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Opko Health Inc (OPK)

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Last Post: 2/21/2017 2:10:15 AM - Followers: 163 - 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: Statement of Changes in Beneficial Ownership (4) 02/17/2017 07:34:31 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 02/16/2017 06:26:43 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 02/15/2017 08:42:46 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 02/14/2017 07:21:47 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 02/13/2017 07:28:16 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#5151   Not all cases of prostate cancer need surgery. tomsylver 02/21/17 02:10:15 AM
#5150   I agree completely. game7alcs 02/10/17 05:47:10 PM
#5149   Over the last 10 years , I have Sky10 02/10/17 05:45:58 PM
#5148   Listen...? I don't know if this was a game7alcs 02/10/17 10:39:45 AM
#5147   Listen... I think the shorts will continue to now invest 02/09/17 12:40:26 PM
#5146   Hgh-ctp not high Cyprus lol auto correct on cell game7alcs 02/08/17 03:39:43 PM
#5145   OPKO has 1.2 bln in revs right now game7alcs 02/08/17 03:29:47 PM
#5144   Market hates us they will never free us Sone 02/08/17 03:23:53 PM
#5143   Short term yes. Long term I disagree. game7alcs 02/08/17 03:19:08 PM
#5142   This is officially a turd. Sone 02/08/17 09:49:02 AM
#5141   I project we'll be mid 7's before earnings seppi08162 02/08/17 09:47:15 AM
#5140   Excellent entry point! game7alcs 02/07/17 04:29:20 PM
#5139   In at 8.28 NathanH 02/07/17 03:28:36 PM
#5138   I thought yah might find it interesting since mrfence 02/02/17 10:58:49 PM
#5137   Interesting. Thanks for the article. It's amazing the game7alcs 02/02/17 10:17:17 PM
#5136   purcell julie & lefkowitz llp now under investigation... mrfence 02/02/17 01:47:16 PM
#5135   Thanks for posting... now invest 02/02/17 10:48:26 AM
#5134 tomsylver 02/01/17 04:15:25 AM
#5133   Some train wrecks occur, some are just a DegenerateGambler 01/25/17 08:43:41 PM
#5132   This is a train wreck..... Myth 01/24/17 12:55:08 PM
#5131   that's were I started also.... and I now invest 01/24/17 11:02:33 AM
#5130   I was first in opko at 4.50-5.0 range tredenwater2 01/23/17 03:30:20 PM
#5128   I mentioned I have been in OPK at now invest 01/20/17 05:39:57 PM
#5127   I am a LOOOOONG time holder here terry hallinan 01/20/17 11:45:31 AM
#5126   Also long. seppi08162 01/20/17 11:14:06 AM
#5125   I am a LOOOOONG time holder here... However now invest 01/20/17 10:31:09 AM
#5124   Reload time on bear raid games. dshade 01/19/17 12:13:40 PM
#5123   A $4.8 bil market cap is awful low game7alcs 01/19/17 11:20:33 AM
#5122   How low will it go.. Sone 01/19/17 10:07:24 AM
#5121   Dr Frost was a buyer at yesterdays prices, Sasquatch81 01/19/17 09:08:44 AM
#5120   This is becoming exhausting seppi08162 01/18/17 01:16:24 PM
#5119   This doesn't seem to have a bottom. pauljon4 01/17/17 03:06:04 PM
#5118   Bottom is in. JTrader 01/13/17 10:12:15 AM
#5117   TESARO Receives Complete Response Letter for Rolapitant IV tomsylver 01/12/17 04:15:30 AM
#5116   Nice presentation. I see they skirted around the game7alcs 01/11/17 11:18:56 AM
#5115   Jan 11, 2017 J.P. Morgan 35th Annual Healthcare joe_techi 01/11/17 10:18:50 AM
#5114   Agreed. Despite all of OPKO's repeated, amateur errors seppi08162 01/07/17 08:56:51 AM
#5113   Frost has bought at least three times since now invest 01/06/17 11:10:47 AM
#5112   Thanks now invest 01/05/17 11:28:57 PM
#5111   try this. I saw it in my account game7alcs 01/05/17 09:32:40 PM
#5110   Have a link.... missed that one now invest 01/05/17 09:01:04 AM
#5109   Opko would be meeting with the FDA in game7alcs 01/04/17 08:41:10 PM
#5108   It was a no brained here. I've been JTrader 01/04/17 09:52:38 AM
#5107   Ah... Just had to add... just a couple now invest 01/03/17 09:53:37 AM
#5106   Frost and Rubin bought on Friday!! now invest 01/03/17 08:30:25 AM
#5105   $8's!!! PM Sone 01/03/17 07:18:14 AM
#5104   I could not agree more- folks in the seppi08162 01/02/17 09:04:01 PM
#5103   I agree with the statement that the smart game7alcs 01/02/17 01:23:43 PM
#5102   In the past ...he has stopped several times now invest 12/31/16 12:08:18 PM
#5101   No sure him not buying this month is Fangster 12/30/16 11:17:13 PM