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Bisantrene investigator-initiated AML trial to start in Israel
Race Oncology has announced that it has signed an agreement to conduct a trial of Race’s cancer drug, Bisantrene, at the Sheba Medical Center in Israel.
The trial has been approved by the Israeli Ministry of Health and the hospital’s Research Ethics Committee, so the expectation is that the trial can start immediately.
“This is a major development, as it’s the first use of Bisantrene in patients since the drug disappeared more than 25 years ago,” said Race Oncology CEO, Peter Molloy.
Bisantrene was lost after a series of mergers in the early 1990s, despite its potential as a treatment for AML. Race has rescued Bisantrene and is developing it for treating relapsed or refractory AML.
Race has submitted an IND to conduct a US registration trial. Race is also pursuing investigator-initiated Phase II trials, such as this one at Sheba Medical Center.
The Sheba Medical Center trial, in 12 patients with relapsed/refractory AML, will be led by Professor Arnon Nagler as the principal investigator. Professor Nagler is a highly-regarded international leader in the leukaemia field (see ‘About Professor Nagler’).
“It’s a testament to Bisantrene’s contemporary potential in AML that an international leader of Professor Nagler’s stature has decided to do this trial,” said Mr Molloy.
“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.
“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,” he added.