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news.BioLineRx, a drug development company, has announced that the Independent Safety Monitoring Board for the BL-1040 pilot study authorized the completion of the Phase I/II study and enrollment of the additional 25 patients.
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The Independent Safety Monitoring Board’s (ISMB) decision is based on safety assessments of the first five patients to complete at least 30 days of follow up following treatment with BL-1040 without noticeable adverse events. BL-1040 is a breakthrough treatment for preventing further heart damage following acute myocardial infarction (AMI).
The pilot Phase I/II multi-center open label study is designed to assess the safety and preliminary efficacy of BL-1040 in up to 30 patients. The trial is currently taking place in six active sites in Germany and Belgium, with four additional sites pending. Interim results presenting a six months follow-up of the first five patients are expected during second quarter of 2009, and final results of the pilot Phase I/II study are expected in third quarter of 2009.
BL-1040 is being developed as a class III medical device utilizing FDA’s pre-marketing approval regulatory pathway. This expedited regulatory pathway should allow marketing of BL-1040 by 2012.
Morris Laster, CEO of BioLineRx, said: BioLineRx anticipates potential initial revenues in 2009 if and when out-license agreements may be secured from the partnering of BL-1040 and/or BL-1020, our Phase II small molecule for the treatment of schizophrenia that will also be available for licensing following final Phase IIb data in third quarter of 2009.
The company has sufficient capital to fund its activities through the end of 2010, which is four to five quarters after achievement of key clinical milestones, allowing ample time to close a partnering deal.