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Last Post: 9/28/2016 12:52:21 PM - Followers: 161 - 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.

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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) 09/29/2016 06:31:14 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 09/28/2016 06:18:34 AM
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OPK News: Confidential Treatment Order (ct Order) 09/26/2016 03:01:06 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 09/29/2016 06:31:14 AM
PostSubject
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#4942   Agree always a buy in the low $9s, DegenerateGambler 09/28/16 12:52:20 PM
#4941   OPK always a buy in low 9s dshade 09/27/16 03:33:48 PM
#4940   I wonder if RAYALDEE could play a role joe_techi 09/26/16 02:03:52 PM
#4939   OPK @ Stockcharts Investor100 09/24/16 11:41:38 PM
#4938   Yea it's doing well. Nice push through. game7alcs 09/23/16 12:26:41 PM
#4937   11.05!!! Nice.... And on a down day now invest 09/23/16 10:43:01 AM
#4936   Wake me up when we get back to Juice555 09/23/16 10:19:52 AM
#4935   I was just watching that. It might take game7alcs 09/23/16 09:49:04 AM
#4934   Hit 11.00 this morning... lots of shares show now invest 09/23/16 09:46:25 AM
#4933   Looking good. Nice slow move as you said game7alcs 09/23/16 09:44:27 AM
#4932   latest move due to 50-50 joint venture with joe_techi 09/21/16 03:49:28 PM
#4931   Opk... has been just moving up slowly... for now invest 09/20/16 09:43:00 AM
#4930   June, gotta love the sentiment but while appearing connyank 09/17/16 02:09:25 PM
#4929   Nice chart on the Golden Cross part... and now invest 09/16/16 11:10:29 AM
#4928   stockcharts.com/c-sc/sc?s=OPK&p=D&b=5&g=0&i=t87378893985&r=1473940855849[ stonsetr 09/15/16 08:02:49 AM
#4927   Sky, I completely agree that the revenues produced DegenerateGambler 09/14/16 07:06:43 PM
#4926   1.1M at $10.15! joe_techi 09/14/16 03:22:44 PM
#4925   Huge block trades going through Sone 09/14/16 03:08:32 PM
#4924   My guess is OPK will reach $12 by Sky10 09/14/16 12:12:04 PM
#4923   the shorts know that they have only a Sky10 09/14/16 12:10:19 PM
#4922   Chart looking better !! if we can keep now invest 09/14/16 08:01:28 AM
#4921   Interesting reading.. junewong 09/10/16 01:24:53 PM
#4920   Chart looks ready stonsetr 09/09/16 09:28:48 AM
#4919   From WS Journal , the average analysts price Sky10 09/07/16 01:51:11 PM
#4918   Like how we are starting to drift back now invest 09/07/16 09:57:56 AM
#4917   LATEST OPKO HEALTH, INC. (NASDAQ:OPK) TARGET PRICE SUGGESTS junewong 09/05/16 10:31:07 PM
#4916   Nothing majorly significant. It just shows he is game7alcs 09/01/16 03:17:57 PM
#4915   He bought 544,000 in one day in August ILS142 09/01/16 03:14:45 PM
#4914   OPK is a stock with little downside risk Sky10 09/01/16 12:04:52 PM
#4913   A run back to $10 for the long seppi08162 09/01/16 10:06:17 AM
#4912   yep - sold those .28's yesterday at .30+ Atlanta1 08/31/16 11:51:46 AM
#4911   Lol makapia 08/31/16 11:42:00 AM
#4910   Opko completes acquisition of TTHI MIAMI--(BUSINESS WIRE)-- OPKO Health, tomsylver 08/31/16 02:46:54 AM
#4909   OPK is one of the best stock to Sky10 08/30/16 04:11:39 PM
#4908   out at $9.42, back in at $9.28 Atlanta1 08/30/16 02:53:12 PM
#4907   Cramer LR: Opko Health: "A lot of people are tomsylver 08/30/16 02:21:23 AM
#4906   oops i see. mod,please delete. ash111 08/29/16 01:28:53 PM
#4905   Yea he still likes to suck up the game7alcs 08/29/16 01:24:27 PM
#4904   Wrong board game7alcs 08/29/16 01:23:33 PM
#4903   $27m in cash,vs $22m cap(6.3m O/S). float about ash111 08/29/16 12:42:12 PM
#4902   What I like in OPK is the risk Sky10 08/29/16 12:39:07 PM
#4901   I think in 5 years OPK will be Sky10 08/29/16 11:47:11 AM
#4900   Well.. at least over the past week... Frost now invest 08/29/16 10:36:29 AM
#4899   What will OPK trade for in 5 Years? Jahred 08/27/16 05:08:32 PM
#4898   Gremlin, I had to do a double check DegenerateGambler 08/26/16 04:09:42 PM
#4897   touched 9 again. nice entry again for some. dshade 08/26/16 03:45:05 PM
#4896   You might want to look at ONTX. $2 Gremlin9999 08/26/16 02:54:43 PM
#4895   OPK $9.03. Are you buying more? Gremlin9999 08/26/16 02:44:40 PM
#4894   Starting in January 2017 substantial revenues will be Sky10 08/26/16 11:36:05 AM
#4893   Transition Therapeutics Shareholders Approve Acquisition by OPKO Health August game7alcs 08/26/16 09:09:41 AM
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