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Last Post: 5/17/2019 2:00:39 PM - Followers: 167 - 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: Current Report Filing (8-k) 05/17/2019 04:04:49 PM
OPK News: Aerobic Vaginitis (AV) Testing Now Available At BioReference Laboratories 05/17/2019 08:30:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/17/2019 06:07:45 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/15/2019 06:34:04 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/14/2019 06:11:49 AM
PostSubject
#6496   News: $OPK Aerobic Vaginitis (AV) Testing Now Available whytestocks 05/17/19 02:00:39 PM
#6495   * * $OPK Video Chart 05-14-2019 * * ClayTrader 05/14/19 06:13:25 PM
#6494   Dr. Frost bought around 900k shares the day game7alcs 05/09/19 08:05:06 PM
#6493   Another crappy CC with two whole people asking game7alcs 05/07/19 07:41:41 PM
#6492   Means nothing. Happens pretty much every cc. game7alcs 05/05/19 09:45:43 PM
#6491   Frost not buying last couple of days at joe_techi 05/02/19 10:12:44 AM
#6490   I hear you. And I enjoy hearing other spotrader 04/26/19 08:53:31 AM
#6489   In my opinion this did it’s unsupported upward game7alcs 04/25/19 08:05:16 PM
#6488   My gut spotrader 04/25/19 07:06:28 PM
#6487   Based on? game7alcs 04/25/19 06:31:23 PM
#6486   Ok people this is ready to explode! spotrader 04/25/19 02:50:25 PM
#6485   Wow I had no idea spotrader 04/12/19 10:44:49 AM
#6484   FWIW OPKO Health Price to Book Value:0.8695 for April joe_techi 04/11/19 09:59:08 AM
#6483   It definitely is. There is potential with Bio game7alcs 04/10/19 10:37:24 PM
#6482   I believe it's worth holding spotrader 04/10/19 09:50:04 PM
#6481   More interesting is that they are going to game7alcs 04/10/19 09:33:19 PM
#6480   Oh? spotrader 04/10/19 06:15:00 PM
#6479   They have a nice new website game7alcs 04/10/19 04:01:10 PM
#6478   Could be that frost is wanting price to spotrader 04/09/19 02:19:23 PM
#6477   This should be a huge mover with the spotrader 04/09/19 12:27:56 PM
#6476   I would if I had ten percent! spotrader 04/08/19 04:27:48 PM
#6475   He has been buying for years. game7alcs 04/08/19 04:22:49 PM
#6474   Pretty sure he'd like the gazillion he already gronk 04/08/19 03:35:19 PM
#6473   It appears that the owner of this is spotrader 04/08/19 03:04:52 PM
#6472   I'm unsure why, you can call it a spotrader 04/07/19 12:59:13 PM
#6471   Or not! What makes you think so? Lonetree 04/06/19 08:51:39 PM
#6470   Probably just going up from here spotrader 04/06/19 07:03:21 PM
#6469   News: $OPK OPKO Announces Positive Topline Results In whytestocks 03/21/19 12:30:39 PM
#6468   I know every bit of what has happened game7alcs 03/20/19 11:12:39 PM
#6467   Four years of straight decline....sophisticated or not, it's Acumen 03/19/19 03:20:34 PM
#6466   I’m not sure how that affects an unsophisticated game7alcs 03/13/19 08:07:59 PM
#6465   Sure, under the SEC reprimanded Frost, 61% of Acumen 03/13/19 07:44:06 PM
#6464   Care to explain? game7alcs 03/13/19 05:36:47 PM
#6463   Man o Man is Frost giving it hard Acumen 03/12/19 11:41:04 AM
#6462   More “this and that are going to happen game7alcs 02/27/19 06:17:50 PM
#6461   OPKO Health to Announce Fourth Quarter 2018 Financial game7alcs 02/26/19 10:43:26 AM
#6460   * * $OPK Video Chart 02-05-2019 * * ClayTrader 02/05/19 05:30:29 PM
#6459   Ouch! WovenO2 02/05/19 08:30:28 AM
#6458   Must have saved a little good news for game7alcs 02/01/19 08:58:24 AM
#6457   OPKO Health Receives FDA Approval for the Point-of-Care game7alcs 02/01/19 08:57:52 AM
#6456   It seems like there is an agenda here game7alcs 01/31/19 10:49:26 PM
#6455   So sad... Juice555 01/31/19 10:29:14 PM
#6454   OPKO Provides Update on the Development of OPK-88004, game7alcs 01/31/19 09:42:41 PM
#6453   Future Non-Coverage Determination for 4Kscore Test Posted by game7alcs 01/31/19 08:15:20 PM
#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
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