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BioLineRx to Present at the 12th Annual Needham Healthcare Conference in New York on April 30, 2013

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By Business Wirevia The Motley Fool

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BioLineRx to Present at the 12 th Annual Needham Healthcare Conference in New York on April 30, 2013

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that its Chief Executive Officer, Kinneret Savitsky, Ph.D., and its Chief Financial and Operating Officer, Philip Serlin, will be presenting at the 12th Annual Needham Healthcare Conference in New York.

Dr. Savitsky and Mr. Serlin are scheduled to present at 3:40 P.M. EST on Tuesday, April 30, 2013.

A live Webcast of the presentation will be available on the BioLineRx Website at http://biolinerx.com/default.asp?pageid=63&itemid=181. A replay will be available one hour after the presentation ends and will be accessible for three months following the presentation.

Investors attending the conference that wish to meet with Dr. Savitsky and Mr. Serlin for a one-on-one meeting should contact the Needham Conference Team at conferences@needhamco.com.

About BioLineRx

BioLineRx is a publicly-traded biopharmaceutical development company. BioLineRx is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx’s current portfolio consists of six clinical stage candidates: BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc., is currently undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-7040 for treating inflammatory bowel disease (IBD) has completed a Phase IIa trial; BL-8040 for treating acute myeloid leukemia (AML) and other hematological cancers will shortly commence a Phase II study; BL-1021 for neuropathic pain is in Phase I development; and BL-1020 for schizophrenia. In addition, BioLineRx has six products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, infectious diseases, cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government’s Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visitwww.biolinerx.com, the content of which does not form a part of this press release.

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From: http://www.dailyfinance.com/2013/04/18/biolinerx-to-present-at-the-12th-annual-needham-he/

Business, Finance, Occupation & Industry

BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatmen

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By Business Wirevia The Motley Fool

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BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatment of Leukemia


Partial results expected in Q4 2013


Final results expected in H2 2014

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that it has received all necessary regulatory approvals in the US to commence a Phase IIa trial for BL-8040, for the treatment of Acute Myeloid Leukemia (AML).

The study is a multicenter, open-label study under an IND, designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adult subjects with relapsed/refractory AML. The primary endpoints of the study are the safety and tolerability of the drug. Secondary endpoints will include the pharmacokinetic profile of the drug and an efficacy evaluation, as assessed by various parameters, such as the response rate by bone marrow biopsy. The study is also designed in a way that will enable the investigators to evaluate the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death. The study is expected to be conducted in the U.S. and Israel, and will enroll up to 50 patients.

“This program is generating a lot of enthusiasm from our clinical research partners, and we are very pleased that several renowned and respected investigators will be leading our study in the U.S. and Israel,” said Kinneret Savitsky, PhD, CEO of BioLineRx. “AML is one of the most common types of leukemia in adults, yet survival rates continue to be low relative to other leukemias. In particular, treatment options for patients with relapsed or refractory AML are extremely limited, and in many cases, only palliative care is offered. We look forward to the partial results expected towards the end of this year, and have sincere hopes that BL-8040 will be a significant and efficient addition in the battle with this devastating disease.”

“We are honored to collaborate with BioLineRx on this exciting project,” said Dr. Gautam Borthakur, the principal investigator of the trial at the MD Anderson Cancer Center …read more

Source: FULL ARTICLE at DailyFinance

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BioLineRx Reports Year End 2012 Financial Results

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By Business Wirevia The Motley Fool

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BioLineRx Reports Year End 2012 Financial Results

JERUSALEM–(BUSINESS WIRE)– BioLineRx Ltd. (NAS: BLRX) (TASE: BLRX), a biopharmaceutical development company, today reported its results for the year ended December 31, 2012.

“BioLineRx is rapidly approaching a significant landmark in the evolution of the Company,” stated Kinneret Savitsky, Ph.D., CEO of BioLineRx. “We are eagerly anticipating the interim analysis of the on-going CLARITY Phase 2/3 trial for our lead compound, BL-1020 for schizophrenia, which we expect to receive next week. The analysis will include a recommendation by an independent Data Monitoring Committee (DMC) regarding the number of additional patients needed in order to reach statistical significance on the cognitive effect of BL-1020 compared to Risperidone. Although the data from the ongoing study is completely confidential, based on promising evidence received in previous clinical and pre-clinical trials, we hope the information received will provide a clear indication regarding the strength of the cognition improvement signal, thereby putting us in a stronger position to out-license BL-1020 and move towards commercializing the compound.”

“The PRESERVATION I pivotal CE mark registration trial for our other lead compound, BL-1040 for ventricular remodeling post-AMI, which is being carried out by Ikaria, Inc., continues to progress on an accelerated basis. Currently, there are 15 sites recruiting in Australia, Belgium, Canada, Israel and Spain, and results from the trial are expected in 2014.”

“In addition, our Phase 2 proof-of-concept study for BL-7040, an oral treatment for Inflammatory Bowel Disease (IBD), is nearing completion. This is an open-label study to evaluate the efficacy, pharmacodynamics, safety and tolerability of BL-7040 in up to 30 patients with moderately active ulcerative colitis, a type of IBD. This trial is being carried out at five sites in Israel, and we are expecting to announce results in April 2013.”

“During 2012, we in-licensed several high-profile therapeutic compounds that are already advancing towards clinical testing. This includes BL-8040, a Phase 2-ready drug for the treatment of acute myeloid leukemia (AML) and other hematological cancers. The interest in this program is high, and we have recently signed an agreement with one of the premier cancer centers in the world, MD Anderson Cancer Center in Houston, Texas, to be the lead site in the trial. We are currently in negotiations with two other U.S.-based, world-class facilities for their participation in the trial as well,” continued Dr. Savitsky.

“At the beginning of 2012, we entered the competitive HCV market with the in-licensing of two orally-available compounds for the treatment of Hepatitis C from world renowned experts …read more
Source: FULL ARTICLE at DailyFinance