BioLineRx Announces Initiation of Phase 2 Trial
News Mar 26, 2016
BioLineRx has 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. 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.
The study will also evaluate the safety and tolerability of BL-8040 in healthy donors, as well as graft durability, the incidence of grade 2-4 acute graft versus host disease (GvHD), and other recipient related parameters in patients who have undergone transplantation of hematopoietic cells mobilized with BL-8040.
Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, "We are pleased to be collaborating with the Washington 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.”
"We continue to expand and enhance the potential of our unique BL-8040 oncology platform, with multiple clinical studies in additional indications, including as a potential combination treatment with immune checkpoint inhibitors. We are also eagerly awaiting the top-line results from BL-8040’s Phase 2 trial for the treatment of relapsed and refractory AML patients, which we expect to report by the end of this month,” added Dr. Savitsky.
Cryo-EM Reveals Interaction Between Major Drug TargetsNews
For the first time, scientists have visualized the interaction between two critical components of the body's vast cellular communication network, a discovery that could lead to more effective medications with fewer side effects for conditions ranging from migraine to cancer.READ MORE
New Ovarian Cancer TargetNews
Researchers have found a prescription drug, Calcitriol, approved by the Food and Drug Administration for the treatment of calcium deficiency and kidney diseases, may increase the likelihood of surviving ovarian cancer. This new study opens a potential avenue for treating ovarian cancer. Since Calcitriol is an FDA-approved drug, no additional research is needed before the drug can advance to human clinical trials for ovarian cancer.READ MORE
Sartorius Stedim Biotech and Siemens Sign Automation AgreementNews
Siemens becomes a preferred supplier for automation solutions. Product portfolio of Sartorius Stedim Biotech to feature a globally standardized automation platform in the future.READ MORE