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Quotes & Info
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| DYAX > SEC Filings for DYAX > Form 8-K on 20-Aug-2008 | All Recent SEC Filings |
20-Aug-2008
Other Events
On August 18, 2008, Dyax Corp. announced positive topline results from its second Phase 3, placebo-controlled trial, EDEMA4, for its lead product candidate DX-88 (ecallantide) for hereditary angioedema (HAE). The EDEMA4 trial, conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA), achieved statistically significant improvements in the intent-to-treat population in primary and secondary endpoints. DX-88 was also found to be well tolerated with no drug-related serious adverse events reported in the EDEMA4 trial. Based on the safety and efficacy results from its EDEMA4 and EDEMA3 Phase 3 trials, Dyax intends to submit the last module of its Biologics License Application (BLA) to the FDA early in the fourth quarter of 2008.
The primary endpoint of EDEMA4, patient reported assessment of individual
symptom burden at four hours measured using the Mean Symptom Complex Severity
(MSCS) score, had a p-value of 0.010. Symptom improvement at four hours measured
by a Treatment Outcome Score (TOS), a secondary endpoint, had a p-value of
0.003. Other secondary endpoints reported on the proportion of responders and
the sustainability and durability of response. The proportion of patients with
successful response at four hours was 93.8% for the DX-88-treated group versus
58.3% for the placebo group (p=0.001). The proportion of patients maintaining
significant improvement in overall response (defined for this trial as patient
response to "Overall how are you feeling?" as "a lot better or resolved" prior
to the 4-hour post dosing assessment and through the 24-hour post dosing
assessment) was 43.8% for the DX-88-treated group versus 20.8% for the placebo
group (p= 0.022).
This current report contains forward-looking statements, including statements regarding the timing and prospects for filing, review and FDA approval of the BLA for DX-88. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this current report are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the timing and prospects for filing, review and FDA approval of the BLA for DX-88, include the risks that: DX-88 may not show sufficient therapeutic effect or an acceptable safety profile in clinical trials or could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88 or that are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of DX-88; and other risk factors described or referred to Item 1A, "Risk Factors" in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this current report. These statements speak only as of the date of this current report, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
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