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BioLineRx Ltd. (BLRX)

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Last Post: 3/22/2017 2:59:33 PM - Followers: 82 - Board type: Free - Posts Today: 1

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: Report of Foreign Issuer (6-k) 03/20/2017 07:01:21 AM
BLRX News: BioLineRx Provides Update on Phase 2 Open-Label Study for BL-8040 as Novel Stem Cell Mobilization Treatment 03/20/2017 07:00:00 AM
BLRX News: BioLineRx to Report Annual 2016 Results on March 23, 2017 03/16/2017 10:00:00 AM
BLRX News: Amended Statement of Beneficial Ownership (sc 13d/a) 03/08/2017 04:11:46 PM
BLRX News: Report of Foreign Issuer (6-k) 02/13/2017 04:25:46 PM
PostSubject
#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
#1377   Dam after trading down all day BLRX is lakingsphan0427 02/21/17 02:48:59 PM
#1376   It may well be!...I'm no doctor or biochemist...Are you? shub 02/20/17 03:25:23 PM
#1375   You know less than I do. Promise Flying Albatross 02/19/17 05:29:37 PM
#1374   Good luck Lakingsphan: I think it's a good bet. shub 02/17/17 04:35:15 PM
#1373   It wouldn't be the first time i'd blown shub 02/17/17 04:26:01 PM
#1372   Hi Midas; shub 02/17/17 04:19:39 PM
#1371   You blew it No need to make excuses Flying Albatross 02/17/17 04:06:25 PM
#1370   I've been in AVXL for years and have shub 02/17/17 03:48:35 PM
#1369   I am in 2500 shares.. Lets see what lakingsphan0427 02/16/17 12:01:57 PM
#1368   Just lurking.. BLRX looks promising..Trying to read more lakingsphan0427 02/15/17 06:42:23 PM
#1367   BLRX shares are deeply undervalued because having about midastouch017 02/15/17 04:08:22 PM
#1366   BioLineRx - Undervalued With Significant Pipeline, Large Pharma midastouch017 02/15/17 04:08:04 PM
#1365   I don't know about all of that Institutional Flying Albatross 02/15/17 02:22:55 PM
#1364   I sold AVXL but not BLRX...or a number shub 02/15/17 02:14:12 PM
#1363   You sold Avxl for this? Oh boy &@$&@&::&@ Flying Albatross 02/15/17 01:44:54 PM
#1362   Going to have to keep up a smattering shub 02/14/17 02:57:06 PM
#1361   On February 13, 2017, BioLineRx Ltd. (the “Company”) midastouch017 02/14/17 12:02:27 PM
#1360   Right on Midas...But this is only the beginning. DOGONE 02/13/17 01:52:08 PM
#1359   BioLineRx perks up 7% on Rodman bullish call midastouch017 02/13/17 01:03:06 PM
#1358   BioLineRx to Present at 2017 BIO CEO & midastouch017 02/13/17 09:01:44 AM
#1357   BioLineRx (NASDAQ:BLRX) initiated with Buy rating and $3 midastouch017 02/13/17 09:00:22 AM
#1356   Guessing that it isn't a clinical announcement seeing shub 02/09/17 01:27:03 PM
#1355   BioLineRx to Present at 2017 BIO CEO & midastouch017 02/07/17 07:48:16 AM
#1354   Thanks again Midas; it's a rather compelling argument, shub 01/26/17 02:28:49 PM
#1353   BioLine Rx: This Under-The-Radar Biotech Stock Is A midastouch017 01/26/17 01:46:17 PM
#1352   FORM 6-K midastouch017 01/26/17 08:13:16 AM
#1351   Hello again Midas; shub 01/25/17 03:36:08 PM
#1350   BioLineRx Announces Initiation of Immuno-Oncology Phase 2 Study midastouch017 01/17/17 07:15:40 AM
#1349   BioLineRx Ltd. (BLRX) Stake Raised by Senvest Management LLC midastouch017 01/03/17 12:34:28 PM
#1348   Completely agree, with all the positives here... It's Carlosstock 12/06/16 09:47:06 AM
#1347   CAN SOMEONE TELL ME WHAT ITS GOING TO chevelle 396 12/05/16 09:38:54 PM
#1346   BioLineRx lead product candidate beats cytarabine in myeloid midastouch017 12/05/16 10:51:09 AM
#1345   BioLineRx Presents Positive Phase 2a AML Study and midastouch017 12/05/16 08:29:26 AM
#1344   BLRX: Important news....Very good indeed. remind2 12/05/16 08:03:00 AM
#1343   BLRX: Major good news being released on 12/03 remind2 12/02/16 11:40:21 AM
#1342   Thanks Sugarplum 11/23/16 12:02:24 PM
PostSubject