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Last Post: 2/12/2016 9:56:43 AM - Followers: 151 - Board type: Free - Posts Today: 3
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: Statement of Changes in Beneficial Ownership (4) 07:06 AM
OPK News: Study Demonstrates OPKO’s 4Kscore Test Reduces Unnecessary Prostate Biopsies While Improving Risk Prediction for Aggressive... 02/09/2016 08:30:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 02/09/2016 06:44:54 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 02/08/2016 07:01:10 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 02/05/2016 08:05:48 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 02/12/2016 07:06:59 AM
PostSubject
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#4456   Time to buy more if you can game7alcs 02/12/16 09:56:43 AM
#4455   Down we go Sone 02/12/16 09:52:36 AM
#4454   OPKO Health Acquires Interest in Xenetic Xenetic Biosciences, game7alcs 02/12/16 09:35:11 AM
#4453   Tesaro to Announce Fourth Quarter 2015 Financial Results tomsylver 02/11/16 04:25:02 PM
#4452   Tesaro at LEERINK Partners 5th Annual Global Healthcare Conference http://ir.te tomsylver 02/11/16 02:20:21 AM
#4451   Last few buys... by Frost... now invest 02/10/16 02:00:10 PM
#4449   Cocrystal Pharma Announces In-Licensing of CRISPR Cas Technologies now invest 02/10/16 10:08:08 AM
#4448   wow..? Your analysis is WRONG!,, now invest 02/10/16 08:07:53 AM
#4446   day traders control these huge fluctuations, they feast Tmguns 02/10/16 04:45:40 AM
#4445   I have read that more than one time Matrix999 02/09/16 02:16:41 PM
#4444   Study Demonstrates OPKO's 4Kscore Test Reduces Unnecessary Prostate tomsylver 02/09/16 08:36:55 AM
#4443   Will be nice once we get back to Juice555 02/05/16 12:42:08 AM
#4442   Nice day.... IN OPK land... now invest 02/04/16 10:45:53 PM
#4441   TESARO to Present at the Leerink Partners 5th tomsylver 02/04/16 04:35:45 AM
#4440   Dr. Frost continues his buying (50k in the game7alcs 02/03/16 11:33:20 AM
#4439   MabVax Therapeutics Receives FDA Authorization for Phase I tomsylver 02/02/16 12:52:35 AM
#4438   beware, we've entered the retracement box up to Tmguns 01/30/16 06:25:53 AM
#4437   Interesting write-up now invest 01/29/16 03:19:18 PM
#4436   He has been doing this for years. I game7alcs 01/29/16 01:17:30 PM
#4435   Gonna load up on calls next week Picks77 01/29/16 11:29:36 AM
#4434   Something must be very good in the coming reports. Matrix999 01/29/16 11:26:50 AM
#4433   this is like clock work by the trader Tmguns 01/29/16 10:17:46 AM
#4432   80k bought in the last two days. He's game7alcs 01/29/16 08:15:38 AM
#4431   Biotechs aim for noninvasive prostate cancer biopsies http://www.cbsnews.com/ne tomsylver 01/29/16 01:30:42 AM
#4430   well, the trading houses are boxing this stock Tmguns 01/28/16 03:01:02 PM
#4429   I really don't know if there will be game7alcs 01/27/16 09:25:27 PM
#4428   Hopefully on the heels of good numbers in game7alcs 01/27/16 09:20:23 PM
#4427   What's the next catalyst here? Sone 01/27/16 11:39:59 AM
#4426   Opko Health Inc. (OPK) CEO, Chairman and 10% Matrix999 01/26/16 06:47:01 PM
#4425   Speaking of this March PDUFA, how much of LS1 01/26/16 05:39:06 PM
#4424   March is coming... :-) now invest 01/26/16 01:58:45 PM
#4423   You would be CRAZY to sell right now game7alcs 01/26/16 01:45:49 PM
#4422   Glad I didn't sell any today...... 26 now invest 01/26/16 12:27:45 PM
#4418   Tmguns, Like the charts as well as inside buying Investor100 01/23/16 09:45:08 AM
#4417   Investor 100, what is there to like about Tmguns 01/23/16 06:19:44 AM
#4416   Stockcharts @ OPK Investor100 01/22/16 04:02:12 PM
#4415   I don't think that's odd at all. This game7alcs 01/22/16 10:33:22 AM
#4414   OPKO's GeneDx to Present at Personalized Medicine World tomsylver 01/22/16 09:26:23 AM
#4413   well, here's an ounce of my technical suspicion, Tmguns 01/22/16 08:11:00 AM
#4412   Yes.... Seems he has a family trust..... now invest 01/21/16 08:52:10 PM
#4411   Am I understanding that right. Does he own Bacon23 01/21/16 06:56:59 PM
#4410   That's why he's a billionaire game7alcs 01/21/16 10:19:48 AM
#4409   Frost just keeps buying over $100000 now invest 01/21/16 09:47:08 AM
#4408   I agree with all you said. I've been game7alcs 01/21/16 08:42:42 AM
#4407   I've been to this dance many times before, Tmguns 01/21/16 07:49:38 AM
#4406   TM, I find all your posts informative and game7alcs 01/20/16 08:50:02 PM
#4405   well, Netflix is down 16% from its after Tmguns 01/20/16 10:23:18 AM
#4404   this from a most learned technician Tmguns 01/20/16 04:44:07 AM
#4403   there's never any soldiers left standing in a Tmguns 01/20/16 04:16:49 AM
#4402   Just in case anyone isn't aware of this, surgeon_general 01/20/16 01:08:34 AM
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