MOUNTAIN VIEW, Calif., June 9 CA-Alexza-results
MOUNTAIN VIEW, Calif., June 9 /PRNewswire-FirstCall/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today preliminary results from
its Phase 2a proof-of-concept clinical trial with AZ-002 (Staccato(R)
alprazolam) in patients with panic disorder. The study did not meet its two
primary endpoints, which were the effect of AZ-002 on the incidence of a
doxapram-induced panic attack and the effect of AZ-002 on the duration of a
doxapram-induced panic attack, both as compared with placebo. There were no
serious adverse events in the clinical trial, and AZ-002 was safe and well
tolerated in the study patient population. AZ-002 is being developed through
Symphony Allegro, a development collaboration formed between Alexza and
Symphony Capital LLC in 2006.
The Company also announced today, in a separate news release, that it has
completed enrollment of its first Phase 3 clinical trial with AZ-004 (Staccato
loxapine)for the treatment of acute agitation in patients with schizophrenia
or bipolar disorder. Alexza will host an investor conference call to discuss
today's announcements on Monday, June 9, 2008 at 5:15 p.m. Eastern Time.
"The failure to reach statistical significance on the primary endpoints is
disappointing, but this proof-of-concept clinical trial was designed to
capture data and measurements for a number of clinical parameters in this
clinical setting," said James V. Cassella, PhD, Senior Vice President,
Research and Development at Alexza and chairman of the Symphony Allegro
Development Board. "There is no FDA-approved therapy for the acute treatment
of a panic attack or an established clinical development pathway for this
potential new indication. We plan to work with our colleagues at Symphony
Allegro and our external clinical experts to further analyze the data from
this study to determine our next steps with AZ-002."
AZ-002 Phase 2a Clinical Trial Design
The AZ-002 Phase 2a clinical trial was an in-clinic, randomized,
double-blind, placebo-controlled proof-of-concept evaluation of patients with
panic disorder. After an open-label pilot phase, 40 patients were enrolled at
3 U.S. clinical centers, with 20 patients receiving 1 mg AZ-002 and 20
patients receiving Staccato placebo. The primary aim of the clinical trial
was to assess the safety and efficacy of a single dose of AZ-002 in treating a
pharmacologically-induced panic attack.
Two primary endpoints were prospectively defined for the study, one to
assess the effect of treatment on the occurrence of a doxapram-induced panic
attack of sufficient intensity and a second to assess the effect of treatment
on the duration of the doxapram-induced panic attack. Data for these two
endpoints were based on the Acute Panic Inventory, a commonly used 22-item
self-report questionnaire designed to measure panic-like response to
biological challenges or other stressful situations.
After receiving training and baseline assessments, all patients in the
double-blind phase of the study received a Staccato device (randomized to
either 1 mg AZ-002 or placebo) and an intravenous administration of doxapram,
a respiratory stimulant used to induce a simulated panic attack.
About Symphony Allegro
In December 2006, Alexza entered into a collaboration with Symphony
Capital LLC, a biotech-focused private equity firm. Under the terms of the
agreement, Alexza and Symphony Capital established Symphony Allegro, Inc.,
which is providing funding to Alexza to accelerate clinical and other related
development activities of Staccato alprazolam (AZ-002) and Staccato loxapine
(AZ-004 and AZ-104). Alexza has granted a license to certain intellectual
property rights for the selected product candidates. Through a purchase
option, Alexza retains the exclusive right, but not the obligation, to acquire
100% of the equity of Symphony Allegro at specified prices during the term of
the agreement. If Alexza chooses not to exercise the purchase option,
Symphony Allegro retains the rights to the product candidates. The purchase
option expires December 31, 2010.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is an emerging specialty pharmaceutical company
focused on the development and commercialization of novel, proprietary
products for the treatment of acute and intermittent conditions. The
Company's technology, the Staccato system, vaporizes unformulated drug to form
a condensation aerosol that allows rapid systemic drug delivery through deep
lung inhalation. The drug is quickly absorbed through the lungs into the
bloodstream, providing speed of therapeutic onset that is comparable to
intravenous administration, but with greater ease, patient comfort and
convenience.
Alexza has six product candidates in clinical development. Alexza's lead
program, AZ-004 (Staccato loxapine) for the treatment of acute agitation in
schizophrenic or bipolar disorder patients, is in Phase 3 testing. AZ-001
(Staccato prochlorperazine) for the acute treatment of migraine headaches has
completed Phase 2 testing. AZ-104 (Staccato loxapine) for the acute treatment
of migraine headaches and AZ-002 (Staccato alprazolam) for the acute treatment
of panic attacks associated with panic disorder are in Phase 2 testing.
Product candidates in Phase 1 testing include AZ-003 (Staccato fentanyl) for
the treatment of breakthrough pain, which is partnered with Endo
Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the
treatment of insomnia. More information, including this and past press
releases from Alexza is available online at http://www.alexza.com.
Safe Harbor Statement
This press release includes forward-looking statements regarding the
development, therapeutic potential, efficacy and safety of AZ-002. Any
statement describing a product candidate or Alexza's goals, expectations or
beliefs is a forward-looking statement, as defined in the Private Securities
Litigation Reform Act of 1995, and should be considered an at-risk statement.
Such statements are subject to certain risks and uncertainties, particularly
those inherent in the process of developing and commercializing drugs. The
Company's forward-looking statements also involve assumptions that, if they
prove incorrect, would cause its results to differ materially from those
expressed or implied by such forward-looking statements. These and other
risks concerning Alexza's business are described in additional detail in the
Company's Annual Report on Form 10-K for the year ended December 31, 2007, and
the Company's other Periodic and Current Reports filed with the Securities and
Exchange Commission including the risks under the headings: "Failure or delay
in commencing or completing clinical trials for our product candidates could
harm our business" and "If our product candidates do not meet safety and
efficacy endpoints in clinical trials, they will not receive regulatory
approval, and we will be unable to market them". Forward-looking statements
contained in this announcement are made as of this date, and the Company
undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise.
SOURCE Alexza Pharmaceuticals, Inc.
