Our business model
Our first important asset is a chemotherapy drug called Bisantrene, which was the subject of more than 40 phase II clinical studies before it was lost in a series of pharmaceutical mergers during the 1990s.
Race Oncology has now rediscovered Bisantrene. In the United States, Race owns two granted patents on Bisantrene and has secured Orphan Drug designation and Rare Paediatric Disease designation. Our goal is to complete clinical development and gain approval by the US FDA.
What is Bisantrene?
Bisantrene is a cancer chemotherapy drug that has shown excellent activity in several cancers, notably Acute Myeloid Leukaemia (AML).
A comprehensive review of the science around Bisantrene was recently published in the International Journal of Cancer Research & Therapy. The article, titled:“The Rediscovery of Bisantrene: A Review of the Literature” is by Dr John Rothman - Chief Scientist of Race Oncology. You can view the article here.
Bisantrene is a small molecule cancer drug related to the 'anthracyclines', the most widely used class of cancer chemotherapy drugs.
However, unlike the anthracyclines, Bisantrene has a greatly reduced risk of cardiotoxicity (heart damage).
This means Bisantrene may be used with patients who have reached their cardiotoxic limit with anthracyclines, or cannot tolerate anthracyclines due to existing heart conditions, age or other factors.
Bisantrene was tested in more than 40 phase II clinical trials during the 1980s and 1990s, before it was lost in a series of pharmaceutical mergers. Before it was lost, Bisantrene demonstrated impressive activity in treating AML, so much so that it was approved for the treatment of AML in France in 1988.
What is Acute Myeloid Leukaemia (AML)
AML (Leukaemia) is a deadly blood cancer that starts in bone marrow. Despite all the improvements in treatment for many cancers, the treatment of AML has not changed appreciably in the last three decades.
Chemotherapy is the standard treatment, followed by a bone marrow transplant in qualifying patients. However, around 80% of patients are not cured by this approach and have a very poor prognosis once they relapse after standard therapy.
Today, relapsed/refractory AML remains a disease with a high unmet medical need. We believe that Bisantrene has an important role to play in treating AML, especially once standard treatment fails.
History
2016
Race Oncology lists on the ASX (RAC) with the mission to rescue Bisantrene and return it to the clinic.
2013-2015
Bisantrene re-discovered, new patents filed and orphan drug designation obtained.
1990s
Bisantrene was approved for marketing in France for the treatment of AML. Lederle was acquired by Wyeth, which was then acquired by Pfizer. In the process, the French registration was withdrawn.
1980s
Tested in more than 40 published phase II clinical trials to assess its efficacy and safety in a wide range of cancers. The studies covered more than 2,000 treated patients and revealed that Bisantrene was shown to possess low cardiotoxicity potential and useful therapeutic efficacy in several cancers, notably AML.
1970s
Bisantrene discovered in the United States by US Pharmaceutical company Lederle (a division of American Cyanamid).