Nov 15 2010
Dyax Corp. (NASDAQ: DYAX) today announced that an abstract featuring KALBITOR® (ecallantide) data was accepted for oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting held November 11-16, at the Phoenix Convention Center in Phoenix, AZ. Two additional abstracts were selected as poster sessions.
“These findings are especially reassuring, as swelling of the larynx can cause airway obstruction.”
At the ACAAI meeting, Andrew MacGinnitie, MD, PhD, of Children's Hospital of Pittsburgh of UPMC and the University of Pittsburgh School of Medicine, gave an oral presentation titled "Efficacy of Ecallantide for Attacks of Hereditary Angioedema: Analysis of Individual Symptoms by Severity and Attack Site." According to Dr. MacGinnitie, the study's lead investigator, "The data presented today highlight the efficacy of KALBITOR when compared to placebo for several anatomical sites, especially the abdominal and laryngeal locations." He added, "These findings are especially reassuring, as swelling of the larynx can cause airway obstruction."
Combined data from two double-blind, placebo-controlled, Phase 3 trials of ecallantide, EDEMA3® and EDEMA4®, were analyzed by anatomical site and symptom severity. Five anatomical sites were evaluated including internal head/neck (laryngeal), stomach/gastrointestinal (abdominal), cutaneous, genital/buttocks, and external head/neck. Efficacy endpoints included two validated, hereditary angioedema (HAE)-specific, patient reported outcome measures: Mean Symptom Complex Severity (MSCS) score and Treatment Outcome Score (TOS). The proportion of patients who achieved sustained improvement, which is defined as a patient report of feeling better for a continuous duration of at least 45 minutes, was also analyzed.
"When analyzing KALBITOR's efficacy across attack severity symptoms, these data indicated numerical or statistical significant improvements over placebo across all anatomical sites," commented Patrick Horn, MD, PhD, Vice President of Clinical and Medical Affairs at Dyax Corp., and one of the study authors. "As such, we remain committed to educating patients and physicians about this rare disease and that there is an effective treatment for all ranges of HAE attacks - whether mild, moderate or severe."
Poster Sessions
In addition to the oral presentation, the following two posters were shown highlighting KALBITOR efficacy and safety:
- Ecallantide for Treatment of Acute Attacks of Acquired C1 Esterase Inhibitor Deficiency - Nisha S. Patel, MD, Asthma Allergy & Pulmonary Associates, Thomas Jefferson University, Philadelphia, PA.
- Second Dose of Ecallantide Treatment for Acute Attacks of Hereditary Angioedema: An Analysis of "Dose B" Administration - Jonathan A. Bernstein, MD, Professor of Clinical Medicine, Department of Internal Medicine, Division of Immunology and Allergy at the University of Cincinnati Medical Center.