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Alexza Reports 2008 First Quarter Financial Results and Updates Development of Product Candidates

cts will be recorded throughout the 24-hour period.

A second Phase 3 clinical trial is projected to begin in the third

quarter of 2008. The design of the second study will be similar to

the first trial, except that the patient population will be patients

with bipolar disease. AZ-004 has been licensed to Symphony Allegro,

Inc., and Alexza has the right to repurchase all rights to this

product candidate.

-- AZ-001 (Staccato prochlorperazine). Alexza is developing AZ-001 to

treat patients suffering from acute migraine headaches. In December

2007, the Company completed enrollment of a thorough QT clinical

trial, in which two doses of AZ-001 (5 and 10 mg) were compared to

active control and to placebo. The purpose of a thorough QT study is

to determine a drug's effect on cardiac rhythms. Based on a

preliminary analysis of the data from the study, neither of the doses

of AZ-001 produced a QT/QTc prolongation that would suggest an

increased risk of cardiac arrhythmia. The Company recently completed

a 28-day repeat dose inhalation study in dogs. Consistent with

previous findings in shorter-term and higher dose studies, the Company

observed dose-related minimal to slight metaplasia in the upper

respiratory tract, primarily in the nasal epithelium, in all treated

groups. These changes were partially reversible by the end of a

28-day post-treatment period. No lower respiratory tract or lung

findings were reported. Alexza has requested an end of Phase 2

meeting with the FDA for AZ-001.

-- AZ-104 (Staccato loxapine). Alexza is developing AZ-104 to treat

patients suffering from acute migraine headaches. AZ-104 is a lower

dose version of AZ-004. In March 2008, the Company announced positive

initial results o

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

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Related biology technology :

1. Alexza Completes $10 Million Equity Financing with Bio*One Capital to Initiate Commercial Manufacturing in Singapore
2. Alexza to Announce 2007 Financial Results and Update Its Clinical Pipeline on Monday, March 17, 2008
3. Michael J. Simms Joins Alexza Pharmaceuticals as Senior Vice President, Operations and Manufacturing
4. Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
5. Alexzas Corporate Presentation to be Webcast at the 10th Annual BIO CEO & Investor Conference
6. Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference to Webcast Alexzas Corporate Presentation
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8. Alexza Elects Dr. Hal V. Barron to Its Board of Directors
9. 19th Annual Piper Jaffray Health Care Conference to Webcast Alexzas Corporate Presentation
10. The 4th Annual BIO Investor Forum to Webcast Alexzas Corporate Presentation
11. MGT Capital Investments Reports First Quarter 2008 Financial Results and Provides Update on Recent Developments
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