VIA Pharmaceuticals, a biotechnology company focused on the development of compounds for the treatment of cardiovascular disease, said the independent Data Safety Monitoring Board (DSMB) for its VIA-2291 phase II clinical trial programme recently met to review patient safety for its current phase II studies. The DSMB observed a continued acceptable safety profile of VIA-2291 and recommended VIA continue its ongoing trials as planned.
"We are encouraged by the continued positive safety profile of VIA-2291 as we enrol more patients in our phase II clinical programme," said Adeoye Olukotun, M.D., chief medical officer, VIA Pharmaceuticals. "We believe that a drug that reduces inflammation, an underlying cause of atherosclerosis and complications including heart attack and stroke, would help to address a significant unmet medical need."
VIA recently announced enrolment completion of its phase II carotid endarterectomy (CEA) trial and expects to present top-line results in the third quarter of 2008. Enrolment is also nearing completion for the company's acute coronary syndrome (ACS) phase II trial and data is expected to follow soon after the CEA data. Patient enrolment continues in the FDG-PET study, the company's third phase II clinical trial.
"With the recent completion of our CEA trial enrolment, and this positive DSMB recommendation, we continue to make significant progress with our phase II clinical programme, and remain on track to deliver our first proof of concept data later this year," said Lawrence K. Cohen, Ph.D., chief executive officer, VIA Pharmaceuticals.
VIA-2291 is a selective and reversible inhibitor of 5-LO, which is believed to be a key enzyme in the biosynthesis of leukotrienes (important mediators of inflammation involved in the development and progression of atherosclerosis). Potentially a complement to current standard of care therapies that treat risk factors, such as statins, antiplatelet and blood pressure medications, VIA-2291 is initially targeted to address the secondary prevention market for patients who have already suffered a major adverse cardiac event, but eventually could be beneficial to the broader 15.8 million patients in the US who have coronary artery disease. VIA have exclusive worldwide rights to develop and commercialise VIA-2291. Based upon prior trials of VIA-2291 in more than 1,100 patients, VIA believes that VIA-2291 will be safe and well tolerated in doses currently being administered in the ongoing clinical trials.