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Opko Health Inc (OPK)

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Last Post: 11/21/2014 12:21:56 AM - Followers: 121 - 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) 11/21/2014 09:22:08 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/20/2014 09:31:29 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/18/2014 06:51:55 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/17/2014 07:15:35 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/17/2014 07:13:34 AM
PostSubject
#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
#3151   Frost is buying 10, 20, 30 thousand shares hogfan2 11/21/14 12:21:56 AM
#3150   OPK CEO keeps buying, at this pace he stonsetr 11/20/14 07:55:56 PM
#3149   University of Birmingham Receives Grant from Wellcome Trust tomsylver 11/20/14 02:30:09 PM
#3148   Jefferies 2014 Global Healthcare Conference on Wednesday, November tomsylver 11/20/14 03:48:40 AM
#3146   Dr. Crawford Highlighted Two New Tests On When tomsylver 11/16/14 02:08:31 AM
#3145   Biotech Investors Bullish On Large Cap; Citi Adds tomsylver 11/15/14 02:27:08 AM
#3144   Cocrystal Pharma Reports Third Quarter Financial Results and tomsylver 11/14/14 11:44:46 AM
#3143   OPKO Renal ASN Kidney Week 2014 Detailed Data tomsylver 11/13/14 11:23:10 PM
#3142   OPKO Strategic Investment> RXI Pharmaceuticals Third Quarter of tomsylver 11/13/14 02:44:44 PM
#3141   OPKO Health to Present at the Jefferies 2014 tomsylver 11/13/14 11:05:32 AM
#3140   OPKO (CTAP101) Phase 1 Study For Breast/Prostate Cancer tomsylver 11/13/14 01:37:20 AM
#3139   OPKO Licensee TESARO Jefferies 2014 Global Healthcare Conference TESARO tomsylver 11/12/14 11:16:06 PM
#3138   $OPK Oppenheimer Reiterates Outperform On Opko Health Following maytepper 11/12/14 11:56:59 AM
#3137   Conferences & Events Monday, November 10, 2014, 8:30 a.m. tomsylver 11/10/14 11:28:30 PM
#3136   OPKO Announces Publication of Large, Prospective, Multi-Institutional Clinical tomsylver 11/10/14 09:56:36 AM
#3135   Neovasc, an OPKO Investee, Receives FDA Conditional Approval tomsylver 11/10/14 03:37:38 AM
#3134   Spain Salamanca24horas News OPKO 4Kscore The new test for tomsylver 11/09/14 10:40:44 PM
#3133   Phillip Frost seeks SciGen reverse merger The Opko Health tomsylver 11/09/14 04:34:28 PM
#3132   Thanks fur the full script. I just saw game7alcs 11/09/14 03:09:48 PM
#3131   CNBC Nov 7, 2014 5:40 PM Mad Money w/Jim tomsylver 11/08/14 05:16:10 PM
#3130   Cramer's lightning round game7alcs 11/07/14 08:11:07 PM
#3129   OPK STOCK i am putting on watch here stockchaser64 11/07/14 06:51:58 PM
#3128   OPKO To Hold Conference Call on November 10, 2014 tomsylver 11/07/14 03:42:32 PM
#3127   This has been a 2015/2016 play as far game7alcs 11/07/14 09:19:14 AM
#3126   OPKO Announces Third Quarter Operating and Financial Results Rayaldee™ game7alcs 11/07/14 09:15:53 AM
#3125   Q is out Sone 11/07/14 08:47:26 AM
#3124   Hog, i'm long in opk since seven years. tomsylver 11/07/14 02:15:46 AM
#3123   Rolapitant NDA accepted On November 4, 2014 the Company’s tomsylver 11/07/14 01:53:55 AM
#3122   tom...i really appreciate the dd you do here...do hogfan2 11/06/14 08:24:57 AM
#3121   TESARO Announces Third-Quarter 2014 Operating Results ( http://ir.tesarobio.com/ tomsylver 11/06/14 01:19:36 AM
#3120   4KSCORE, Diario Medico, opko health https://opkodd.files.wordpress.com/2014/11/ tomsylver 11/05/14 11:15:42 PM
#3119   Now available in Spain 4Kscore®, new screening test tomsylver 11/05/14 11:10:39 PM
#3118   DSG and OPKO Health Enter into Enterprise Licensing tomsylver 11/05/14 01:31:20 AM
#3117   im not betting against him...im sure he's not hogfan2 11/04/14 03:41:22 AM
#3116   Frost is an old billionaire....he's almost 80 with Myth 11/03/14 10:16:29 AM
#3115   Arno Therapeutics Advances Phase I Trial Evaluating Onapristone tomsylver 10/27/14 11:27:15 AM
#3114   RXII patent application 10/24/2014 09:24:58 AM ED Alexandria, Oct. tomsylver 10/24/14 03:22:50 PM
#3113   FLEMINGTON, N.J., Oct. 23, 2014 (GLOBE NEWSWIRE) -- tomsylver 10/23/14 11:27:51 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
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