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Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
Date:4/29/2008

MOUNTAIN VIEW, Calif., April 29 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced positive results from a Phase 1 clinical trial of AZ-007 (Staccato(R) zaleplon). AZ-007 is an inhalation product candidate being developed for the treatment of insomnia patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep.

"This is the fifth product candidate using our single-dose Staccato technology platform that has completed a Phase 1 clinical trial," said James V. Cassella, PhD, Senior Vice President of R&D at Alexza. "We have again shown that the Staccato system can deliver IV-like pharmacokinetics, even with water insoluble compounds, in a simple, easy-to-use, one-breath device. We were pleased with the initial results. As we continue our analysis of the data collected in this study, we plan to present these data in scientific and medical forums at future dates, and determine the next steps for this product candidate."

Phase 1 Clinical Trial Results

The AZ-007 Phase 1 clinical trial enrolled 40 healthy volunteers at a single U.S. clinical center. The purpose of this trial was to assess the safety, tolerability and pharmacokinetic parameters of a single dose of AZ-007. Using a double blind, randomized, dose-escalation trial design, 4 doses of AZ-007 (ranging from 0.5 to 4.0 mg) were compared to placebo.

AZ-007 delivered an IV-like pharmacokinetic profile with a median time to peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was dose proportional across the 4 doses studied, as calculated by power analysis. Pharmacodynamics, measured as sedation assessed on a 100 mm visual-analog scale, s
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SOURCE Alexza Pharmaceuticals, Inc.
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