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Highlights
- Race Oncology has received encouraging results from the first-stage trial of Zantrene in relapsed or refractory Acute Myeloid Leukaemia.
- The very heavily pre-treated AML patient population has shown encouraging clinical responses.
- The trial will now enter the Phase 2 stage.
Shares of Race Oncology Limited (ASX:RAC) jumped nearly 6% to AU$1.845 in the early hours of 27 May 2022 after a crucial company update.
The precision oncology company has received positive results from Phase 1b stage of the relapsed or refractory Acute Myeloid Leukaemia (R/R AML) trial. Leukaemia is the cancer of body's blood-forming tissues, including the bone marrow and the lymphatic system. Primary refractory or relapsed AML is a serious therapeutic challenge as it has a very poor prognosis.
Related read: Race Oncology (ASX:RAC) receives RGO nod for Zantrene human trial
Positive data from the first-stage trial
The Phase 1b dose escalation stage of the Phase 1b/2 Zantrene® study involving six patients took place at Chaim Sheba Medical Centre, Israel.
Primary endpoint of the trial - establishing the recommended dose to be used in the subsequent Phase 2 expansion (efficacy) stage.
The trial received very encouraging efficacy results in the refractory patient population.
Image source: © 2022 Kalkine Media®
Data: company update
Three (1 CR and 2 PR) out of five patients were bridged to an allogenic stem cell transplant. Bridging is a crucial positive outcome in AML treatment as it provides long-term remission to the patient.
Study Lead Prof Arnon Nagler said: “The encouraging results of our Phase I study with Zantrene monotherapy and moreover the current Phase II study altogether with Zantrene in combination in extremely heavily treated advanced high risk AML patients are encouraging and may indicate a role for Zantrene in modern AML treatment paradigm to the benefit of our patients.”
Road ahead - Phase 2 efficacy stage
Now, the trial will advance to the Phase 2 efficacy (expansion) stage using a 4-day schedule of Zantrene®, combined with fludarabine and clofarabine. The open-label trial will recruit 17 patients and is expected to complete in 20-30 months.
Zantrene®, a potent inhibitor of the Fatso/Fat mass and obesity associated (FTO) protein, is a phase 2/3 cancer drug candidate of RAC. Race is exploring the use of Zantrene® as a new therapy for melanoma and clear cell renal cell carcinoma, which are both frequent FTO over-expressing cancers.
Also read: WFL, OSL, AVE: Three ASX healthcare stocks with over 20% QTD returns
