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Last Post: 7/30/2015 1:04:58 PM - Followers: 141 - 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: OPKO To Announce Second Quarter Operating and Financial Results on August 5, 2015 07/30/2015 04:35:00 PM
OPK News: FDA Accepts OPKO’s New Drug Application for Rayaldee™ 07/28/2015 01:41:00 PM
OPK News: Statement of Changes in Beneficial Ownership (4) 07/20/2015 04:22:49 PM
OPK News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 07/20/2015 06:02:20 AM
OPK News: Notice of Effectiveness (effect) 07/20/2015 06:01:42 AM
PostSubject
#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
#3991   NICE !!!!!!!! :-) now invest 07/30/15 01:04:58 PM
#3990   • Tesaro (TSRO -3.8%) secures an exclusive license game7alcs 07/30/15 10:48:04 AM
#3989   https://opkodd.wordpress.com/2015/07/29/opko-licensee-tesaro-rolapitant-asco-201 tomsylver 07/29/15 04:28:00 PM
#3988   FDA Accepts OPKO’s New Drug Application for Rayaldee™ Source: PennyStalker 07/28/15 01:53:49 PM
#3987   He's gone two weeks without buying many times someconcerns 07/25/15 09:42:12 PM
#3986   Even 16 days is a lot for "Frost" Juice555 07/25/15 06:07:11 PM
#3985   Guys, We have had this conversation before. someconcerns 07/25/15 05:31:03 PM
#3984   Totally agree with OPK. But I will keep Matrix999 07/25/15 04:15:58 PM
#3983   I don't blame you. It's not a short ronk 07/25/15 01:13:18 PM
#3982   Ronk, I have read some good things about Frost's Matrix999 07/25/15 01:01:10 PM
#3981   Here's a link to the story. ronk 07/25/15 12:19:09 PM
#3980   What company did they invest in? Juice555 07/25/15 11:46:50 AM
#3979   I bought some OPKO yesterday. A group of ronk 07/25/15 10:41:41 AM
#3978   Source Seeking alpha: Opko Health: Why Recent Weakness Represents tomsylver 07/25/15 02:32:23 AM
#3977   That means something is in the works in game7alcs 07/24/15 11:19:24 AM
#3976   Been a few weeks since Frost bought. stonsetr 07/24/15 10:41:07 AM
#3975   Just some information I personally obtained calling the DegenerateGambler 07/23/15 09:00:33 PM
#3974   Is it wrong that I am in love Juice555 07/23/15 07:28:03 PM
#3973   TWO NICE Articles !! OPK is now invest 07/23/15 06:40:11 PM
#3972   https://opkodd.wordpress.com/2015/07/23/bullish-signals-show-its-time-to-bu WiseFool 07/23/15 04:19:18 PM
#3971   OPKO's Prostate Cancer Hit ( http://www.forbes.com/sites/genemarcial/2015/07/23 tomsylver 07/23/15 03:38:52 PM
#3970   Nice to see it again above $17.00 while now invest 07/23/15 12:31:05 PM
#3969   Tick tock.... Juice555 07/20/15 10:04:25 AM
#3968   http://investor.opko.com/secfiling.cfm?filingid=1193125-15-256157&CIK=944809 tomsylver 07/20/15 07:03:23 AM
#3967   That was a good move - picking up someconcerns 07/19/15 12:01:00 PM
#3966   Thanks Yes. I wasn't too fond of shai so Juice555 07/19/15 11:49:22 AM
#3965   Juice, I can't disagree with anything you said, someconcerns 07/19/15 09:38:01 AM
#3964   You mean stole by opk I am a shareholder Juice555 07/19/15 02:18:05 AM
#3963   OK Edit: confusing is right. I suspect this someconcerns 07/15/15 01:31:05 PM
#3962   For an explanation (it is confusing) of the sttone 07/15/15 01:14:01 PM
#3961   One step at a time, but in the someconcerns 07/15/15 10:52:43 AM
#3960   Would be great to see 17s today Would do PennyStalker 07/15/15 10:44:48 AM
#3959   Right, I added the OPK shares I received someconcerns 07/15/15 09:48:34 AM
#3958   I was in all the way through the dshade 07/15/15 09:32:22 AM
#3957   Yes, it was a proposition that was hard someconcerns 07/15/15 09:22:35 AM
#3956   I wish we had been able to keep someconcerns 07/15/15 09:20:23 AM
#3955   I was in Prolar dshade 07/15/15 09:13:42 AM
#3954   I posted a few on the Zecotek board sttone 07/14/15 11:11:54 PM
#3953   OK. Please let us know. someconcerns 07/14/15 06:16:41 PM
#3952   I should be finding out more tomorrow........thanks sttone 07/14/15 05:51:36 PM
#3951   I missed that. I'll look it over, someconcerns 07/14/15 04:26:18 PM
#3950   no I was not but wish I were. sttone 07/14/15 04:20:06 PM
#3949   no I was not but wish I were. sttone 07/14/15 04:20:00 PM
#3948   Sttone, Weren't you with me in Prolor? someconcerns 07/14/15 03:58:55 PM
#3947   what exactly does the new UNCLE post mean sttone 07/14/15 02:40:51 PM
#3946   Opko ‘The Frost Factor’ – Carboxyl Terminal Peptide WiseFool 07/13/15 10:41:53 AM
#3945   I smile when I see one of the someconcerns 07/11/15 12:47:03 PM
#3944   OPKO & Pfizer Global Agreement on ‘hGH-CTP could WiseFool 07/11/15 11:21:37 AM
#3943   OPKO Announces Completion of Enrollment in Phase 3 tomsylver 07/10/15 11:49:49 AM
#3942   AND... OPK.. grows and grows... now invest 07/10/15 09:09:02 AM
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