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Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
Date:8/6/2008

SS (Positive and Negative Symptom Scale) Excited Component (PEC) score, measured at two hours after the first dose. Various assessments of a patient's agitation state were conducted at serial time points using standard agitation scales over the first 4-hour post- dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects were recorded throughout the 24-hour period. The Company expects to release initial results of this trial before the end of September 2008.

A second Phase 3 clinical trial was initiated in July 2008 and is designed to enroll approximately 300 patients diagnosed with bipolar I disorder and acute agitation at 18 U.S. clinical centers. The trial is an in-clinic, multicenter, randomized, double-blind, placebo-controlled study and will test AZ-004 at two dose levels, 5 and 10 mg. Patients may receive up to three doses of study drug in a 24-hour period, depending on their clinical status. Patients eligible for the study include those who are admitted through an emergency department and those who are already in-patients in a hospital setting, as long as they have acute agitation at the time of patient randomization. This study is the first AZ-004 study enrolling bipolar disorder patients. The Company projects that this second Phase 3 clinical trial will take approximately 12 months to complete patient enrollment. The primary endpoint for the study is the change from baseline in the PEC score, measured at two hours after the first dose. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24-hour period. AZ-004 has been licensed to Symphony Allegro, Inc., or Symphony Allegro, and Alexza has the right to repurchase all rights to this product candidate.

-- AZ-001 (Staccato prochlorper
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SOURCE Alexza Pharmaceuticals, Inc.
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