BioLineRx Ltd. announced in early May that following a successful meeting with the U.S. FDA, the initiation of a Phase 3 clinical trial for stem cell mobilization in multiple myeloma patients is expected in the latter part of this year.
This news is extremely exciting for the stem cell research community and highly encouraging for patients who need bone marrow transplants.
The therapy targeted would be BL-8040, and it is used in “autologous bone-marrow transplantation,” which is a way to treat multiple myeloma. For this transplantation to work, first stem cells from the bone marrow must be mobilized to the peripheral blood. After this process is complete, transplantation can occur.
Interestingly, provisional results of the BL-8040 Phase 2 trial showed that the single injection of the therapy actually achieved similar results to four-six injections of G-CSF, the standard blood-mobilizing procedure for stem cell transplantation, a highly significant improvement to the current care strategy.
In addition to this encouraging data, BL-8040 also works to fight against cancer by sensitizing cancer cells to chemo- and bio-based anti-cancer therapy as well as inducing apoptosis (death of cells), which has a direct anti-cancer effect. Thus, it can be combined with other anti-tumor therapy options as well.
If the anticipated Phase 3 study is successful, it could pave the way for future commercialization of BL-8040 and a higher standard of care for multiple myeloma patients, overall.
In the meantime, if you want to learn more about BL-8040, click here!
