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Opko Health Inc (OPK)

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Last Post: 4/17/2014 2:14:22 PM - Followers: 111 - Board type: Free - Posts Today: 0
Opko Health Initiates Phase 3 Trial of Bevasiranib for the Treatment of AMD Wednesday July 11, 8:00 am ET -Trial Designed to Compare Efficacy of Bevasiranib Administered Every 8 Weeks or 12 Weeks with Lucentis(R) Administered Every 4 Weeks- -Represents First-Ever Phase 3 Pivotal Trial of an RNAi Therapeutic- MIAMI, July 11 /PRNewswire-FirstCall/ -- Opko Health Inc. (Amex: OPK - News) 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. ADVERTISEMENT 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." About Wet AMD 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 and leakiness of 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. Opko Health, Inc. Announces Early Termination of Hart-Scott-Rodino Waiting Period for Proposed Purchase of Shares by Dr. Phillip Frost Thursday July 12, 8:00 am ET MIAMI July 12 /PRNewswire-FirstCall/ -- Opko Health Inc. (Amex: OPK - News) today announced that that the U.S. Department of Justice has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the potential acquisition of additional shares of Opko Health common stock by Dr. Phillip Frost, CEO and Chairman of Opko. Dr. Frost has requested clearance to purchase additional shares of Opko Health common stock, which this action by the Justice Department now makes feasible.
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OPK News: Current Report Filing (8-k) 04/17/2014 03:48:52 PM
OPK News: OPKO Acquires Next Generation Dry Powder Inhaler to Treat Respiratory Disorders 04/17/2014 11:22:00 AM
OPK News: OPKO Health Announces Executive Appointments 04/01/2014 09:25:00 AM
OPK News: Biotech Equities Technical Study -- Research on Prana Biotechnology, Amarin, United Therapeutic, and OPKO Health 03/28/2014 12:19:00 PM
OPK News: American Urological Association (AUA) Accepts 4Kscore Test Clinical Study for Plenary Presentation at 2014 Annual Meeting 03/25/2014 12:18:00 PM
#2048  Sticky Note OK Read this,opk will rise again. Recognizer 02/24/14 09:34:30 AM
#1531  Sticky Note OPKO Commences Pivotal Clinical Validation Study for 4Kscore(TM) Sone 11/04/13 09:00:42 AM
#1096  Sticky Note OPKO Point-of-Care Technology Demonstrated on Mobile Device with lbman 03/03/13 07:11:22 AM
#2266   added a little today.... I think in now invest 04/17/14 02:14:22 PM
#2265   OPKO Acquires Next Generation Dry Powder Inhaler to tomsylver 04/17/14 12:06:26 PM
#2264   News out! Sone 04/17/14 11:24:34 AM
#2263   Smart. Lines crossed. Expecting this to rise now. md84 04/16/14 01:39:59 PM
#2262   I did also..... now invest 04/16/14 06:26:10 AM
#2261   Eh... just another game of chess for Frost. md84 04/15/14 01:11:39 PM
#2260   Adding here :) Fossil-Fuel 04/15/14 10:21:52 AM
#2259   This is why MM's were scared and sabotaging. md84 04/14/14 03:12:01 PM
#2258   Time to load up! Good luck to all tomsylver 04/14/14 02:31:01 PM
#2256   Thanks. Anyways, CEO continues buying shares again. dshade 04/12/14 10:26:07 AM
#2255 Not bullish to say the least.... Tmguns 04/12/14 07:07:43 AM
#2254   you boyz got big ballz to be buying Tmguns 04/12/14 06:08:49 AM
#2253   bet someone added BIG today near end... dshade 04/11/14 04:03:27 PM
#2252   Have an order in to add.... so let now invest 04/10/14 02:09:46 PM
#2251   Regardless, chart is setting up bullish with these md84 04/10/14 12:25:21 PM
#2250   I'm getting motion sickness! Lol Sone 04/10/14 11:22:56 AM
#2249   Thanks, I read over the 10k, it's obvious Myth 04/10/14 09:43:29 AM
#2248   My understanding of it is that you have Ag Boy 04/10/14 09:27:03 AM
#2247   I think you mean they have to " Myth 04/10/14 08:18:52 AM
#2246   1.7 million shares traded and the price for Ag Boy 04/10/14 08:09:46 AM
#2245   what do you mean " up " ? Myth 04/10/14 08:00:09 AM
#2244   1.7 million shares up today. Shorts Beware! Ag Boy 04/09/14 06:35:06 PM
#2243   due due deligence Ag Boy 04/09/14 04:43:37 PM
#2242   you are missing the fine print. thanks anyways. dshade 04/09/14 10:35:29 AM
#2241   Yes happened in Aug 2013 what about 120 ID Supermoney 04/09/14 10:33:43 AM
#2240   you need to DD the PBTH merger details...take care. dshade 04/09/14 10:29:49 AM
#2239   So WHAT mergers came between Dec 31, 2013 ID Supermoney 04/09/14 10:26:59 AM
#2238   lol. you ignore the 2 huge mergers, but thanks dshade 04/09/14 10:20:37 AM
#2237   Dec 31 2012 price 4.81........ Yesterday...... $9.50!!! now invest 04/09/14 07:26:08 AM
#2235   He better buy another $1 billion his percentage ID Supermoney 04/09/14 03:11:54 AM
#2234   Haha June and September . No more mistakes lol spay 04/08/14 01:06:47 PM
#2233   July and September not August. Typo spay 04/08/14 01:05:22 PM
#2232   Anyone have an idea why someone keeps straddling spay 04/08/14 01:03:45 PM
#2231   Shorts to get squeezed. Green is the future dshade 04/08/14 09:46:58 AM
#2230   Ah... INSIDER FROST.... A BUYER AGAIN... $261,618!!!! now invest 04/08/14 09:46:21 AM
#2229   Ah nice UP day!!! Many people know of now invest 04/07/14 08:35:29 PM
#2228   Up again for Frost at the close! Ag Boy 04/07/14 05:46:51 PM
#2226   the stock is dropping, Frost can't hold it Myth 04/07/14 03:16:08 PM
#2225   Frost... is just such a good CEO who now invest 04/07/14 02:35:38 PM
#2224  Restored Frost bought 1.2 bill in stock ? Myth 04/07/14 10:07:54 AM
#2223   Frost ADDS ANOTHER $247,547 worth of stock now invest 04/07/14 09:48:54 AM
#2222  Restored Frost bought 1.2 bill in stock ? Myth 04/06/14 05:44:16 PM
#2221   CEO will own over 140 million shares by dshade 04/06/14 03:29:58 PM
#2220   Those extra shares involved 2 mergers PBTH being dshade 04/06/14 03:25:13 PM
#2219   So... Is the conclusion... that Frost is an now invest 04/04/14 10:40:45 PM
#2218   Explanation WHY this continues to trade side ways1!! ID Supermoney 04/04/14 09:41:21 PM
#2217   Lol. Short nonsense. L and his minions will dshade 04/04/14 05:41:00 PM
#2216   longs sell and shorts buy.....also Ag Boy 04/04/14 04:47:52 PM
#2215   I doubt it's heading that low. We'll see Blown Income 04/04/14 04:21:05 PM
#2214   that's because smart money knows it was overbought... Myth 04/04/14 04:16:40 PM