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BioLineRx Ltd. (BLRX)

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Last Post: 5/14/2019 9:01:17 AM - Followers: 119 - 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




BLRX
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BLRX News: Report of Foreign Issuer (6-k) 05/14/2019 07:01:17 AM
BLRX News: Report of Foreign Issuer (6-k) 05/07/2019 07:01:33 AM
BLRX News: Annual and Transition Report (foreign Private Issuer) (20-f) 03/28/2019 07:10:40 AM
BLRX News: Report of Foreign Issuer (6-k) 03/28/2019 07:01:52 AM
BLRX News: Report of Foreign Issuer (6-k) 03/27/2019 07:03:24 AM
PostSubject
#2092   Fine by me. Solidifying the fundamentals is BooDog 05/14/19 09:01:17 AM
#2091   Yes but no volume this morning. John_Langston 05/14/19 08:52:22 AM
#2090   Nice imo! BooDog 05/14/19 08:39:54 AM
#2089   earnings whisper for Tues beats by .01. - nokomis 05/10/19 11:45:08 AM
#2088   * * $BLRX Video Chart 05-07-2019 * * ClayTrader 05/07/19 06:00:31 PM
#2087   News: $BLRX BioLineRx Announces FDA Approval of IND whytestocks 05/07/19 04:10:35 PM
#2086   market trying to bounce. BLRX could get serious nokomis 05/07/19 12:31:54 PM
#2085   algorithms buying at lows. This is a runner nokomis 05/07/19 12:07:54 PM
#2084   I agree. It may take a day or PennyWorld 05/07/19 11:35:09 AM
#2083   I just got out of a meeting. Thinking BooDog 05/07/19 08:20:25 AM
#2082   Fund managers are sipping on their coffee and BillG2436 05/07/19 08:09:43 AM
#2081   Yes, but buying pressure needs to exceed the 420man 05/07/19 08:00:46 AM
#2080   Lol, if I flipped this 4 times this BillG2436 05/07/19 07:57:00 AM
#2079   Yes, but flipping for a nickel .38 to 420man 05/07/19 07:55:00 AM
#2078   May be just PM flipping. We’ll see as BillG2436 05/07/19 07:52:24 AM
#2077   Unfortunately, it appears current shareholders want out for 420man 05/07/19 07:46:58 AM
#2076   I’d be surprised if this doesn’t go .75+ today. BillG2436 05/07/19 07:33:36 AM
#2075   U.S. Food and Drug Administration (FDA) has approved erik007tc 05/07/19 07:26:21 AM
#2074   Big news here today. FDA approval for anti BillG2436 05/07/19 07:23:47 AM
#2073   Nice volume today. John_Langston 04/29/19 10:28:17 PM
#2072   Will be nice to see the momentum come BooDog 04/26/19 12:15:40 PM
#2071   $BLRX Book Value only $.36 High of Year SlaptheSwing 04/26/19 10:41:26 AM
#2070   $BLRX Management Effectiveness SlaptheSwing 04/26/19 10:36:19 AM
#2069   Slowly maxing the oversolds. May make it BooDog 04/25/19 03:33:37 PM
#2068   Good 'ole bios eh? Looks like BooDog 03/28/19 01:55:38 PM
#2067   News: $BLRX BioLineRx Announces Successful Engraftment Data From whytestocks 03/27/19 09:50:36 AM
#2066   If they can stop making stupid decisions that All_In4DNAX 03/27/19 09:28:07 AM
#2065   BioLineRx Announces Successful Engraftment Data From Phase 3 BooDog 03/27/19 07:27:48 AM
#2064   BioLineRx Announces Successful Engraftment Data From Phase 3 crudeoil24 03/27/19 07:23:33 AM
#2063   BiolinRX SP depends on 28TH March report and Mark441 03/27/19 06:49:02 AM
#2062   There may be some life in this stock All_In4DNAX 03/22/19 09:52:37 AM
#2061   There’s some major institutional holders that are loading Hopeful1037 03/03/19 12:58:00 PM
#2060   I don't so, why. BLRX will r3lease TAB78 03/02/19 03:34:58 PM
#2059   I think that we are at least 6 PennyWorld 02/27/19 09:01:03 PM
#2058   Ugly delisted to otc soon? Diluting pos Axeman 02/27/19 08:56:21 PM
#2057   Can flip it . While waiting. Slowly Kid-Gloves 02/27/19 02:42:42 PM
#2056   I’m so upside down on this thing I All_In4DNAX 02/25/19 11:19:08 AM
#2055   We need great progress on the EPS front PennyWorld 02/25/19 11:01:16 AM
#2054   The wall at .42 must be thick All_In4DNAX 02/25/19 10:15:11 AM
#2053   Looks like she wants to start moving back BooDog 02/25/19 07:55:09 AM
#2052   We'll see a pr soon imo. Kid-Gloves 02/19/19 08:07:39 PM
#2051   Finally getting some upward movement. Won’t be easy All_In4DNAX 02/19/19 10:05:49 AM
#2050   Looks ready to move up Kid-Gloves 02/15/19 01:12:08 PM
#2049   :( IB_ 02/15/19 11:53:10 AM
#2048   No.…………………………………………………………………..Money is all tied up IB_ 02/15/19 11:48:16 AM
#2047   Yeah BLRX at 0.4051 ? -0.0019 (-0.47%) really IB_ 02/14/19 11:38:27 PM
#2046   No PM on BLRX IB_ 02/14/19 10:27:50 AM
#2045   Wrong board, this is the big boy's board. John_Langston 02/14/19 10:13:10 AM
#2044   Yes still holding !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! IB_ 02/14/19 10:05:16 AM
#2043   Why an F3? John_Langston 02/14/19 09:31:34 AM
PostSubject