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Last Post: 7/16/2018 5:17:45 PM - Followers: 168 - 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: Statement of Changes in Beneficial Ownership (4) 07/17/2018 07:20:02 AM
OPK News: OPKO Partner Vifor Fresenius Receives Marketing Approval for RAYALDEE in Canada 07/16/2018 11:57:02 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 07/12/2018 07:13:35 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 07/05/2018 07:36:21 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 07/02/2018 06:25:31 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 07/17/2018 07:20:02 AM
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#6114   OPKO Partner Vifor Fresenius Receives Marketing Approval for terry hallinan 07/16/18 05:17:45 PM
#6113   Thanks for your reply,, let me knoe if Country Squire 07/13/18 02:10:40 PM
#6112   And thank you very much. terry hallinan 07/13/18 01:18:53 PM
#6111   Glad we had BTFD situation today hope we Juice555 07/13/18 01:11:15 PM
#6110   TY I heard a story that Dr, Country Squire 07/13/18 12:14:03 PM
#6109   Country Squire, terry hallinan 07/13/18 11:53:29 AM
#6108   WHAT HAPPENED ,,,Down 57 cents Country Squire 07/13/18 10:21:24 AM
#6107   MW Harry Boxer's four health-care stocks to watch terry hallinan 07/12/18 02:58:35 PM
#6106   Awesome. Leave Clay alone. Go Opko. Idunno 07/12/18 09:13:19 AM
#6105   maybe he will get burnt along with the terry hallinan 07/12/18 08:32:35 AM
#6104   Yes I second that We don't need him Juice555 07/11/18 08:07:26 PM
#6103   Please stay away from this message board game7alcs 07/11/18 06:11:37 PM
#6102   * * $OPK Video Chart 07-11-18 * * ClayTrader 07/11/18 04:21:32 PM
#6101   Hope we get back to teens so I terry hallinan 07/11/18 02:43:10 PM
#6100   Yes very weird we are up so much Juice555 07/11/18 01:48:37 PM
#6099   Doesn't appear OPK even wants to stop for terry hallinan 07/11/18 12:55:37 PM
#6098   Golden cross soon. stonsetr 07/11/18 10:21:27 AM
#6097   * * $OPK Video Chart 07-06-18 * * ClayTrader 07/06/18 05:43:24 PM
#6096   Juice, If I remember correctly we suppose to hear terry hallinan 07/06/18 03:02:59 PM
#6095   If I remember correctly we suppose to hear Juice555 07/06/18 01:20:51 PM
#6094   Options Traders Expect Huge Moves in OPKO Health terry hallinan 07/06/18 12:34:50 PM
#6093   And now that imaginary toils and trouble and terry hallinan 07/06/18 11:15:28 AM
#6092   Support at the 200 ma stonsetr 07/03/18 10:26:24 AM
#6091   I had to wander over here to see connyank 06/26/18 06:31:22 PM
#6090   Thanks Terry. You’re so right. And NONE of Idunno 06/26/18 02:07:53 PM
#6089   And suddenly a little known, tiny Biotch [except terry hallinan 06/26/18 01:03:16 PM
#6088   Lonetree, My copy from another posting was an atrocious blunder. terry hallinan 06/25/18 10:43:23 PM
#6087   Ed Jankowski to replace Andrew Perlman as CEO terry hallinan 06/25/18 05:42:38 PM
#6086   Always nice to see insiders buying! Lonetree 06/21/18 08:54:59 PM
#6085   Game7, The completion of the 100K genome sequences sounds terry hallinan 06/15/18 01:11:13 PM
#6084   Flirting with the 200 MA stonsetr 06/14/18 09:54:22 AM
#6083   Terry, You seem to be by far the most game7alcs 06/12/18 09:18:30 AM
#6082   Ahh yes here is the ph 2b diabetes tredenwater2 06/11/18 08:13:46 PM
#6081   Game7, everybody knows who wins when $ are involved. terry hallinan 06/04/18 01:29:10 PM
#6080   Terry, everybody knows who wins when $ are game7alcs 06/04/18 12:31:17 PM
#6079   Biomarkers/Epidemiology/Outcomes - presented at terry hallinan 06/04/18 10:01:30 AM
#6078   Here's why investors are cheering Quest and LabCorp terry hallinan 05/26/18 05:31:47 PM
#6077   There is a huge movement happening on Twitter Gradywhite 05/24/18 12:38:26 PM
#6076   Thanks, Juice. terry hallinan 05/23/18 05:14:29 PM
#6075   There is new tweeter account called Medicare should Juice555 05/23/18 04:30:05 PM
#6074   Yes I have been following that Twitter handler Juice555 05/21/18 08:34:22 PM
#6073   Juice, I never considered the huge publicity terry hallinan 05/21/18 08:30:16 PM
#6072   Yes if anyone notice this weekend 4kscore Twitter Juice555 05/21/18 08:13:35 PM
#6071   Back to being a turd terry hallinan 05/21/18 06:43:49 PM
#6070   Wow. Great co like. Imun. Hopeful1037 05/21/18 05:10:29 PM
#6069   Yup. My gut told me to stay WovenO2 05/21/18 04:08:56 PM
#6068   Back to being a turd Sone 05/21/18 04:05:40 PM
#6067   Dr. Frost did his normal big buy on game7alcs 05/21/18 10:47:20 AM
#6066   MAn, how many pricks knew this PR was tredenwater2 05/20/18 08:34:27 AM
#6065   Your response is just what I was hunting game7alcs 05/18/18 09:03:17 PM
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