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Opko Health Inc (OPK)

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Last Post: 11/25/2015 2:24:19 PM - Followers: 151 - 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: How Big Could This Drug Be for Opko Health? 08:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 07:04 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/23/2015 07:37:14 AM
OPK News: Opko Health's New Era Begins 11/21/2015 07:02:03 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/20/2015 06:57:34 AM
News News Alert: How Big Could This Drug Be for Opko Health? 11/25/2015 08:00:07 AM
#3864  Sticky Note I added a discussion on PSA tests because stargazer123 06/20/15 12:58:21 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#4327   Good Classification Model as a Whole Reveals Preliminary WiseFool 11/25/15 02:24:19 PM
#4326   Varubi could be a solid eight-figure revenue generator tomsylver 11/25/15 09:26:00 AM
#4325   DR. DAVID SAMADI: ‘NEW BLOOD TESTS BEING DEVELOPED WiseFool 11/24/15 03:55:18 PM
#4324   :-D Cbdpotential 11/23/15 03:59:18 PM
#4323   Go $opk ! Cbdpotential 11/23/15 11:18:37 AM
#4322   Added 10.85 Cbdpotential 11/23/15 09:51:33 AM
#4321 tomsylver 11/21/15 08:35:27 AM
#4320   FORBES: “The cash register is ringing at OPKO tomsylver 11/21/15 06:26:05 AM
#4319   g CNBC jt. Vywdw makapia 11/20/15 01:56:35 PM
#4318   Yeah I think what got my attention with makapia 11/20/15 01:49:49 PM
#4317   My projections may be conservative or as you DegenerateGambler 11/19/15 10:08:04 PM
#4316   Once revs start kicking in from 4k, Rolapitant, game7alcs 11/19/15 11:38:10 AM
#4315   I believe the high for this yr was makapia 11/18/15 09:46:11 PM
#4314   IMO, the share price should not fall back DegenerateGambler 11/18/15 06:36:34 PM
#4313   Have not forgotten you ;-) Cbdpotential 11/18/15 02:17:10 PM
#4312   OPK..Cocrystal Pharma Announces Filing Its Quarterly.. junewong 11/17/15 09:28:12 PM
#4311   OPKO Health to Present at the Jefferies Autumn tomsylver 11/17/15 01:05:04 PM
#4310   TESARO ANNOUNCES THE LAUNCH OF VARUBI™ (ROLAPITANT) IN tomsylver 11/16/15 09:56:34 AM
#4309   TESARO ANNOUNCES THE LAUNCH OF VARUBI™ (ROLAPITANT) IN tomsylver 11/16/15 09:55:01 AM
#4307   OPK daily trading on top BB. Watch 15/30min soybanzai 11/12/15 02:12:50 PM
#4306   I know this was something very important to surgeon_general 11/12/15 01:18:08 PM
#4305   OPK... got their number for 4k... see news now invest 11/12/15 10:08:31 AM
#4304   Hopefully.. we will break 11.00 today... now invest 11/11/15 09:58:00 AM
#4303   Love it Cbdpotential 11/10/15 10:33:17 AM
#4302   Earnings look GREAT, chart looks READY! stonsetr 11/10/15 09:38:22 AM
#4301   Where's this close today? Picks77 11/10/15 08:22:36 AM
#4300   shorts will BURN... Matrix999 11/10/15 07:54:32 AM
#4299   Transcript Q3 Anne Marie Fields - LHA, Investor tomsylver 11/10/15 03:50:28 AM
#4298   Some.... but the point I got... is now invest 11/09/15 07:30:27 PM
#4297   I am going to listen to the call game7alcs 11/09/15 07:07:25 PM
#4296   All... I can say about the earnings... is now invest 11/09/15 06:50:27 PM
#4295   OPKO Health (NYSE:OPK): Q3 EPS of $0.25 may game7alcs 11/09/15 05:10:25 PM
#4294   OPKO Announces Third Quarter Financial and Operating Results surgeon_general 11/09/15 04:22:54 PM
#4293   OPK looking good UHD 11/09/15 08:49:00 AM
#4292   Earnings after the close on Monday the 9th... now invest 11/06/15 01:20:40 PM
#4291   OPKO Health Refinances Bio-Reference Laboratories Credit Facility OPKO game7alcs 11/06/15 12:51:12 PM
#4290   This is a nice article. I think starting game7alcs 11/06/15 12:49:24 PM
#4289   Nice article below... And I now invest 11/05/15 10:09:09 AM
#4288   Etrade shows earnings were to be reported before Picks77 11/05/15 09:49:51 AM
#4287   Additional Phase 3 Data Supporting OPKO's Rayaldee as tomsylver 11/05/15 08:58:40 AM
#4286   dditional Phase 3 Data Supporting OPKO’s Rayaldee as Sone 11/05/15 08:44:27 AM
#4285   That is what I assumed. Do you have game7alcs 11/04/15 03:19:31 PM
#4284   Looking good Cbdpotential 11/03/15 01:11:54 AM
#4283   I'm holding through these earnings and the next game7alcs 11/02/15 07:34:31 PM
#4282   Your probably right. It was my lotto pick Picks77 11/02/15 06:46:50 PM
#4281   I saw that earnings would be out after now invest 11/02/15 06:23:41 PM
#4280   i dont think BRLI revenue will make a soybanzai 11/02/15 06:14:58 PM
#4279   .44 Picks77 11/02/15 06:05:16 PM
#4278   how much did you pay for them? just curious soybanzai 11/02/15 04:46:35 PM