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Opko Health Inc (OPK)

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Last Post: 9/16/2014 10:01:06 AM - Followers: 117 - Board type: Free - Posts Today: 2
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) 06:31 AM
OPK News: OPKO Launches the 4Kscore Test in Europe 09/15/2014 09:13:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 09/15/2014 06:19:22 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 09/12/2014 06:43:16 AM
OPK News: Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to be Presented as a Late Brea... 09/11/2014 09:00:00 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 09/16/2014 06:31:22 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
#3027   His buying is great. I think it's time game7alcs 09/16/14 10:01:06 AM
#3026   Frost.... Still at it.. BUYING... now invest 09/16/14 09:42:49 AM
#3025   Great news...AGAIN dshade 09/15/14 10:17:39 AM
#3024   OPKO Launches the 4Kscore Test in Europe MIAMI--(BUSINESS WIRE)-- tomsylver 09/15/14 10:04:21 AM
#3022   I'm liking the RED. It's allowing me to game7alcs 09/12/14 06:55:02 PM
#3021   OPKO is up 110%. stupid to say he dshade 09/12/14 10:27:14 AM
#3019   He is going to make A LOT of dshade 09/12/14 10:25:24 AM
#3018   yes, the billionaire can afford to lose money... Myth 09/12/14 09:47:39 AM
#3017   yeah, real good... .RED is the dominant color here Myth 09/12/14 09:45:55 AM
#3016   Article ... on how the chart looks.... GOOD!! now invest 09/12/14 09:33:38 AM
#3015   4Kscore in “Review of Predictive/Prognostic Biomarkers in Prostate tomsylver 09/12/14 02:06:41 AM
#3014   That, along with the rest of that platform someconcerns 09/11/14 05:37:56 PM
#3013   nice add spots early this afternoon dshade 09/11/14 04:03:37 PM
#3012   if it helps better people's health, shorts love dshade 09/11/14 10:52:37 AM
#3011   just 1 product of many with $bil market dshade 09/11/14 10:01:31 AM
#3010   Market Size about $3.5 BN tomsylver 09/11/14 09:56:55 AM
#3009   That hormone alone will help many children dshade 09/11/14 09:15:36 AM
#3008   That is the ProLar Biotech merger showing it's results! dshade 09/11/14 09:13:15 AM
#3007   Major update! Data Supporting Once-Weekly Dosing of hGH-CTP dshade 09/11/14 09:12:21 AM
#3006   Prostate Health PCEC Gets The Word Out On tomsylver 09/10/14 11:04:19 PM
#3005   I don't think a merger'll come soon (in tomsylver 09/10/14 03:27:59 PM
#3004   I don't think a merger'll come sone(in the tomsylver 09/10/14 03:23:34 PM
#3003   me too, today, well not quite as much dshade 09/10/14 01:56:36 PM
#3002   Another $305,129 buy yesterday by FROST!! now invest 09/10/14 09:41:34 AM
#3001   OPKO Licensee TESARO Submits New Drug Application for Rolapitant dshade 09/09/14 10:03:26 AM
#3000 dshade 09/09/14 10:02:21 AM
#2999   RXII in which OPK has an investment is now invest 09/09/14 09:59:08 AM
#2998   good. merger and takeover path cleared when the dshade 09/09/14 09:37:26 AM
#2997   If you add shares and options of the tomsylver 09/09/14 09:23:05 AM
#2996   By next year, insiders will have 50.1% I believe dshade 09/09/14 08:50:08 AM
#2995   He & Frost Foundation have nearly 150,000,000 OPK shares dshade 09/09/14 08:48:07 AM
#2994   Frost bought another 150,000 shares last week dshade 09/09/14 08:44:27 AM
#2993   Yes one can see that, but it doesn't specular 09/08/14 02:42:09 PM
#2992   Here is the kind of money OPK can get!! now invest 09/08/14 01:02:09 PM
#2991   OPKO Licensee TESARO Submits New Drug Application for now invest 09/08/14 12:56:53 PM
#2989   ESMO 2014 Congress, opko health, Rolapitant, tesaro http://opkodd.files.wordpre tomsylver 09/07/14 05:20:31 PM
#2988   4Kscore, OPKO Health T tomsylver 09/06/14 03:56:15 PM
#2987   2014 AUA Annual Meeting, 4Kscore, OPKO Health, Video New tomsylver 09/06/14 02:13:39 PM
#2986   The phase IIa trial'll start in the end tomsylver 09/06/14 05:15:43 AM
#2985   Look in the post: Under terms of the license tomsylver 09/05/14 05:21:07 PM
#2984   close above 8.50 and makes trip bottom dshade 09/05/14 03:34:33 PM
#2983   Does OPK get a milestone payment with the specular 09/05/14 03:21:13 PM
#2982   OPKO - Factor VIIa-CTP already obtained orphan status dshade 09/05/14 11:16:50 AM
#2981   they will have 3 multi $billion products out dshade 09/05/14 10:38:50 AM
#2980   Frost added $301,116 worth of shares yesterday... now invest 09/05/14 10:36:21 AM
#2979   maybe we can get it all today? all dshade 09/05/14 10:21:18 AM
#2978   yep. Frost is making bigger buys on this dip dshade 09/05/14 10:09:53 AM
#2977   almost ready for the big buy just like May/June dshade 09/05/14 10:03:53 AM
#2976   never happen....I see RED again....I guess the shorts Myth 09/05/14 09:42:14 AM
#2975   opko health, Rolapitant, tesaro TESARO Baird's 2014 Health Care tomsylver 09/04/14 11:28:37 PM