BioLineRx Ltd. (NASDAQ: 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.