Israel-based biopharmaceutical firm BioLineRx has dosed first patient in a two-part Phase I trial for a second indication of its BL-8040 cancer therapy platform, as a new stem cell mobilisation treatment.
BL-8040 is indicated to treat the mobilisation of stem cells from the bone marrow to the peripheral blood circulation, where they can be harvested for transplant supporting the treatment of haematological indications.
The randomised, double-blind, placebo-controlled dose escalation first part of the trial is exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers.
Secondary objectives of this part of the trial include evaluation of the efficacy of BL-8040 in mobilising stem cells as a stand-alone therapy, and also determine the pharmacokinetic profile of the drug.
The first part will be performed in about four groups, with eight healthy volunteers in each group.
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Data from this first part will help in selecting the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in second part of the study.
BioLineRx chief executive officer Dr Kinneret Savitsky said: "Stem cell mobilisation is used more and more as a method of collecting haematopoietic stem cells for transplantation, which is used to treat certain types of cancer such as myeloma, leukaemia or lymphoma, as well as for the treatment of severe anaemia or immune deficiency disorders.
"Traditionally, these cells were harvested from the bone marrow using a surgical procedure, which involves general anaesthesia. Current treatment regimens involve daily injections for 4-6 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.
"Although it is a Phase I study, the current trial will provide us with efficacy data regarding the mobilisation 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."
The open-label second part of the trial is designed to evaluate the drug’s stem cell mobilisation capacity, as well as the yield of cells collected by apheresis.
It will be conducted in a single group of eight healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from first part.
The trial’s secondary endpoints include assessment of the viability and biological activity of cells mobilised by BL-8040 and collected by apheresis.
The company expects to announce results from Phase I trial by the end of 2014 or early 2015.
Currently, BL-8040 is in the midst of the dose-escalation part of a Phase II trial for the treatment of acute myeloid leukaemia, which is being conducted at several cancer research centres in the US and Israel, and its results are expected to be reported in early 2015.