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Opko Health Inc (OPK)

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Last Post: 7/23/2016 10:39:32 AM - Followers: 159 - Board type: Free - Posts Today: 1

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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Current Price
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OPK News: Statement of Changes in Beneficial Ownership (4) 07/14/2016 06:07:38 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 07/12/2016 06:19:37 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 07/01/2016 10:36:32 AM
OPK News: Current Report Filing (8-k) 07/01/2016 09:47:20 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 06/30/2016 07:12:50 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#4824   Last week was one of those unusual weeks game7alcs 07/23/16 10:39:32 AM
#4823   ..A little more Press or some Updates of seppi08162 07/20/16 12:28:14 PM
#4822   Earnings Focus and Crowd Sourced Sentiment Review for junewong 07/18/16 08:13:13 PM
#4821   Nice to see OPK over 10 !! now invest 07/18/16 10:28:35 AM
#4820   ENGOT and TESARO Partnership Generates Positive Data The ENGOT-OV16/NOVA tomsylver 07/08/16 04:33:45 PM
#4819   OPKO Health's Latest Acquisition A Winner junewong 07/08/16 12:27:19 PM
#4818   Short Interest up about 5 Million junewong 07/06/16 09:02:32 PM
#4817   Here’s What Opko Gets For Its $60 Million venturecapp 07/05/16 02:22:56 PM
#4816   A Big Breakthrough for Ovarian Cancer Patients Tesaro's PARP-inhibitor tomsylver 07/03/16 02:25:58 PM
#4815   Yes... IMO... it is great... AND LONG OVER now invest 07/03/16 10:00:18 AM
#4814   awesome Atlanta1 07/02/16 10:45:06 AM
#4813 now invest 07/02/16 10:22:53 AM
#4812   OPK bullish 9.71 stocktrademan 07/01/16 04:45:29 PM
#4811 Robert Wasserman Jun 30, 2016 5:15 PM tomsylver 07/01/16 01:00:44 AM
#4810   OPKO Health to Acquire Transition Therapeutics tomsylver 06/30/16 03:36:09 AM
#4809   $OPK - Frost was in there snapping up Atlanta1 06/28/16 09:28:07 AM
#4808   This price under $9 is a steal! DegenerateGambler 06/27/16 12:50:30 PM
#4807   that should work out very nicely. Atlanta1 06/27/16 12:35:56 PM
#4806   After getting completely out on May 5 at DegenerateGambler 06/27/16 12:31:17 PM
#4805   $OPK - Frost bought more on Friday. Atlanta1 06/27/16 07:11:15 AM
#4804   A little dangerous to buy right now until game7alcs 06/24/16 09:19:16 AM
#4803   $OPK - bought pre-market @ 9.26 Atlanta1 06/24/16 08:13:13 AM
#4802   ok - thanks Atlanta1 06/24/16 07:21:08 AM
#4801   DD? Opko licensed Rolapitant (now Varubi) to Tesaro... tomsylver 06/24/16 07:19:37 AM
#4800   what does this have to do with OPK? Atlanta1 06/24/16 05:32:05 AM
#4799   TESARO Announces Rolapitant Data Presentations at the 2016 tomsylver 06/24/16 05:07:33 AM
#4798   It might send us to $10 lol just game7alcs 06/23/16 09:18:25 PM
#4797   Wait until we get approval for the hgh Juice555 06/23/16 05:17:31 PM
#4796   $25+? I would not sell at $25, even not tomsylver 06/23/16 04:15:10 PM
#4795   $OPK - have been loading up the last Atlanta1 06/23/16 03:35:10 PM
#4794   FDA Approval @ OPK Investor100 06/22/16 04:52:43 PM
#4793   10:35 IBB Biotech/pharma stocks surging after Medicare ruling: Did not Atlanta1 06/22/16 10:37:07 AM
#4792   Nope Sone 06/22/16 09:55:28 AM
#4791   We break out tomorrow mid 10's to 11.... makapia 06/21/16 09:37:05 PM
#4790   Me long three... Stock Barber 06/21/16 06:40:37 PM
#4789   I agree.. Me long too Sone 06/21/16 06:35:26 PM
#4788   It's looking that way right now. If the game7alcs 06/21/16 06:34:21 PM
#4787   I think this goes back down a bit.. Sone 06/21/16 06:28:08 PM
#4786   I agree. Some are saying they don't expect game7alcs 06/21/16 06:16:38 PM
#4785   UNCLETLZZ OPKO DUE DILIGENCE junewong 06/21/16 04:54:26 PM
#4784   21-Jun-16 14:59 ET Atlanta1 06/21/16 03:18:48 PM
#4783   Why This Top Analyst is Bullish on Opko now invest 06/21/16 11:33:58 AM
#4782   My two cents... Really... The day now invest 06/21/16 11:25:49 AM
#4781   You are welcome Sky10 06/21/16 11:02:45 AM
#4780   I think it is expected though. For some game7alcs 06/21/16 09:55:45 AM
#4779   This Is embarrassing Sone 06/21/16 09:46:42 AM
#4778   21.73% Matrix999 06/21/16 09:36:06 AM
#4777   how large is the short position? Atlanta1 06/21/16 09:09:30 AM
#4776   I don't believe we will get even close game7alcs 06/21/16 09:02:25 AM
#4775   NO! Go FROST & $OPK Matrix999 06/21/16 08:59:37 AM