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Opko Health Inc (OPK)

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Last Post: 4/23/2014 1:51:26 AM - Followers: 111 - Board type: Free - Posts Today: 1
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) 04/22/2014 04:43:17 PM
OPK News: OPKO Announces Presentation of Data on Long-Acting Oxyntomodulin at Diabetes Conference 04/22/2014 03:06:00 PM
OPK News: Statement of Changes in Beneficial Ownership (4) 04/22/2014 07:14:33 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 04/21/2014 06:50:30 AM
OPK News: Current Report Filing (8-k) 04/17/2014 03:48:52 PM
News News Alert: Current Report Filing (8-k) 04/22/2014 04:43:17 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
#2289   Your post reminds me of the MAD comic doglover1 04/23/14 01:51:26 AM
#2288   Good view... of REAL NEWS... as presented here.. now invest 04/22/14 10:38:39 PM
#2287   All systems go! Positive news and more Ag Boy 04/22/14 04:11:22 PM
#2286   so the pps will rise tomorrow ? Myth 04/22/14 04:08:46 PM
#2285   Far ... From it... Simply FACTS on ONE now invest 04/22/14 03:49:29 PM
#2284   fluff.....getting desperate now... Myth 04/22/14 03:46:29 PM
#2283   MORE good news!! FOR OPK!! now invest 04/22/14 03:44:10 PM
#2282   OPKO Announces Presentation of Data on Long-Acting Oxyntomodulin tomsylver 04/22/14 03:41:08 PM
#2280   Ah.... When the time is right!!! The now invest 04/22/14 03:32:08 PM
#2279   Red again, when is this bleeding going to Myth 04/22/14 03:25:08 PM
#2278   Add no worries. dshade 04/22/14 03:16:22 PM
#2277   Well.. concerns Frost.. ?? ah he now invest 04/22/14 02:18:18 PM
#2276   Was this written by a short or somebody game7alcs 04/22/14 11:59:58 AM
#2275   Does not look good.. JTORENCE 04/22/14 11:20:44 AM
#2274   DL1, Thanks for the response. OPK someconcerns 04/21/14 02:14:31 PM
#2273   Sports betting and stock market investing - two doglover1 04/21/14 02:00:14 PM
#2272   Doglover1, I am also long and have been since someconcerns 04/21/14 01:03:40 PM
#2271   Actually there is DD on horse betting - doglover1 04/21/14 12:36:23 PM
#2270   Up = 49%, Down = 49%, Unchanged = Ag Boy 04/21/14 12:15:19 PM
#2269   Please excuse that post. I'd got home from doglover1 04/21/14 10:18:54 AM
#2268   POOR dd..... Hmmm 1/3 chance being now invest 04/21/14 07:33:04 AM
#2267   Looking at it as a math projection: You doglover1 04/21/14 01:13:14 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