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Opko Health Inc (OPK)

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Last Post: 8/31/2014 6:36:04 PM - Followers: 116 - 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) 08/29/2014 07:11:57 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/28/2014 07:15:52 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/25/2014 11:31:48 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/22/2014 07:52:47 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/21/2014 09:07:09 AM
PostSubject
#2474  Sticky Note May 22, 2014 OPKO Completes Acquisition of Inspiro dshade 06/04/14 10:29:14 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
#2957   OPKO Health/Tesaro Rolapitant NDA On Track September 2014 tomsylver 08/31/14 06:36:04 PM
#2956   Art Cashin, Nasdaq, shortAnalytics.com, Squawk on the Street Categories tomsylver 08/31/14 06:26:14 PM
#2955   Bloomberg Radio Interview, opko health, Phillip Frost Categories : tomsylver 08/31/14 05:05:10 PM
#2954   OPKO Strategic Investment Tesaro New Frontiers in the tomsylver 08/30/14 11:42:42 AM
#2953   OPKO Strategic Investment Senesco Technologies 8/29/2014 Senesco Closes Enroll tomsylver 08/30/14 04:53:10 AM
#2952   DS, From an old May 2013 article on Prolor, someconcerns 08/29/14 04:11:30 PM
#2951   Not just the one hormone. Prolor also someconcerns 08/29/14 10:49:09 AM
#2950   Their ProLar Biotech hormone is a multi billion dshade 08/29/14 09:27:43 AM
#2949   I think, if only Reyaldee starts up, the tomsylver 08/29/14 09:24:19 AM
#2948   He knows this will be sold for $40-$50 dshade 08/29/14 09:06:44 AM
#2947   Frost will be 80 years old and still Ag Boy 08/29/14 09:04:35 AM
#2946   "Rayaldy is currently the only product of its dshade 08/29/14 08:27:27 AM
#2945   CTAP101 (Rayaldee) Categories : OPKO Health, Prolor Biotech Rayaldee™ Capsules tomsylver 08/29/14 05:29:34 AM
#2944   lol. green from buys this AM again. dshade 08/28/14 04:11:23 PM
#2943   RED again....this thing just can't get any traction.. Myth 08/28/14 04:08:04 PM
#2942   Dr. Phillip Frost Leads Investment in Drone Aviation Ag Boy 08/28/14 01:19:10 PM
#2941   bad link dshade 08/28/14 10:39:53 AM
#2940   Dr Frost in the news Ag Boy 08/28/14 10:31:02 AM
#2939   Thanks. That is a good link. dshade 08/28/14 08:23:26 AM
#2938   Opko 4Kscore™ Test Physician Location This is a listing tomsylver 08/28/14 06:29:29 AM
#2937   opko health, Phillip Frost Interviews, W MEDICAL STRATEGY tomsylver 08/28/14 06:06:55 AM
#2936   4Kscore Test Case Studies The 4Kscore™ Test Correctly Identifies tomsylver 08/27/14 09:11:25 AM
#2935   Frost buys... $272,965 more OPK !! now invest 08/26/14 09:31:26 AM
#2934   THANKS for posting such good information... As now invest 08/25/14 12:11:58 PM
#2933   OPKO Diagnostics Sony DADC Case Study URL tomsylver 08/25/14 08:32:05 AM
#2930   Perhaps if you read you'd understand what's going md84 08/24/14 01:59:51 PM
#2929   almost at strike point. thiiisss close dshade 08/22/14 02:33:31 PM
#2927   Well with these last couple of buys... he now invest 08/22/14 10:26:30 AM
#2926   he's trying to keep up with me.. dshade 08/22/14 09:57:02 AM
#2925   Over $500K of stock in two days!! now invest 08/22/14 09:55:32 AM
#2924   Broward Urology Center Offers OPKO 4Kscore URL tomsylver 08/21/14 11:42:18 PM
#2923   Yea it's only a matter of time. I game7alcs 08/21/14 07:17:34 PM
#2922   Let "Dip" have a little honey. He Ag Boy 08/21/14 07:14:01 PM
#2921   Buy the dips I agree. Not talking about game7alcs 08/21/14 05:14:22 PM
#2920   see post #2914 - that's how/when to buy dshade 08/21/14 04:19:10 PM
#2919   falling down again.....must be another bear raid, or Myth 08/21/14 03:06:27 PM
#2918   His buy from Yesterday... $311,853 !!! now invest 08/21/14 10:48:12 AM
#2917   Dr. Frost buying opk every day.... bulldurham 08/21/14 10:43:10 AM
#2916   Can someone explain " statement of changes in Runner1 08/21/14 10:17:11 AM
#2915   time to add soon dshade 08/21/14 08:42:08 AM
#2914   You should read this conversation. It's pretty spot on. md84 08/19/14 10:20:01 AM
#2913   The stock has amazing potential not including the investing102 08/18/14 04:30:52 PM
#2912   but probably not here dshade 08/18/14 11:06:54 AM
#2911   margin is VERY dangerous... Myth 08/18/14 10:55:38 AM
#2910   you're welcome. lol dshade 08/18/14 09:48:49 AM
#2909   "If the long call specs would just buy md84 08/18/14 09:39:06 AM
#2908   Thanks... diannedawn 08/18/14 09:35:59 AM
#2906   I ran across this ticker quite awhile ago, diannedawn 08/18/14 09:14:41 AM
#2905   I don't care.....about that useless DD now invest 08/18/14 12:02:38 AM
#2904   This is a good post. md84 08/17/14 07:23:41 PM
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