Biotech Values

[DewDiligence]

Opko Initiates Phase-3 Trial of Bevasiranib for AMD

[Bevasiranib is the drug OPK acquired in a reverse merger of a shell company with Acuity Pharma (#msg-18262352). In my opinion, the phase-2 results were mediocre (#msg-13224022) but OPK is nonetheless pressing ahead—Zebra’s Law may be at work. The phase-3 is a non-inferiority trial vs Lucentis in which Bevasiranib is dosed every 2-3 months vs every month for Lucentis, which strikes me as an especially high-risk design. This is the first RNAi drug in any indication to make it to phase-3.]

http://biz.yahoo.com/prnews/070711/nyw053.html?.v=98

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Wednesday July 11, 8:00 am ET

MIAMI, July 11 /PRNewswire-FirstCall/ -- Opko Health Inc. (Amex: OPK ) today announced the initiation of the Phase 3 COBALT (Combining Bevasiranib And Lucentis Therapy) clinical trial of bevasiranib for the treatment of wet age-related macular degeneration (wet AMD.) The multi-national COBALT study is currently open and enrolling patients. The 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.

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 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.

"This first-ever Phase 3 trial of an agent based on RNAi technology is an important milestone in this new field. We are proud of the ability demonstrated by our clinical group to have successfully moved this innovative compound through development rapidly and cost effectively," said Philip Frost, M.D., Chairman and CEO of Opko Health. "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."

"Bevasiranib's demonstrated safety profile, its ability to inhibit the growth of the retinal lesions associated with wet AMD and its potential for prolonged duration are a promising foundation for this pivotal trial," said Lawrence Singerman M.D., founder and Executive Secretary of the Macula Society, Clinical Professor of Ophthalmology at Case University and a Principal Investigator for the Phase 3 study. "Bevasiranib's potential to serve as a long-term maintenance therapy for wet AMD could provide important benefits to patients, and I look forward to helping to assess its utility in this groundbreaking study."

"We are very pleased at the enthusiastic reception the COBALT trial has received from retinal centers around the globe," said Denis O'Shaughnessy, Ph.D., Senior Vice President of Clinical Development at Opko. "Retinal physicians are keenly aware of the burden that frequent drug injections places on elderly patients and their families, and they are eager to help test an innovative new approach that has the potential to significantly reduce that burden while preserving patients' vision."

For more information about COBALT bevasiranib clinical sites currently open and enrolling patients, please visit www.opko.com/clinicaltrials

About Opko Health, Inc.

Miami-based Opko is a specialty healthcare company. Its lead investigational drug, the pioneering gene silencing agent bevasiranib, has entered a pivotal Phase 3 trial after successfully completing Phase 2 trials for wet age-related macular degeneration and macular degeneration. Opko is developing a preclinical pipeline of novel agents for ophthalmic diseases, and it also intends to market diagnostic systems that complement its therapeutic products. The company recently announced it has entered into an agreement to acquire Ophthalmic Technologies, Inc. (OTI), a provider of innovative patient imaging systems to eye care professionals worldwide.
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