Pharmaceutical Business review

BioLineRx closes dose escalation stage of Phase I trial of BL-8040

In the trial, all healthy volunteers completed the treatment phase and results are scheduled to be released during the first quarter of 2015.

The company is developing BL-8040 along multiple tracks to treat hematological malignancies and other hematological indications, with multiple clinical milestones expected in 2015.

BioLineRx chief executive officer Dr Kinneret Savitsky said: "Stem cell mobilization is used increasingly as a method of collecting hematopoietic stem cells for transplantation, forming part of the treatment regimen for certain types of hematological cancers, as well as severe anemia or immune deficiency disorders.

"Although it is a Phase I study, the current trial will provide us with efficacy data regarding the mobilization capacity of one or two injections of BL-8040 as a stand-alone therapy, which could significantly shorten and reduce the cost of treatment, as well as eliminate the painful side effects associated with G-CSF."

Separately, BL-8040 is also undergoing a Phase II trial for treating relapsed and refractory acute myeloid leukemia patients and its results are expected to be reported in the second half 2015.

The company also intends to start clinical trials for three additional indications for BL-8040 during 2015.

The Phase I trial consists of two parts and the first part is a randomized, double-blind, placebo-controlled dose escalation trial exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers.

The trial’s second part is an open-label study designed to evaluate BL-8040’s stem cell mobilization capacity, as well as the yield of cells collected by apheresis.