Connect with LRI:
Facebook
Twitter
YouTube
Change.org

Lupus Clinical Trials

New Medical Therapies™

Hemoglobinuria, Paroxysmal

Patient Medical Areas

June 19, 2006

Alexion Pharmaceuticals has announced positive interim results of a phase III trial, dubbed SHEPHERD of Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 6-month data met their primary surrogate efficacy endpoint, significantly reducing median lactate dehydrogenase levels (a biomarker for intravascular hemolysis) by 87%, from 2051 U/l at baseline to 270 U/l at 26 weeks (p<<0.00000000001). Significance was also achieved in all pre-specified secondary endpoints, including reduction in mean LDH change from baseline and quality of life as measured by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) diagnostic measure. The most frequent adverse events associated with Soliris treatment were headache, nasopharyngitis, and nausea. This open-label study enrolled 97 PNH patients across 33 sites in the US, Canada, Europe and Australia, who were to receive treatment with the drug for 12 months.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.