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Dyax Corp. (NASDAQ:
DYAX) announced today that two poster presentations featuring updated
KALBITOR® (ecallantide) data in pediatric patients with hereditary angioedema (HAE) and HAE patients with abdominal attacks were presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2012 Annual Scientific Meeting, held November 8-13, at the Anaheim Convention Center in Anaheim, CA. Both presentations pooled results from patients enrolled in four different clinical trials of ecallantide for the treatment of acute HAE attacks: DX-88/19, an open-label continuation study; EDEMA2
®, an open-label, Phase 2 dose-ranging, repeat-dosing study; and EDEMA3
® and EDEMA4
®, two Phase 3 double-blind, placebo-controlled studies. KALBITOR is indicated for the treatment of acute attacks of HAE in patients 16 years of age and older.
Commenting on the study “Clinical Trial Experience of Pediatric Patients Treated with Ecallantide for Acute Attacks of Hereditary Angioedema,” Andrew MacGinnitie, MD, PhD, Associate Clinical Director, Division of Immunology at Boston Children’s Hospital, and lead investigator of the study, stated: “In order to provide patients with effective relief from the disease’s often debilitating, acute attacks, it is important that pediatric and other specialist communities learn to diagnose and treat HAE as early as possible.”
“Our clinical studies of KALBITOR reinforce its demonstrated ability to effectively treat various patient populations and attack locations,” commented Dr. Burt Adelman, Executive Vice President and Chief Medical Officer at Dyax Corp. “The presentation of these data is part of our ongoing effort to educate the healthcare community about hereditary angioedema and novel treatments such as KALBITOR. Dyax remains committed to providing an HAE support, education and treatment awareness program that is second to none.”
Complete List of Poster Presentations on KALBITOR at ACAAI 2012Poster Presentations
Clinical Trial Experience of Pediatric Patients Treated with Ecallantide for Acute Attacks of Hereditary Angioedema – Andrew MacGinnitie, MD, PhD, Associate Clinical Director, Division of Immunology, Boston Children’s Hospital, Boston, MA, Poster P303 presented on Saturday, November 10, 12:30-1:30p.m. PST and Sunday, November 11, 12:00-1:00p.m. PST
Treatment of Abdominal Attacks of Hereditary Angioedema with Ecallantide – Christopher Stevens, MD, Gastroenterology Medical Consultant, Poster P305 presented on Saturday, November 10, 12:30-1:30p.m. PST and Sunday, November 11, 12:00-1:00p.m. PST
About KALBITOR®(ecallantide)KALBITOR is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. KALBITOR, which was discovered and developed by Dyax, is the first subcutaneous treatment available in the U.S. for treating acute HAE attacks.
Important KALBITOR Safety InformationAnaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. KALBITOR should not be administered to patients with known clinical hypersensitivity to KALBITOR.
As part of product approval, Dyax has implemented a Risk Evaluation and Mitigation Strategy (REMS) program. The goal of the REMS is to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms.