Bioline RX 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.
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. (Original Source)
Shares of Biolinerx are up 2.5% in pre-market trading. BLRX has a 1-year high of $2.80 and a 1-year low of $0.85. The stock’s 50-day moving average is $1.03 and its 200-day moving average is $1.28.
On the ratings front, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on BLRX, with a price target of $7, in a report issued on March 21. The current price target represents a potential upside of 493.2% from where the stock is currently trading. According to TipRanks.com, Pantginis has a total average return of -7.5%, a 32.4% success rate, and is ranked #3719 out of 3757 analysts.
Bioline Rx Ltd is a clinical stage biopharmaceutical development company engaged in identifying, in-licensing & developing therapeutic compounds.