Phase 2 Trial Initiated for Second Line Treatment of AML and MDS


A phase 2 trial of aspacytarabine (BST-236) was initiated in patients with AML and MDS.

Patients with relapsed or refractory myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) may eventually have another treatment option – aspacytarabine (BST-236), a drug being studied in a phase 2 clinical trial.

Patients with MDS are eligible for the trial if their disease has failed to respond to – or relapsed after – first line therapy, and patients with AML are eligible if they are considered unfit for standard therapy.

Biosight Ltd. recently announced its initiation of a phase 2 trial to determine whether aspacytarabine meets treatment needs for these patients.

“Patients with relapsed or refractory AML and MDS have limited treatment options and poor prognoses, with many patients unable to tolerate intensive chemotherapy,” said Dr. Eytan Stein, a hematologic oncologist at Memorial Sloan Kettering Cancer Center and lead investigator of the study, in a release. “I look forward to leading this new Phase 2 study to evaluate the potential of aspacytarabine which may ultimately become the standard of care for relapsed or refractory MDS and AML patients for whom currently there are no effective treatments.”

The treatment demonstrated positive results in the phase 2b trial, where efficacy was achieved, along with complete remission, minimal residual disease negativity rates, duration of response and overall survival.

“Furthermore, these results were particularly impressive as they were achieved with a favorable safety and tolerability profile in patients who are unfit for intensive chemotherapy,” Stein said.

The trial will be conducted at 18 U.S. and Israeli sites, including Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center.

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