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Last Post: 11/12/2018 4:31:40 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) 11/13/2018 07:45:29 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/13/2018 07:44:12 AM
OPK News: DEADLINE TUESDAY: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against OPKO Health, Inc. & Encourages I... 11/12/2018 12:44:00 PM
OPK News: Quarterly Report (10-q) 11/09/2018 04:13:43 PM
OPK News: Current Report Filing (8-k) 11/09/2018 04:10:12 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 11/13/2018 07:45:29 AM
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#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
#6399   I haven’t been able to check. It was game7alcs 11/09/18 05:05:56 PM
#6398   Not as bad as I expected at least Juice555 11/09/18 04:39:38 PM
#6397   Yea I expected that the market wouldn’t like game7alcs 11/08/18 09:23:45 PM
#6396   Market acting like numbers leaked - seems to connyank 11/08/18 03:02:26 PM
#6395   I guess market agreed with us that Friday Juice555 11/08/18 02:02:58 PM
#6394   At least it’s something. BioReference Laboratories Named as Preferred game7alcs 11/08/18 01:09:51 PM
#6393   I agree 100% in my opinion not a game7alcs 11/08/18 10:14:37 AM
#6392   Conference is tomorrow after close ? That’s weird. Friday Juice555 11/08/18 09:22:58 AM
#6391   PR about the earnings dated should come out thought013 11/06/18 01:44:39 AM
#6390   I would have expected it by today. game7alcs 11/05/18 09:30:47 PM
#6389   Yes very odd/concerning that they don’t have CC scheduled Juice555 11/04/18 09:15:27 AM
#6388   No buying or news in a month and game7alcs 11/04/18 08:56:50 AM
#6387   There is an ongoing case involved (supposedly) so connyank 11/03/18 02:36:07 PM
#6386   I would expect the CC to be next game7alcs 11/01/18 02:02:04 PM
#6385   Cramer tonight - unless Frost comes on show DegenerateGambler 10/17/18 06:53:05 PM
#6384   1987 - timely. connyank 10/17/18 04:19:48 PM
#6383   Michael Jesselson SEC history, ILNS STOCK investor with montanus 10/17/18 02:24:35 PM
#6382   OT - SEC behavior connyank 10/16/18 12:04:41 PM
#6381   Thats just a rehash of the same sorry connyank 10/15/18 03:12:19 PM
#6380   Thanks Montanus. Connyank If your out there these tredenwater2 10/15/18 09:51:01 AM
#6379   https://www.philstockworld.com/2018/09/09/july-2015-barry-honig-dr-frost-and-mor montanus 10/14/18 02:17:00 PM
#6378   daily gap fill and basing above last support. soybanzai 10/11/18 10:53:56 AM
#6377   Obviously someone in the know ahead of time tredenwater2 10/06/18 04:00:39 PM
#6376   I don’t care for Musk but I thought game7alcs 10/06/18 11:22:48 AM
#6375   Yea I have to say the only slight game7alcs 10/06/18 11:20:29 AM
#6374   "...someone is setting up shareholders ahead of time connyank 10/05/18 08:37:29 PM
#6373   "Dr. Frost being used for his name in tredenwater2 10/05/18 07:36:13 PM
#6372   Somewhat OT but amusing... connyank 10/05/18 01:43:16 PM
#6371   Unfortunately I can’t disagree with you. I can game7alcs 10/04/18 01:39:42 PM
#6370   Although all of that is probably true, that DegenerateGambler 10/04/18 01:15:14 PM
#6369   Thanks for that. In my opinion nothing close game7alcs 10/04/18 10:41:11 AM
#6368   NeoVasc +24% connyank 10/03/18 05:38:42 PM
#6367   WTF is your point? connyank 10/02/18 07:58:42 PM
#6366   The connection to OPKO besides the ridiculous Honig game7alcs 10/01/18 02:14:33 PM
#6365   HONIG, MAZA, Jesselson,Chain and Intellect Neurosciences montanus 10/01/18 11:50:06 AM
#6364   With the dark clouds (SEC) hanging over the DegenerateGambler 09/28/18 11:38:37 AM
#6363   What is the new buy point? srains 09/28/18 10:50:08 AM
#6362   Yes. I have an order at 2.84 Hope Juice555 09/28/18 10:08:27 AM
#6361   Slowly creeping towards the high 2s game7alcs 09/28/18 10:07:53 AM
#6360   Waste. Most law firms probably won’t have enough doubleb73 09/26/18 03:03:28 PM
#6359   Well let's put it this way If there are Juice555 09/26/18 12:25:42 PM
#6358   Compared to many, I only lost a little srains 09/26/18 12:03:37 PM
#6357   A waste of time in my opinion also. game7alcs 09/26/18 12:00:56 PM
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