HGS announces positive Phase 2 LymphoStat-B at A...(and most importantly by the response rat...)
and, most importantly, by the response rate chosen as the primary efficacy endpoint of the Phase 3 trials. We are encouraged by the continued improvement in these patients, and by the improvement over time in patients crossing over from placebo to LymphoStat-B after 52 weeks. If the Phase 2 results are confirmed in our ongoing Phase 3 trials, we believe that LymphoStat-B could represent a breakthrough in the treatment of SLE.
The primary objectives of the Phase 2 study were to evaluate the efficacy and safety of LymphoStat-B (belimumab) plus standard of care, versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. At the end of 52 weeks, 345 patients chose to participate in an optional 24-week extension phase of the study, during which all patients received LymphoStat-B. At Week 76, 296 patients chose to remain on LymphoStat-B treatment in an open-label long-term continuation phase of the Phase 2 trial, in which all patients are receiving 10 mg/kg LymphoStat-B. As of October 1, 2007, 244 patients remained on LymphoStat-B treatment in the continuation study.
Key Findings to Date from the Phase 2 Study
In June 2006, HGS reported the 52-week results of the Phase 2 trial of LymphoStat-B in patients with SLE. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity versus placebo in patients with serologically active SLE across multiple clinical measures, exhibited clinically relevant biological activity, and appeared generally safe and well tolerated. Frequency and severity of adverse events were similar to placebo, with no increase at higher doses. Among the findings at Week 52 was a significantly improved response rate among serologically active patients, as defined by
'/>"/>
| Contact: Jerry Parrot Jerry_Parrott@hgsi.com 301-315-2777 Edelman Public Relations Source:Eurekalert |
Related biology news :
1. Selexis Announces Advanced Approach to Maximize Power of Genetic Elements for Rapid Development of High Performance Cell Lines
2. LaserCard Corporation Announces Expansion of Middle East Project
3. BIO-key(R) Announces Contracts for New Criminal Justice Data Sharing Solution
4. Balzan Foundation announces 2007 winners
5. The American Society of Plant Biologists announces 2007 awards
6. ASPB announces Summer Undergraduate Research Fellowship 2007 recipients
7. NIST announces 56 new awards for innovative technology research and development
8. Titanium Group Announces Contract With Haitong Securities
9. Measurement Specialties, Inc. Announces Impact of German Business Tax Reform 2008 Resulting in Lower Combined German Tax Rate - Impacts 2Q08 Reported Financial Results
10. FIJI Water announces sustainable growth initiative with commitment to help mitigate climate change
11. Positive results for airway bypass
| Copyright © 2003-2009 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |