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BioLineRx Ltd. (BLRX)

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Last Post: 9/21/2018 12:43:18 PM - Followers: 101 - Board type: Free - Posts Today: 0

BIOLINERX
BioLineRx is a clinical-stage, publicly-traded (NASDAQ/ TASE: BLRX) biopharmaceutical development company based in Jerusalem, Israel.
The Company develops products suitable for the pharmaceutical market satisfying an unmet medical need or exhibiting advantages over current therapies.

BioLineRx's close ties with universities, research institutes, academic institutions, technology transfer offices and biotechnology companies, both in Israel and globally, enable access to promising projects at an early stage. The first stage involves a stringent selection process. BioLineRx's scientists specialize in evaluating potential drug candidates from both scientific and marketing perspectives. After acquiring the most promising projects, the Company then performs feasibility assessment studies and development through pre-clinical and clinical stages. Supported and assisted by a distinguished panel of scientific advisers, the Company's scientists and experts in pharmacy and regulation, clinical trials and IP work together to advance BioLineRx’s pipeline usually through Phase II proof of concept in humans. And finally, the Company partners with medium size and large pharmaceutical companies to complete the clinical development and bring the product to market.
 
BioLineRx also operates BioLine Innovations Jerusalem (BIJ) a biotechnology incubator for the development of pre-clinical therapeutic candidates, and an Early Development Program (EDP) dedicated to identifying and advancing promising early stage programs.

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HIGHLIGHTS:: BioLineRx Ltd.(BLRX)

BL-7040 (IBD) – Received positive results from a Phase 2 proof-of-concept study to evaluate the effectiveness of BL-7040 for the treatment of inflammatory bowel disease (IBD)

Immediate next steps include evaluating the most advantageous ways to progress with this therapeutic candidate from a clinical and business perspective, including examining potential additional indications. Plans also include accelerating discussions with potential co-development and licensing partners.

BL-8040 (AML) – Received U.S. regulatory approvals to commence a Phase 2a trial for the treatment of relapsed/refractory acute myeloid leukemia (AML); trial to be conducted at three sites in the U.S. and five sites in Israel, with initial patient enrollment expected in Q2 2013; partial results expected in Q4 2013 and final results expected in the second half of 2014

BL-1040 (ventricular remodeling) – Recruitment commenced at U.S. sites for the PRESERVATION I clinical trial, a CE Mark registration trial for BL-1040 (BCM), a novel medical device for the prevention of ventricular remodeling following an acute myocardial infarction; there are currently multiple active sites recruiting in six countries

BL-5010 (skin lesions) – Reached final stages of development for proprietary pen-like applicator for BL-5010, a novel formulation of two acids being developed for the non-surgical removal of skin lesions; planning to commence pivotal CE-Mark registration trial for European approval in the second half of 2013

BL-8020 (HCV) – Commenced a Phase 1/2 clinical trial to evaluate the effectiveness of an orally-available, interferon-free treatment for Hepatitis C (HCV) at two sites in France, following approval from the French regulatory authorities; partial results expected in Q4 2013; final results expected in the first half of 2014

BL-1020 (schizophrenia) – Disappointing results of interim analysis for the Phase 2/3 CLARITY trial led to termination of the trial; full unblinded study data is expected during Q3 2013

BL-9010 (severe asthma) – Added a novel, bi-specific antibody for the treatment of severe and persistent asthma to the main therapeutic pipeline, following promising pre-clinical data

Capital Raise – $8 million direct equity placement to the OrbiMed Group was completed in February 2013


“In the past few months, we have seen major progress on a number of clinical and pre-clinical programs in our pipeline, which offer exciting opportunities to address unmet medical needs in a wide range of therapeutic areas. We believe our active programs offer significant potential for patients around the world, as well as for the future success of our Company and its shareholders,” stated Kinneret Savitsky, Ph.D, Chief Executive Officer of BioLineRx. “In the third quarter of this year, we expect to receive a full analysis of the unblinded study data for all participants in the CLARITY Phase 2/3 trial for BL-1020. While we discontinued this clinical trial in mid-March based on disappointing results of the interim analysis, we will not decide the future of the overall BL-1020 program until we have carried out a more thorough review of the full unblinded results.”

“The PRESERVATION I study being conducted by our partner, Ikaria, for BL-1040, for the treatment of ventricular remodeling post-AMI, is moving forward at full steam, with multiple sites in six countries around the world actively recruiting, including a number of sites in the U.S. BL-1040 remains one of our leading compounds, with significant clinical data expected to be reported next year, and we hope that it will eventually offer a great benefit to heart attack patients,” continued Dr. Savitsky.

“We continue to accelerate development of our clinical pipeline, with three of our compounds completing significant milestones since the beginning of the year. Our BL-7040 compound for IBD completed a Phase 2a open-label, proof-of-concept study with very encouraging and positive results. We are now evaluating next steps for BL-7040 in order to identify the best way to move forward from both a clinical and business perspective, including examining potential additional indications. In parallel, we are also planning to accelerate discussions with potential co-development and licensing partners for this asset.”

“In addition, BL-8040, for hematological cancers, one of our most exciting programs, just received FDA approval to commence a Phase 2a trial for the treatment of relapsed/refractory AML. We are excited to initiate this multicenter, open-label study under an IND, which will be conducted in the U.S. and Israel, and will enroll up to 50 patients. MD Anderson Cancer Center in Houston will be the initial site for this trial, with two additional premier sites in the US and five other well-known sites in Israel expected to participate. We believe the excitement surrounding the trial, especially at these particular sites, is a testament to the need for an AML therapy, as well as the potential of BL-8040 shown in the previous pre-clinical and clinical data.”

“Finally, we recently reported enrollment of the first patient in our Phase 1/2 trial for BL-8020, an oral treatment for HCV, at a leading hospital in Paris, France. We look forward to partial results from the trial in the fourth quarter of 2013, as well as final results in the first half of 2014. I would also like to point out that as our pipeline evolves, we continue to replenish our pre-clinical pipeline with the addition of promising assets, such as BL-9010 for the treatment of severe and persistent asthma, which recently graduated from our Early Development Program,” concluded Dr. Savitsky



Link To Interview with BioLineRX VP Of Business Development:
http://www.pharmatelevision.com/Video/1176-PTVNRDavidMalek.aspx



biolinerx.com -  BioLineRX Website




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BLRX News: BioLineRx to Present at 20th Annual Rodman & Renshaw Global Investment Conference in New York 08/30/2018 07:00:00 AM
BLRX News: Report of Foreign Issuer (6-k) 08/13/2018 07:03:37 AM
BLRX News: BioLineRx Reports Second Quarter 2018 Financial Results 08/13/2018 07:00:00 AM
BLRX News: Report of Foreign Issuer (6-k) 08/07/2018 07:01:27 AM
BLRX News: BioLineRx Announces Positive Results of Lead-in Period for Phase 3 GENESIS Trial in Stem-Cell Mobilization 08/07/2018 07:00:00 AM
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#1808   Come on now we need a few more tone3 09/21/18 12:43:18 PM
#1807   I'm not sure if BLRX ever made their BooDog 09/21/18 11:56:36 AM
#1806   Wow the Bowser Report that’s a blast from tone3 09/21/18 11:13:40 AM
#1805   I use to be a big fan of BooDog 09/21/18 10:33:15 AM
#1804   What Is the Delisting Process for the NASDAQ?[/quote] TAB78 09/21/18 09:29:56 AM
#1803   Hi BMA! This is a phase iii company BarrellofHay 09/21/18 09:23:28 AM
#1802   Hello BOH... I've been with BioLine for a BollixMeArse 09/21/18 12:16:48 AM
#1801   Could be phase ii data leaking BarrellofHay 09/20/18 10:33:21 PM
#1800   Been with BLRX for over five years and BarrellofHay 09/20/18 10:31:30 PM
#1799   Need to find out - the 3.4 million Amatuer17 09/20/18 10:03:07 PM
#1798   A source suggests that this pop was do tone3 09/20/18 09:36:27 PM
#1797   10 I believe Ditryin 09/20/18 08:26:24 PM
#1796   Amateur17 Looks like they used a couple of tone3 09/20/18 07:07:54 PM
#1795   Don ‘t think It looks like paint job to Amatuer17 09/20/18 06:55:57 PM
#1794   What did I miss? tone3 09/20/18 03:58:23 PM
#1793   Thanks TAB78 09/10/18 10:12:35 PM
#1792   30 days Amatuer17 09/10/18 09:04:51 PM
#1791   Getting some Good press here the last week. TAB78 09/10/18 08:29:50 PM
#1790   BLRX upgraded from hold to buy https://www.fairfieldcurrent.com/2018/09/ TAB78 09/10/18 08:22:42 PM
#1789   Interesting question. Maybe a 2 -1 RS, if TAB78 09/10/18 08:19:22 PM
#1788   Approaching the Oct date - stock may be Amatuer17 08/24/18 07:34:16 AM
#1787   Press release looks encouraging. Presenting at a European tone3 08/13/18 11:52:56 AM
#1786   At least it's not a flop like RDHL.... midastouch017 08/07/18 08:29:11 AM
#1785   I concur... final resilts too far away... midastouch017 08/07/18 08:27:07 AM
#1784   I was thinking the same about timing of Amatuer17 08/07/18 08:03:15 AM
#1783   They can do it! It is a BooDog 08/07/18 07:35:13 AM
#1782   Lol, here is your calayst. :-) midastouch017 08/07/18 07:28:39 AM
#1781   BioLineRx Announces Positive Results of Lead-in Period for Amatuer17 08/07/18 07:07:31 AM
#1780   Stock has not closed above $ 1 for Amatuer17 08/07/18 06:31:34 AM
#1779   Does anyone have the latest news Mrvince 07/31/18 06:05:03 PM
#1778   Now that's a nice chunk, congrats TAB78 07/26/18 06:44:59 PM
#1777   Loaded another 10K @.90 Grandmasters 07/26/18 12:51:04 PM
#1776   Well this looks real good I called Israel Mrvince 07/26/18 11:21:40 AM
#1775   Been away a while, anything new shaking TAB78 07/25/18 11:59:35 PM
#1774   Any word on this stock Mrvince 07/25/18 12:46:30 PM
#1773   BIOLINERX Ltd/S ADR (NASDAQ: BLRX) is set BooDog 07/19/18 09:39:53 AM
#1772   BLRX .91 Grandmasters 07/05/18 11:28:40 AM
#1771   The results are so good and SP just Amatuer17 06/18/18 09:45:27 AM
#1770   BioLineRx Presents New Overall Survival Data From Phase Amatuer17 06/18/18 07:38:59 AM
#1769   So it closed for $1 and above - Amatuer17 06/16/18 10:21:27 AM
#1768   BLRX I’m in! What’s the outlook here? Eagle1 06/08/18 03:25:28 PM
#1767   Might just see some life come back into BLRX BooDog 05/17/18 09:43:54 AM
#1766   I don't like the nasdaq CM just for BooDog 04/24/18 09:40:44 AM
#1765   Thx - the delisting is a real problem I Amatuer17 04/24/18 08:57:25 AM
#1764   I'm sure I'm not the only one that BooDog 04/24/18 08:03:57 AM
#1763   Not sure if effect of this but could Amatuer17 04/24/18 06:30:14 AM
#1762   I am not on here much, anyone mind TAB78 04/21/18 08:32:59 PM
#1761   Almost. Had an order at .85 now thinking BooDog 03/27/18 04:23:38 PM
#1760   Picking up a few for the move back BooDog 03/26/18 09:56:16 AM
#1759   It's one to keep an eye on till BooDog 03/06/18 02:13:33 PM
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