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Last Post: 12/18/2014 9:57:15 AM - Followers: 123 - 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: Statement of Changes in Beneficial Ownership (4) 12/18/2014 06:50:18 AM
OPK News: Current Report Filing (8-k) 12/15/2014 09:29:48 AM
OPK News: OPKO and Pfizer Enter into Global Agreement for OPKO’s Long-Acting Human Growth Hormone (hGH-CTP) 12/15/2014 08:00:00 AM
OPK News: Tiger Media Announces Agreement to Acquire Interactive Data, LLC 12/15/2014 08:00:00 AM
OPK News: OPKO Health to Present at the Oppenheimer 25th Annual Healthcare Conference 12/03/2014 08:30:00 AM
PostSubject
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#2454  Sticky Note May 9, 2014, 10:17am EDT Myth 06/03/14 02:38:24 PM
#3219   You are welcome. stonsetr 12/18/14 09:57:15 AM
#3218   Ok. I knew there was a chance it game7alcs 12/18/14 09:49:17 AM
#3217   Disregard my last post, Frost bought more on stonsetr 12/18/14 09:43:20 AM
#3216   Was thinking the same. Perhaps another event in stonsetr 12/18/14 09:37:08 AM
#3215   Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#3214   Pfizer, Inc. Invests in Growth... Literally ( http://www.fool.com/investing/gene tomsylver 12/18/14 01:35:53 AM
#3213   * * $OPK Video Chart 12-17-14 * * ClayTrader 12/17/14 04:59:40 PM
#3212   No new buys showing up yet from him. game7alcs 12/17/14 04:09:52 PM
#3211   NICE MOVE TODAY..... AND HOPEFULLY WE WILL BE now invest 12/17/14 02:16:27 PM
#3210   In my opinion the importance of this deal game7alcs 12/16/14 08:11:03 PM
#3209   Pfizer Ponies Up to Develop Long-acting Growth Hormone tomsylver 12/16/14 04:09:16 PM
#3208   Oppenheimer analyst Rohit Vanjani reiterated an Outperform rating tomsylver 12/16/14 03:47:18 PM
#3207   The Motley Fool on OPKO "keep an eye tomsylver 12/15/14 03:55:50 PM
#3206   I agree completely game7alcs 12/15/14 12:21:12 PM
#3205   There has to be some back and forth.. now invest 12/15/14 12:20:15 PM
#3204   I would have expected the price to hold game7alcs 12/15/14 12:00:39 PM
#3203   Yep! stonsetr 12/15/14 09:47:31 AM
#3202   Yes, IHub has a Prolor/PBTH board, even though someconcerns 12/15/14 09:45:51 AM
#3201   OPKO's PR: OPKO and Pfizer Enter into Global Agreement tomsylver 12/15/14 09:41:35 AM
#3199   Yea I believe this is just the beginning game7alcs 12/15/14 09:35:40 AM
#3198   Yes. A valid reason for why Dr Frost someconcerns 12/15/14 09:31:31 AM
#3197   PHILLIP FROST PLAYS RULE starbuxsux 12/15/14 09:05:38 AM
#3196   I guess maybe our wish came true game7alcs 12/15/14 08:59:13 AM
#3195   $IDI - Tiger Media Announces Agreement to Acquire starbuxsux 12/15/14 08:49:55 AM
#3194   Remember. .... More PRODUCTS TO COME!!!! RAYALDEE now invest 12/15/14 08:33:29 AM
#3193   OPKO and Pfizer Enter into Global Agreement for abbey1212 12/15/14 08:13:24 AM
#3192   Yes, I have faith in the Doktah, I Gingi 12/12/14 09:58:59 PM
#3191   I am patient. My cost range is someconcerns 12/12/14 04:48:17 PM
#3190   Pretty big volume in Pre market trading....$OPK Gingi 12/12/14 09:25:55 AM
#3189   We can hope that's the case :-) game7alcs 12/11/14 10:07:07 PM
#3188   Yes, I was in Prolor and took $OPK someconcerns 12/11/14 07:34:12 PM
#3187   I actually do not want him to buy Gingi 12/11/14 04:54:37 PM
#3186   Ask him when he is buying more $OPK someconcerns 12/11/14 04:46:12 PM
#3185   Some & game, Gingi 12/11/14 04:43:27 PM
#3184   Yup. someconcerns 12/11/14 03:28:59 PM
#3183   That might be good. It certainly isn't up game7alcs 12/11/14 03:18:08 PM
#3182   That explains the gap. $OPK was VERY someconcerns 12/11/14 01:45:47 PM
#3181   It was for almost 2 weeks from 11/29/13 game7alcs 12/11/14 01:40:23 PM
#3180   OK. Thank you for checking. someconcerns 12/11/14 01:16:41 PM
#3179   Not that I found game7alcs 12/11/14 01:14:52 PM
#3178   Did that gap in his buying $OPK coincide someconcerns 12/11/14 12:34:59 PM
#3177   Yea I'm hoping for the announcement too.. lol game7alcs 12/11/14 12:32:59 PM
#3176   I don't know. I doubt that the someconcerns 12/11/14 12:29:50 PM
#3175   I was wondering if that had anything to game7alcs 12/11/14 12:12:00 PM
#3174   The election of the new Chairman was several someconcerns 12/11/14 11:43:38 AM
#3173   The board of Teva Pharmaceutical Industries Ltd elected game7alcs 12/10/14 07:29:34 PM
#3172   I hear ya, and share the wishful thinking :) Gingi 12/10/14 03:55:47 PM
#3171   To all shareholders ? Myth 12/10/14 02:31:28 PM
#3170   Let's hope it's because you can't have an game7alcs 12/10/14 01:56:16 PM
#3169   The talked, pretty much the same info except FastFish 12/10/14 01:17:29 PM
PostSubject