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Opko Health Inc (OPK)

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Last Post: 3/28/2015 10:07:32 AM - Followers: 130 - 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: Insider Weekends - March 27, 2015 03/29/2015 02:46:55 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 03/27/2015 06:17:35 PM
OPK News: Phase 3 Data Supporting Rayaldee™ As a Treatment for Secondary Hyperparathyroidism in Chronic Kidney Disease to be Presente... 03/27/2015 09:12:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 03/26/2015 07:11:14 AM
OPK News: OPKO Investee SciVac Ltd. Enters into Transaction with Levon Resources 03/23/2015 09:06:00 AM
#3575  Sticky Note David Miller, Catalyst Funds: "Wall Street also sees tomsylver 03/09/15 06:06:19 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#2454  Sticky Note May 9, 2014, 10:17am EDT Myth 06/03/14 02:38:24 PM
#3621   Transcript taken from opkodd site. Ceo of Renal WiseFool 03/28/15 10:07:31 AM
#3620   Phase 3 Data Supporting Rayaldee(TM) As a Treatment tomsylver 03/27/15 09:17:22 AM
#3619   Arizona Urology Specialists Use Opko 4Kscore WiseFool 03/26/15 03:44:43 PM
#3618   Barrington Research Assumes Coverage On Opko Health WiseFool 03/26/15 03:23:26 PM
#3617   He is very steady in his buys. Price game7alcs 03/26/15 09:28:02 AM
#3616   Yes, I see at $14.15 pps. I feel joe_techi 03/26/15 09:26:53 AM
#3615   Frost purchased another $500,000 worth yesterday PennyStalker 03/26/15 09:19:55 AM
#3614   A selloff was being called for this week game7alcs 03/25/15 02:52:37 PM
#3613   Interesting, if you simultaneously display today's charts for joe_techi 03/25/15 02:42:18 PM
#3612   It's biotech in general today game7alcs 03/25/15 02:00:08 PM
#3611   Yikes! Had a GTC buy order in that joe_techi 03/25/15 01:57:41 PM
#3610   https://opkodd.wordpress.com/2015/03/24/opko-4kscore-at-eau15-madrid-spain- WiseFool 03/24/15 04:39:52 PM
#3609   Opko Health After Hours Most Active List WiseFool 03/23/15 07:01:25 PM
#3608   Opko Health - Daily Trading Update https://opkodd.wordpress.com/2015/03/23/ WiseFool 03/23/15 06:45:49 PM
#3607   OPKO Investee SciVac Ltd. Company Overview March 23, 2015 WiseFool 03/23/15 05:49:27 PM
#3606   RXi Pharmaceuticals Reports Positive Advancements in its Dermatology tomsylver 03/23/15 04:25:22 PM
#3605   Emerging Bio Markers for Prostate Cancer Detection WiseFool 03/23/15 03:22:43 PM
#3604   News !! now invest 03/23/15 10:15:00 AM
#3603   https://opkodd.wordpress.com/2015/03/21/dr-dipen-parekh-on-opko-4kscore-as- WiseFool 03/21/15 10:03:31 AM
#3602   Opko Health Options Contracts New Ninety Day Record WiseFool 03/21/15 09:51:00 AM
#3601   Neovasc Launches Reducer in Select European Countries ( tomsylver 03/21/15 04:30:11 AM
#3600   OPKO Health Invests in Cardiac Device Company. WiseFool 03/20/15 07:23:38 PM
#3599   OK cool. I'll look at your other someconcerns 03/20/15 02:09:26 PM
#3598   Steve, I also posted this along with one Minding 03/20/15 02:05:02 PM
#3597   Development for OPK holdings (from my Fidelity news someconcerns 03/20/15 12:51:14 PM
#3596   Cocrystal Pharma Inc (OTCBB:COCP) continues to move up tomsylver 03/19/15 05:07:39 PM
#3595   BMO Capital analyst Jim Birchenough reiterated an Outperform tomsylver 03/19/15 04:33:16 PM
#3594   EAU15 Madrid WiseFool 03/18/15 05:46:08 PM
#3593   OPKO Lab Receives Accreditation From College of American tomsylver 03/18/15 09:37:52 AM
#3592   Scripps Research Institute and OPKO Health Global License WiseFool 03/16/15 04:54:24 PM
#3591   WF, Thanks for posting that. Some decent someconcerns 03/15/15 02:48:10 PM
#3590   Opko Health In ETF (XBI) Top Fund Holdings WiseFool 03/15/15 12:25:38 PM
#3589   yes indeed, the chart looks very healthy, recharged Tmguns 03/13/15 07:52:47 AM
#3588   Sto crossed,closed above the 10 and 20 sma, stonsetr 03/12/15 11:34:27 PM
#3587   Nice move today !!! My buddy now invest 03/12/15 09:33:49 PM
#3586   David Miller of Catalyst Funds Highlighted Opko in WiseFool 03/11/15 07:26:05 PM
#3585   Very good news! game7alcs 03/11/15 07:14:11 PM
#3584   With a CPT Code already in the works WiseFool 03/11/15 07:05:50 PM
#3583   https://opkodd.wordpress.com/ Opko 4Kscore Confirmed by UM Uro WiseFool 03/11/15 03:20:11 PM
#3582   Frost has purchased over 100,000 shares since March 1st. stonsetr 03/11/15 12:33:34 PM
#3581   Big news coming here. Frost is almost done PennyStalker 03/11/15 10:31:26 AM
#3580   fwiw, looks like we fought off a very Tmguns 03/11/15 07:39:17 AM
#3579   Frost bought another $151,000 yesterday. He has invested PennyStalker 03/10/15 07:26:24 AM
#3578   Emerging drugs for secondary hyperparathyroidism ( http://www.ncbi.nlm.nih.gov/p tomsylver 03/10/15 02:09:05 AM
#3577   Liking that $18.50 target in that article!! now invest 03/09/15 10:33:00 AM
#3576   Frost bought on Friday..... Price doesn't seem to now invest 03/09/15 09:16:12 AM
#3575   David Miller, Catalyst Funds: "Wall Street also sees tomsylver 03/09/15 06:06:19 AM
#3574   One of my friends is waiting for this Miracleman 1 03/07/15 01:52:42 PM
#3573   Phase 3 Data Supporting Rayaldee As a Treatment tomsylver 03/06/15 11:47:51 AM
#3572   Make it 4 in a row now.. buying.. now invest 03/06/15 10:22:57 AM