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Last Post: 12/7/2016 6:27:33 PM - Followers: 160 - Board type: Free - Posts Today: 6

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.

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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) 12/05/2016 06:09:22 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 07:47:20 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 12/01/2016 06:09:52 AM
OPK News: OPKO Health to Participate at Three Investment Conferences in December 11/30/2016 08:00:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 11/29/2016 07:38:25 AM
PostSubject
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#5068   exegenics and cytoclonal pharm or something like that. joe_techi 12/07/16 06:27:33 PM
#5067   Patience my friend I am sure dr frost has Juice555 12/07/16 02:13:46 PM
#5066   thanks. Since I'm in at $11.90 a while ago, Matrix999 12/07/16 02:05:27 PM
#5065   Buy Sone 12/07/16 01:39:14 PM
#5064   to buy or sell? Matrix999 12/07/16 01:38:33 PM
#5063   Email alerts being sent on opko Sone 12/07/16 08:44:01 AM
#5062   I hope it continues Sone 12/06/16 06:18:43 PM
#5061   Another good day in OPK land!! $11.33!! now invest 12/06/16 06:14:31 PM
#5060   Nice to see the creeping up.... now 10.75.... now invest 12/05/16 11:33:52 AM
#5059   That's good to hear. I completely agree in game7alcs 11/29/16 05:45:56 PM
#5058   I am a long term subscriber of The Sky10 11/29/16 03:38:08 PM
#5057   Yea I would expect some updates end of game7alcs 11/23/16 03:45:37 PM
#5056   Yep..... going to happen..... Can't wait for UPDATES now invest 11/23/16 02:14:12 PM
#5055   I think we will. We won't see it game7alcs 11/23/16 12:35:31 PM
#5054   Don't forget phase 3 result of the hgh Juice555 11/23/16 12:29:45 PM
#5053   We can expect OPK to gradually going up Sky10 11/23/16 12:28:06 PM
#5052   Let's hope we get income coming in quickly Juice555 11/23/16 12:08:45 PM
#5051   Yeah! stonsetr 11/23/16 12:06:32 PM
#5050   OPKO Announces U.S. Launch of RAYALDEE™ GlobeNewswire•November 23, 2016 MIAMI, game7alcs 11/23/16 12:03:38 PM
#5049   What's up with this guy Frost? Every Matrix999 11/22/16 08:40:40 AM
#5048   OPK price does not go up until they Sky10 11/21/16 01:27:44 PM
#5047   Sales numbers you'll see 2H 2017. unfortunately. tomsylver 11/15/16 04:12:36 PM
#5046   Solid move. dshade 11/14/16 04:53:16 PM
#5044   Nice day today... That seeking alpha article not now invest 11/14/16 02:54:50 PM
#5043   News? Sone 11/14/16 02:30:56 PM
#5042   Nice movin today Cbdpotential 11/14/16 01:37:35 PM
#5041   http://seekingalpha.com/article/4021970-opko-health-significant-growth-potential seppi08162 11/10/16 07:38:18 AM
#5040   Thanks JT - very much appreciated. With seppi08162 11/08/16 11:56:48 AM
#5039   also earning transcript joe_techi 11/08/16 11:49:42 AM
#5038   From the Earnings Call transcript joe_techi 11/08/16 11:44:52 AM
#5037   Not disagreeing game7alcs 11/07/16 07:07:18 PM
#5036   Still, seems nice for the long term. I joe_techi 11/07/16 06:39:34 PM
#5035   "..revenues rose 108.4% year/year to $298 mln vs Atlanta1 11/07/16 06:32:35 PM
#5034   Revenues are up big compared to last year game7alcs 11/07/16 06:29:13 PM
#5033   It's a matter of expectations. Atlanta1 11/07/16 05:25:13 PM
#5032   Overall seems to read pretty good to me. joe_techi 11/07/16 05:23:36 PM
#5031   Does anyone here who participated in the quarterly seppi08162 11/07/16 05:11:06 PM
#5030   OPKO Health Reports Third Quarter Financial and Operating game7alcs 11/07/16 04:29:10 PM
#5029   Opko Healthcare's Phillip Frost Is a Major Microcap tomsylver 11/05/16 02:42:19 AM
#5028   Not sure it will be ready by 2020 Juice555 11/04/16 12:05:18 PM
#5027   My guess : OPK's revenue FY 2020 about Sky10 11/04/16 11:18:32 AM
#5026   OPKO to Announce Third Quarter Operating and Financial tomsylver 11/03/16 03:35:51 PM
#5025   I wonder what price OPK will reach if Sky10 11/02/16 06:44:53 PM
#5023   I do not see any connection between OPK now invest 11/01/16 06:18:05 AM
#5022   CEO DR. Frost other co,. BCDA getting hot remind2 10/31/16 10:11:48 AM
#5021   I found the Frost connection. Atlanta1 10/28/16 11:51:30 AM
#5020   OPK: Dr. Philip Frost bought 65% of a remind2 10/28/16 11:37:10 AM
#5019   OPK: CEO bought 65% of BCDA @ .13 cents remind2 10/28/16 10:16:42 AM
#5018   I think this is good news . I Sky10 10/27/16 12:10:55 PM
#5017   Hey appreciate that response and definitely the positive seppi08162 10/27/16 11:00:49 AM
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