Tag Archives: IBD

BioLineRx to Present at the 12th Annual Needham Healthcare Conference in New York on April 30, 2013

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BioLineRx to Present at the 12 th Annual Needham Healthcare Conference in New York on April 30, 2013

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that its Chief Executive Officer, Kinneret Savitsky, Ph.D., and its Chief Financial and Operating Officer, Philip Serlin, will be presenting at the 12th Annual Needham Healthcare Conference in New York.

Dr. Savitsky and Mr. Serlin are scheduled to present at 3:40 P.M. EST on Tuesday, April 30, 2013.

A live Webcast of the presentation will be available on the BioLineRx Website at http://biolinerx.com/default.asp?pageid=63&itemid=181. A replay will be available one hour after the presentation ends and will be accessible for three months following the presentation.

Investors attending the conference that wish to meet with Dr. Savitsky and Mr. Serlin for a one-on-one meeting should contact the Needham Conference Team at conferences@needhamco.com.

About BioLineRx

BioLineRx is a publicly-traded biopharmaceutical development company. BioLineRx is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx’s current portfolio consists of six clinical stage candidates: BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc., is currently undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-7040 for treating inflammatory bowel disease (IBD) has completed a Phase IIa trial; BL-8040 for treating acute myeloid leukemia (AML) and other hematological cancers will shortly commence a Phase II study; BL-1021 for neuropathic pain is in Phase I development; and BL-1020 for schizophrenia. In addition, BioLineRx has six products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, infectious diseases, cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government’s Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visitwww.biolinerx.com, the content of which does not form a part of this press release.

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From: http://www.dailyfinance.com/2013/04/18/biolinerx-to-present-at-the-12th-annual-needham-he/

BioLineRx Announces Positive Phase II Results for BL-7040, an Orally Available Treatment for Inflamm

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BioLineRx Announces Positive Phase II Results for BL-7040, an Orally Available Treatment for Inflammatory Bowel Disease


– BL-7040 met the primary efficacy endpoint of the study –


– BL-7040 was also shown to be safe and well tolerated –

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today positive Phase IIa results for BL-7040, an orally available drug for treating inflammatory bowel disease (IBD). The study showed that BL-7040 is safe and effective in treating ulcerative colitis, a form of IBD.

The Phase IIa trial was an open-label, proof-of-concept study to evaluate the efficacy, safety and tolerability of BL-7040 in patients with moderately active ulcerative colitis. Patients were treated for up to five weeks with BL-7040: 12 mg/day for up to three weeks, followed by 40 mg/day for two additional weeks. The clinical trial was carried out at five leading medical centers in Israel.

Sixteen of the 22 patients who were enrolled in the clinical trial completed the full five-week course of treatment and two-week follow-up. The primary clinical endpoint in the study – a reduction in the Mayo score between baseline and completion of treatment – was achieved. Fifty percent of patients (8 patients) met the primary endpoint, while the remaining 8 patients demonstrated a stable clinical condition or minor improvement. Fifty-six percent of patients (9 patients) demonstrated decreases of at least 1 point in the rectal-bleeding sub-score and 69% (11 patients) had rectal-bleeding sub-scores of ≤1 (in 6 of the 11 patients, no rectal bleeding was seen at all).

Fifty percent of the patients completing study treatment also met certain secondary endpoints, such as a partial Mayo score reduction and mucosal healing evaluated by endoscopy sub-score measurements. Additional secondary endpoints in the study were the IBD Quality-of-Life Questionnaire, and the serum CRP and fecal calprotectin measurements. The results of these additional secondary endpoints were not conclusive, although certain positive trends were noted.

BL-7040 was highly safe and well tolerated by the study participants, with a very low incidence of drug related, mild-to-moderate adverse events (AEs), as well as one

From: http://www.dailyfinance.com/2013/04/17/biolinerx-announces-positive-phase-ii-results-for-/

Securities America Wins BISA Technology Innovation Award for Advisor Dashboard

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Securities America Wins BISA Technology Innovation Award for Advisor Dashboard

Honor recognizes IBD’s commitment to advisor-focused tech investment

LA VISTA, Neb.–(BUSINESS WIRE)– Securities America received the inaugural Technology Innovation Award for its advisor workstation dashboard at the Bank Insurance & Securities Association (BISA) annual conference in March. Securities America Financial Corp. is a wholly owned subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE MKT: LTS).

BISA created the award to recognize leadership in the advancement of the industry’s products, services and platforms through technology innovation. The organization plans to grant the awards annually at its annual convention each spring.

“As the industry continues to evolve, we want to recognize significant technology advancements and the early innovators that lead the way,” said BISA President-Elect Dan Overbey. “This award symbolizes the unparalleled investment in technology made by key BISA constituencies, namely our product manufacturer partners and the companies engaged in the third-party marketer program space.”

Securities America‘s e*Office Advantage workstation dashboard offers advisors three views: client, office and branch. Each view can be customized by the advisor or assistant using dozens of available widgets, which draw data from multiple sources in seconds. This data aggregation makes advisors more efficient and effective, whether dealing with clients, identifying the practice’s most profitable clients, or analyzing production for a group of advisors.

“With our e*Office Advantage Dashboard, advisors can easily identify trends, spot new opportunities, streamline their office workflow and provide superior customer service,” said Jim Nagengast, Securities America chief executive officer and president. “Advisors can now easily meet client expectations for getting data while they’re on the phone with the advisor, not hours or days later. We’re honored that BISA recognized our contribution with their first-ever Technology Innovation Award.”

The dashboard is accessible 24/7 through Securities America‘s mobile solutions, giving advisors a single point for accessing consolidated data any time, any place, on any device.

Securities America‘s financial institutions division continues to expand as more advisors and program managers recognize the significant advantage they achieve by leveraging the technology, practice management, advisory programs and income distribution support,” said Michael Anderson, first vice president of financial institutions and merger & acquisitions. “Securities America focuses on what’s important for advisors – technology that makes their routine, day-to-day tasks more efficient and frees their time for …read more

Source: FULL ARTICLE at DailyFinance

BioLineRx Reports Year End 2012 Financial Results

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BioLineRx Reports Year End 2012 Financial Results

JERUSALEM–(BUSINESS WIRE)– BioLineRx Ltd. (NAS: BLRX) (TASE: BLRX), a biopharmaceutical development company, today reported its results for the year ended December 31, 2012.

“BioLineRx is rapidly approaching a significant landmark in the evolution of the Company,” stated Kinneret Savitsky, Ph.D., CEO of BioLineRx. “We are eagerly anticipating the interim analysis of the on-going CLARITY Phase 2/3 trial for our lead compound, BL-1020 for schizophrenia, which we expect to receive next week. The analysis will include a recommendation by an independent Data Monitoring Committee (DMC) regarding the number of additional patients needed in order to reach statistical significance on the cognitive effect of BL-1020 compared to Risperidone. Although the data from the ongoing study is completely confidential, based on promising evidence received in previous clinical and pre-clinical trials, we hope the information received will provide a clear indication regarding the strength of the cognition improvement signal, thereby putting us in a stronger position to out-license BL-1020 and move towards commercializing the compound.”

“The PRESERVATION I pivotal CE mark registration trial for our other lead compound, BL-1040 for ventricular remodeling post-AMI, which is being carried out by Ikaria, Inc., continues to progress on an accelerated basis. Currently, there are 15 sites recruiting in Australia, Belgium, Canada, Israel and Spain, and results from the trial are expected in 2014.”

“In addition, our Phase 2 proof-of-concept study for BL-7040, an oral treatment for Inflammatory Bowel Disease (IBD), is nearing completion. This is an open-label study to evaluate the efficacy, pharmacodynamics, safety and tolerability of BL-7040 in up to 30 patients with moderately active ulcerative colitis, a type of IBD. This trial is being carried out at five sites in Israel, and we are expecting to announce results in April 2013.”

“During 2012, we in-licensed several high-profile therapeutic compounds that are already advancing towards clinical testing. This includes BL-8040, a Phase 2-ready drug for the treatment of acute myeloid leukemia (AML) and other hematological cancers. The interest in this program is high, and we have recently signed an agreement with one of the premier cancer centers in the world, MD Anderson Cancer Center in Houston, Texas, to be the lead site in the trial. We are currently in negotiations with two other U.S.-based, world-class facilities for their participation in the trial as well,” continued Dr. Savitsky.

“At the beginning of 2012, we entered the competitive HCV market with the in-licensing of two orally-available compounds for the treatment of Hepatitis C from world renowned experts …read more
Source: FULL ARTICLE at DailyFinance