Israel-based biopharmaceutical firm BioLineRx has received approval from the Israeli Ministry of Health to start a Phase I trial for BL-8040, a new treatment for the mobilisation of stem cells from the bone marrow to the peripheral blood circulation.
The trial is scheduled to start during the third quarter of 2014 at Hadassah Medical Center in Jerusalem.
BioLineRx chief executive officer Kinneret Savitsky said: "Current treatment regimens involve daily injections for four to six days of G-CSF, with or without the addition of a mobilising agent such as Plerixafor (Mozobil).
"BL-8040 given as a single injection was previously shown in a Phase I/II study in multiple myeloma patients to be highly effective in mobilising stem cells in combination with G-CSF injections."
The Phase I trial aims to assess the mobilisation capacity of one or two injections of BL-8040 as a standalone therapy, which could significantly shorten and reduce treatment costs.
Separately, BL-8040 is undergoing a Phase II trial for relapsed and refractory acute myeloid leukemia patients, the results of which are expected in early 2015.
The company also expects the start of an investigator-led Phase I/II trial in chronic myeloid leukemia patients during 2014.
The Phase I trial includes two parts. Part I of the two-part trial is a randomised, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers.
Secondary objectives include evaluation of the efficacy of BL-8040 in mobilising stem cells as a stand-alone therapy, as well as determining the pharmacokinetic profile of the drug.
This part will be performed in about four groups, with 8 healthy volunteers in each group.
Part I of the trial will serve to select the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in Part II of the trial.
Part II is an open-label trial designed to evaluate BL-8040’s stem cell mobilisation capacity, as well as the yield of cells collected by apheresis.
Secondary endpoints of this part of the trial include evaluation of the viability and biological activity of cells mobilised by BL-8040 and collected by apheresis.
This part will be performed in a single group of eight healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from Part I.