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Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
Date:2/5/2008

g developed for the

treatment of acute agitation in patients with schizophrenia or bipolar

disorder. Alexza reported positive results from a 129 patient Phase 2a

clinical trial in 2007. In the second half of 2007, Alexza conducted

an End of Phase 2 meeting with the FDA and completed enrollment in a

multiple-dose tolerability and pharmacokinetics clinical trial in

schizophrenic patients. Alexza plans to initiate two AZ-004 Phase 3

clinical trials during 2008, with the first Phase 3 clinical trial

scheduled to start in late Q1 2008 and the second Phase 3 clinical

trial scheduled to start Q3 2008. AZ-004 is being developed through

Symphony Allegro, a product development partnership formed between

Alexza and Symphony Capital, LLC.

-- AZ-001 (Staccato prochlorperazine) is being developed for the acute

treatment of migraine headaches. Alexza reported positive results from

a 400 patient Phase 2b clinical trial in 2007. Alexza is conducting a

thorough QT clinical trial in subjects and a 28-day inhalation

toxicology study in animals. Dosing has been completed in both of

these studies and data analysis is expected to be completed by the end

of Q1 2008. These data, along with the data from three previously

completed clinical trials, represent testing in more than 500 patients

and subjects, and will serve as the basis for an End of Phase 2 meeting

with the FDA, projected for late Q2 2008.

-- AZ-104 (Staccato loxapine), a lower dose version of AZ-004, is being

developed for the acute treatment of migraine headaches. In December

2007, Alexza completed enrollment of a Phase 2a proof-of-concept

clinical trial with AZ-104 in patients with migraine headache. The

Phase 2a clinical trial was an in-clinic, multi-center, randomized,

double blind
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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