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Last Post: 3/22/2017 8:26:46 AM - Followers: 165 - 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: Statement of Changes in Beneficial Ownership (4) 03/24/2017 07:26:20 AM
OPK News: Current Report Filing (8-k) 03/23/2017 04:33:25 PM
OPK News: OPKO Receives FDA Orphan Drug Status for its New Oligonucleotide to Treat Genetic Neurological Disorder 03/22/2017 08:00:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 03/22/2017 07:29:48 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 03/21/2017 07:33:40 AM
PostSubject
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#5240   Fda News :) stock1ace1 03/22/17 08:26:46 AM
#5239   OPKO Receives FDA Orphan Drug Status for its midastouch017 03/22/17 08:19:06 AM
#5238   geeze - glad I sold at $8.50 pre market... Atlanta1 03/17/17 10:10:35 AM
#5237   anyone know why this is gapping? Atlanta1 03/17/17 09:26:40 AM
#5236   I understand that there are many reasons to now invest 03/16/17 01:01:08 PM
#5235   They have always done that. Must be part game7alcs 03/16/17 12:48:27 PM
#5234   Probably they do not have enough cash to Sky10 03/16/17 12:06:18 PM
#5233   To bad a director and the CFO... decided now invest 03/16/17 11:05:42 AM
#5232   I agree with what you are saying. The game7alcs 03/15/17 01:26:34 PM
#5231   Actually I do think it could make shorts now invest 03/15/17 01:23:49 PM
#5230   Ehh I doubt it. I think that's a game7alcs 03/15/17 12:12:16 PM
#5229   $OPK - back in at $8.08 Atlanta1 03/15/17 11:33:50 AM
#5228   Thanks! game7alcs 03/14/17 10:20:49 PM
#5227   Guggenheim Starts Opko Health (OPK) at Buy, "Dr. midastouch017 03/14/17 01:26:08 PM
#5226   Yea I saw a couple SA articles come game7alcs 03/14/17 10:40:27 AM
#5225   that quote came from Seeking Alpha ... had now invest 03/14/17 10:38:25 AM
#5224   grapes in season..... Atlanta1 03/14/17 10:21:35 AM
#5223   What was their reason? game7alcs 03/14/17 10:18:06 AM
#5222   RECOMMENDATION...!! Opko Health (NYSEMKT:OPK) initiated with Buy rating and now invest 03/14/17 10:09:32 AM
#5221   OPKO Health, Inc. (NASDAQ:OPK) announces that GenPath Women’s now invest 03/07/17 09:52:46 AM
#5220   but he is now back down... IF you now invest 03/06/17 09:43:19 AM
#5219   I agree with you. I have been really game7alcs 03/03/17 06:33:27 PM
#5218   From Motley Fool: someconcerns 03/03/17 03:57:07 PM
#5216   Cool. I like the emails j3sg sends someconcerns 03/03/17 02:37:26 PM
#5215   FYI... The form 4s are shown in the now invest 03/03/17 02:28:25 PM
#5214   I was just going off my report from someconcerns 03/03/17 01:26:31 PM
#5213   well, the Form 4 shows 94.8K Atlanta1 03/03/17 01:01:12 PM
#5212   Atl, It's just a nitpicking difference, but I someconcerns 03/03/17 12:28:25 PM
#5211   There is no doubt he believes in the game7alcs 03/03/17 09:33:49 AM
#5210   I was expecting Frost to pick up his Atlanta1 03/03/17 08:27:52 AM
#5209   Yes I did notice that. This is the game7alcs 03/03/17 07:47:05 AM
#5208   Did you notice the analyst asking why scripts now invest 03/03/17 07:43:06 AM
#5207   I would not be surprised to see this game7alcs 03/02/17 11:05:45 PM
#5206   I am listening to it right now. I game7alcs 03/02/17 09:47:08 PM
#5205   just got home was out of pocket today... now invest 03/02/17 09:38:00 PM
#5204   Yup. First gear, then second.... someconcerns 03/02/17 09:07:23 PM
#5203   Yea that might be. Never thought I would game7alcs 03/02/17 08:56:38 PM
#5202   Yes, those are pretty economical and easy to someconcerns 03/02/17 08:13:26 PM
#5201   Oh nice. One of BIOs sales reps I game7alcs 03/02/17 08:07:02 PM
#5200   Have not posted here for a while but someconcerns 03/02/17 08:05:12 PM
#5199   Ok thanks. I read SA and the article game7alcs 03/02/17 01:51:22 PM
#5198   I posted the link earlier Atlanta1 03/02/17 11:59:58 AM
#5197   Thanks. I will read it. game7alcs 03/02/17 11:58:38 AM
#5196   I guess my thoughts of $7.60-$7.70 were too game7alcs 03/02/17 11:57:50 AM
#5195   the transcript is on SA Atlanta1 03/02/17 11:57:42 AM
#5194   I plan on listening to the CC tonight. game7alcs 03/02/17 11:56:39 AM
#5193   a 100K buy just crossed at $7.69 Atlanta1 03/02/17 09:52:42 AM
#5192   I got nothing left!! Lol no powder Sone 03/02/17 09:47:33 AM
#5191   yep - it happens. Atlanta1 03/02/17 09:45:56 AM
#5190   Just a comment on Management.... now invest 03/02/17 09:44:40 AM
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