Navigation Links
Ardea Biosciences Announces Positive End-of-Phase 2 Meetings with FDA for Lesinurad
Date:9/7/2011

SAN DIEGO, Sept. 7, 2011 /PRNewswire/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and successfully reached agreement on the following key aspects of its proposed lesinurad Phase 3 development plan: the overall size and design of the planned Phase 3 clinical studies, the primary endpoints, the total safety database proposed for NDA filing, manufacturing plans for both drug substance and drug product, the preclinical toxicology program and the clinical pharmacology program. The Company continues to target commencing Phase 3 studies before the end of this year. Lesinurad is Ardea's lead product candidate in development for the chronic treatment of gout.  

"There is a major unmet medical need for a well-tolerated, orally administered urate-lowering therapy that works by a novel mechanism of action and can be given alone or in combination with other agents to the many patients who are not adequately treated with currently available products," commented Michael Becker, MD, Professor Emeritus of Medicine, Department of Medicine, University of Chicago Medical Center. "The encouraging safety and efficacy results from Phase 2 clinical trials of lesinurad provide strong support for successful Phase 3 clinical development."

In connection with the Company's Phase 3 development program and as previously announced, the Company recently commenced a multinational, interventional study designed to identify gout patients not reaching target serum uric acid (sUA) levels on allopurinol, currently the most widely prescribed gout medication.  In addition to collecting clinically relevant information on the use of allopurinol, this study will also assist in pre-screening and determining the eligibility of gout patients to enroll into two pivotal Phase 3 studies, which
'/>"/>

SOURCE Ardea Biosciences, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Ardea Biosciences Reports Recent Accomplishments and Second Quarter 2011 Financial Results
2. Ardea Biosciences to Present at Upcoming Investor Conferences
3. Ardea Biosciences Announces Data on MEK Inhibitor BAY 86-9766 (RDEA119) to be Presented at 2011 American Society of Clinical Oncology Annual Meeting
4. Ardea Biosciences Reports Recent Accomplishments and Announces First Quarter 2011 Financial Results
5. Ardea Biosciences Reports Recent Accomplishments and Announces Fourth Quarter and Full-Year 2010 Financial Results
6. Ardea Biosciences Announces Exercise in Full of Overallotment Option for Common Stock Offering
7. Ardea Biosciences Prices Public Offering of Common Stock
8. Ardea Biosciences Announces Positive Top-Line Results from Phase 2b Combination Study of RDEA594 in Allopurinol-Refractory Gout Patients
9. Ardea Biosciences to Present at Two Upcoming Investor Conferences
10. Ardea Biosciences Awarded a $733,438 Grant from the U.S. Government Under the Patient Protection and Affordable Care Act
11. Ardea Biosciences to Present at the Oppenheimer 21st Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/31/2015)... Trimb Healthcare AB ("Trimb") today announced that it has ... a Dutch OTC company with operations in key European ... 16 million, with solid growth and leading brands in ... build a leading international OTC company, and this acquisition ... us a stronger North European OTC platform, from which ...
(Date:8/31/2015)... ... August 31, 2015 , ... The Food Processing ... and beverage processors, equipment manufacturers and leaders in the field of academia. ... and formulation for manufacturers of bakery and snacks; beverages; dairy; meat, poultry and ...
(Date:8/31/2015)... ... August 31, 2015 , ... Proove Biosciences, Inc. is a ... Annual High Tech Awards. , Now in its 22nd year, this premier awards ... innovation here, across the nation and around the world. The OC Tech Alliance will ...
(Date:8/28/2015)... , Aug. 28, 2015 ... addition of the "Global & USA BioSimilar Market ... The highly awaited US Biosimilar market will be ... filigrastim biologic, Zarxio. How will the global market react? ... reveals that biosimilars could save the US economy up ...
Breaking Biology Technology:METTLER TOLEDO Hosts Food Safety Educational Center at 2015 PROCESS EXPO 2Proove Biosciences, Inc. Named a Finalist for 22nd OC Tech Alliance High-Tech Awards for Company of the Year 2Proove Biosciences, Inc. Named a Finalist for 22nd OC Tech Alliance High-Tech Awards for Company of the Year 3Proove Biosciences, Inc. Named a Finalist for 22nd OC Tech Alliance High-Tech Awards for Company of the Year 4Global & USA BioSimilar Market Analysis Report 2015-2021 2Global & USA BioSimilar Market Analysis Report 2015-2021 3
... EXTON, Pa. , Feb. 2 ... company focused on the development of regenerative cell therapy ... David Pernock , Chairman of the Board of ... immediately. Pernock most recently served as Senior Vice President ...
... , , SANTA ROSA, ... Health Month, EcoNugenics introduces the newest ...  The Santa Rosa, CA -based nutraceutical company, founded in 1995 by ... MS, LAc, has once again demonstrated excellence in being at the ...
... , SAN DIEGO , Feb. 1 ... it will report results for its fourth quarter and year ended ... 10, 2010 . , Alan D. Gold , Chairman and ... Officer, will host an investor conference call at 10:00 a.m. Pacific ...
Cached Biology Technology:Fibrocell Science, Inc. Names David Pernock Chief Executive Officer 2Fibrocell Science, Inc. Names David Pernock Chief Executive Officer 3Just in Time for Heart Health Month... TRIPLE Cardiovascular Health Support From EcoNugenics 2Just in Time for Heart Health Month... TRIPLE Cardiovascular Health Support From EcoNugenics 3BioMed Realty Trust to Report 2009 Fourth Quarter and Year-End Results 2
(Date:8/19/2015)... , Aug. 19, 2015  VOXX International Corporation ... has entered into a Definitive Agreement to purchase ... iris authentication market leader EyeLock through an acquiring ... have a controlling interest in the acquiring entity. ... completion of due diligence.  Expanding on its existing ...
(Date:8/12/2015)... , Aug. 12, 2015   MedNet Solutions , ... entire spectrum of clinical research, is proud to announce ... company,s comprehensive SaaS-based eClinical technology platform, has led the ... first two quarters of 2015.   Q2 2015 and ... quarters measured by contract value sold in the company,s ...
(Date:8/11/2015)... Sweden , August 11, 2015 Today, ... FPC1155. Already received as well as expected revenues in 2015 that ... in FPC,s communicated revenue guidance of approximately 2,200 MSEK for 2015. ... is a prominent smartphone manufacturer in ... ZUK selected FPC1 155 for ...
Breaking Biology News(10 mins):VOXX International Corporation Signs Definitive Agreement To Acquire The Assets And A Controlling Interest Of Biometric Leader EyeLock 2VOXX International Corporation Signs Definitive Agreement To Acquire The Assets And A Controlling Interest Of Biometric Leader EyeLock 3VOXX International Corporation Signs Definitive Agreement To Acquire The Assets And A Controlling Interest Of Biometric Leader EyeLock 4VOXX International Corporation Signs Definitive Agreement To Acquire The Assets And A Controlling Interest Of Biometric Leader EyeLock 5MedNet Solutions Experiences Explosive Corporate Growth 2FPC's Touch Fingerprint Sensor FPC1155 in ZUK's Smartphone Z1 2
... patients with castration-resistant prostate cancer, the addition of ... compared with either treatment alone or when the ... published in the July 15 Clinical Cancer ... for Cancer Research. Philip M. Arlen, M.D., ...
... fossil and the reinterpretation of previously known fossils, all from ... "missing link" in the evolution of flatfishes and explain one ... include halibut, flounder and sole, have a bizarre structural adaptation: ... is even more remarkable is that every flatfish is born ...
... issue of the journal Nature, the research reveals ... necessary for viral entry into human cells, bound to an ... provides a major step forward in understanding how the deadly ... potential Ebola virus vaccines, or treatments for those infected. ...
Cached Biology News:Prostate cancer vaccines more effective with hormone therapy 2New fossil tells twisted tale of how flatfishes ended up with two eyes on one side of head 2New fossil tells twisted tale of how flatfishes ended up with two eyes on one side of head 3New fossil tells twisted tale of how flatfishes ended up with two eyes on one side of head 4Scripps research scientists reveal key structure from ebola virus 2
... 1. 1000 V, 400 mA, 100 ... constant power modes.Single-unit increments in settings ... and recalls three protocols.Outstanding choice for ... Multiphor II or GenePhor systems. Category: ...
Mouse Serpin F1/PEDF MAb (Clone 199315)...
Mouse Nodal Affinity Purified Polyclonal Ab...
Immunogen: Full length M32 fusion protein. Storage: -20 C, Avoid Freeze/Thaw Cycles...
Biology Products: