Impressive Preclinical Bisantrene Breast Cancer Results

• Bisantrene as a single drug shows similar efficacy to doxorubicin and epirubicin in a range of different breast cancer types.
• Bisantrene can kill some breast cancer cells resistant to doxorubicin and epirubicin.
• Cyclophosphamide shown to act very similarly when used in combination with either Bisantrene, doxorubicin or epirubicin.
• Results provide the necessary preclinical evidence to advance Bisantrene into human breast cancer clinical trials as a potentially safer treatment.

Race Oncology Limited (ASX: RAC) is pleased to share results of the collaborative preclinical research program between Race and The University of Newcastle. Eminent cancer researcher, Associate Professor Nikki Verrills of the Hunter Medical Research Institute is leading the project.

The aim of this research program is to identify combinations of current breast cancer drugs that when paired with Bisantrene show equivalent efficacy to existing treatment options, but with significantly reduced serious side effects. Bisantrene was the subject of a large Phase III single agent clinical trial in the USA in advanced breast cancer patients in the late 1980s and early 1990s. This Phase III trial showed that Bisantrene had the same efficacy as the standard of care treatment, doxorubicin, but caused significantly less damage to the patient’s heart; 23% of the patients who received doxorubicin had serious heart failure compared to only 4% who received Bisantrene.

The University of Newcastle’s results showed Bisantrene to be an effective chemotherapeutic agent across a wide range of different genetically defined breast cancer subtypes. Bisantrene was able to kill some cancer subtypes that were resistant to the currently used anthracyclines doxorubicin and epirubicin. Importantly, Bisantrene showed near identical additive benefit when used in combination with cyclophosphamide as that seen with doxorubicin and epirubicin. Finally, initial data obtained by the University of Newcastle team on Fat mass and obesity-associated protein (FTO) suggests an association between FTO expression level and cancer sensitivity to Bisantrene.

Associate Professor Nikki Verrills of the University of Newcastle and Hunter Medical Research Institute said “Our data shows that the combination of Bisantrene and cyclophosphamide is more effective than either drug alone, in killing a wide range of different human breast cancer subtypes. The findings are very encouraging as they show the clinical potential for combining Bisantrene with standard of care for breast cancer patients. While the early clinical data tells us that Bisantrene is effective in breast cancer patients as a single agent, decades of experience tells us that combination therapy is far more effective in eliminating cancers and blocking the development of treatment resistance. Our data provides the necessary preclinical evidence to now test this combination in clinical trials.”

Race’s CSO Dr Daniel Tillett commented “These high quality results from Nikki’s team fully support our clinical plans for the use of Bisantrene as a safer alternative to the commonly used anthracyclines which can be very dangerous to the hearts of patients. These result show that Bisantrene is compatible with existing treatment regimes and can be combined with standard chemotherapy drugs. I am very excited that we are now in a position to move Bisantrene into its next clinical trial and offer a potentially less harmful, but equally effective, treatment alternative for breast cancer patients.”

Race’s CEO Mr Phillip Lynch added, “This new research not only underscores our confidence in moving Bisantrene into a Phase II breast cancer trial, but continues to build on the body of evidence we have supporting Bisantrene’s potential for broader use and then commercial opportunity. Breast cancer affects about 2.1m women annually and the drug market is valued at US$20 billion globally [2]. We hope to be able to bring a valuable new treatment option to patients with Bisantrene.”

The full announcement can be download below