BioLineRx announced positive top-line results from its early stage study evaluating its lead candidate BL-8040.
The company said that the drug met all safety and efficacy endpoints in the Phase I safety and efficacy study of BL-8040, as a novel approach for mobilization and collection of bone-marrow stem cells from the peripheral blood circulation. The drug as a single agent was safe and well tolerated at all doses in the study and resulted in efficient stem cell mobilization and collection in all study participants.
BioLineRx noted that results support BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care.
Current stem cell treatments require four or five days of injections from a donor to get into the bloodstream. However, BL-8040 enabled collection of a yield of stem cells that exceeds the number required to support a transplant in all treated participants, following only one collection procedure.
“I am very impressed an encouraged by the activity of BL-8040 in promoting stem cell mobilization and collection as a single agent. The robust effect seen in all participants substantially differentiates this compound from the currently approved mobilization regimens, which require four to five days of treatment and one to three full-day apheresis sessions, and can be associated with side effects including bone pain. Therefore, a novel agent with the capacity to rapidly mobilize substantial amounts of stem cells, while providing a shorter and better tolerated drug administration and cell collection regimen, will be of great value both medically and in terms of patient comfort,” said Dr. John DiPersio, Chief of the Division of Oncology at Washington University School of Medicine in St. Louis.
The company said that it plans to present full results from the study at a hematology conference in June.
“We are very enthusiastic about the study results showing the outstanding activity of BL-8040 in promoting stem cell mobilization. The results exceeded our expectations, and validate BL-8040 as a highly differentiated stand-alone treatment for stem-cell collection. We plan to meet with the FDA as soon as practicable, in order to discuss the results of this study and obtain more clarity on the next steps in the clinical development program for this indication,” said Dr. Kinneret Savitsky, CEO of BioLineRx.
In addition to the stem-cell mobilization, BL-8040 is undergoing a Phase II study for treating relapsed or refractory acute myeloid leukemia patients. Results for the study are expected in the second half of 2015.
Source: BioLineRx Ltd.
Last updated: 3/25/15; 3:25pm EST