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BioLineRx Ltd. (BLRX)

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Last Post: 9/26/2016 7:01:51 PM - Followers: 82 - 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: Report of Foreign Issuer (6-k) 09/23/2016 07:01:44 AM
BLRX News: BioLineRx Announces In-licensing of Novel Treatment for Liver Failure Conditions Under Strategic Collaboration 09/23/2016 07:00:00 AM
BLRX News: Report of Foreign Issuer (6-k) 09/22/2016 09:07:32 AM
BLRX News: Report of Foreign Issuer (6-k) 09/22/2016 09:06:42 AM
BLRX News: BioLineRx Ltd. Presents Corporate Objectives at Investor Breakfast Meeting in NY 09/22/2016 09:00:00 AM
PostSubject
#1316   is it close to 1 share per pill ernie44 09/26/16 07:01:50 PM
#1315   That's ptn akamaii 09/26/16 04:36:46 PM
#1314   so what do they have thats like viagra ernie44 09/26/16 11:15:08 AM
#1313   Looks Good Low Volume Drop In PPS lv2buygarbage 09/26/16 10:26:59 AM
#1312   Alright Who Got Scared And Sold Premarket! lv2buygarbage 09/26/16 08:49:40 AM
#1311   This Ones Another Keeper lv2buygarbage 09/25/16 10:22:37 PM
#1310   Using >5 stocks. Cut that heavy bag Jolivier9712 09/25/16 06:54:27 PM
#1309   Clay, Rocking on Monday. $1.50 wine maker 09/25/16 08:07:22 AM
#1308   BioLineRx (BLRX) Stock Soars on Liver Drug Licensing Agreement midastouch017 09/24/16 06:43:18 AM
#1307   * * $BLRX Video Chart 09-23-16 * * ClayTrader 09/23/16 05:11:07 PM
#1306   5 year chart stinks..I'm still underwater because I shotgun 09/23/16 05:00:26 PM
#1305   Boom Time Baby! lv2buygarbage 09/23/16 03:41:48 PM
#1304   I saw that , thanks Midas, and sold shub 09/23/16 03:23:29 PM
#1303   Pre-clinical results obtained in animal models of liver biotechnician 09/23/16 02:58:34 PM
#1302   20k at 1.20 Average lv2buygarbage 09/23/16 02:49:05 PM
#1301   Wise strategy! midastouch017 09/23/16 11:13:53 AM
#1300   sold 80% @ $1.38 stockdawg44 09/23/16 09:59:32 AM
#1299   Will make it to $1.50 midastouch017 09/23/16 09:51:18 AM
#1298   BLRX nice open ..... now $1.28 stockdawg44 09/23/16 09:44:46 AM
#1297   BioLineRx Announces In-licensing of Novel Treatment for Liver midastouch017 09/23/16 08:58:28 AM
#1296   BioLineRx secures license for novel treatment for liver midastouch017 09/23/16 08:39:32 AM
#1295   Thanks once again Midas; shub 09/22/16 01:39:10 PM
#1294   Today's conference audio... DOGONE 09/22/16 11:36:24 AM
#1293   BioLineRx Ltd. Presents Corporate Objectives at Investor Breakfast midastouch017 09/22/16 09:20:17 AM
#1292   Thanks for this Midas. shub 09/20/16 01:30:06 PM
#1291   BioLineRx Announces Initiation of Phase 2a Trial of midastouch017 09/20/16 08:49:23 AM
#1290   Investor meeting this Thursday in NY. DOGONE 09/18/16 08:06:38 AM
#1289   Very wise strategy shub! midastouch017 09/15/16 08:51:53 AM
#1288   Did any of you listen to the investor DOGONE 09/14/16 05:51:23 PM
#1287   Phil Serlin is doing everything he can to Bickema 09/14/16 05:09:16 PM
#1286   True that: That's why i spread my small shub 09/14/16 02:52:58 PM
#1285   Don't get too excited, the midastouch017 09/09/16 11:43:02 AM
#1284   BioLineRx Ltd. to Host Investor Breakfast Meeting September midastouch017 09/09/16 07:53:26 AM
#1283   I did and it's up already! Root! shub 09/08/16 02:10:39 PM
#1282   Thankyou Midas....going to buy more shares quickly! shub 09/08/16 01:51:07 PM
#1281   Nice Pre market action: midastouch017 09/08/16 08:47:46 AM
#1280   BioLineRx's lead product candidate BL-8040 shows positive results midastouch017 09/08/16 08:21:02 AM
#1279   Holding LONG and STRONG. Great news on AML DOGONE 09/08/16 07:55:29 AM
#1278   BioLineRx Presents Final Results from Phase 2a Trial midastouch017 09/08/16 07:08:17 AM
#1277   Excellent, thanks Midas. shub 09/07/16 03:16:01 PM
#1276   BioLineRx Announces Clinical Research Collaboration to Investigate Combinatio midastouch017 09/07/16 09:07:50 AM
#1275   Diz, ...and you sleep better for it, right? someconcerns 09/05/16 04:45:57 PM
#1274   Pre market insider pump and dump, wow they Dizzle96 08/25/16 11:07:10 AM
#1273   With all due respect this midastouch017 08/25/16 09:37:26 AM
#1272   Now I can see why all the volume oregon 1 08/25/16 08:05:50 AM
#1271   BioLineRx and I-Bridge Capital Establish a New Drug midastouch017 08/25/16 07:28:14 AM
#1270   Time to buy now with insiders. Merger news caseyryan1986 08/24/16 02:13:14 PM
#1269   With this strong volume we are holding oregon 1 08/24/16 01:35:35 PM
#1268   BioLineRx perks up; shares ahead over 30% in August midastouch017 08/24/16 11:53:33 AM
#1267   Biolinerx Ltd. ADS (BLRX) midastouch017 08/24/16 11:27:34 AM
PostSubject