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Opko Health Inc (OPK)

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Last Post: 5/28/2016 1:41:57 PM - Followers: 158 - 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: OPKO Health Receives Proposed/Draft Medicare Local Coverage Determination for 4Kscore® Test 05/27/2016 08:30:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/27/2016 06:05:27 AM
OPK News: Amended Statement of Changes in Beneficial Ownership (4/a) 05/17/2016 05:14:18 PM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/17/2016 04:24:42 PM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/13/2016 06:13:16 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#4713   OPKO Health, Inc. (NYSE:OPK) (“OPKO” or the “Company”) Traderbytrade 05/28/16 01:41:57 PM
#4712   Nice milestone... sell off on the news... but now invest 05/27/16 10:43:11 AM
#4711   OPKO Health Receives Proposed/Draft Medicare Local Coverage Determination game7alcs 05/27/16 10:25:55 AM
#4710   Thanks g7. I first got interested in OPK stockspirit 05/24/16 08:36:30 AM
#4709   Lol true Sone 05/23/16 10:38:03 PM
#4708   I didn't want to jinx it ?? game7alcs 05/23/16 10:37:35 PM
#4707   Some day or October? ;-) Sone 05/23/16 10:36:45 PM
#4706   Good to have somebody new on board. I game7alcs 05/23/16 10:23:40 PM
#4705   First post here on the OPK board. I stockspirit 05/23/16 08:59:13 PM
#4704   Add to that the approval in October ( Juice555 05/20/16 08:18:17 PM
#4703   very positive i agree Traderbytrade 05/20/16 08:16:51 PM
#4702   nice action indeed Traderbytrade 05/20/16 08:16:31 PM
#4701   i see your point Traderbytrade 05/20/16 08:16:12 PM
#4700   agreed Traderbytrade 05/20/16 08:15:57 PM
#4699   OPK is a low risk company . Out Sky10 05/20/16 04:55:49 PM
#4698   3-healthcare-stocks-that-bears-are-wrong-about tomsylver 05/18/16 04:35:42 PM
#4697   Opko Health's quest to redefine treatment for secondary PTH joe_techi 05/13/16 12:59:55 PM
#4696   Nice... neg .02 vs now invest 05/09/16 08:48:37 PM
#4695   Great quarterly. Liking the after hours pps action, joe_techi 05/09/16 06:29:23 PM
#4694   this seems to be significantly positive also: Atlanta1 05/09/16 07:56:46 AM
#4693   I guess Dr. Frost knows what he's doing, huh? Atlanta1 05/09/16 07:36:51 AM
#4692   Bet Shorty didn't see this coming! LOL. UHD 05/09/16 06:14:01 AM
#4691   RAYALDEE Deal with Vifor Fresenius tomsylver 05/09/16 04:48:21 AM
#4690   Thanks The BRLI deal should help us move in Juice555 05/09/16 02:35:45 AM
#4689   Analyst estimates show a loss of .034 globalworker 05/09/16 01:11:38 AM
#4688   So will we show profit for the 1st Juice555 05/08/16 11:49:53 PM
#4687   That's one strategy. I like keeping a core game7alcs 05/07/16 09:24:52 AM
#4686   Same here, already sold and now waiting to masterbug1 05/06/16 11:21:46 PM
#4685   For the first time in several years, I DegenerateGambler 05/06/16 10:09:40 PM
#4684   I was thinking same thing would like 8's Sone 05/06/16 02:56:51 PM
#4683   Actually I have to thank the Shorts that Sky10 05/06/16 02:15:06 PM
#4682   Why in the hell is the PPS down Matrix999 05/06/16 01:24:12 PM
#4681   That's good news! game7alcs 05/06/16 12:24:54 PM
#4680   Report from the annual meeting on 4 kscore Sky10 05/06/16 12:10:41 PM
#4679   A bunch of stock options were handed out game7alcs 05/06/16 11:55:04 AM
#4678   May drop more after earnings come out Monday P.M. soloman48 05/06/16 11:46:23 AM
#4677   Me too. Couldn't resists it under $10 here game7alcs 05/06/16 07:42:53 AM
#4676   Me too But only for flipping. I have enough Juice555 05/04/16 08:35:47 PM
#4675   Up or down on earnings? Regardless added a joe_techi 05/04/16 08:15:43 PM
#4674   Most likely shorter term investors not wanting to game7alcs 05/02/16 12:16:40 PM
#4673   What's going on? Sone 05/02/16 11:56:11 AM
#4672   In a regulatory filing, Catalent (CTLT -0.7%) reports game7alcs 04/30/16 10:54:40 AM
#4671   Oh I know. I am. It's just frustrating game7alcs 04/28/16 08:01:11 PM
#4670   Yes. Got to be patient and trust dr. Juice555 04/28/16 05:06:24 PM
#4669 patience.... tomsylver 04/28/16 05:03:53 PM
#4668   Is that right? Do we definitely have to game7alcs 04/28/16 01:54:19 PM
#4667   Lol that was crazy I asked and opk Sone 04/27/16 01:23:57 PM
#4666   Did I read that right that they have game7alcs 04/27/16 01:09:29 PM
#4665   FDA Accepts Resubmission of New Drug Application for RAYALDEE® joe_techi 04/27/16 12:53:05 PM
#4664   Thank you but I meant regarding the facility Sone 04/27/16 12:37:34 PM