CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 29, 2003--Dyax Corp. (Nasdaq: DYAX - News) today announced that it has initiated patient treatment in the United States in its phase II clinical trial of the Company's investigational compound DX-88. In this trial, referred to as EDEMA1 (Evaluation of DX-88's Effect on Mitigating Angioedema), DX-88 is being studied for the treatment of patients with hereditary angioedema (HAE), a rare disorder that leads to acute attacks of localized swelling and inflammation. The first of 48 patients to be evaluated in this double-blind placebo-controlled DX-88 trial was dosed on Saturday, January 25, 2003 at The Allergy & Asthma Research Group in Eugene, Oregon by EDEMA1 clinical investigator Dr. Kraig Jacobson.
The primary endpoints of the EDEMA1 study are efficacy and safety. Drug safety is being monitored during the study by an independent committee. To the Company's knowledge, DX-88 is the only investigational treatment for HAE in clinical trials in the United States, where no marketed therapy is available.
Evaluation of DX-88 in the HAE indication is being conducted by Dyax under its collaboration with Genzyme Corporation. The EDEMA1 study complements the Company's ongoing open-label phase II study of DX-88 in angioedema being conducted in Europe. In that study, eight patients have been treated, all of whom had relief of symptoms within four hours. The duration of a typical angioedema attack would be expected to last from two to five days without treatment. An anaphylactoid reaction occurred in one patient, yet the reaction was controlled quickly and DX-88 treatment was completed per protocol.
"Acute attacks of angioedema are both distressing and potentially fatal to the patient. Currently, there is little specific therapy that can be offered, and EDEMA1 will prospectively study the effect of kallikrein inhibition in this acute and hereditary condition. We look forward to continuing this clinical development program in accordance with U.S. Food and Drug Administration requirements and in close collaboration with our EDEMA1 investigators and patient advocacy groups such as the Hereditary Angioedema Association," commented Tony Williams, M.D., Senior Vice President of Medical Affairs and Clinical Operations for Dyax.
Henry Blair, Chairman and Chief Executive Officer of Dyax, added, "Dyax is committed to clinical studies of DX-88, a highly specific kallikrein inhibitor with the potential to relieve the symptoms suffered by patients with hereditary angioedema. This is one example of Dyax's commitment to developing therapies for conditions such as HAE, where treatment alternatives either do not exist, or where improvements to available treatments would significantly improve patient quality of life. We look forward to reporting on progress of our HAE studies in the months ahead." ... |
