First Patient Dosed in Savient Gout Trial
Posted on: Friday, 16 June 2006, 12:00 CDT
Savient Pharmaceuticals has dosed the first patient in its phase III clinical studies of Puricase investigational drug for the treatment of patients with symptomatic gout for whom conventional therapy is contraindicated or has been ineffective.
The two phase III clinical studies, known as GOUT 1 and GOUT 2, are designed to compare the safety and efficacy of Puricase administered by two-hour intravenous infusion every two weeks or every four weeks versus placebo infusion, over a six-month period. Each study will randomize approximately 100 patients.
"The two GOUT studies now underway at approximately 60 clinical sites in the US, Mexico, and Canada incorporate an innovative design and novel methodologies to demonstrate both uric acid control and attainment of clinical outcomes," said Dr Zeb Horowitz, chief medical officer.
Puricase has successfully completed phase I and II studies, proving to be safe and well-tolerated with few adverse events. Savient licensed exclusive, worldwide rights to the technologies related to the drug from Duke University of North Carolina and Mountain View Pharmaceuticals.
Gout results from deposits of needle-like crystals of uric acid in connective tissue and in the joints. These deposits lead to inflammatory arthritis, which causes joint swelling, redness, heat, pain, and stiffness and damage to the affected joints.
Source: Datamonitor
Related Articles
- Extended Accrual Time and Decreased Sample Size for OVATURE, a Multinational Phase III Clinical Study for Women With Recurrent Ovarian Cancer
- Savient Pharmaceuticals Initiates Patient Dosing for Puricase(R) Phase 3 Clinical Study; Company on Track for BLA Filing in Late 2007
- InSite Vision Completes Enrollment In First Phase 3 AzaSite(TM) Clinical Study
- AVI BioPharma Initiates Phase II Cardiovascular Clinical Study in Europe
- Emergent BioSolutions of Gaithersburg Announces Good Results From Phase II Clinical Study
- Emergent Biosolutions' Typhoid Vaccine Achieves Positive Results in Phase II Clinical Study
- CollaGenex Pharmaceuticals Reports Positive Outcome of Phase 2 Clinical Study Evaluating COL-3 As a Treatment for Rosacea
- Bayer Initiates Phase III Clinical Study of Trasylol(R) Therapy During Primary Total Hip Replacement Surgery
- Bioaccelerate's Development Partner AustCancer Commences Phase II Clinical Study of RP101 for Metastatic Pancreatic Cancer
- AustCancer Commences Phase II Clinical Study of RP101 for Metastatic Pancreatic Cancer
 |
 |
User Comments (0)
RSS Feeds