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Last Post: 1/18/2019 6:07:06 PM - Followers: 165 - 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) 01/18/2019 06:57:06 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 01/17/2019 06:53:27 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 01/15/2019 06:19:31 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 01/14/2019 06:52:40 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 01/11/2019 07:00:25 AM
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#6452   Opko continues its climb back to $4. DegenerateGambler 01/18/19 06:07:06 PM
#6451   It appears the ambulance chasers have found another DegenerateGambler 01/07/19 11:04:33 AM
#6450   Is there going to be additional bad news r clarke 01/06/19 09:42:55 PM
#6449   My ignorance? Sorry I don’t use twitter. Secondly game7alcs 01/05/19 10:20:58 AM
#6446   Alpha Capital fraudulent Martin Shlomo Schlaff and fraudulent montanus 01/04/19 04:35:40 PM
#6445   Frost fraud AGAIN montanus 01/04/19 04:00:07 PM
#6444   I believe with the dems in control of game7alcs 01/04/19 03:24:25 PM
#6443   When OPK held steady in yesterday’s real downer DegenerateGambler 01/04/19 09:53:00 AM
#6442   I believe if you wait you will get game7alcs 01/02/19 09:59:55 PM
#6441   i have been waiting for Opko to clean DegenerateGambler 01/02/19 05:45:49 PM
#6440   Another 135000 on Monday. Dr. Frost must be game7alcs 01/02/19 01:10:27 PM
#6439   Great to see Frost buying again.....! tredenwater2 12/31/18 10:30:33 PM
#6438   Yea 100,000 shares on the 28th. I’m sure game7alcs 12/31/18 11:47:54 AM
#6437   Frost is buying again fwiw joe_techi 12/31/18 09:57:20 AM
#6436   The SEC got enough to pay some people game7alcs 12/28/18 05:10:39 PM
#6435   * * $OPK Video Chart 12-28-18 * * ClayTrader 12/28/18 04:38:02 PM
#6434   I hope Frost's ego gets him motivated to joe_techi 12/28/18 11:55:06 AM
#6433   Nice buy! This will probably drop back and game7alcs 12/28/18 11:34:59 AM
#6432   Added 2K shares @ $2.86 at the open Domino 12/28/18 10:47:49 AM
#6431   I wish I could add. I do believe Juice555 12/27/18 04:49:53 PM
#6430   Well there is some news. Nice. Now is joe_techi 12/27/18 04:48:05 PM
#6429   Nice movement after hours on the resolution of Juice555 12/27/18 04:38:18 PM
#6428   Three recent links, the first I can't read joe_techi 12/27/18 01:40:19 PM
#6427   Nothing from the company as this hits multi-year joe_techi 12/27/18 12:48:50 PM
#6426   I hear you Hope 2019 will be better for Juice555 12/20/18 03:39:50 PM
#6425   Yea just venting because we are in the game7alcs 12/20/18 03:37:44 PM
#6424   Anything new or you referring to the BS Juice555 12/20/18 12:16:51 PM
#6423   MerryChrustmas to all OPKO shareholders from the SEC game7alcs 12/20/18 11:24:15 AM
#6422   I agree with your entire statement. game7alcs 12/05/18 01:09:01 PM
#6421   Tred, I am long this company still. I game7alcs 12/04/18 11:01:14 PM
#6420   Thanks for the reply game and Conny. Just tredenwater2 12/04/18 07:46:00 PM
#6419   Memory serves, the TSRO shares they owned are connyank 12/04/18 12:32:34 PM
#6418   My guess would be they would have to game7alcs 12/03/18 09:06:33 PM
#6417   “GlaxoSmithKline to Acquire Tesaro for $4.16 Billion -- Update” tredenwater2 12/03/18 01:52:14 PM
#6416   It could easily be within a year they tredenwater2 11/21/18 03:45:14 PM
#6415   To what end (besides job security), do you figure? connyank 11/21/18 12:52:42 PM
#6414   As of November 1, 2018, the registrant had game7alcs 11/20/18 09:37:43 PM
#6413   11/9 8k - they snuck that in - connyank 11/20/18 10:46:51 AM
#6412   On November 8, 2018, we entered into stock game7alcs 11/19/18 06:10:28 PM
#6411   I guess I will wait to reenter until tredenwater2 11/16/18 07:57:32 PM
#6410   BTSOM... connyank 11/16/18 04:00:21 PM
#6409   Was this related to the $150 mil loan? game7alcs 11/16/18 03:24:35 PM
#6408   recent form 4 filings connyank 11/16/18 02:38:05 PM
#6406   * * $OPK Video Chart 11-12-18 * * ClayTrader 11/12/18 04:31:40 PM
#6405   It’s designed to keep short sellers from screwing game7alcs 11/11/18 11:09:07 AM
#6404   I see OPK on this Short Sale Circuit joe_techi 11/11/18 10:33:56 AM
#6403   They responded to the SEC INVESTIGATION, as much game7alcs 11/09/18 06:53:58 PM
#6402   Numbers look like they were in line with game7alcs 11/09/18 05:15:43 PM
#6401   It’s at the bottom. It was supposed to game7alcs 11/09/18 05:14:00 PM
#6400   I didn’t see any link to listen in But Juice555 11/09/18 05:06:59 PM
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