Navigation Links
Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
Date:2/25/2008

MOUNTAIN VIEW, Calif., Feb. 25 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has initiated its first Phase 3 clinical trial with AZ-004 (Staccato(R) loxapine). AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. Alexza believes the novel, non-invasive nature and rapid pharmacokinetic (PK) properties resulting from inhaled loxapine administration via the Staccato system have the potential to make AZ-004 a viable product to treat acute agitation. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC.

"We are excited to be initiating our AZ-004 NDA plan with this first Phase 3 clinical trial," said Thomas B. King, Alexza President and CEO. "The results we have seen to date with AZ-004 have been promising and we look forward to enrolling the planned Phase 3 clinical trials as quickly as possible. This is a transitional year in our history as we move into the early commercial planning for the manufacturing, regulatory submissions, and potential sales and marketing of AZ-004."

AZ-004 Phase 3 Clinical Trial Design

The first AZ-004 Phase 3 clinical trial is designed to enroll approximately 300 schizophrenic patients with acute agitation at 25 U.S. clinical centers. The trial is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and will test AZ-004 at two dose levels, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status.

The primary endpoint for the study is the change from baseline in the PANSS (Positive and
'/>"/>

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

Page: 1 2 3 4 5

Related biology technology :

1. The 4th Annual BIO Investor Forum to Webcast Alexzas Corporate Presentation
2. 19th Annual Piper Jaffray Health Care Conference to Webcast Alexzas Corporate Presentation
3. Alexza Elects Dr. Hal V. Barron to Its Board of Directors
4. Alexza Announces Partnership With Endo for AZ-003 (Staccato(R) fentanyl) in North America
5. Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference to Webcast Alexzas Corporate Presentation
6. Alexzas Corporate Presentation to be Webcast at the 10th Annual BIO CEO & Investor Conference
7. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
8. Dawson James Securities Initiates Research Coverage on CryoCor, Inc. (Nasdaq: CRYO) with a Strong Buy Rating and $6.00 Target Price
9. Spectrum Pharmaceuticals Initiates Second Registrational Phase 3 Clinical Trial for EOquin(R) in Patients With Non-Invasive Bladder Cancer
10. XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
11. Nventa Initiates HspE7 Phase 1 Cervical Dysplasia Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2015)... April 27, 2015  Together with its customers, Elekta ... Forum in Barcelona . The funds ... with the mission to improve cancer care, specifically radiation ... believes that no patient should be denied potentially life-saving ... it cooperates with hospitals and clinics around the world ...
(Date:4/24/2015)... California (PRWEB) April 24, 2015 ... key milestones in its allogeneic stem-cell product development ... to properly reflect the corporate strategic direction. , ... allogeneic (donor) adipose stem cell development program has ... of our cGMP manufacturing facility and hiring of ...
(Date:4/24/2015)... N.J. , April 24, 2015  Navitas Life Sciences ... as Head of Clinical and Regulatory Services. Shalabh is ... been a co-founder and CEO of Kinapse, as well as ... Logo - http://photos.prnewswire.com/prnh/20150423/201261LOGO ... Jim Tizzard commented "I am delighted to welcome Shalabh ...
(Date:4/23/2015)... 23, 2015 The Thomas Brain ... conduct a groundbreaking pilot study to see if ... in as little as three to six months. ... and nutritional medicine—will aggressively target and simultaneously treat ... our aging brain. These include oxidative stress, neuroinflammation, ...
Breaking Biology Technology:Elekta helps raise $33,000 to bring radiation treatment to developing countries 2Elekta helps raise $33,000 to bring radiation treatment to developing countries 3Vet-Stem, Inc. Meets New Milestones and Changes Name to VetStem Biopharma 2Shalabh Kumar Joins Navitas Life Sciences to Lead their Clinical and Regulatory Services Teams 2New Study Looks to Reverse Alzheimer’s Disease 2New Study Looks to Reverse Alzheimer’s Disease 3
... BOSTON, Jan. 11, 2012  CBI, a division of Advanstar ... 11th Annual Patient Adherence Forum, which is being held ... in Philadelphia, PA. At the event, industry experts share ... through stakeholder collaboration and patient engagement.  ...
... 11, 2012 What:  Come view ... CES, and hear Lucier and Rothberg discuss the future of ... http://photos.prnewswire.com/prnh/20110216/MM49339LOGO ) When:   Wednesday, ... Where:   Las Vegas Convention Center, North Hall, Booth ...
... 11, 2012  Inovio Pharmaceuticals, Inc. (NYSE Amex: INO ), which ... Dr. J. Joseph Kim, President and CEO, will present an overview of ... Noble Financial 8th Annual Equity Conference January ...   Inovio Presentation Tuesday, ...
Cached Biology Technology:Complete Agenda Announced for 11th Annual Patient Adherence Forum 2Inovio Pharmaceuticals to Present at Noble Financial 8th Annual Equity Conference 2Inovio Pharmaceuticals to Present at Noble Financial 8th Annual Equity Conference 3
(Date:4/1/2015)... OXFORD, Conn. , Apr. 1, 2015  NXT-ID, ... a biometric authentication company focused on the growing mobile ... number of Wocket smart wallets is underway to early ... early access group includes usage at retail outlets including ... CVS Pharmacy. Users report Wocket was accepted at all ...
(Date:3/30/2015)... Mar. 26, 2015 Research and Markets ... "Global Gesture Recognition Market in Automotive Sector 2014-2018" ... forecast the Global Gesture Recognition market in Automotive Sector ... period 2013-2018. Gesture recognition is the ability ... gestures of an individual. Gesture recognition technology can be ...
(Date:3/24/2015)... 2015   NexID Biometrics LLC, whose spoof-mitigation ... today announced the beginning of shipments of version 2.0 ... The company, based in Potsdam, N.Y. ... Expo, which began here today at the Walter E. ... of its SDK boosts the accuracy rate range to ...
Breaking Biology News(10 mins):NXT-ID Reports Second Shipment of Wocket Smart Wallets Underway to Early Access Pre-order Customers and Provides User Feedback 2NXT-ID Reports Second Shipment of Wocket Smart Wallets Underway to Early Access Pre-order Customers and Provides User Feedback 3NXT-ID Reports Second Shipment of Wocket Smart Wallets Underway to Early Access Pre-order Customers and Provides User Feedback 4Global Gesture Recognition Market in Automotive Sector Report 2015 - Growing Number of Partnerships 2NexID Begins Shipments Of Version 2.0 Fake-Finger-Detection Solution 2
... world,s first controlled study of a comprehensive genetic screening test ... twin girls born in Germany in June and a singleton ... in a pilot study of comparative genomic hybridisation (CGH) by ... a full range of chromosomal disorders. Dr Cristina ...
... Rivers and streams supply the lifeblood of ecosystems across the ... well as a wide array of life forms in rivers ... the fish humans eat. But humans and nature itself are ... role to support fish species, according to new research by ...
... global energy demands is the use of Poplar, a ... the most out of Poplar plantations, varieties that are ... or higher yields, for exampleare desired. But do these ... populations of Poplar? In particular, is the genetic makeup ...
Cached Biology News:First babies born from genetic screening study 2First babies born from genetic screening study 3A river ran through it 2A river ran through it 3A river ran through it 4The risks and benefits of using poplars for biofuels 2
COMING SOON: Anti-Mouse C5/C5b, Clone BB5.1. Monoclonal Antibody...
... Goat anti-Human Alpha 1 Acid ... azide Goats were immunized ... glycoprotein in Freund's adjuvant. ... absorbed to ensure specificity. ...
Anti-Mouse Valpha 2 TCR, Purified (Clone B20.1) (rat IgG2a)...
Request Info...
Biology Products: