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Last Post: 7/6/2015 9:54:27 AM - Followers: 138 - Board type: Free - Posts Today: 2
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: Statement of Changes in Beneficial Ownership (4) 06:41 AM
OPK News: Biotech Billionaires: Can They Do It Again? 07/05/2015 01:13:03 PM
OPK News: Current Report Filing (8-k) 07/02/2015 05:33:26 PM
OPK News: Securities Registration: Business Combination (s-4) 07/02/2015 05:08:41 PM
OPK News: OPKO and Bio-Reference Laboratories Announce Early Termination of the Waiting Period for Planned Acquisition 07/02/2015 11:10:00 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 07/06/2015 06:41:49 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
#3937   SITE MODERATOR..perhaps you can remove the opening blurb sttone 07/06/15 12:01:59 PM
#3936   SVON my favorite,solid developments. Well known management,Pfizer,Dr. Frost ash111 07/06/15 09:54:26 AM
#3935   Biotech Dealmaking has made Phil Frost one of WiseFool 07/05/15 02:13:31 PM
#3934   New 52-week highs coming here in the next PennyStalker 07/03/15 10:18:27 PM
#3933   That's a LOT of insider buying! Stock Barber 07/03/15 08:50:37 PM
#3932   OPK..Some of OPK insider buys.. junewong 07/03/15 07:42:33 PM
#3931   new S-8k SEC registration merger filing sttone 07/02/15 05:48:51 PM
#3930   OPKO Health's 4Kscore Test — Used by Dr. WiseFool 07/02/15 05:05:57 PM
#3929   Good info.just checked MBVX's financials.Solid like SVON (another ash111 07/02/15 03:32:00 PM
#3928   John Ford easy enough to find - here barnstormer 07/02/15 03:25:47 PM
#3927   I can't find the article..... you have a link?? now invest 07/02/15 02:53:24 PM
#3926   Frost/Opko holding MabVax MBVX just got $5 IMMINENT jfk 07/02/15 11:31:45 AM
#3925   It looks like both parties involved are anxious sttone 07/02/15 11:21:05 AM
#3924   OPKO Health, Inc.; Bio-Reference Laboratories, Inc. 'Early Termination WiseFool 07/02/15 11:05:18 AM
#3923   https://opkodd.wordpress.com/2015/07/02/lowenthal-capital-partners-sees-sig WiseFool 07/02/15 10:17:08 AM
#3922   Yep....and therefore the chart will look even nicer tomorrow now invest 07/01/15 10:29:24 PM
#3921   Closed above the 50. Sweeeeeeeet! stonsetr 07/01/15 07:46:08 PM
#3920   Todd Campbell E.B. Capital Markets ‘Opko Health, WiseFool 07/01/15 11:17:09 AM
#3919   I was looking at it earlier... kind now invest 06/30/15 10:25:28 PM
#3918   Chart has reset. imo stonsetr 06/30/15 07:46:19 PM
#3917   Nice day so far... UP .66 !! now invest 06/30/15 01:20:33 PM
#3916   Frost is still buying stonsetr 06/30/15 09:28:13 AM
#3915   He keeps buying.... AND... why not... thinking later now invest 06/29/15 11:01:14 AM
#3914   Frost still buying. stonsetr 06/29/15 09:08:28 AM
#3913   Left out in the good Dr's write up sttone 06/28/15 04:47:36 PM
#3912   BioTrades DR. MICHAEL MELTZER on Opko Health WiseFool 06/28/15 12:23:46 PM
#3911   Compared to the normal volumes, Fridays volume was stargazer123 06/28/15 11:50:04 AM
#3910   any comments on Friday's volume of 19,017,020 shares? sttone 06/28/15 10:51:26 AM
#3909   What is so disingenuous about the Editor of WiseFool 06/27/15 02:22:24 PM
#3908   Just tell them you will diversify once you game7alcs 06/27/15 11:02:00 AM
#3907   LOL>... I agree it is a good now invest 06/26/15 04:36:52 PM
#3906   Yea seems like desperation for them now. If game7alcs 06/26/15 04:24:53 PM
#3905   Glad I didn't listen to Barron's !!!!!! BOTH TIMES!! now invest 06/26/15 02:47:07 PM
#3904   Who will win? The shorts or Dr. Frost? game7alcs 06/26/15 12:16:08 PM
#3903   $OPK short interest update The short interest registered:48,041,155 on PennyStalker 06/26/15 11:57:56 AM
#3902   Just was going to post it..... GREAT !!!!!!!!!!!!!!!!!!!!!!!!!!!! now invest 06/26/15 10:49:13 AM
#3901   OPKO 4Kscore® Recommended in National Comprehensive Cancer Network PennyStalker 06/26/15 10:46:57 AM
#3900   IMO... People betting against OPK.... WILL REGRET IT!!!! now invest 06/25/15 12:55:51 PM
#3899   Frost stepping up and buying $876,775 worth at PennyStalker 06/25/15 09:10:21 AM
#3898   Next-Generation Upstart OPKO Health Best Place To Invest Best tomsylver 06/24/15 10:14:19 AM
#3897   9000 shares purchased by Dr Frost June 23 sttone 06/24/15 07:30:20 AM
#3896   OPKO Health Building a Major Pharma Company June WiseFool 06/23/15 07:22:12 PM
#3895   Mizuho Securities USA Inc. Reiterates a BUY on WiseFool 06/23/15 07:16:31 PM
#3894   It was talked about in the SA article... now invest 06/23/15 04:46:02 PM
#3893   Thanks for the Barron's article. stargazer123 06/23/15 09:26:56 AM
#3892   Dr. Frost bought $363,351 worth of $OPK yesterday PennyStalker 06/23/15 08:59:01 AM
#3891   barnstormer 06/23/15 01:33:39 AM
#3890   BARRONS ARTICLE sttone 06/23/15 01:27:01 AM
#3889   Thanks for the reply and thoughts stargazer. Really onewhoknows2much 06/22/15 10:49:12 PM
#3888   Cramer's lightning round. game7alcs 06/22/15 08:41:21 PM
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