NEW YORK, Jan. 17 (UPI) -- U.S. firm Lev Pharmaceuticals said Wednesday it has treated the last patient in its phase 3 trial of C1-INH for hereditary angioedema.
The study, dubbed CHANGE, is assessing C1-INH as a replacement therapy in both the acute and prophylactic treatment of hereditary C1-inhibitor deficiency, or HAE.
There are currently no treatments approved in the United States for acute HAE attacks, the company said, adding that replacement therapy with C1-INH has been the "treatment of choice" for HAE in Europe for more than 30 years.
Lev said it would have results from the first phase of the CHANGE study by the end of the first quarter and anticipates filing for approval of the treatment with the U.S. Food and Drug Administration in the first half of the year.
The company said the second phase of the study will evaluate C1-INH's effectiveness in preventing inflammatory attacks in more severely affected HAE patients and should wrap up in the second half of 2007.
HAE is a genetic disorder marked by recurrent attacks of inflammation affecting the hands and feet, the face, the urogenital tract, the abdomen and the larynx, with the latter condition often life-threatening.
Roughly 10,000 people in the United States have the condition.
