C1-Esterase Inhibitor Concentrate Rapidly Relieves Abdominal and Facial Attacks in Patients with Hereditary Angioedema, According to Piv...(esearch Center Cincinnati OH and a leadi...)

Date:3/18/2008

esearch Center, Cincinnati, OH, and a lead investigator of I.M.P.A.C.T 1. "While HAE attacks can occur all over the body, facial and abdominal swelling can be the most painful and life-threatening for patients and require treatment with a fast-acting therapy."

Currently, there are no specifically-approved therapies for HAE in North America. CSL Behring manufactures and sells C1-INH concentrate in Germany, Austria, Switzerland, and several other countries.

About I.M.P.A.C.T. 1

Findings were based on a double-blind, placebo-controlled study of 124 HAE patients with acute, moderate, or severe abdominal or facial attacks. C1-INH concentrate was administered at two different doses and compared to placebo. The main study endpoints were: time to onset of symptom relief from HAE attacks, and proportion of subjects with worsening clinical HAE symptoms, and safety.

Key Findings

Subjects administered C1-INH 20 U/kg exhibited a highly significant reduction in the median time to onset of HAE symptom relief (30 minutes) compared to subjects receiving placebo (1.5 hours), (p=0.0025). Additionally, the proportion of subjects with worsening HAE symptoms after receiving treatment was significantly lower in the C1-INH P 20 U/kg treated group (p= 0.001). No drug-related serious adverse events were reported.

About I.M.P.A.C.T. 2

In a separate open label study presented at the AAAAI 64th Annual Meeting, Timothy J. Craig, D.O., Professor of Medicine and Pediatrics at Penn State University in Hershey, PA and his colleagues found C1-INH to be a safe and effective treatment for HAE attacks at any body site.

"This study demonstrates that C1-INH replacement therapy is highly effective at rapidly relieving symptoms of peripheral attacks, along with facial, abdominal, and laryngeal attacks," said Dr. Craig. "These findings demonstrate the versatility of C1-INH and confirm the long-standing observation that C1-INH replacement effectively tre
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