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Last Post: 10/20/2016 1:45:53 PM - Followers: 162 - 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.

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) 06:05 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/20/2016 07:50:08 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/19/2016 07:46:45 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/18/2016 06:07:14 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 10/14/2016 06:19:00 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 10/21/2016 06:05:38 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#5004   Good luck to you. I'm sure you will game7alcs 10/20/16 01:45:53 PM
#5003   I know they don't answer emails. game7alcs 10/20/16 01:44:27 PM
#5002   In my opinion , OPK is undervalued at Sky10 10/20/16 12:22:00 PM
#5001   Yes, I became impatient with my OPK holdings, DegenerateGambler 10/20/16 11:31:56 AM
#5000   About the silence... now invest 10/20/16 09:52:42 AM
#4999   Hi, game7alcs. terry hallinan 10/20/16 09:49:05 AM
#4998   Terry, Nice post. Maybe Nr. Boeheim needs to game7alcs 10/20/16 09:42:43 AM
#4997   Here's a prostate cancer test Palmetto apparently loves terry hallinan 10/20/16 09:42:30 AM
#4996   +Morning, Sepp. terry hallinan 10/20/16 09:30:30 AM
#4995   I understand and agree with the frustration. My game7alcs 10/20/16 08:57:00 AM
#4994   You are correct, Sapp game7alcs 10/20/16 08:45:42 AM
#4993   I believe that article (from the summer) refers seppi08162 10/20/16 08:21:34 AM
#4992   "I too am disappointed at Opko's failure to terry hallinan 10/20/16 03:05:23 AM
#4991   I too am disappointed at Opko's failure to DegenerateGambler 10/19/16 10:44:44 PM
#4990   I have to agree. I tried two emails game7alcs 10/19/16 12:17:44 PM
#4989   Extremely disappointing from management to have heard virtually seppi08162 10/19/16 10:55:04 AM
#4988   Vanguard Group Inc. now owns 23,101,477 shares of game7alcs 10/16/16 09:54:25 AM
#4987   Opko Health Inc. (OPK) Short Interest Update game7alcs 10/16/16 09:51:10 AM
#4986   Right. Novitas originally approved coverage but rescinded it game7alcs 10/15/16 11:40:32 PM
#4985   Some analysts expect Palmetto peer Novitas to offer UHD 10/15/16 11:36:54 PM
#4984   Nope UHD 10/15/16 11:30:17 PM
#4983   Ok. From what I read Palmetto is the game7alcs 10/15/16 11:27:25 PM
#4982   Thanks for the article Future always looks promising Juice555 10/15/16 11:17:54 PM
#4981   Palmetto os not the one paying for it UHD 10/15/16 11:08:37 PM
#4980   A good article. The thing that I thought game7alcs 10/15/16 11:07:01 PM
#4979   A Good Long article UHD 10/15/16 10:48:23 PM
#4978   a good short article. game7alcs 10/15/16 10:38:40 AM
#4977   Good point. game7alcs 10/11/16 03:54:47 PM
#4976   Global use outside of US should also be dshade 10/11/16 03:47:51 PM
#4975   While I am a strong supporter and holder now invest 10/10/16 09:46:31 AM
#4974   Not that this article about Zika is a game7alcs 10/09/16 10:07:44 PM
#4973   Thanks for your input I hope Novartis will approve Juice555 10/08/16 10:23:29 AM
#4972   In my opinion the effect long term is game7alcs 10/08/16 10:10:43 AM
#4971   so true, what works gets denied, what doesn't...govt dshade 10/07/16 02:00:20 PM
#4970   So how much this will affect us long term? Juice555 10/07/16 12:47:31 PM
#4969   Yea well this smells of a Clinton type game7alcs 10/07/16 12:22:14 PM
#4968   It seems Palmetto has made a final non-coverage tomsylver 10/07/16 12:19:51 PM
#4967 tomsylver 10/07/16 12:18:16 PM
#4966   More games and politics... I hope they will address Juice555 10/07/16 12:13:48 PM
#4965   I believe he will. I sent an email game7alcs 10/07/16 12:12:11 PM
#4964   Let's see if he steps in and buys Juice555 10/07/16 12:04:59 PM
#4963   he buys almost every day. Atlanta1 10/07/16 11:40:36 AM
#4962   Thanks Makes me feel better about my buy today Juice555 10/07/16 10:42:06 AM
#4961   Form 4 out this morning, he bought more yesterday UHD 10/07/16 10:41:17 AM
#4960   I couldn't resist buying more at these prices. game7alcs 10/07/16 10:39:37 AM
#4959   It would be nice to see some pushback game7alcs 10/07/16 10:27:21 AM
#4958   Looks like some good q&a on game7alcs 10/07/16 10:24:39 AM
#4957   Yeah i'm feeling about the same way. seppi08162 10/07/16 10:24:11 AM
#4956   That's a big setback. Not expected. Curious to game7alcs 10/07/16 10:17:47 AM
#4955   Do we know how significant/legitimate these preliminary claims seppi08162 10/07/16 10:13:26 AM