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Opko Health Inc (OPK)

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Last Post: 10/23/2014 11:27:51 AM - Followers: 120 - 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: Statement of Changes in Beneficial Ownership (4) 10/23/2014 06:13:46 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/20/2014 06:07:06 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/17/2014 06:10:23 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/14/2014 09:37:33 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/14/2014 07:03:40 AM
#3001  Sticky Note OPKO Licensee TESARO Submits New Drug Application for Rolapitant dshade 09/09/14 10:03:26 AM
#2454  Sticky Note May 9, 2014, 10:17am EDT Myth 06/03/14 02:38:24 PM
#1096  Sticky Note OPKO Point-of-Care Technology Demonstrated on Mobile Device with lbman 03/03/13 07:11:22 AM
#3113   FLEMINGTON, N.J., Oct. 23, 2014 (GLOBE NEWSWIRE) -- tomsylver 10/23/14 11:27:51 AM
#3112 someconcerns 10/23/14 09:38:04 AM
#3111   Tom please don't take that post wrong..i am hogfan2 10/22/14 06:52:30 PM
#3110   OPKO Licensee Tesaro to Announce Third-Quarter 2014 Financial tomsylver 10/22/14 05:11:30 PM
#3109   Cancer Therapy Advisor On Rolapitant Post tomsylver 10/22/14 03:49:37 PM
#3108   Lol Lets have a look at the decision in november tomsylver 10/22/14 03:45:22 PM
#3107   That' funny. I agree with you :-) game7alcs 10/22/14 12:42:17 PM
#3106   I wish i knew what i just read... hogfan2 10/22/14 11:47:54 AM
#3105   Update: CPT®/HCPAC Annual Meeting on OPKO 4Kscore Post tomsylver 10/21/14 03:18:26 AM
#3104   Many catalysts in coming months. The fact that nolossray 10/19/14 12:26:22 PM
#3103   OPKO MAD MONEY LIGHTNING ROUND RECAP October 15, 2014 Mad tomsylver 10/16/14 11:19:16 PM
#3102   I agree with you but I still think game7alcs 10/16/14 10:28:31 AM
#3101   2014 ASCO Annual Meeting, 4KSCORE, Four Kallikrein Markers, tomsylver 10/16/14 01:18:52 AM
#3100   Right, Frost buys x0,000 shares a day, but tomsylver 10/15/14 11:46:31 PM
#3099   Well... first of all... don't think that Frost now invest 10/15/14 03:24:12 PM
#3098   CPT code news in November; NDA Filling for tomsylver 10/15/14 02:47:56 PM
#3097   What is expected to be the next positive game7alcs 10/15/14 12:31:27 PM
#3096   Between Friday... and Monday.... FROST... BOUGHT OVER $1.1 now invest 10/15/14 12:23:43 PM
#3095   He is a beast starbuxsux 10/14/14 03:41:05 PM
#3094   He just keeps buying...... $442,584 !! now invest 10/14/14 11:18:13 AM
#3093   nice chart move there dshade 10/13/14 12:10:03 PM
#3092   Opko October Key Events Calendar OPKO Health management to tomsylver 10/11/14 11:53:12 AM
#3091   MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK ( http://cts.businesswire.c tomsylver 10/09/14 04:23:43 PM
#3090   Neovasc, an OPKO Investee, Receives FDA Conditional Approval tomsylver 10/09/14 12:56:44 PM
#3089   Money is just the result of successfully doing Ag Boy 10/08/14 11:19:06 AM
#3088   The Oncology Report Rolapitant Categories : OPKO Health, Tesaro Rolapitant tomsylver 10/08/14 02:18:35 AM
#3087   OPKO Licensee TESARO Rated ‘BUY’ at Jefferies Jefferies Starts tomsylver 10/07/14 10:56:02 PM
#3086   When I'm 80 the last thing I'll care Myth 10/07/14 11:54:35 AM
#3085   Make money like he did when he was Ag Boy 10/07/14 11:53:03 AM
#3084   He sure does....then again what else is an Myth 10/07/14 11:40:51 AM
#3083   Frost definitely supports his company... hogfan2 10/06/14 11:04:51 AM
#3082   OPKO / Tesaro’s Rolapitant: Competition for Emend or tomsylver 10/04/14 05:15:19 PM
#3081   Guggenheim Starts Tesaro (TSRO) at Buy On October 2, tomsylver 10/03/14 04:25:18 PM
#3080   No, but if we get a form 4 someconcerns 10/02/14 10:51:09 AM
#3079   Anyone notice that 82,000 shares buy after hours ? Sone 10/01/14 05:53:02 PM
#3078   still dropping...... RED again... Myth 10/01/14 03:26:25 PM
#3077   Windsor Urology UK Endorses OPKO 4Kscore We provide expert tomsylver 09/30/14 11:06:26 PM
#3076   Mad Money, OPKO Health tomsylver 09/30/14 03:44:44 PM
#3075   OPKO Health Supports National Prostate Cancer Council Legislation tomsylver 09/29/14 11:40:19 AM
#3074   “The 4Kscore™ test, recently launched by OPKO Health, dshade 09/29/14 10:12:33 AM
#3073   MACD has crossed up along with RSI,chart setting East Texas 09/27/14 12:14:45 AM
#3072   CEO accelerated buying adding 60k more on the 24th dshade 09/26/14 08:34:31 AM
#3071   add when you can. OPK has a growing dshade 09/25/14 03:11:08 PM
#3070   I see that....bout time for a little bounce...I'm Myth 09/25/14 01:43:50 PM
#3069   Somebody's buying what he's selling today. Green game7alcs 09/25/14 01:36:45 PM
#3068   $OPK Oppenheimer Reiterates $12 dshade 09/25/14 09:14:01 AM
#3067   wise ET dshade 09/25/14 09:13:19 AM
#3066   Picked up 2400 more. East Texas 09/24/14 11:56:32 PM
#3065   I recall your experience and noted the import dshade 09/24/14 03:23:22 PM
#3064   This CPT code is extremely important for the DegenerateGambler 09/24/14 03:19:56 PM