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Biotech Tracker News -
Small Study Supports DX-88 Development
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March 10, 2003
Interim phase II data presented at the 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) confirmed the therapeutic potential of Dyax’s (NASDAQ: DYAX) DX-88 for the treatment of hereditary and acquired angioedema. DX-88 should move into phase III trials.
Nine patients with non life-threatening angioedema, both hereditary and acquired, were enrolled, and eight have been thus far treated. Each study subject received one of three doses (10, 40 and 80 mg) of DX-88 as a 10-minute intravenous infusion.
All study subjects experienced symptomatic relief, with time to relief ranging from 25 minutes to 3 hours. Time to symptom resolution ranged from 2 to 72 hours. An untreated hereditary angiodema episode lasts from a day or two to a week. The agent’s adversity profile was manageable and reassuring.
Dyax and Genzyme (NASDAQ: GENZ) are recruiting patients to the placebo-controlled phase II EDEMA1 (Evaluation of DX-88’s Effect on Mitigating Angioedema) study, which is enrolling patients 10 years of age or older who suffer from acute attacks of hereditary angioedema. Participants will be administered one dose by intravenous infusion, and will be followed for a period of 28 days.
DX-88 is a peptide inhibitor of the protein kallikrein, an elusive molecule involved in blood vessel responses to various stimuli. Its role in initiating a cascade of molecular events leading to increased vascular permeability, smooth muscle contraction, vasodilation, and pain is the prime therapeutic focus. A deficiency of C1 esterase inhibitor (C1- INH), a naturally occurring kallikrein inhibitor, is responsible for hereditary angioedema. When hereditary angioedema involves airway passages, it can be life threatening. Plasma derived C1-INH products are marketed in certain European countries, but are unavailable in the United States. DX-88 has orphan drug status in Europe and the U.S. for the management of hereditary angioedema.
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