New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 16, 2014
07:02 EDTBLRXBioLineRx receives approval to commence Phase 1 trial
BioLineRx has received approval from the Israeli Ministry of Health to commence a Phase 1 trial for BL-8040, a novel treatment for the mobilization of stem cells from the bone marrow to the peripheral blood circulation. The study is expected to commence during the third quarter of 2014 at Hadassah Medical Center in Jerusalem. The Phase 1 study consists of two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study exploring the safety and tolerability of escalating repeated doses of BL-8040 in healthy volunteers. Secondary objectives include assessment of the efficacy of BL-8040 in mobilizing stem cells as a stand-alone therapy, as well as determining the pharmacokinetic profile of the drug. This part will be performed in up to 4 cohorts, with 8 healthy volunteers in each cohort. Part 1 of the study will serve to select the optimal safe and efficacious dose of BL-8040 to be used as a stand-alone therapy in Part 2 of the study. Part 2 is an open-label study designed to assess BL-8040ís stem cell mobilization capacity, as well as the yield of cells collected by apheresis. Secondary endpoints of the study include evaluation of the viability and biological activity of cells mobilized by BL-8040 and collected by apheresis. This part will be performed in a single cohort of 8 healthy volunteers who will receive the selected dose regimen of BL-8040 based on the data from Part 1.
News For BLRX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
December 16, 2014
07:06 EDTBLRXBioLineRx and Novartis enter into strategic collaboration agreement
Subscribe for More Information
December 15, 2014
09:18 EDTBLRXBioLineRx price target raised to $10.50 from $8 at Roth Capital
Roth Capital raised its price target on BioLineRx as the firm thinks the company showed the ability of its BL-8040 drug to affect the tumor microenvironment and regulate the apoptosis of tumor cells during its Investor Day. The firm keeps a Buy rating on the shares.
December 12, 2014
07:06 EDTBLRXBioLineRx says trials in three added BL-8040 indications to be initiated in 2015
BioLineRx will disclose its multi-year development plan for BL-8040, a unique platform for the treatment of hematological cancers. The main development program for BL-8040 relates to acute myeloid leukemia. BL-8040 is currently undergoing a Phase 2a clinical trial for the treatment of relapsed or refractory AML. Positive data from the dose-escalation stage of the study, which was recently presented at the 2014 ASH Conference, has shown substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood and robust apoptosis of these cells, as well as an excellent safety and tolerability profile. The dose-escalation stage of the study is expected to be completed in early 2015, while the full study results from both the dose- escalation and dose-expansion stages of the study are expected in the second half of 2015. Targeting a second AML treatment line, BL-8040 is scheduled to commence a Phase 2b trial, as a consolidation treatment for AML patients who have responded to standard induction treatment, in the first quarter of 2015. The trial will be conducted in collaboration with the German Study Alliance Leukemia Group. The trial aims to improve the response of AML patients to the second stage of AML treatment, termed consolidation therapy, by eliminating the minimal residual disease left in the bone marrow after the first stage of the standard treatment regimen, called induction therapy. BL-8040 will also target a third population of AML patients, and is scheduled to commence a Phase 1/2 trial, for the treatment of AML patients with the FLT3-ITD mutation, in the first quarter of 2015.
December 11, 2014
11:23 EDTBLRXBioLineRx to host investor and analyst breakfast meeting
Investor and Analyst Breakfast Meeting to present the company's 2015 clinical development strategy for BL-8040 will be held in New York on December 12 at 8 am. Webcast Link
December 8, 2014
09:20 EDTBLRXOn The Fly: Pre-market Movers
Subscribe for More Information
07:06 EDTBLRXBioLineRx reports data from ongoing Phase 2a study of BL-8040
BioLineRx Ltd. announced that data from the on-going Phase 2a clinical trial of BL-8040 for the treatment of patients with relapsed or refractory acute myeloid leukemia were reported at the American Society of Hematology meeting, held on December 6-9, 2014, in San Francisco. Results reported to date in the dose-escalation stage of the Phase 2a study show that, even at the highest dose reached to date, there were no dose-limiting toxicity events or serious adverse events, nor early discontinuations attributable to BL-8040. Furthermore, BL-8040 triggered substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood, with a median 6-fold increase of AML cells in the blood. This mobilization is crucial for exposing a higher ratio of AML cells to accompanying chemotherapy such as Ara-C. Additional results show that after only two days of BL-8040 monotherapy, there was a median decrease of approximately 70% in the amount of AML cells in the bone marrow, while the levels of normal progenitor cells remained stable. Furthermore, BL-8040 as a monotherapy showed a 3.5-fold increase in cell death of AML cells, both in the bone marrow and in peripheral blood samples.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the disclaimer & terms of use