The disease can develop at any point in life, from infancy to late adulthood and is more common among women than men.
According to Dr. Savitsky, the company's CEO, there are currently no approved celiac therapies aside from a strict, life-long and difficult to maintain gluten-free diet. There are only a few clinical-stage projects under development worldwide for this disease, creating a significant opportunity for BioLineRx's product.
BL-7010, the companys novel treatment for celiac disease, successfully completed the single administration, dose-escalation stage of its on-going Phase 1/2 clinical study. No serious adverse events were reported and there were no dose-limiting safety issues. The full results of the current Phase 1/2 study is expected in mid-2014 and assuming they are successful, the company will begin a randomized, controlled efficacy study in celiac patients by the end of this year.
Another promising development in BioLineRx's disease-fighting arsenal is the positive pre-clinical results for BL-8040, as a treatment for chronic myeloid leukemia (CML). According to the American Cancer Society, CML, also known as chronic myelogenous leukemia, is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. In CML, leukemia cells tend to build up in the body over time, but many people don't have any symptoms for at least a few years. In time, the cells can also invade other parts of the body, including the spleen. CML can also change into a fast-growing acute leukemia that invades almost any organ in the body.
Most cases of CML occur in adults, but very rarely it occurs in children, too.
A study, led by Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, produced results showing that the BL-8040 treatment directly inhibited cancer cell growth and induced apoptotic cell death of CML cells in-vitro. According to Prof. Nagler, BL-8040 has the potential to be an important addition to the drug war in fighting CML.
BL-8040 is currently undergoing a Phase 2 trial for AML and is expected to enter a Phase 1 trial for stem cell mobilization in the second quarter of this year, with top-line results for both of these studies expected in the fourth quarter of 2014. The company has high hopes that this promising drug will realize its potential to help cancer patients, both as a stand-alone therapy and in combination with other therapies in the foreseeable future, according to Dr. Savitsky.
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