre concluded bisantrene represents a promising and safe anti-leukaemic therapy
  • The company will pursue further clinical trials of bisantrene in the treatment of AML, breast and ovarian cancers through 2020
  • Race Oncology shareholders must be happy with the news — company shares are up 52.4 per cent to 48 cents each

Cancer pharmaceutical company Race Oncology (RAC) is reporting impressive results from a phase two clinical trial in acute myeloid leukaemia.

The small open-label trial at Israel’s Sheba Medical Centre returned a 40 per cent response rate in patients with relapsed or refractory acute myeloid leukaemia (R/R AML).

While the trial cohort consisted of just 10 subjects, the results are still significant given the patients had been unresponsive to three prior therapies on average.

A new hope

R/R AML remains difficult to treat, so any clinical advance will be significant.

The 40 per cent response rate — including one patient in complete remission — is impressive given the cohort’s failure to respond to prior treatments.

The trial drug, bisantrene, has been around since the 1980s, however, most trial data are old and studies were not conducted using the current formulation.

The fact the drug presents significantly lower toxicities than current treatments (anthracyclines), means it also represents a therapeutic option often unavailable to fragile patients with R/R AML.

While the drug does exhibit some side-effects including thrombocytopaenia (low blood platelets) and mucositis (mouth ulcers), these are known and expected toxicities for this family of drugs, and are less severe than the cardiotoxicity (heart problems) associated with anthracyclines.

Race Oncology Chief Scientific Officer Dr Daniel Tillett says the results show positive indications for application in a vulnerable patient group.

“A key focus of this trial was a determination of bisantrene’s safety in a modern context, so it was encouraging to see the drug’s tolerability profile compared favourably with other commonly used chemotherapy agents such as the anthracyclines,” Daniel said.

“The side effects were in keeping with what we would expect to see with all chemotherapeutics of this class and provide further evidence of bisantrene’s clinical safety.

“These results are pleasing from both a safety and activity perspective, particularly given the clinically challenging patient population included in this trial,” he added.

The Sheba team concluded bisantrene represents a promising anti-leukaemic therapy with an acceptable safety profile.

Data from the study will be submitted for peer review.

Next steps

While the study results by no means represent a silver bullet in the treatment of R/R AML, the positive indications are well worth pursuing in further, larger trials.

Race Oncology Executive Chairman Dr John Cullity says the company will follow up with further studies of bisantrene for R/R AML and other cancers.

“This drug is talking to us. As this was an open-label, single-agent trial, we can be confident that it was the bisantrene exposure which generated the positive results,” John said.

“The patient cohort had advanced AML and had previously failed an average of three lines of therapy, so they were always going to be tough to treat,” he continued.

“A 40 per cent overall response rate after only a single course of treatment markedly exceeds expectations. It’s a hugely promising result and one which reinforces our development plans for bisantrene.”

Executive Chairman, Dr John Cullity

Race Oncology will pursue its ‘5-Path’ clinical development strategy across the U.S. and Australia, with clinical trials of bisantrene in the treatment of AML, breast and ovarian cancers through 2020.

Race Oncology shareholders must be happy with the news — company shares are up 52.4 per cent to 48 cents each as at 11:40 am AEST.

RAC by the numbers
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