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Opko Health Inc (OPK)

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Last Post: 5/22/2015 4:56:36 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: OPKO Announces 4Kscore® Abstracts at the 2015 American Urological Association (AUA) Annual Meeting 05/18/2015 09:21:00 AM
OPK News: OPKO Announces Publication of Study Using Kallikrein Biomarkers of the 4Kscore® Test in a Large Community-Based Referral Coh... 05/15/2015 09:06:00 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/14/2015 07:10:07 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/13/2015 06:19:54 AM
OPK News: Statement of Changes in Beneficial Ownership (4) 05/12/2015 06:29:41 AM
#3215  Sticky Note Pfizer Partners With Young Little Known Biotech For tomsylver 12/18/14 09:06:21 AM
#3766   Opko 4Kscore Reviews In Urology Official Journal Validation WiseFool 05/22/15 04:56:36 PM
#3765   Among the OPKO 4Kscore Test, PHI, and PCA3, WiseFool 05/21/15 04:13:23 PM
#3764   Opko paid $49 Mil for claros. Back in 2011 Gingi 05/21/15 09:12:08 AM
#3763   TESARO Announces Webcast of Presentation at the Jefferies tomsylver 05/21/15 02:10:11 AM
#3762   Samuel K. Sia 'Smartphone Mchip' Partner Opko Health WiseFool 05/20/15 05:04:49 PM
#3761   I wish I had had the funds then someconcerns 05/20/15 01:28:47 PM
#3760   True. I have 80% of my investment in game7alcs 05/20/15 01:21:52 PM
#3759   Indeed :) Gingi 05/20/15 12:53:24 PM
#3758   And here is to the next Chai (double someconcerns 05/20/15 12:29:03 PM
#3757   This is true, but better accomplished in a someconcerns 05/20/15 12:25:45 PM
#3756   OPK..... BROKE $18 !!! now invest 05/20/15 12:02:46 PM
#3755   Hopefully we hear about the filing for Rayaldee now invest 05/20/15 11:56:05 AM
#3754   L'chaim is well deserved, Gingi 05/20/15 11:14:42 AM
#3753   Jefferies 2015 Global Healthcare Conference tomsylver 05/20/15 05:56:18 AM
#3752   As painful as it may seem. It never game7alcs 05/19/15 02:39:36 PM
#3751   I agree. Not planning on selling my someconcerns 05/19/15 02:20:02 PM
#3750   OPK.. was my largest holding for a few now invest 05/19/15 02:15:33 PM
#3749   L'Chaim! OPK is now my largest holding. someconcerns 05/19/15 12:52:17 PM
#3748   I m with you pal,,,, Gingi 05/19/15 11:34:23 AM
#3747   $OPK recent news/filings stocktrademan 05/18/15 05:15:36 PM
#3746   It will be interesting to see what the game7alcs 05/18/15 04:53:19 PM
#3745   Opko Health’s Rayaldee (CTAP101) Is A Game Changer WiseFool 05/18/15 03:32:00 PM
#3744   More presentations.. this week... now invest 05/18/15 10:07:57 AM
#3743   2015 AUA Opko Health's 4Kscore Session Highlights WiseFool 05/17/15 05:40:01 PM
#3742   Looks pretty. md84 05/16/15 04:07:13 PM
#3741   Sitting here enjoying OPK at $16.92, whether as someconcerns 05/15/15 05:22:34 PM
#3740   I like this article... !!!! Look at now invest 05/15/15 10:53:29 AM
#3739   I think much higher tomsylver 05/14/15 06:02:11 PM
#3738   Pfizer’s Mikael Dolsten "Opko’s product, which is the WiseFool 05/14/15 04:28:33 PM
#3737   weeeeeeeeeeeeeeeeeeeee! starbuxsux 05/14/15 03:09:56 PM
#3736   Gonna be SWEET when they show a profit. stonsetr 05/14/15 02:22:15 PM
#3735   OPK.... UP $1.00 !!!! 16.67 !! now invest 05/14/15 02:16:35 PM
#3734   I think higher stonsetr 05/14/15 11:51:50 AM
#3733   I think that this is still cheap.... not now invest 05/14/15 11:35:12 AM
#3732   Hope you are all enjoying the ride... I now invest 05/14/15 11:30:41 AM
#3731   16s game7alcs 05/14/15 10:22:26 AM
#3730   Approximately a 10% gain on a $117 million loss. stonsetr 05/14/15 09:40:45 AM
#3729   Nice move old favorite! dshade 05/14/15 08:27:11 AM
#3728   The question only should a little bit funny. tomsylver 05/14/15 04:22:51 AM
#3727   Opko EirGen Product Approvals WiseFool 05/13/15 06:49:23 PM
#3726   Easy there. I'm working on DD, so I'm LS1 05/13/15 06:21:01 PM
#3725   LS1? Are doing DD or LSD??? Do you know tomsylver 05/13/15 05:36:47 PM
#3724   Excellent. I missed that. Being able to integrate LS1 05/13/15 03:15:39 PM
#3723   It is a test that can be done now invest 05/13/15 01:34:49 PM
#3722   Oh,,, I have no doubts at all:) Gingi 05/13/15 12:05:08 PM
#3721   What is the bit about Testosterone testing? Is LS1 05/13/15 10:08:00 AM
#3720   Anyone who has doubts... please read the now invest 05/12/15 10:00:23 PM
#3719   Opko A Solid Candidate That May Be Offering WiseFool 05/12/15 04:45:15 PM
#3718   I now think that it's the looking forward Gingi 05/12/15 12:46:28 PM
#3717   I'm with you. Quick drop to 14.01 in LS1 05/12/15 11:37:58 AM