BioLineRx has announced enrollment of the first patient in a Phase 2 trial for BL-8040, for the treatment of acute myeloid leukemia (AML).
The patient was enrolled at the MD Anderson Cancer Center in Houston, Texas. The Company also announced that, in addition to receiving regulatory approval for commencing the trial in the U.S. this past April, it has also recently received regulatory approval from the Israeli Ministry of Health to conduct the trial in Israel. The activation of Israeli sites is anticipated during the next few weeks.
The study is a multicenter, open-label study under an IND, designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adult subjects with relapsed or refractory AML.
The primary endpoints of the study are the safety and tolerability of BL-8040. Secondary endpoints include the pharmacokinetic profile of the drug and an efficacy evaluation, as assessed by various parameters, such as the response rate by bone marrow biopsy.
The study is also designed in a way that will enable the investigators to evaluate the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death.
Up to 50 patients are expected to be enrolled in the study, which is expected to be conducted at 8 sites in the U.S. and Israel.
“We are very excited that BL-8040's Phase 2 trial has begun at a world-leading cancer research center such as MD Anderson,” said Kinneret Savitsky, Ph.D., CEO of BioLineRx.
Savitsky continued, "We anticipate that additional world-leading cancer research centers in the U.S. will join MD Anderson in this promising Phase 2 trial. In addition, the recently received regulatory approval from the Israeli Ministry of Health will also expedite recruitment of patients at several leading sites in Israel.”
“The development of novel drugs for AML is critical, since treatment options for this common type of leukemia are still limited compared to other leukemia types. This is particularly apparent with respect to patients with relapsed or refractory diseases. Considering the compound’s unique biological pathway and its promising pre-clinical results, BioLineRx and its clinical partners are enthusiastic about BL-8040. We have high hopes for BL-8040 and look forward to the partial results expected towards the end of this year,” concluded Dr. Savitsky.