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BioLineRx Reports Third Quarter 2013 Financial Results
Date:11/13/2013

cond half of 2014. In addition, during the first half of 2014, we expect to commence additional clinical trials for BL-8040 in stem cell mobilization and chronic myeloid leukemia (CML)."

BL-5010 (skin lesions):

  • Pivotal CE-Mark registration trial in Germany expected to commence by end of 2013, following receipt of regulatory approval
  • Finalized CRO and all other study vendor contracts in anticipation of study commencement
  • "We look forward to commencing the CE-Mark registration trial for BL-5010, our novel composition for the non-surgical removal of skin lesions, by the end of 2013, once we receive regulatory approval from the German regulatory authorities. We expect to announce results from the study around mid-2014. Positive results could potentially allow BL-5010 to enter the European market by the end of next year. During 2014, we also plan to expand BL-5010 into additional therapeutic indications, such as actinic keratosis, a pre-cancerous skin condition. In parallel with completing preparations for the pivotal study, we continue to engage in meaningful discussions with potential partners."

    BL-7010 (celiac disease):

  • Received approval to commence Phase 1/2 clinical trial from regulatory authorities in Finland
  • Finalized CRO and all other study vendor contracts in anticipation of study commencement by end of 2013
  • "Our unique therapeutic candidate for celiac disease, BL-7010, continues to generate a lot of excitement from notable scientists and physicians. Despite the unmet medical need and enormous size of the celiac market, there is no available treatment for the disease, and only a few clinical-stage products in development. We recently received approval from the Finnish regulatory authorities to commence a Phase 1/2 safety trial for BL-7010 at a world-leading site for celiac disease in Finland. We expect to begin this study by the end of 2013, and receive results by mid-2014. Assuming the study pr
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    SOURCE BioLineRx Ltd.
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    Related medicine technology :

    1. BioLineRx to Report Third Quarter 2013 Results on November 13, 2013
    2. BioLineRx to Hold Analyst and Investor Day in New York on November 21, 2013
    3. BioLineRx Receives Regulatory Approval to Commence Phase 1/2 Trial for Novel Treatment of Celiac Disease
    4. BioLineRx Announces In-Licensing of BL-9020, for Treatment of Type 1 Diabetes
    5. BioLineRx Announces Regulatory Submission for Phase 1/2 Trial for Novel Treatment of Celiac Disease
    6. BioLineRx Announces Receipt of a Notice of Allowance from USPTO for Patent on Use of BL-8020, an Oral, Interferon-Free Treatment for Hepatitis C
    7. BioLineRx To Present At 15th Annual Rodman & Renshaw Global Investment Conference In New York
    8. BioLineRx Announces Issuance of United States Patent Covering Use of BL-8040 for Obtaining Stem Cells
    9. BioLineRx to Present at 15th International Celiac Disease Symposium
    10. BioLineRx to Present at 2013 Stifel Nicolaus Healthcare Conference In Boston
    11. BioLineRx Appoints B. J. Bormann to Board of Directors
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