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BioLineRx Ltd. (BLRX)

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Last Post: 11/20/2018 7:15:46 AM - Followers: 108 - 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) 07:02 AM
BLRX News: Report of Foreign Issuer (6-k) 11/08/2018 07:02:21 AM
BLRX News: Report of Foreign Issuer (6-k) 10/22/2018 07:01:59 AM
BLRX News: Report of Foreign Issuer (6-k) 10/19/2018 07:02:20 AM
BLRX News: Confidential Treatment Order (ct Order) 10/18/2018 03:00:39 PM
News News Alert: Report of Foreign Issuer (6-k) 11/20/2018 07:02:14 AM
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#1909   News: BioLineRx Announces Receipt of FDA Biological Product BooDog 11/20/18 07:15:46 AM
#1908   Everything is so far in terms of key Amatuer17 11/11/18 07:09:35 AM
#1907   Conference call quotes. Why this didn't jump to BarrellofHay 11/09/18 02:11:55 PM
#1906   THE ENGINE STARTING TO SMOKE , ITS GOING sell sell 11/09/18 11:14:49 AM
#1905   That seller is finally out so we're basing Axeman 11/07/18 03:46:13 PM
#1904   When $0.60? Zaks94 11/07/18 11:00:12 AM
#1903   And 60s are here this thing as flatlined Axeman 10/30/18 11:26:39 AM
#1902   It keeps breaking support until it gets back Axeman 10/28/18 09:51:44 PM
#1901   it will settle and then peeps will start TAB78 10/28/18 07:51:55 AM
#1900   HI HO - HI HO -ITS OFF TO sell sell 10/28/18 01:29:40 AM
#1899   Next stop $0.60 unfortunately reminds me of when Axeman 10/27/18 03:42:13 PM
#1898   IMO - All is good, just peeps who TAB78 10/26/18 12:39:03 PM
#1897   look at the 2 year chart. Incumbent SH PennyWorld 10/26/18 10:54:42 AM
#1896   Yes..falling knife continues. Axeman 10/26/18 10:40:39 AM
#1895   Ditto. Averaging down here (scaling in). No PennyWorld 10/26/18 10:31:36 AM
#1894   Bought close to low sing all indicators way Axeman 10/25/18 11:23:35 PM
#1893   Snooze you lose. Picking up some here BooDog 10/25/18 12:11:34 PM
#1892   Off a cliff... Axeman 10/25/18 10:39:03 AM
#1891   Any movement soon? Zaks94 10/25/18 05:06:05 AM
#1890   ITS JUST A JUNK CAR WITH A NEW sell sell 10/24/18 02:20:14 PM
#1889   Who sings behaving like some of my pink Axeman 10/24/18 01:34:41 PM
#1888   Just another piece of shit Axeman 10/24/18 01:33:28 PM
#1887   Interesting after hours movement up. Not sure if BarrellofHay 10/22/18 06:57:50 PM
#1886   Thanks much BarrellofHay 10/22/18 06:53:02 PM
#1885   Paid subscribers do not have that post limitation. PennyWorld 10/22/18 05:33:33 PM
#1884   I'll work on my sticky when i get BooDog 10/22/18 03:29:26 PM
#1883   IMO blrx is a long term investment not TAB78 10/22/18 01:46:11 PM
#1882   That way as news comes out it can TAB78 10/22/18 01:44:07 PM
#1881   SOMETHING IS JUST NOT RIGHT HERE. NO MATTER sell sell 10/22/18 12:34:30 PM
#1880   Curious, Why the significance of a moderator? J_Dean 10/22/18 10:58:50 AM
#1879   I was, now I am again. Good BooDog 10/22/18 08:48:05 AM
#1878   Go to the top left where it says TAB78 10/22/18 08:43:19 AM
#1877   I would like to be a mod. How BarrellofHay 10/21/18 10:21:04 PM
#1876   Serious question folks, how come there's no mods here?? TAB78 10/21/18 08:13:24 AM
#1875   I sold most of mine for a gain.The bbhuey 10/20/18 11:52:23 AM
#1874   Got out of biotech investing last years. Know austexjam 10/19/18 12:01:50 PM
#1873   In earlier this morning with 10K shrs @.92 marketbuy 10/19/18 11:36:01 AM
#1872   been with this company for about 2 years chevelle 396 10/19/18 09:50:36 AM
#1871   Got some under a dollar. willlbone 10/19/18 09:44:35 AM
#1870   Yes, serious over reaction for the "sell on news". BooDog 10/19/18 09:39:53 AM
#1869   Let’s gooooo to $4 at least!! Zaks94 10/19/18 08:59:59 AM
#1868   I think that's a little to much oversold,,, crazy Country Squire 10/19/18 08:50:57 AM
#1867   Morning, First yesterdays selloff was do to Country Squire 10/19/18 07:30:37 AM
#1866   About 24 a share up from around 1.25 BarrellofHay 10/19/18 12:06:14 AM
#1865   What was the increase shareholders got per share? Ditryin 10/18/18 11:43:15 PM
#1864   Timing is interesting....the night before data is released. GLTA, Murocman murocman 10/18/18 06:44:13 PM
#1863   I would say a CT Order is a BarrellofHay 10/18/18 05:48:19 PM
#1862   That is one purpose, sure. There are BooDog 10/18/18 03:56:04 PM
#1861   Thank u for that link, appreciate it... “to keep erik007tc 10/18/18 03:42:07 PM
#1860   What does what mean? This?...... BooDog 10/18/18 03:30:01 PM
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