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Opko Health Inc (OPK)

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Last Post: 8/31/2015 4:16:12 PM - Followers: 145 - 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) 09:44 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 07:13 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/31/2015 07:22:19 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/28/2015 07:21:46 AM
OPK News: Current Report Filing (8-k) 08/26/2015 09:21:00 AM
News News Alert: Current Report Filing (8-k) 09/01/2015 09:44:20 AM
#3864  Sticky Note I added a discussion on PSA tests because stargazer123 06/20/15 12:58:21 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#4075   OPKO – Performing Consistently WiseFool 08/31/15 04:16:12 PM
#4074 WiseFool 08/30/15 03:51:27 PM
#4073   NEW Competitor to Aprepitant, Opko's Rolapitant Effectively Reduces WiseFool 08/27/15 04:40:38 PM
#4072   Bought more today. It may still drop but game7alcs 08/27/15 01:03:19 PM
#4071   I thought I was pretty educated on OPK joe_techi 08/26/15 10:19:32 PM
#4070   I don't disagree. I just think this market game7alcs 08/26/15 10:14:16 PM
#4069   who knows where this market is going... but now invest 08/26/15 10:11:08 PM
#4068   OK, but I think the news will attract joe_techi 08/26/15 09:50:45 PM
#4067   Yea that's a lot of cash. I think game7alcs 08/26/15 09:46:54 PM
#4066   How much cash might we get soon after PDUFA? joe_techi 08/26/15 09:45:40 PM
#4065   I think Rolapitant is known and in the game7alcs 08/26/15 09:40:32 PM
#4064   If Rolapitant comes through you only have a joe_techi 08/26/15 09:20:16 PM
#4063   If it stays in this $10-$11 range I game7alcs 08/26/15 08:59:32 PM
#4062   God summary. A lot of potential here. The game7alcs 08/26/15 01:53:19 PM
#4061   Yes indeed dshade 08/26/15 01:19:24 PM
#4060   Some interesting things.... now invest 08/26/15 01:17:07 PM
#4059   Whew. A lot of information there. game7alcs 08/26/15 12:34:41 PM
#4058   Letter To Shareholders from Frost. stonsetr 08/26/15 10:31:08 AM
#4057   It seems like the next 2 qtrs. should game7alcs 08/25/15 12:37:06 PM
#4056   I can't imagine Rolapitant PDUFA is priced into joe_techi 08/25/15 11:27:28 AM
#4055   Me at 10:46 .... late in the day... now invest 08/24/15 05:25:51 PM
#4054   Added some more at $10.45 game7alcs 08/24/15 04:46:33 PM
#4053   more lucky than good I can assure you. jehu 08/24/15 03:15:57 PM
#4052   wow. nice dshade 08/24/15 03:14:12 PM
#4051   just hit 10.30!...... jehu 08/24/15 03:06:16 PM
#4050   you may very well be correct. cramers jehu 08/24/15 03:03:47 PM
#4049   INTERESTING.. I am thinking BRLI now invest 08/24/15 02:59:52 PM
#4048   Details... ANOTHER BUY... now invest 08/24/15 12:27:54 PM
#4047   Yea thinking about it. Unfortunately I added about game7alcs 08/24/15 11:04:36 AM
#4046   thanks for response. jehu 08/24/15 10:37:13 AM
#4045   LOL.... ANYTHING POSSIBLE.... However... I now invest 08/24/15 10:32:15 AM
#4044   $10.30's possible?? anyone jehu 08/24/15 10:24:45 AM
#4043   Added a little... 11.24 now invest 08/24/15 10:00:37 AM
#4042   Breaking News; ASCO POST: ‘OPKO Health’s Rolapitant Significantly WiseFool 08/22/15 10:34:09 AM
#4041   $12 a share? Ridiculously cheap! Buy up! game7alcs 08/21/15 06:57:23 PM
#4040   Single dose of Opko Health's Rolapitant with standard WiseFool 08/21/15 02:35:00 PM
#4039   OPKO “EirGen Pharma is a stand-out example of WiseFool 08/21/15 02:16:57 PM
#4038   translation...cramer is quietly loading the boat, again jehu 08/21/15 12:54:43 PM
#4037   Cramer Calls out to Dr. Frost for Clarification Mad tomsylver 08/21/15 02:05:08 AM
#4036   WOW... a $6 MILLION DOLLAR BUY !! now invest 08/20/15 09:41:28 PM
#4035   When does Brli get their opk shares? Sone 08/20/15 06:14:14 PM
#4034   A Massive Buy from CEO Phil Frost Today..... WiseFool 08/20/15 05:33:53 PM
#4033   Does anybody know the share count after the game7alcs 08/20/15 01:25:59 PM
#4032   Will Frost start buying again now? PennyStalker 08/20/15 12:10:10 PM
#4031   Merger a Done Deal WiseFool 08/20/15 10:14:15 AM
#4030   On August 20, 2015, Shareholders of Bio-Reference Laboratories, joe_techi 08/20/15 09:57:16 AM
#4029   How did the voting go for BR$&? Sone 08/19/15 01:43:19 PM
#4028   OPKO Lab Signs Contracts with Leading Preferred Provider now invest 08/19/15 01:38:37 PM
#4027   I think you're right. I believe somebody posted game7alcs 08/17/15 01:00:27 PM
#4026   Game, Frost will have more impact buying OPK someconcerns 08/15/15 01:59:32 PM