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Opko Health Inc (OPK)

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Last Post: 3/3/2015 8:51:16 PM - Followers: 128 - 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) 06:14 AM
OPK News: Twelve Months Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to Be Presented ... 03/03/2015 09:31:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 03/03/2015 06:26:02 AM
OPK News: Current Report Filing (8-k) 03/02/2015 06:18:32 AM
OPK News: Annual Report (10-k) 02/27/2015 06:34:23 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 03/04/2015 06:14:42 AM
#3500  Sticky Note OPKO Announces Publication of 20 Year Outcome Study tomsylver 02/20/15 01:36:55 PM
#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
#3568   Absolutely true. Gingi 03/03/15 08:51:16 PM
#3567   But, as you implied earlier, $OPK has so someconcerns 03/03/15 07:56:31 PM
#3566   IMHO Some, OPK pps now is based on Gingi 03/03/15 07:48:58 PM
#3565   Gingi, I agree it takes time, as someconcerns 03/03/15 07:01:55 PM
#3564   OPK is a "Winner & Keeper" Gingi 03/03/15 04:06:18 PM
#3563   Hope you got an open contract with Kleenex! Gingi 03/03/15 03:53:12 PM
#3562   Cocrystal Pharma to Present at Barclays Global Healthcare tomsylver 03/03/15 10:26:55 AM
#3561   Twelve Months Data Supporting Once-Weekly Dosing of hGH-CTP tomsylver 03/03/15 10:24:02 AM
#3560   Dr. Frost back at buying. $600k purchase yesterday. game7alcs 03/03/15 09:34:57 AM
#3559   Opko Health at ENDO 2015 General Information Event: ENDO 2015 Event tomsylver 03/03/15 12:46:35 AM
#3558   Study Confirms 4Kscore Accurately Predicts High-Grade Prostate Cancer tomsylver 03/02/15 11:19:23 PM
#3557   From seeking alpha: OPKO Health, Inc. (NYSE:OPK) Q4 2014 Results tomsylver 03/02/15 11:06:49 PM
#3556   Could you please post a link? stonsetr 03/02/15 10:24:28 PM
#3555   I agree. Dr. Frost's comment about staying tuned game7alcs 03/02/15 09:43:02 PM
#3554   everyone should read the Analyst meeting after earnings... now invest 03/02/15 09:35:19 PM
#3553   Closed near HOD. The earnings didn't seem to stonsetr 03/02/15 08:00:53 PM
#3552   And we had a pretty good pps recovery someconcerns 03/02/15 05:51:07 PM
#3551   Cheers to Myth. Nice OPK moves these months. dshade 03/02/15 05:12:55 PM
#3550   Good that we're on the same page. lol game7alcs 03/02/15 03:17:26 PM
#3549   Just was going to post that comment...!!! now invest 03/02/15 02:49:48 PM
#3548   side effects. We also have a contract with a game7alcs 03/02/15 01:34:20 PM
#3547   The headline is "might" but the article is game7alcs 03/02/15 09:43:11 AM
#3546   #GU15 - A multi-institutional prospective trial in the tomsylver 03/02/15 01:28:21 AM
#3545   February 26, 2015 4Kscore Might Reduce Unnecessary Prostate Biopsies tomsylver 03/02/15 12:54:46 AM
#3544   Based on? game7alcs 02/28/15 01:03:53 PM
#3543   Looks like I'll be buying more next week. md84 02/28/15 08:43:42 AM
#3542   Yea agreed.. Long term. At some point Frost game7alcs 02/27/15 06:32:53 PM
#3541   Well some of us may have expected it, LS1 02/27/15 06:31:03 PM
#3540   I don't know Gingi.. The report was as game7alcs 02/27/15 05:51:43 PM
#3539   Loss of 53 million glad I shorted this sucker papabb 02/27/15 05:43:37 PM
#3538   A/H just traded at $14.83 up from $14.56 close,,, Gingi 02/27/15 04:27:49 PM
#3537   I wouldn't be betting on it dropping much now invest 02/26/15 11:51:15 AM
#3536   LOVE what Opk has been doing for all LS1 02/26/15 11:17:45 AM
#3535   OPKO to Announce Fourth Quarter and Full Year tomsylver 02/26/15 10:43:06 AM
#3534   Getting near my $20 call. As original mod dshade 02/26/15 07:57:32 AM
#3533   $10.000/year/patient??? That would mean 1M patients = $10B. HUGE! tomsylver 02/26/15 01:32:27 AM
#3532   Rayaldee a Game Changer Click Here ( tomsylver 02/25/15 11:57:50 PM
#3531   Yea. They sound very excited in the conference. game7alcs 02/25/15 10:48:30 PM
#3530   I think it's anybody's guess right now. game7alcs 02/25/15 10:47:29 PM
#3529   Impressive. stonsetr 02/25/15 10:15:44 PM
#3528   I have been convinced for a long time now invest 02/25/15 09:46:05 PM
#3527   I listened to this event. They actually ran game7alcs 02/25/15 08:54:17 PM
#3526   Don't forget.... People were at this event today.... now invest 02/25/15 03:49:29 PM
#3525   where did you get my picture???? :-) now invest 02/25/15 02:45:02 PM
#3524   SWEET!!! stonsetr 02/25/15 02:38:14 PM
#3523   Stone, Yes, yes, yes.... that's the $OPK someconcerns 02/25/15 02:25:04 PM
#3522 stonsetr 02/25/15 02:21:54 PM
#3521   I'm very happy with the current $OPK price someconcerns 02/25/15 02:06:15 PM
#3520   It kinda seems that way. LOL stonsetr 02/25/15 01:44:14 PM
#3519   All you got to do..... is post a Gingi 02/25/15 01:17:06 PM