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BioLineRx Ltd. (BLRX)

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Last Post: 9/21/2017 11:37:21 AM - Followers: 95 - Board type: Free - Posts Today: 2

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 the 19th Annual Rodman & Renshaw Global Investment Conference in New York 09/07/2017 08:00:00 AM
BLRX News: Report of Foreign Issuer (6-k) 08/21/2017 07:03:34 AM
BLRX News: BioLineRx Announces Regulatory Submission of Phase 3 Registrational Study for BL-8040 in Stem Cell Mobilization 08/21/2017 07:00:00 AM
BLRX News: Report of Foreign Issuer (6-k) 08/15/2017 03:31:34 PM
BLRX News: Report of Foreign Issuer (6-k) 08/08/2017 07:01:34 AM
PostSubject
#1557   Why do you delete some of my posts? Dizzle96 09/21/17 03:35:57 PM
#1556   Better late than never. Dubb10 09/21/17 11:37:21 AM
#1555   Yes Rogerthat1 09/20/17 12:46:27 PM
#1554   Is the BL-8040 phase 2 partial data for dmsrz8 09/20/17 09:35:42 AM
#1553   How Analysts Feel About Biolinerx Limited Ads (NASDAQ:BLRX) midastouch017 09/17/17 09:36:23 AM
#1551   Why don't you ask BLRX multiple midastouch017 09/16/17 07:16:32 AM
#1548   This is company is in Israel ? Wow Dizzle96 09/15/17 01:36:11 PM
#1541   Brokers Set Expectations for BioLineRx midastouch017 09/15/17 09:23:30 AM
#1538   BioLineRx to Present at the 19th Annual Rodman midastouch017 09/07/17 09:13:06 AM
#1537   Volume was pretty low with a lot of Dubb10 09/06/17 05:02:40 PM
#1536   Lot of red sales today Dizzle96 09/06/17 11:41:45 AM
#1535   Yup and the problem here is there won't Dizzle96 09/05/17 09:20:13 AM
#1534   Very nice - pasted on another board Charts Amatuer17 09/04/17 07:55:23 AM
#1533   Charts can be very useful and it's true Dubb10 09/04/17 06:03:08 AM
#1532   I sure hope your prognosis midastouch017 09/04/17 12:48:17 AM
#1531   Watching for potential reversal in the making. Dubb10 09/03/17 03:32:19 PM
#1530   LOL, by your own previous midastouch017 09/02/17 01:48:02 AM
#1529   Short it all the way to the bank!! Dizzle96 09/01/17 07:47:22 PM
#1528   BioLineRx: Why I See Significant Upside Potential In midastouch017 09/01/17 10:53:24 AM
#1527   Short Interest in BioLineRx Ltd. midastouch017 09/01/17 09:27:31 AM
#1526   Get in imo not out. Golden cross today. Rogerthat1 08/30/17 10:13:19 PM
#1525   Put on your parachutes and JUMP !!!! Dizzle96 08/30/17 05:18:27 PM
#1521   I want 30¢ in a couple hours or Rogerthat1 08/28/17 01:42:03 PM
#1519   You want to wait until year end to Rogerthat1 08/26/17 04:27:03 PM
#1518   Check the charts back from Jan 2015 to Dizzle96 08/23/17 05:34:13 PM
#1517   Trending down this last week ...... Dizzle96 08/23/17 03:03:52 PM
#1515   Lol the rule is 3 losses in a Dizzle96 08/22/17 10:37:50 AM
#1514   Same I like the odds here and will dave86 08/21/17 03:42:19 PM
#1513   With 5 collaborations - I am hoping that Amatuer17 08/21/17 03:36:52 PM
#1512   the good thing is that the company is dave86 08/21/17 03:32:41 PM
#1511   Not so - the end of trial is Amatuer17 08/21/17 03:27:05 PM
#1510   99k bid now at 1.08 lol who knows dave86 08/21/17 10:47:11 AM
#1509   Wow big sell off this morning. Interesting ...... Dizzle96 08/21/17 10:26:40 AM
#1508   1.08 ? Really? Dizzle96 08/21/17 10:24:45 AM
#1507   BioLineRx readies late-stage study of BL-8040 in multiple myeloma midastouch017 08/21/17 08:05:05 AM
#1506   BioLineRx Announces Regulatory Submission of Phase 3 Registrational midastouch017 08/21/17 08:02:33 AM
#1505   All depends where you have set your selling Dizzle96 08/19/17 05:45:33 PM
#1504   So right now your saying it's a buy dave86 08/19/17 12:45:35 PM
#1503   An improved idea! Buy now, midastouch017 08/19/17 11:30:32 AM
#1502   Good luck to you! midastouch017 08/19/17 10:59:13 AM
#1501   I will once we get close to the Dizzle96 08/19/17 10:57:57 AM
#1500   there has already been a pump and dump midastouch017 08/19/17 10:01:21 AM
#1499   The reply post , this happened almost a Dizzle96 08/18/17 03:31:53 PM
#1498   6 Analysts Bullish Bioline RX Ltd (BLRX) midastouch017 08/18/17 09:22:22 AM
#1497   When I sell this for a 10% or dave86 08/18/17 01:17:03 AM
#1496   They won't risk big in long term with Dizzle96 08/17/17 11:07:23 AM
#1495   There are still buying as of a few dave86 08/16/17 08:43:16 PM
#1494   Your numbers are right as of Q2-2017 end https://fintel.io/sob/us/blrx Check Amatuer17 08/16/17 01:02:37 PM
#1493   How do you get 62 million because this dave86 08/16/17 12:54:02 PM
#1492   Just wait for it, Rich. If it Dizzle96 08/16/17 12:31:56 PM
PostSubject