Press Release Source: Dyax Corp.
Dyax Presents Interim Results From its Phase II DX-88 Clinical Trial for the Treatment of Hereditary Angioedema
Wednesday September 25, 10:27 am ET
CAMBRIDGE, Mass.--(BW HealthWire)--Sept. 25, 2002--Dyax Corp. (Nasdaq:DYAX - News) today announced interim clinical response data from a European exploratory study of the Company's DX-88 compound for the treatment of patients with acute hereditary angioedema (HAE). The interim data are being presented at the XIX International Complement Workshop in Palermo, Italy.
In a poster entitled "The Synthetic Kunitz Domain Protein DX-88 to Treat Angioedema in Patients with Hereditary Angioedema," clinical data on the first five patients treated in the dose-escalating study are being highlighted at the workshop. To date, two dose groups of 10 mg and 40 mg of DX-88 have been examined. Two patients were administered 40 mg doses, and 3 were administered 10 mg doses. All five treated patients responded favorably and tolerated DX-88 well, with the exception of one patient with a history of allergies, who suffered an allergic response and responded quickly and completely with standard medical therapy. The patients suffered from a variety of differing manifestations of HAE attacks, and all five demonstrated symptomatic relief within 3 hours of treatment with DX-88. The primary endpoint of this trial is relief of HAE symptoms within 4 hours post-dosing.
"These data provide early confirmation of the activity of DX-88 in this disease, and is consistent with laboratory data showing that DX-88 is a potent and selective kallikrein inhibitor. We expect to complete this European study by early 2003, and have also begun enrollment in a second DX-88 study as part of our HAE program," remarked Tony Williams, M.D., Senior Vice President of Medical Affairs and Clinical Operations for Dyax.
The Company recently announced the launch of an automated call center to facilitate U.S. patient enrollment into a second phase II DX-88 study, a 48-patient dose-ascending study for the treatment of HAE. Dyax expects treatment to begin shortly at study centers located in both the United States and Europe.
Hereditary Angioedema
While incidence numbers are difficult to obtain, primarily due to the rarity of HAE, it is believed that hereditary angioedema affects between 1/10,000 and 1/50,000 people, and that between 10,000 and 86,000 people in the United States are afflicted with the disease. HAE is caused by the deficiency of the C1 esterase inhibitor (C1-INH), a molecule that inhibits kallikrein and other serine proteases. The disease is characterized by acute episodic attacks of edema (swelling) in body parts, most notably the hands, feet, face, and airway passages. In addition, patients often have bouts of severe abdominal pain, nausea, and vomiting caused by swelling in the intestinal wall. Using its patented phage display technology, Dyax has identified its DX-88 compound, a small protein with high affinity and specificity for inhibiting kallikrein, as a potential therapeutic for the treatment of HAE. Due to its high affinity and specificity, DX-88 potentially may have fewer side effects and greater effectiveness than recombinant or plasma derived C1-INH. C1-INH is the current standard-of-care in Europe but is unavailable in the United States. |
