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BioLineRx Ltd. (BLRX)

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Last Post: 7/20/2017 9:08:28 AM - Followers: 85 - Board type: Free - Posts Today: 0

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.



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: -  BioLineRX Website

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BLRX News: Report of Foreign Issuer (6-k) 07/10/2017 07:01:16 AM
BLRX News: BioLineRx Announces Initiation of Phase 1b/2 Trial of BL-8040 in Pancreatic Cancer Under Immunotherapy Collaboration 07/10/2017 07:00:00 AM
BLRX News: Report of Foreign Issuer (6-k) 07/05/2017 09:01:41 AM
BLRX News: Confidential Treatment Order (ct Order) 06/22/2017 11:14:30 AM
BLRX News: Report of Foreign Issuer (6-k) 06/12/2017 07:03:47 AM
#1427   SA again..Lead candidate BL-8040 showing tremendous promise xzy007 07/20/17 09:08:27 AM
#1426   SA again..BioLineRx: At Around $1, This Sleeper Biotech xzy007 07/13/17 03:35:35 PM
#1425   BioLineRx Ltd. (NASDAQ: BLRX), a clinical-stage biopharmaceutical company xzy007 07/10/17 09:29:42 AM
#1424   Yes, soon, and not for the midastouch017 07/07/17 08:48:00 AM
#1423   Do ADS have minimum price requirement for listing? The Amatuer17 07/07/17 05:49:51 AM
#1422   Bioline RX. midastouch017 06/19/17 11:59:07 PM
#1421   Given that Amateur: shub 06/19/17 04:00:38 PM
#1420   Actually 5 collaborations Genentech - Merck - Novartis for Amatuer17 06/13/17 08:52:06 AM
#1419   Check the latest deck Amatuer17 06/13/17 07:51:32 AM
#1418   Hoping a positive results will come out of lakingsphan0427 06/01/17 03:30:14 PM
#1417   Hello again Midas: shub 06/01/17 03:07:29 PM
#1416   Genentech readies three early-stage studies of BioLineRx's BL-8040 midastouch017 06/01/17 08:26:08 AM
#1415   Are we going to have to do a shub 05/22/17 02:49:03 PM
#1414   This from Barrons ( is their opinion barren?) shub 05/22/17 02:45:27 PM
#1413   Hi Midas; shub 05/03/17 03:55:09 PM
#1412   BioLineRx to Initiate Phase 3 Study with BL-8040 midastouch017 05/03/17 08:42:36 AM
#1411   BiolineRx: COMBAT Engagement midastouch017 04/19/17 04:12:06 PM
#1410   Biotechnology Value Fund L P has filed a wiltonio 04/10/17 05:19:15 PM
#1409   Why buy in @ 10 cents? midastouch017 04/01/17 09:51:24 AM
#1408   It sure did. I thought so midastouch017 04/01/17 09:49:27 AM
#1407   * * $BLRX Video Chart 03-31-17 * * ClayTrader 03/31/17 04:59:25 PM
#1406   Good move...It's up to 97 all ready. shub 03/31/17 03:08:29 PM
#1405   I did just that at 0.91 lakingsphan0427 03/31/17 02:52:38 PM
#1404   Looks like overcompensation to me. shub 03/31/17 01:51:47 PM
#1403   Nice call on the "no offering" looking to Short-Hunter 03/31/17 08:45:39 AM
#1402   BioLineRx Prices $25 Million Underwritten Public Offering midastouch017 03/31/17 08:31:32 AM
#1401   BioLineRx -14% on capital raise midastouch017 03/30/17 11:30:07 PM
#1400   I keep imagining the combination of the products shub 03/27/17 03:06:12 PM
#1399   Conclusions I probably sound like a broken record when midastouch017 03/27/17 02:50:09 PM
#1398   BioLineRx: Grows Oncology Pipeline With Addition Of Another midastouch017 03/27/17 02:49:20 PM
#1397   Thanks for these Midas. shub 03/27/17 02:29:36 PM
#1396   BioLineRx's AGI-134 to be Presented at AACR 2017 midastouch017 03/27/17 01:34:43 PM
#1395   BioLineRx's (BLRX) CEO Philip Serlin on Q4 2016 midastouch017 03/23/17 01:04:38 PM
#1394   BioLineRx Reports Year End 2016 Financial Results midastouch017 03/23/17 08:33:17 AM
#1393   BioLineRx Announces Acquisition of Agalimmune Ltd. to Accelerate midastouch017 03/23/17 08:30:19 AM
#1392   I CANT WAIT TILL THIS THING GETS TO chevelle 396 03/22/17 08:58:45 PM
#1391   BioLineRX: Update And Preview Of The Company's Q4 midastouch017 03/22/17 02:59:32 PM
#1390   The cause is more Trump vituperation. shub 03/21/17 02:54:18 PM
#1389   Mine too .... midastouch017 03/21/17 02:35:52 PM
#1388   Looked better earlier...even now. shub 03/21/17 02:06:44 PM
#1387   From ~ +7% to -5%..... midastouch017 03/21/17 01:18:58 AM
#1386   Hello again Midas: shub 03/20/17 02:46:40 PM
#1385   BioLineRx's lead product candidate shows encouraging advantages over midastouch017 03/20/17 01:21:19 PM
#1384   BioLineRx Provides Update on Phase 2 Open-Label Study midastouch017 03/20/17 09:28:02 AM
#1383   First, then, Bioline. midastouch017 03/14/17 03:00:54 PM
#1382   Today March 12 TASE closed midastouch017 03/12/17 09:57:19 AM
#1381   That'd depend on how long one expects to shub 03/03/17 02:16:30 PM
#1380   Daily swings mean nothing! midastouch017 02/23/17 11:55:39 PM
#1379   What happened today then? volume drop down to DavidW2 02/23/17 08:13:09 PM
#1378   The sheer volume says it all! midastouch017 02/21/17 03:12:03 PM