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What is Bisantrene?

Bisantrene is a cancer drug that is related to the anthracyclines, the most widely used class of chemotherapy drugs.

Bisantrene is a cancer chemotherapy drug related to the anthracyclines, a class of drugs used as the first line of treatment for AML and many other cancers. However, one of the disadvantages of anthracyclines is their risk of cardiac toxicity and consequent heart failure. This means that once patients have received an amount of anthracyclines that approaches the maximum recommended dose to avoid cardio-toxicity, the oncologist may have to stop treatment, even when the drug is working. In addition, anthracyclines are associated with high levels of cancer drug resistance after initial treatment. Essentially, this means that the after an initial remission, the cancer relapses and progresses.

Bisantrene has been shown to have greatly reduced cardiac toxicity compared to anthracyclines and to be effective against some cancers that have relapsed after the patients have already received high levels of anthracyclines. This makes Bisantrene potentially well-suited as a second- or third-line treatment for patients who have reached their cardio-toxic limit of anthracyclines or whose cancer has become resistant to anthracycline treatment. The initial clinical opportunity for Bisantrene is as a salvage treatment for elderly patients with Acute Myeloid Leukaemia (AML).

History

Bisantrene was discovered by the US pharmaceutical company Lederle (a division of American Cyanamid) in the 1970s. Through the 1980s and into the early 1990's, Bisantrene was tested in more than 40 published phase II clinical trials, including 33 clinical trials at the National Cancer Institute (NCI) in the US, to assess its efficacy and safety in a wide range of cancers. In these studies, in total covering more than 2,000 treated patients, Bisantrene was shown to possess low cardiotoxicity potential and useful therapeutic efficacy in several cancers, notably AML (Acute Myeloid Leukaemia).

Acute myeloid leukaemia (AML)

In 1990, and despite its phase II clinical status, Bisantrene was actually approved for marketing in France for the treatment of AML.

Since then, and despite all the improvements in treatment for breast and other cancers, the treatment of AML has not changed appreciably. Today, it remains a disease of the elderly with a high unmet medical need and where a clear opportunity exists for Bisantrene, once anthracycline and other chemotherapy treatments fail.

Mode of Action

In addition to its direct cytotoxic actions (like other chemotherapy drugs), Bisantrene has also been shown to have immunologic and genomic effects. In allogeneic transplant (animal) models, Bisantrene has been found to activate macrophages (one type of immune cell) to attack and destroy tumour cells. Further, it binds to DNA at a site that displaces telomerase binding proteins, enabling tumour cells to regain their mortality and die of old age (apoptosis), rather than continue to proliferate.

Because of these additional immune-stimulating and apoptotic mechanisms of action, Race Oncology believes that Bisantrene may have an important role in certain cancers in combination with some of the new immunotherapeutic agents.

Race Oncology plans to generate early sales revenues under a Named Patient Program.

Development Plan

Race Oncology intends to re-open the Bisantrene IND in the US and complete its clinical development, allowing it to be brought to market in the US, Europe and other markets as a useful chemotherapeutic agent, initially for salvage therapy in AML, and then in certain other cancers, where it could be used in combination with modern immunotherapeutic agents. Apart from AML, Bisantrene also has potential in breast cancer, lymphoma and ovarian cancer.

 

Named Patient Program Sales

In addition, once the IND is re-opened in the US, the company will apply to offer the drug for sale in France and several other countries on a Named Patient Program basis, which is expected to generate valuable early sales revenues for Race Oncology and provide funding for the US development and FDA registration program. The NPP will be aimed initially at AML and Race believes there are at least four countries in Europe where it will be possible to make early sales under the NPP arrangement, before the drug is registered in the US.