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BioLineRx Ltd. (BLRX)

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Last Post: 9/4/2020 10:44:31 AM - Followers: 107 - 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) 08/19/2020 04:34:51 PM
BLRX News: Notice of Effectiveness (effect) 08/13/2020 06:03:44 AM
BLRX News: Post-effective Amendment to Registration Statement (pos Am) 08/10/2020 06:14:46 AM
BLRX News: Report of Foreign Issuer (6-k) 08/06/2020 07:48:42 AM
BLRX News: Notice of Effectiveness (effect) 07/06/2020 06:30:23 AM
PostSubject
#2209   MM ACRX sitting at 1.58 BooDog 09/04/20 10:44:31 AM
#2208   BioLineRx reports progress for Phase 3 Genesis trial midastouch017 08/23/20 08:34:55 AM
#2207   There will be multi catalyst events before year Dr._Paddleboarder 08/21/20 07:12:01 PM
#2206   Our hidden little gem is coming to life. BooDog 08/20/20 09:19:21 AM
#2205   Nice late action...eom Dr._Paddleboarder 08/19/20 04:12:04 PM
#2204   BioLineRx advances late-stage study of motixafortide midastouch017 08/19/20 09:24:07 AM
#2203   BioLineRx Achieves Enrollment Target in Phase 3 GENESIS midastouch017 08/19/20 08:13:24 AM
#2202   Thanks midastouch017! Looking forward to seeing the BooDog 08/07/20 01:00:08 PM
#2201   BioLine RX Ltd (BLRX) CEO Philip Serlin on midastouch017 08/07/20 12:17:33 PM
#2200   Well done BooDog! And midastouch017 08/07/20 12:15:09 PM
#2199   Figured this would go back under the $2 BooDog 08/06/20 10:43:04 AM
#2198   BioLineRx Reports Second Quarter 2020 Financial Results and midastouch017 08/06/20 08:33:12 AM
#2197   Patent news: https://research.ameritrade.com/grid/wwws/research/stocks/news/arti BooDog 08/05/20 01:45:27 PM
#2196   Pre earnings topping? Locked in a few just BooDog 08/05/20 12:50:54 PM
#2195   BioLineRx to Report Second Quarter 2020 Results on midastouch017 08/02/20 06:06:42 AM
#2194   wrong board. Sorry PennyWorld 07/27/20 08:01:33 AM
#2193   BLRX / BioLineRx Ltd. - Institutional Ownership and Shareholders midastouch017 06/27/20 07:13:55 AM
#2192   Bright future* lakingsphan0427 06/18/20 03:16:09 AM
#2191   Started my long position today.. Bioline looks like lakingsphan0427 06/17/20 10:50:31 PM
#2190   Dipping my toes here...looks like the science warrants futrcash 06/16/20 08:37:35 PM
#2189   How much will BL-8040 be worth just for BarrellofHay 06/12/20 05:04:42 PM
#2188   Altium is managed almost completely by MD doctors. Interesting BarrellofHay 06/06/20 09:42:47 AM
#2187   Altium Capital Management Lp discloses 8.60% ownership in BooDog 06/05/20 07:25:57 AM
#2186   BioLineRx Announces $4.39 Million Registered Direct Offering midastouch017 06/01/20 08:31:28 AM
#2185   Works for me too! And with upcoming data BooDog 05/29/20 03:53:37 PM
#2184   Works for me too! And with upcoming data BooDog 05/29/20 03:53:14 PM
#2183   Price Target $11.33. midastouch017 05/29/20 12:43:37 PM
#2182   I think so, the analysts have it BUY tk2007 05/29/20 12:25:52 PM
#2181   Good news in the horizon? midastouch017 05/29/20 12:21:37 PM
#2180   Rockin and a rollin!! BooDog 05/29/20 12:08:26 PM
#2179   BioLineRx Ltd. (BLRX) midastouch017 05/27/20 12:28:57 PM
#2178   This is GREAT to see! Peer review BooDog 05/27/20 08:35:23 AM
#2177   BioLineRx Announces Publication of Data from Ongoing COMBAT/KEYNOTE-202 midastouch017 05/27/20 07:19:59 AM
#2176   All my portfolio is 90% bios. BLRX is one midastouch017 05/26/20 04:38:42 PM
#2175   I agree. With trial data coming this BooDog 05/26/20 04:25:28 PM
#2174   It can of course get lower, but midastouch017 05/26/20 04:10:35 PM
#2173   1.63's loaded on the LII's. I went BooDog 05/26/20 04:00:04 PM
#2172   Thanks! Almost got them back at 1.64/5. BooDog 05/26/20 10:29:49 AM
#2171   BioLineRx Announces $9.0 Million Registered Direct Offering midastouch017 05/26/20 08:57:57 AM
#2170   Always a good idea to lock midastouch017 05/22/20 11:59:23 AM
#2169   Nice push!!!!! Couldn't resist locking in some BooDog 05/22/20 09:50:07 AM
#2168   BLRX waking up big time today! midastouch017 05/18/20 01:37:30 PM
#2167   I.hope good things are coming with blrx bbhuey 04/29/20 08:13:47 PM
#2166   Anyway, just a vibe that has me thinking BooDog 04/29/20 05:11:47 PM
#2165   I'd have to look at the time-line for BooDog 04/29/20 02:06:07 PM
#2164   I bought this company because of the 8040 bbhuey 04/29/20 01:49:50 PM
#2163   It's all about the science. Seeing the BooDog 04/29/20 01:06:26 PM
#2162   How Is this good or bad for blrx? bbhuey 04/29/20 11:13:10 AM
#2161   https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-dosing-regimen-pembrolizumab BooDog 04/29/20 09:43:25 AM
#2160   $BLRX Management Effectiveness SpotOnTrade 04/08/20 07:23:25 AM
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