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6-K
BIOLINERX LTD. filed this Form 6-K on 03/10/2016
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exhibit_1.htm


Exhibit 1
 
For immediate release

BioLineRx Reports Year End 2015 Financial Results
 
Tel Aviv, Israel - March 10, 2016 - BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today reported its financial results for the year ended December 31, 2015.

Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, “2015 was a year of significant progress for BioLineRx on several fronts, as we advanced our lead therapeutic clinical programs both from a development and regulatory perspective, and entered into an exciting new collaboration in the immuno-oncology space.”

“During the past year, we enhanced and expanded the development strategy for our BL-8040 cancer therapy platform, which is currently being investigated for multiple cancer and hematological indications. These include a Phase 2 study for treating relapsed and refractory AML patients, top line results of which are expected by the end of this month. Results from the first part of this trial continue to demonstrate substantial mobilization of leukemic cells from the bone marrow to the peripheral blood and robust induction of cancer cell apoptosis, which, combined with the reported 38% composite remission rate, strongly suggest that BL-8040 has potent anti-leukemic activity. In addition, we are also assessing BL-8040 as an AML consolidation treatment in a large Phase 2b study that is currently up and running at full steam. Successful top-line safety and efficacy results were also reported from a Phase 1 study in stem cell mobilization, supporting BL-8040 as one-day, single-dose collection regimen, which is a significant improvement upon the current standard of care. We now await receipt of regulatory approval in order to begin, by the end of the month, a Phase 2 trial for BL-8040 as a stem cell mobilizer for allogeneic transplantation. Finally, we are advancing an ongoing Phase 1/2 study for BL-8040 as a novel treatment for hMDS and AA, two bone marrow failure conditions.”

“We recently entered the exciting field of immuno-oncology through our collaboration with Merck, a pioneer and world leader in cancer immunotherapy. A Phase 2 study is planned to commence by mid-year investigating BL-8040 in combination with KEYTRUDA®, Merck’s anti-PD-1 immunotherapy, in patients with metastatic pancreatic cancer. Although there have been significant advances in the immuno-oncology field, many cancer types, such as pancreatic cancer, remain resistant to immunotherapy, and combination treatments appear to offer a better chance to treat these cancers. We are therefore enthusiastic about this opportunity to evaluate the potential of our lead drug candidate as a combination therapy with immune checkpoint inhibitors. We are also planning to commence a Phase 2a trial for BL-8040 in the second half of 2016, for the treatment of AML patients with the FLT3-ITD mutation. With the guidance and insight of our newly established Oncology Scientific Advisory Board, consisting of world-renowned key opinion leaders, we look forward to realizing the potential of this promising oncology platform and to reaching several meaningful development milestones during 2016.”

“BL-7010, for the treatment of celiac disease and gluten sensitivity, which was found to be safe and well tolerated in a Phase 1/2 trial in celiac patients, has recently received confirmation for the medical device designation pathway in Europe. Over the past year, we have invested considerable efforts in examining the potential of BL-7010 as a food supplement, in order to address the multi-billion dollar market for gluten sensitivity, which we believe has a significantly shorter time to market than drug or device pathways, especially in the US market. We are currently conducting a number of activities towards the development of BL-7010 as a food supplement, including the development of a suitable product formulation, preparation of the documents necessary for a GRAS designation submission, and preparations for a relatively small clinical trial to support future marketing efforts. We expect to complete these activities by mid-2017, in order to support future expected partnering discussions for the food supplement market in the US and other relevant territories. We also plan to continue to evaluate the pathway in Europe for celiac disease and intend to make a decision about the timing and scope of the next efficacy study for European registration over the next few months.”