Race Oncology (ASX:RAC) has announced that the first patient has been dosed in the Phase 1b/2 trial of Zantrene (bisantrene dihydrochloride) in combination with fludarabine and clofarabine for patients with relapsed/refractory Acute Myeloid Leukaemia.
The company said the investigator-led trial supervised by Professor Arnon Nagler will use Zantrene in a novel three-drug combination that has demonstrated efficacy in pre-clinical studies.
Professor Nagler was the principal investigator of the Phase 2 investigator-initiated trial where Zantrene was used as a single agent in R/R AML patients and reported a 40 per cent clinical response rate.
The new trial will run in parallel with a separate Australian Phase 2 trial in patients with extramedullary AML. The company said both trials are key components of its three-pillar strategy.
According to Race chief medical officer Dr David Fuller, “We are delighted to see the start of this important clinical project which uses a novel combination approach for relapsed or refractory Acute Myleoid Leukaemia. This study is also an important step in our journey towards approval of Zantrene in this area of high unmet medical need.”
Race CEO and managing director Phillip Lynch added, “This study led by Professor Nagler who has good experience with Zantrene, supports the building of additional data in AML in line with our three pillar strategy plan. We hope to see improved patient outcomes in what has been historically a difficult to treat disease. We plan on using our trademarked name, Zantrene, in referring to bisantrene dihydrochloride. It’s one of our registered trademarks and its protection is enhanced by its ongoing and appropriate use.”