The following is a summary of data presented at the 2007 American College of Allergy, Asthma & Immunology meeting in Dallas.
• Dynavax Technologies Corp., of Berkeley, Calif., said an analysis of data from its DARTT (Dynavax Allergic Rhinitis Tolamba Trial) study of Tolamba indicated that concomitant use of two parameters of skin test could enable the selection of patients with substantially increased levels of ragweed-specific symptoms. As reported in January, interim data from the 738-patient study showed that the placebo group overall did not demonstrate sufficient levels of ragweed allergic rhinitis, preventing investigators to accurately measure meaningful clinical effect. Dynavax plans to use the latest analysis to help enroll patients in an upcoming Phase III field test of Tolamba. The company also is testing the immunostimulatory drug in an environmental exposure chamber study. (See BioWorld Today, Jan. 9, 2007.)
• Dyax Corp., of Cambridge, Mass., reported outcome measures used to assess symptom severity and symptom change in patients with hereditary angioedema (HAE). The company used a treatment outcome score and a mean symptom complex severity score, both of which measurements were developed to help defined the severity of HAE attack-related symptoms. Dyax currently is conducting a second Phase III trial of its HAE drug, DX-88.
• Lev Pharmaceuticals Inc., of New York, reported results from a Phase III trial of Cinryze, a C1 inhibitor, in acute hereditary angioedema (HAE), showing that patients receiving the drug saw symptoms begin to fade in a median time of two hours vs. more than four hours for patients on placebo. Lev reported in March that the trial met its primary endpoint in HAE patients and submitted a biologics license application in late July. The company amended its application last month to include data for the drug's prophylactic use. (See BioWorld Today, March 15, 2007, and Aug. 1, 2007.)