Zantrene, also known by its generic name bisantrene dihydrochloride, is an anti-cancer drug used both as a low-dose targeted precision oncology agent as well as a cardio-protective chemotherapy drug. Zantrene was developed by Australian Race Oncology, who, together with Sheba, launched a clinical trial for the treatment of relapsed or refractory acute myeloid leukemia (AML) last year.
Led by Prof. Arnon Nagler, a world-renowned cancer researcher and President of Sheba’s Hemato-Oncology Division, the trial studies the effect of Zantrene on a population of clinically challenging patients who failed to achieve AML remission despite having undergone two or more lines of treatment.
Acute myeloid leukemia is an aggressive, fast-growing cancer affecting white blood cells. When AML has relapsed and/or is refractory, it can cease responding to treatments, presenting a major therapeutic challenge for oncologists.
Zantrene stops AML by inhibiting the FTO mass and obesity-associated protein on the molecular level, which has been found to be the genetic driver of growth in several cancers, including AML, melanoma, and kidney cancer.
Phase II of Sheba’s clinical trial will combine Zantrene with two other chemotherapy drugs, Fludarabine and Clofarabine (FluCloZan), for intravenous administration. Seventeen new patients will be recruited, and the trial will take 20-30 months to complete.
During the first part of the phase II trial, in which researchers established the maximum tolerated dose (MTD) of FluCloZan, three of the six participants went on to receive bone marrow transplants. Among patients with relapsed or refractory AML, this is a remarkable result that has the potential to establish long-term remission.
In the trial’s second part, the treatment’s efficacy is tested by examining a patient’s bone marrow over time.
“The encouraging results of our phase I study with Zantrene monotherapy and the current phase II study with Zantrene in high-risk, advanced AML patients are encouraging and may indicate a role for Zantrene in the modern AML treatment paradigm to the benefit of our patients,” said Prof. Arnon Nagler.
Sheba’s researchers are optimistic that patients will continue to respond favorably to Zantrene as the trial progresses, reporting results as they are analyzed over the study period so that the treatment can be approved for integration into regular clinical use as soon as possible.