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Patient Treatment Completed in Phase 3 Trial of C1-Esterase Inhibitor in Hereditary Angioedema
The clinical trial, known as CHANGE (C1-inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy), is examining the use of C1-INH as a replacement therapy in both the acute and prophylactic treatment of HAE. Clinical trial results for the acute portion of the CHANGE study are expected to be announced by the end of the first quarter of 2007, after the trial data have been unblinded, verified and analyzed. Pending the results of this trial, the Company anticipates filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2007.
The second phase of the CHANGE trial is examining the effectiveness of C1-INH in preventing inflammatory attacks in more severely affected HAE patients. This prophylactic study is ongoing and is expected to conclude in the second half of 2007.
"We are pleased to reach this significant milestone in the development of C1-INH, which brings us one step closer to making this important therapy available to patients in the U.S. who suffer from this debilitating condition," commented Judson Cooper, Chairman of Lev. "We look forward to announcing the results of this study and filing a marketing application with the FDA."
About the CHANGE Trial
The CHANGE trial, the Company believes, is currently the world's largest double-blind, placebo-controlled study of C1-INH and is designed to determine the efficacy and safety of C1-INH for both acute and prophylactic treatment of HAE. The acute part of the study is a 71-patient multi-center trial examining the efficacy and safety of C1-INH in patients suffering from moderate to severe acute HAE attacks in the face, abdomen or genitals. Lev has also initiated two open label studies to provide HAE patients with continued access to C1-INH while the data from the pivotal acute study is analyzed. The second phase of the trial is a prophylactic study examining the efficacy and safety of C1-INH in preventing HAE attacks. Enrollment in this portion of the trial is ongoing.
About Hereditary Angioedema
HAE, or hereditary C1-inhibitor deficiency, is a genetic disorder characterized by recurrent attacks of inflammation affecting the extremities (the hands and feet), the face, the urogenital tract, the abdomen, and the larynx. The inflammation can be disfiguring, debilitating, or, in the case of laryngeal attacks, life-threatening. HAE is caused by a deficiency of the plasma protein C1-INH. While there is no approved therapy for acute attacks in the U.S., the Company believes that replacement therapy with C1-INH is the treatment of choice for HAE in Europe, where it has been used safely and effectively for over 30 years. There are estimated to be 10,000 people with HAE in the United States.
Source: Lev Pharmaceuticals