Bioline RX Ltd (NASDAQ:BLRX) is officially turning its Phase 3 GENESES clinical trial’s wheels, with the Israeli drug maker revealing today the launch of evaluating its stem-cell mobilization asset BL-8040.
In the initiation of the clinical trial, BiolineRx will be investigating the mobilization of hematopoietic stem cells by BL-8040 against a placebo, on top of granulocyte colony-stimulating factor (G-CSF), a powerful inducer of hematopoietic stem cell (HSC) mobilization from the bone marrow into the bloodstream. The GENESIS Phase 3 trial will look to see BL-8040’s impact on mobilizing HSCs used for autologous transportation in multiple myeloma patients.
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The GENESIS study is a Phase 3, randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of BL-8040 and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The study will commence with a lead-in period for dose confirmation, which will include 10-30 patients, and progress to the placebo-controlled main part, which is designed to include 177 patients in more than 15 centers. Treatment will include 5-8 days of G-CSF, with a single dose of BL-8040 or placebo on day 4. Apheresis for stem cell collection will be performed on day 5. Further apheresis sessions may be conducted if needed in order to reach the benchmark of ≥ 6×106 mobilized HSCs.
The primary objective of the study is to demonstrate that BL-8040 on top of G-CSF is superior to G-CSF alone in the ability of mobilize ≥ 6×106 HSCs in up to 2 aphereses. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.
Philip Serlin, Chief Executive Officer of BioLineRx, stated, “The initiation of our first Phase 3 trial for BL-8040 is an important milestone in the robust development plan of our lead oncology platform. Treatment with BL-8040 as a single administration and up-to-two-day collection regimen for rapid mobilization of stem cells could represent a significant improvement over the current treatment, which requires up to four apheresis sessions. We look forward to top-line results from the study expected in 2020.”
Dr. John F. DiPersio, Chief, Division of Oncology at the Washington University School of Medicine, and lead investigator of the study, stated, “I am very excited to test the role of BL-8040, a novel CXCR4 inhibitor with G-CSF for the mobilization of peripheral blood stem cells from patients undergoing autologous transplant for multiple myeloma. I am hopeful that this will provide another approach to the optimal hematopoietic stem cell collection in this challenging group of patients”.
Shares of Biolinerx closed yesterday at $1.09, up $0.01 or 0.93%. BLRX has a 1-year high of $1.38 and a 1-year low of $0.80. The stock’s 50-day moving average is $1.06 and its 200-day moving average is $1.03.
On the ratings front, Biolinerx has been the subject of a number of recent research reports. In a report issued on December 6, H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on BLRX, with a price target of $4, which represents a potential upside of 267% from where the stock is currently trading. Separately, on the same day, Oppenheimer’s Mark Breidenbach reiterated a Buy rating on the stock and has a price target of $3.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Mark Breidenbach have a yearly average loss of -20.2% and a return of 4.8% respectively. Pantginis has a success rate of 29% and is ranked #4679 out of 4727 analysts, while Breidenbach has a success rate of 41% and is ranked #1743.
BioLineRx Ltd. is a clinical-stage biopharmaceutical company, which includes indentifying, in-licensing, and developing therapeutic candidates. Its in-licenses novel compounds, primarily from academic institutions and biotech companies based in Israel, and develops them through pre-clinical and clinical stages, and then partners with pharmaceutical companies clinical development and commercialization.