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Last Post: 8/30/2016 2:21:23 AM - Followers: 160 - 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.

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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: Transition Therapeutics Shareholders Approve Acquisition by OPKO Health 08/26/2016 08:52:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/26/2016 06:27:11 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/25/2016 06:27:20 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 08/24/2016 07:32:30 AM
OPK News: OPKO Health Responds to Law Firm Notice of Investigation 08/23/2016 12:47:00 PM
PostSubject
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#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
#4892   Frost has been on a buying streak lately, stonsetr 08/26/16 09:09:40 AM
#4891   Frost just bought close to $500k worth yesterday UHD 08/26/16 08:27:27 AM
#4890   Roger that! makapia 08/25/16 06:32:06 PM
#4889   Dr. Frost has already created a biotech corporation, surgeon_general 08/25/16 03:02:20 PM
#4888   I don't see that happening. I believe he game7alcs 08/25/16 12:17:35 PM
#4887   Anyone knows if Frost takes OPK private : Sky10 08/25/16 11:35:01 AM
#4886   There are no oops buying at these levels. game7alcs 08/25/16 11:25:50 AM
#4885   oops.. Atlanta1 08/25/16 10:01:11 AM
#4884   bought a bunch pre market 9.18-9.24 Atlanta1 08/25/16 09:25:38 AM
#4883   wow - look what happened after hours Atlanta1 08/24/16 06:17:31 PM
#4882   looks like a trade desk had to take Atlanta1 08/24/16 05:14:06 PM
#4881   There are both good and bad news for Sky10 08/24/16 04:37:10 PM
#4880   I had to buy a little more today... Stock Barber 08/24/16 03:50:24 PM
#4879   we can thank Hillary for these prices today. Atlanta1 08/24/16 03:36:47 PM
#4878   I am actually averaging up LOL Most of my Juice555 08/24/16 03:33:50 PM
#4877   avg down at 9.23 Atlanta1 08/24/16 03:10:51 PM
#4876   in at $9.325 Atlanta1 08/24/16 02:52:16 PM
#4875   Nice article on seeking a Matrix999 08/24/16 09:50:27 AM
#4874   Yea agreed. ?? I didn't grab anymore but game7alcs 08/23/16 07:56:53 PM
#4873   They should have waited a couple more days Juice555 08/23/16 06:43:40 PM
#4872   OPKO Health Responds to Law Firm Notice of game7alcs 08/23/16 05:48:25 PM
#4871   You may be right, but I feel very DegenerateGambler 08/18/16 08:28:14 PM
#4870   Since OPK will be around $ 10 for Sky10 08/18/16 03:30:29 PM
#4869   Agree game7alcs 08/15/16 06:13:51 PM
#4868   I do not mind the share price sitting DegenerateGambler 08/15/16 04:18:29 PM
#4867   DG, Good luck with the cancer. My bladder cancer Matrix999 08/10/16 10:11:42 AM
#4866   Good luck on your new buy !! now invest 08/10/16 09:57:52 AM
#4865   My funds cleared last night, so I bought DegenerateGambler 08/10/16 09:53:31 AM
#4864   OPK has very minimal downside risk but a Sky10 08/09/16 07:53:41 PM
#4863   Well.... then you will have more than me... now invest 08/09/16 07:31:26 PM
#4862   I plan to double by 10,000 share position DegenerateGambler 08/09/16 05:37:06 PM
#4861   Thanks... now invest 08/09/16 03:47:22 PM
#4860   I received the newsletters by mail on August 3 Sky10 08/09/16 03:46:05 PM
#4859   That has been the nature of this stock. game7alcs 08/09/16 03:14:30 PM
#4858   Very surprised to see the sell off since seppi08162 08/09/16 01:56:31 PM
PostSubject