BioLineRx Initiates Phase 2 Trial for BL-8040 as Novel Stem Cell Mobilization Treatment

BioLineRx Ltd. (NASDAQ:BLRX) announced the initiation of a Phase 2 trial for BL-8040 as a novel approach for the mobilization and collection of bone marrow stem cells from the peripheral blood circulation.
According to the news:

The Phase 2 open-label study will be conducted in collaboration with the Washington University School of Medicine, Division of Oncology and Hematology, and will enroll up to 24 donor/recipient pairs, aged 18-70. The trial is designed to evaluate the ability of BL-8040, as a single agent, to promote stem cell mobilization for allogeneic transplantation. On the donor side, the primary endpoint of the study is the ability of a single injection of BL-8040 to mobilize sufficient amounts of cells for transplantation following up to two leukapheresis collections. On the recipient side, the study aims to evaluate the functionality and engraftment following transplantation of the BL-8040 collected graft.

Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated:

We are pleased to be collaborating with theWashington University School of Medicine, whose bone marrow and stem cell transplantation program is one of the largest in the world, in this Phase 2 trial for our lead oncology platform. The trial will assess BL-8040 as a single agent for stem cell mobilization, for the purpose of harvesting hematopoietic stem cells for transplantation. Hematopoietic stem cells are increasingly used as part of the treatment regimen for certain types of hematological cancers, as well as for severe anemia or immune deficiency disorders. We have already completed a successful Phase 1 safety and efficacy study in healthy volunteers, supporting BL-8040 as one-day, single-dose collection regimen for rapidly mobilizing substantial amounts of stem cells. This represents a significant improvement upon the current standard of care. Since there are no approved drugs for stem cell mobilization to support allogeneic transplant, we are looking forward to the partial results expected by the end of 2016 and topline results expected by the end of 2017.

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