Opko Doses First Patient In Phase 3 COBALT Trial Of Bevasiranib For AMD Treatment

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Opko Health announced first patient enrollment in the Phase 3 COBALT (Combining Bevasiranib And Lucentis Therapy) clinical trial of bevasiranib for the treatment of wet age-related macular degeneration (wet AMD).

COBALT Trial Of Bevasiranib

The multi- national trial will include more than 330 wet AMD patients and will assess whether bevasiranib administered every 8 or 12 weeks is safe and has equivalent efficacy in preventing vision loss as Genentech's Lucentis administered every four weeks.

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Bevasiranib is a first-in-class small interfering RNA (siRNA) drug designed to silence the genes that produce vascular endothelial growth factor (VEGF), believed to be largely responsible for the growth of the abnormal and leaky blood vessels that result in the vision loss of wet AMD. Bevasiranib is the first therapy based on the Nobel Prize-winning RNA interference (RNAi) technology to advance to Phase 3 clinical trials. Currently patients with wet AMD undergo intravitreal injections every four weeks to achieve the vision- preserving benefits of Lucentis, so the potential ability of bevasiranib to achieve similar results while requiring less frequent injections would be an important benefit for these patients who often have limited mobility.

"We believe initiation of patient dosing in the COBALT trial is significant both because it is the first-ever Phase 3 trial of an agent based on RNAi gene silencing technology and because the growing population of older people at risk of vision loss from AMD requires therapeutic options that are effective, safe and convenient," said Phillip Frost, M.D., Chairman and CEO of Opko Health. "Our clinical group has already demonstrated its ability to conduct high quality clinical trials rapidly and cost effectively, and we look forward to continued good progress now that patient dosing is underway."

Wet age-related macular degeneration is the leading cause of irreversible vision loss in the developed world and its incidence is growing rapidly. Advanced age is the main risk factor for wet AMD, and it is expected to become an increasingly common condition as the population grows older. An estimated 1.65 million Americans have wet AMD today and an estimated 11 million people worldwide will have AMD by 2013. Until recently, treatments for wet AMD were of limited efficacy.

In the search for more effective treatments, researchers targeted VEGF, shown to be a key cause of the excess growth of abnormal and leaky ocular blood vessels that result in loss of vision in these patients. Current VEGF antagonists, such as Lucentis, slow this vision loss, but require injections into the eye every four weeks, a particular issue for elderly patients who often have limited mobility.

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