Pharmaceutical company Race Oncology (ASX: RAC) has made incremental progress on its path towards commercialising its first asset Bisantrene, a chemotherapy drug that treats acute myeloid leukaemia (AML).
The company revealed that it had signed an agreement to conduct a Bisantrene trial at the Sheba Medical Center in Israel, with work to commence “immediately”, with Race confirming that all next steps have already been approved by the Israeli Ministry of Health and the hospital’s Research Ethics Committee.
Given current circumstances, the agreement foresees the trial to be completed by “no later than 1 December 2021”.
Under the agreement, Race is obliged to provide Bisantrene at no cost, pay a €78,975 (A$127,560) grant to Sheba to support the trial, and provide clinical trial insurance.
Furthermore, Race said that all trial results will be jointly owned by Race and Sheba, with Race reserving the right to publish headline study results and to use the results in support of any future regulatory submissions.
In terms of technical specifics, the trial is expected to comprise 12 patients with relapsed or refractory AML and will be led by Professor Arnon Nagler as the principal investigator.
The primary objective of the phase 2 trial will be to generate what are known as clinical remissions (CR) in patients with AML.
In other words, to test the drug on people who are resistant to other therapy (refractory), have relapsed after previous therapy, or cannot receive further anthracycline treatment.
Race said that all qualified patients will receive Bisantrene at a dosage of 250mg per day for seven days, in conjunction with conventional supportive care. In the event of clinical remission, patients will receive a three-day consolidation course of Bisantrene also at 250mg per day.
Race chief executive officer Peter Molloy hailed the news as a “major development” for the company and raising hopes that a drug that had effectively been “lost” for over 25 years would now have a second chance of being administered to cancer patients.
Bisantrene was lost after a series of pharmaceutical industry mergers in the early 1990s, with its applications and potential as a treatment for AML seemingly wasted.
To further support the drug’s potential safety and efficacy, Bisantrene was the subject of more than 40 clinical studies during the 1980s and 1990s.
Race says it has gone out into the market and “rescued” Bisantrene in order to redevelop it for treating relapsed or refractory AML.
In order to prepare the drug for market adoption, Race has submitted an investigational new drug (IND) application to conduct a US registration trial.
However, late last month Race received word that the FDA had decided to place its application on “clinical hold” pending “resolution of outstanding FDA questions”.
Questions and feedback from the FDA covered a range of topics, including safety, pharmacology, manufacturing and the trial protocol.
At the time, Mr Molloy explained that the trial could not start until the company has secured funding from a licencing partner, and stated the clinical hold would not have a material effect on the timing of the trial.
In parallel to the ongoing work with the FDA, Bisantrene is the subject of two recently granted US patents and has been awarded US Orphan Drug designation and a Rare Paediatric Disease designation.
“I am excited about the potential for Bisantrene in our leukaemic patients in whom the disease is unresponsive and have very few alternatives,” said Professor Nagler.
The professor added that “a number of new targeted agents have become available, but these are only useful in the small percentage of patients who have specific, identifiable mutations.”
This morning’s news helped Race’s shares grow 40% to $0.08.