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BioLineRx Ltd. (BLRX)

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Last Post: 2/28/2020 3:58:09 AM - Followers: 108 - 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: Confidential Treatment Order (ct Order) 02/19/2020 09:11:12 AM
BLRX News: Statement of Ownership (sc 13g) 02/14/2020 04:03:07 PM
BLRX News: Report of Foreign Issuer (6-k) 11/12/2019 06:22:12 AM
BLRX News: Report of Foreign Issuer (6-k) 11/05/2019 09:01:00 AM
PostSubject
#2154   One of the very few stocks which ended midastouch017 02/28/20 03:58:09 AM
#2153   Major over reaction imo. Though I do BooDog 02/27/20 10:56:31 AM
#2152   Not a good timing for buying. Panic all midastouch017 02/27/20 10:38:28 AM
#2151   Very nice! BioLineRx Announces Notice of Allowance from BooDog 02/27/20 08:15:58 AM
#2150   Orders filled 1.82. See how it goes. BooDog 02/26/20 02:53:28 PM
#2149   MM's see where I am and keep wanting BooDog 02/26/20 10:17:45 AM
#2148   BioLineRx Completes Recruitment in Triple Combination Arm of BooDog 01/30/20 09:25:05 AM
#2147   Liking this. Eom BooDog 01/24/20 03:39:34 PM
#2146   On track and looking to be impressive imo. BooDog 01/22/20 08:12:44 AM
#2145   Nice pre market this morning. Glad it BooDog 01/14/20 03:45:14 PM
#2144   This hits $2 again I'll be adding big time. BooDog 12/13/19 02:16:05 PM
#2143   2.5 low, some serious whipsaw there! Missed BooDog 12/13/19 11:06:53 AM
#2142   This has made some nice swings. Knew BooDog 12/13/19 10:39:00 AM
#2141   Nice swing. Cheers BooDog 12/09/19 04:17:51 PM
#2140   * * $BLRX Video Chart 12-05-2019 * * ClayTrader 12/05/19 05:42:49 PM
#2139   Picking up a few here. With a float BooDog 12/05/19 12:01:56 PM
#2138   Nice shake out. News looked favorable to BooDog 12/05/19 10:30:37 AM
#2137   Bid 99 cents. willlbone 12/05/19 10:12:10 AM
#2136   LOOKS LIKE GONNA BE INTERESTING DAY PREMARKET IS chevelle 396 12/05/19 07:19:48 AM
#2135   Looks like BLRX has been dumping following the PennyWorld 09/04/19 10:51:18 AM
#2134   Just wait until they start dumping (dilutting) to PennyWorld 07/19/19 11:32:41 AM
#2133   I cannot believe they did the split without BarrellofHay 07/18/19 10:41:58 PM
#2132   What happened to the mdacc phase ii expected BarrellofHay 07/18/19 10:40:13 PM
#2131   Wishful Thinking! But I 'get that'. Either way PennyWorld 06/29/19 11:35:49 PM
#2130   Thanks for your opinion. rocketeer357 06/29/19 10:18:44 PM
#2129   Because I don't buy it. Would you believe PennyWorld 06/29/19 09:26:24 PM
#2128   I'm not convinced there's much value in referencing rocketeer357 06/29/19 08:29:17 PM
#2127   Maxim Group analysts commented... PennyWorld 06/29/19 04:40:15 PM
#2126   Where are you getting your information PennyWorld? rocketeer357 06/29/19 11:27:50 AM
#2125   BLRX will run out of cash runway by PennyWorld 06/29/19 10:16:32 AM
#2124   I think they understand and have been told BarrellofHay 06/29/19 09:43:21 AM
#2123   OK. I have to ask this. Your alias PennyWorld 06/28/19 11:04:34 PM
#2122   OK. I have to ask this. Your alias PennyWorld 06/28/19 11:04:33 PM
#2121   I SOLD TODAY .I HAD 1 R/S UNDER sell sell 06/28/19 09:00:41 PM
#2120   IMO it depends on how knowledgeable the incumbent PennyWorld 06/28/19 08:27:48 PM
#2119   I WONDER WHAT THE STOCK PRICE WILL OPEN sell sell 06/28/19 07:45:50 PM
#2118   Unless I miscalculated, delisting due to PPS < PennyWorld 06/28/19 07:24:47 PM
#2117   That company is a total joke. CEO says lorbas95 06/28/19 05:23:52 PM
#2116   Me as well. Yup, i don't play the BooDog 06/28/19 04:49:18 PM
#2115   Bad news. I thought they would wait until PennyWorld 06/28/19 04:46:24 PM
#2114   1:15 RS 16 July. Thought they would BooDog 06/28/19 04:19:21 PM
#2113   $BLRX A few days old but still worth stockguard 06/23/19 11:09:04 AM
#2112   Nice close today. jaytea 06/21/19 04:18:32 PM
#2111   I sure hope so Bugguybob 06/20/19 03:20:17 PM
#2110   Does anyone else think the dump-a-thon is over? John_Langston 06/20/19 12:14:13 PM
#2109   What’s everyone’s thoughts on the JMP Securities 2019 John_Langston 06/18/19 03:31:09 PM
#2108   That (> $1) will only happen if they PennyWorld 06/05/19 06:18:09 PM
#2107   I've seen this language plenty of times. BooDog 06/05/19 09:39:45 AM
#2106   So, it looks like an extension has been PennyWorld 06/05/19 07:47:01 AM
#2105   Too much risk IMO. John_Langston 06/04/19 04:10:04 PM
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