CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary ...( KING OF PRUSSIA Pa. Nov. 26 /- CS...),Health

KING OF PRUSSIA, Pa., Nov. 26 /PRNewswire/ -- CSL Behring announced today that it has reached the primary endpoint of a Phase III clinical trial of human pasteurized C1-inhibitor (C1-INH) concentrate to treat patients with hereditary angioedema (HAE), a rare genetic disorder that can lead to painful and sometimes life-threatening attacks of edema (swelling) of the face, airway, abdomen, and extremities.

The results from the Phase III, double blind, placebo-controlled trial I.M.P.A.C.T. (International Multi-centre Prospective Angioedema C1-inhibitor Trial), showed that patients treated with 20 U/kg b.w. C1-INH experienced a highly significant reduction in time to onset of relief of symptoms of HAE attacks compared to placebo (p= 0.003, one sided). In addition, all secondary endpoints of the trial have shown significant positive results, e.g. worsening of symptoms (p= 0.001, one sided).

"The results of this trial can immediately impact the lives of the thousands of HAE patients around the world who live with the burden of acute HAE attacks without approved treatment," said Timothy Craig, M.D., professor of medicine and pediatrics, Penn State Hershey Medical Center, USA, coordinating investigator of the I.M.P.A.C.T. trial.

I.M.P.A.C.T. is a multi-center, prospective clinical trial conducted globally in more than 45 centers in 15 countries, enrolling 125 patients, and is the largest trial ever conducted in HAE. For the first time, a dose comparison study was conducted for a human C1-INH comparing 20U/ kg b.w. and 10U/ kg b.w. in a randomized, placebo-controlled, double-blind study design. The results will be submitted in the near future to the United States Food and Drug Administration, Health Canada and European Health Authorities in support of applications to license C1-INH concentrate for the treatment of acute attacks of HAE in the U.S., Canada, and Europe. CSL Behring has manufactured and provided C1-INH concentrate to HAE patients for o
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