BioLineRx Receives Approval to Complete Phase 1/2 Clinical Trials of BL-1040
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BioLineRx Ltd. has announced that the Independent Safety Monitoring Board (ISMB) for the BL-1040 pilot study authorized the completion of the Phase 1/2 study and enrollment of the additional 25 patients.
The ISMB's decision is based on safety assessments of the first 5 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 (MI).
The pilot Phase 1/2 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 6 active sites in Germany and Belgium, with 4 additional sites pending.
Interim results presenting a 6 months follow-up of the first 5 patients are expected during Q2, 2009, and final results of the pilot Phase 1/2 study are expected in Q3, 2009. BL-1040 is being developed as a Class III medical device utilizing U.S. Food and Drug Administration’s pre-marketing approval regulatory pathway. This expedited regulatory pathway should allow marketing of BL-1040 by 2012.
"We are extremely pleased with the progress in the development of BL-1040, and expect that the compound will complete the Phase 1/2 study in Q3 and hope to partner with a global device or drug company following our Q3 results. Business development activities have already begun, and several global biopharmaceutical and device companies are showing significant interest,” said Morris C. Laster, MD, CEO of BioLineRx.
"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 2 small molecule for the treatment of Schizophrenia that will also be available for licensing following final Phase 2b data in Q3 2009. The Company has sufficient capital to fund its activities through the end of 2010, which is 4-5 quarters after achievement of key clinical milestones, allowing ample time to close a partnering deal," added Dr. Laster.
The ISMB's decision is based on safety assessments of the first 5 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 (MI).
The pilot Phase 1/2 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 6 active sites in Germany and Belgium, with 4 additional sites pending.
Interim results presenting a 6 months follow-up of the first 5 patients are expected during Q2, 2009, and final results of the pilot Phase 1/2 study are expected in Q3, 2009. BL-1040 is being developed as a Class III medical device utilizing U.S. Food and Drug Administration’s pre-marketing approval regulatory pathway. This expedited regulatory pathway should allow marketing of BL-1040 by 2012.
"We are extremely pleased with the progress in the development of BL-1040, and expect that the compound will complete the Phase 1/2 study in Q3 and hope to partner with a global device or drug company following our Q3 results. Business development activities have already begun, and several global biopharmaceutical and device companies are showing significant interest,” said Morris C. Laster, MD, CEO of BioLineRx.
"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 2 small molecule for the treatment of Schizophrenia that will also be available for licensing following final Phase 2b data in Q3 2009. The Company has sufficient capital to fund its activities through the end of 2010, which is 4-5 quarters after achievement of key clinical milestones, allowing ample time to close a partnering deal," added Dr. Laster.
