| HOME >> BIOLOGY >> TECHNOLOGY |
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 |