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Opko Health Inc (OPK)

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Last Post: 4/19/2017 11:03:19 AM - Followers: 166 - 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) 07:33 AM
OPK News: Xenetic Biosciences’ PolyXen™ Platform Technology Accepted for Poster Presentation at the 13th Annual Protein Engineering... 04/20/2017 07:35:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 04/20/2017 07:28:51 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 04/19/2017 07:33:42 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 04/18/2017 07:05:05 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 04/24/2017 07:33:34 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#5279   Even though I called it I missed the game7alcs 04/19/17 11:03:18 AM
#5278   Thanks Highly appreciate your input I agree with you what Juice555 04/19/17 10:11:19 AM
#5277   Sorry... but have to disagree with you... OPK now invest 04/19/17 10:08:04 AM
#5276   Yeah Very painful Let's hope Dr. Frost is eyeing another Juice555 04/18/17 06:38:36 PM
#5275   Ok I can say I would never thought game7alcs 04/18/17 05:20:47 PM
#5274   Well.... FROST JUST TAKES HIS TIME..... now invest 04/17/17 12:28:25 PM
#5273   $OPK - back in at $7.53 Atlanta1 04/13/17 02:01:56 PM
#5272   OPK Acquired Common Stock swanlinbar 04/13/17 01:51:28 PM
#5271   So then what does table 2 signify with seppi08162 04/12/17 08:28:39 AM
#5270   That's incorrect. She simply exercised her options thought013 04/12/17 12:31:32 AM
#5269   Maybe she needed the $150k for something. I game7alcs 04/11/17 08:12:24 PM
#5268   Thanks for the clarification. I just see the Juice555 04/11/17 07:37:08 PM
#5267   No, she "acquired" 20000 shares (stock option) within seppi08162 04/11/17 07:34:06 PM
#5266   What are you talking about??? I see Alice buying Juice555 04/11/17 06:23:31 PM
#5265   Always great seeing a director sell 20000 shares seppi08162 04/11/17 05:35:16 PM
#5264   Yea me too. My thought has always been game7alcs 04/07/17 09:21:41 PM
#5263   Hmm... I am more leaning toward frost buying the Juice555 04/07/17 09:16:51 PM
#5262   One more thing. I'm thinking the same but game7alcs 04/07/17 09:12:50 PM
#5261   Nice job and good luck to you. game7alcs 04/07/17 09:09:18 PM
#5260   Yeah I am up to 25k shares now Juice555 04/07/17 09:06:05 PM
#5259   I agree. Nice buy. I was thinking of game7alcs 04/07/17 09:03:36 PM
#5258   I picked up another 2000 shares over the Juice555 04/07/17 09:00:54 PM
#5257   My guess is the next cc is around game7alcs 04/07/17 04:42:59 PM
#5256   Yeah - this is also my biggest holding, seppi08162 04/06/17 07:24:29 PM
#5255   I feel you Now Invest! I was in tredenwater2 04/06/17 03:41:37 PM
#5254   Seriously, I have spoke to the shareholders rep now invest 04/06/17 12:54:04 PM
#5253   We have $1.2 bil in revs and many game7alcs 04/05/17 08:30:58 AM
#5252   Idk im just frustrated, having been here for seppi08162 04/05/17 08:01:24 AM
#5251   why? Atlanta1 04/05/17 07:49:26 AM
#5249   I wonder what Ladenburg Thalmann has been telling tredenwater2 04/04/17 09:44:27 AM
#5248   To reiterate something I brought up after it seppi08162 04/03/17 10:14:25 AM
#5247   OPK owned these shares when the merger took UHD 04/02/17 09:26:12 AM
#5246 seppi08162 04/01/17 03:07:29 PM
#5245   Well... Maybe Frost will give another interview with now invest 03/31/17 12:11:18 PM
#5244   Ah... so far they are hitting it... so now invest 03/29/17 02:35:38 PM
#5243   Ole!!! We have lots of gaps to fill Juice555 03/28/17 05:13:44 PM
#5242   Today... first day since Dec. 30th that OPK now invest 03/28/17 04:53:43 PM
#5241   4kScore getting a positive mention.. seppi08162 03/28/17 11:12:58 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