Mon, Aug. 17, 8:24 AM
- BioLineRx (NASDAQ:BLRX) initiates a Phase 2b clinical trial evaluating BL-8040 as consolidation treatment for acute myeloid leukemia (AML). The study will assess BL-8040 as second-line treatment, called consolidation therapy, in AML patients who have achieved remission after standard-of-care induction therapy. The aim of consolidation treatment is eliminating the minimal residual disease in the bone marrow after induction therapy, which can lead to relapse.
- BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers. Its expression is often correlated with disease severity.
- The estimated completion date of the 194-subject trial is July 2018.
- Shares are up 6% premarket on increased volume.
Mon, Jul. 27, 12:48 PM
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Mon, Jul. 27, 7:41 AM
- Less than two weeks ago, Bellerophon Therapeutics (NASDAQ:BLPH) said that it expected a positive outcome in its PRESERVATION 1 clinical trial assessing one of its two lead product candidates, Bioabsorbable Cardiac Matrix (BCM), for the prevention of left ventricular remodeling and progression to congestive heart failure in patients who have had a serious heart attack. In an embarrassing about-face, this morning it announced that the study failed to achieve its primary and secondary efficacy endpoints. The performance of BCM was no different than placebo.
- The primary endpoint of the 303-subject, randomized, double-blind, placebo-controlled trial was the enlargement in the end-diastolic volume at six months after a heart attack versus baseline as measured by the Left Ventricular Diastolic Volume Index compared to placebo. Secondary endpoints included the six minute walk test, the Kansas City Cardiomyopathy Questionaire and the New York Heart Association functional classification.
- BCM is a specially formulated sterile solution of sodium alginate and calcium gluconate that transitions from a liquid state to a hydrogel in the presence of elevated calcium levels present in injured tissues. It is delivered in liquid form to damaged heart muscle via percutaneous coronary intervention (PCI).
- Bellerophon licensed BCM from BioLineRx (NASDAQ:BLRX) in 2009. It has paid BioLineRx $17M to date under its agreement.
- Management will host a conference call this morning at 8:30 am ET to discuss the results. Complete data will be presented on September 1 at the European Society of Cardiology meeting in London.
- Previously: Bellerophon Therapeutics expects successful outcome in BCM trial; MAA to be filed in Europe in mid-2016 (July 15)
- BLRX is off 17% premarket on increased volume. BLPH has not traded premarket.
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Mon, Jun. 22, 12:38 PM
- Thinly traded nano cap BioLineRx (BLRX +3.9%) has been up as much as 18% over the past two trading days on robust volume. Shares were up almost 10% today on 10x higher volume before moderating. CFO Philip Serlin is scheduled to present an overview of the company tomorrow at 11:00 am ET at the JMP Securities conference.
- The company's pipeline includes product candidates for acute myocardial infarction, blood cancers, celiac disease, inflammatory bowel disease and hepatitis C.
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Jan. 8, 2014, 8:54 AM
- Higher by 6% in early action are shares of BioLineRX (BLRX).
- The company has inked a development and commercialization agreement with JHL Biotech for the monoclonal antibody BL-9020 in Type 1 diabetes.
- JHL will process and manufacture the treatment during pre-clinicals, while BLRX will shoulder pre-clinical development.
- The companies will share responsibility for clinical development.
- JHL will also have commercialization rights in China and SE Asia. (PR)
Dec. 16, 2013, 3:41 PM
- Aegis' Raghuram Selvaraju is sticking with a Buy rating and a $7 target on shares of BioLineRx (BLRX +13.3%) after today's BL-8040 update.
- "It appears to [provide] a dual-layered benefit to patients," Selvaraju says, referencing the company's suggestion that the drug may make cancer cells more susceptible to chemo and may also contribute to cell death.
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