The search for a viable treatment for cancer has been an ongoing effort for oncology experts around the globe for decades. With the current chemotherapeutic drugs exhibiting only a minimal change in patient condition while causing undesirable side effects, Race Oncology, a pharmaceutical company based in Melbourne, Australia, is trying a different approach. In their quest to find an active treatment for cancer, the company focuses on promising late-stage drug assets that have previously failed to capture the attention of pharmaceutical giants.
Bisantrene, a promising chemotherapeutic medication used for the treatment of Acute Myeloid Leukemia (AML) is Race Oncology’s first important asset. It is a small molecule that belongs to the most widely used ‘anthracycline’ class of anticancer drugs. However, unlike other anthracycline-related molecules, Bisantrene has a significantly reduced risk of causing cardiotoxicity. The U.S. based pharmaceutical company, Lederle, was the first to discover the drug in the 1970s. Subsequently, between 1980 and 1990, the drug was the subject of over 40 phase II clinical trials to determine its efficacy against a wide range of cancers. Approved for marketing in France in the year 1988, Bisantrene was never commercialized and eventually the approval was withdrawn due to a series of pharmaceutical company acquisitions in the 1990s. Race Oncology re-discovered Bisantrene in 2015 and has since then, received a notice of allowance on one of the two patents filed and an Orphan Drug Designation for the treatment of AML in the U.S.
In February 2018, Race Oncology released its investor presentation prior to CEO Peter Molloy’s address at the BIO CEO Conference in New York City. The presentation clearly lays out the company’s aim to make Bisantrene the first-line drug for all types of AML. Currently, the company is striving to get approval from countries that permit a Named Patient Program (NPP), which allows the supply of an unapproved drug under special conditions and earn revenues. The conditions include the lack of treatment for a specific disease, the nomination of patients by doctors and the company supplying the drug will not promote the product in any way. After gaining approval, Race Oncology will use the earned revenues to support registration trial and approval in the U.S.