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Last Post: 9/17/2018 5:20:17 PM - Followers: 171 - 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: Current Report Filing (8-k) 09/14/2018 05:10:13 PM
OPK News: OPKO Confirms Resumption of Common Stock Trading on Nasdaq 09/14/2018 01:33:00 PM
OPK News: Nasdaq Scheduled Resumption in OPKO Health, Inc. 09/14/2018 12:47:23 PM
OPK News: Federman & Sherwood Announces Filing of Securities Class Action Lawsuit Against OPKO Health, Inc. 09/14/2018 10:37:00 AM
OPK News: OPKO Class Action: Bernstein Liebhard LLP Announces That A Securities Class Action Lawsuit Has Been Filed Against OPKO Health... 09/12/2018 07:04:00 PM
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#6341   Yes I guess we will find out tomorrow But Juice555 09/17/18 05:20:17 PM
#6340   Yea maybe he bought today game7alcs 09/17/18 05:15:51 PM
#6339   I thought maybe this would be a special circumstance game7alcs 09/17/18 05:15:13 PM
#6338   * * $OPK Video Chart 09-17-18 * * ClayTrader 09/17/18 05:11:33 PM
#6337   Yes. I guess it wasn't him Juice555 09/17/18 04:08:38 PM
#6336   I rarely see a Frost trade that large. Atlanta1 09/17/18 04:02:15 PM
#6335   I was referring to Friday’s trades. Juice said game7alcs 09/17/18 03:56:45 PM
#6334   connyank: Thanks for reiterating my point that a Straightshot 09/17/18 03:14:20 PM
#6333   you haven't seen one? Atlanta1 09/17/18 03:13:47 PM
#6332   I haven’t seen an SEC form 4 filing game7alcs 09/17/18 03:11:15 PM
#6331   this is fascinating to watch. I wonder how Atlanta1 09/17/18 12:37:55 PM
#6330   A mistake? If the private sector made as game7alcs 09/17/18 10:24:57 AM
#6329   Is there anyone here who hasn't seen the DegenerateGambler 09/16/18 09:59:17 PM
#6328   The SEC isn’t that stupid? lol it is game7alcs 09/16/18 07:37:43 PM
#6327   We should know soon enough. But. Frost Hopeful1037 09/15/18 09:44:18 PM
#6326   For them to list such a public name. Hopeful1037 09/15/18 09:40:20 PM
#6325   You say we need the truth to come DegenerateGambler 09/15/18 07:57:58 PM
#6324   good thoughts but this is the SEC, nothing connyank 09/15/18 06:41:25 PM
#6323   Dr frost Has donated. Over 145 Hopeful1037 09/15/18 03:16:44 PM
#6322   The slime balls will not get a nickel connyank 09/15/18 01:41:21 PM
#6321   "Remember Ivan Boesky??" connyank 09/15/18 01:34:59 PM
#6320   Let's hope there is no blood for them game7alcs 09/15/18 09:52:42 AM
#6319   I always thought he would sell to a game7alcs 09/15/18 09:51:12 AM
#6318   your opinion of lawyers is spot on and DegenerateGambler 09/15/18 12:07:16 AM
#6317   I am with you Will see this through My "gut" Juice555 09/14/18 09:08:19 PM
#6316   There is a very good chance you are game7alcs 09/14/18 08:15:56 PM
#6315   I believe Dr. Frost as well. However, there DegenerateGambler 09/14/18 08:03:48 PM
#6314   Yes I know what you mean but I Juice555 09/14/18 05:32:41 PM
#6313   I can’t blame you. Maybe one day you game7alcs 09/14/18 05:28:52 PM
#6312   I agree. I don’t know if we will game7alcs 09/14/18 05:27:40 PM
#6311   We will have to disagree on that. Dr. game7alcs 09/14/18 05:26:37 PM
#6310   * * $OPK Video Chart 09-14-18 * * ClayTrader 09/14/18 05:10:28 PM
#6309   Investor Frost "stunned" by SEC charges realfast95 09/14/18 04:57:01 PM
#6308   Considering everything and the past week I would Juice555 09/14/18 04:26:21 PM
#6307   4.01 crowin 09/14/18 03:36:09 PM
#6306   Sold the 10,000 shares I bought a week DegenerateGambler 09/14/18 02:33:53 PM
#6305   So you walk into a bank and hold Straightshot 09/14/18 02:28:24 PM
#6304   Resumed trading...not showing that is margianable like before homeboy 09/14/18 02:18:47 PM
#6303   Yes me too. I feared the low 3's Juice555 09/14/18 01:45:03 PM
#6302   I agree although it’s still bouncing. It’s doing game7alcs 09/14/18 01:44:06 PM
#6301   I can't believe we are close on going Juice555 09/14/18 01:26:15 PM
#6300   Hopefully he/they do something. game7alcs 09/14/18 01:24:02 PM
#6299   Yes I saw 250k on the bid at Juice555 09/14/18 01:22:16 PM
#6298   Yea any big trades you see are most game7alcs 09/14/18 01:20:59 PM
#6297   I have a feeling he bought 250k today Juice555 09/14/18 01:19:25 PM
#6296   Yea it’s holding. Wonder if Dr. Frost bought? game7alcs 09/14/18 01:18:45 PM
#6295   So far so good but too early to Juice555 09/14/18 01:16:17 PM
#6294   Here we go game7alcs 09/14/18 01:15:36 PM
#6293   I will be a buyer in the 2.90's/3 Juice555 09/14/18 01:06:05 PM
#6292   ihub has it realfast95 09/14/18 01:01:03 PM
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