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Opko Health Inc (OPK)

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Last Post: 6/23/2017 12:51:59 PM - Followers: 164 - Board type: Free - Posts Today: 3

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) 06:32 AM
OPK News: OPKO Health Announces KDIGO Clinical Practice Guideline Update on CKD-MBD 06/22/2017 08:30:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 06/20/2017 05:06:57 PM
OPK News: Statement of Changes in Beneficial Ownership (4) 06/16/2017 04:22:44 PM
OPK News: Statement of Changes in Beneficial Ownership (4) 06/16/2017 04:21:29 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 06/23/2017 06:32:30 AM
#5407   anyone know the reason for the jump? or Toninho 06/23/17 12:51:59 PM
#5406   wow 360% Toninho 06/23/17 12:05:00 PM
#5405   With the new KDIGO published guidelines , doctors Sky10 06/23/17 11:25:12 AM
#5404   IMO... we got a little boost from the now invest 06/22/17 08:46:36 PM
#5403   Was there news today? Outside of the kdigo investor011214 06/22/17 07:46:29 PM
#5402   Picked up more today. We will see what game7alcs 06/22/17 04:43:03 PM
#5401   Another one of those.. IMO... TOP HEAVY guys now invest 06/22/17 09:21:09 AM
#5400   OPKO Health Announces KDIGO Clinical Practice Guideline Update Sone 06/22/17 08:39:03 AM
#5399   This has been known for sometime!!!! now invest 06/22/17 07:46:23 AM
#5398   FOR all trying to understand the new guidelines:there Gradywhite 06/21/17 02:38:19 PM
#5397   This gives you an idea of the path Gradywhite 06/21/17 02:08:14 PM
#5396   RAYALDEE FIRST CHOICE! Gradywhite 06/21/17 02:04:03 PM
#5395   I did a rough calculation on the back Sky10 06/21/17 12:57:06 PM
#5394   Chart looking better. Needs to break through the 50day. stonsetr 06/21/17 12:16:39 PM
#5393   saw the news alert above... FROST STOP GETTING now invest 06/21/17 11:19:08 AM
#5392   Read past PRs and cc documents to find game7alcs 06/20/17 04:04:55 PM
#5391   Actually I am sure that there are stats... now invest 06/20/17 03:36:22 PM
#5390   After reading the presentation nbm16yankees 06/20/17 03:16:07 PM
#5389   Many Bio's are up today... hope you are now invest 06/20/17 12:32:18 PM
#5388   I think OPK has turned the corner . Sky10 06/20/17 11:57:30 AM
#5387   Looked at the slides from the SHM.... I now invest 06/19/17 09:53:36 AM
#5386   Very very nice. Thanks for sharing. $$$$ WovenOxygen 06/16/17 10:02:49 AM
#5385 game7alcs 06/16/17 09:41:23 AM
#5384   It's good news that the new study showed game7alcs 06/15/17 10:49:57 AM
#5383   Good Luck... but... don't see buyers coming in now invest 06/15/17 10:17:04 AM
#5382   09:12 OPK Opko Health provides update to the topline data Atlanta1 06/15/17 09:15:31 AM
#5381   Agreed dshade 06/14/17 03:36:58 PM
#5380   Back in. The 6s are too low DegenerateGambler 06/13/17 11:07:28 AM
#5379   Sounds to me like it isn't as good game7alcs 06/12/17 04:50:53 PM
#5378   So currently up... .17 to 6.55... nice.. now invest 06/12/17 01:40:10 PM
#5377   Frost and the BOD got us into RXII.... now invest 06/12/17 01:33:01 PM
#5376   WELL... looks like 4k may have more competition... now invest 06/12/17 01:23:14 PM
#5375   It seems to look that way but I game7alcs 06/09/17 08:45:15 PM
#5374   They don't seem to care about the share Sone 06/09/17 08:00:18 PM
#5373   I don't think it will be 5 yes game7alcs 06/09/17 07:16:43 PM
#5372   5yrs!! Do you think Frost has 5yrs?? How Sone 06/09/17 06:45:06 PM
#5371   I agree with the impact of Dr. Frosts game7alcs 06/09/17 01:07:46 PM
#5370   With what OPKO has in the pipelines , Sky10 06/09/17 12:57:04 PM
#5369   In my opinion this is an excellent entry game7alcs 06/09/17 11:21:27 AM
#5368   $OPK This looks like a nice lull to WinnerSanctum 06/09/17 10:58:58 AM
#5367   Major news?? Says FROST owns some.... NOTHING now invest 06/09/17 09:23:00 AM
#5366   That is huge news! Thanks Gradywhite! WovenOxygen 06/08/17 03:36:55 PM
#5365 Gradywhite 06/08/17 03:18:50 PM
#5364   looks like Frost wasn't the only insider who Atlanta1 06/06/17 08:21:15 AM
#5363   I saw almost nothing new that wasn't already now invest 06/05/17 10:02:36 PM
#5362   seemed like reasonable news too. market reacted odd. dshade 06/05/17 04:48:53 PM
#5361   Bought more in the 6.20's WovenOxygen 06/05/17 01:55:33 PM
#5360   NEW PR... now invest 06/05/17 12:18:03 PM
#5359   I like the news. Atlanta1 06/05/17 11:35:55 AM
#5358 Look at the clinical trials Gradywhite 06/04/17 05:53:55 PM