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:8/27/2015)... , Aug. 27, 2015 HUYA Bioscience International ... of the Japan Society of HTLV-1, held this week ... The purpose of the Society is to promote research ... development of medical technology and research related to these ... "HUYA is proud to support this prestigious ...
(Date:8/27/2015)... (PRWEB) , ... August 27, 2015 , ... ... customers’ weighing needs and expertly narrows down the product choices to a manageable ... criteria pares down the list to models that fit best with the customer’s ...
(Date:8/26/2015)... ... August 26, 2015 , ... ... today that a second US laboratory is to open in Manhattan, Kansas in ... continued partnership and long-term growth of research and development through collaboration with researchers ...
(Date:8/26/2015)... MO (PRWEB) , ... August 26, 2015 , ... ... it is increasing its investment in the development and manufacture of highly valued ... The company’s scientific team's extensive expertise with protein chemistry has led to ...
Breaking Biology Technology:HUYA Bioscience International Sponsors Japan Society Of HTLV-1 Annual Meeting 2HUYA Bioscience International Sponsors Japan Society Of HTLV-1 Annual Meeting 3HUYA Bioscience International Sponsors Japan Society Of HTLV-1 Annual Meeting 4METTLER TOLEDO Updates Online Scale Selection Tool 2MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 2MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 3Lee Biosolutions Announces Increased Investment in the Development and Manufacturing of Biomarkers Used in Early Detection Of Heart Disease 2
... downtown coverage area will include the isthmus and Alliant Energy ... Wis. A downtown wireless network called Mad City ... almost ready to go live. Cellnet, a firm in Atlanta, ... Internet service providers. , ,Cisco announced that its Aironet ...
... Can a Mac really be hacked in just 30 ... Wisconsin-Madison systems engineer, who criticized recent media reports for sensationalism after ... owner of a computer gave out login accounts to potential hackers. ... who had been given access to the computer to take full ...
... Madison, Wis. Credit unions could take better advantage ... by the UW E-Business Consortium. , ,According to the Federal ... theft in the last five years 10 million last ... just the fact that they could be is a pressing ...
Cached Biology Technology:Madison's downtown wireless network almost ready 2
(Date:8/6/2015)... and TELTOW, Germany , August 6, ... Conference, SensoMotoric Instruments (SMI) shows the world,s ... , based on Epson,s Moverio BT-200 see-through head ... With this new solution, unprecedented quality and efficiency is ... with context-sensitive displays. For the first time, professionals and ...
(Date:8/4/2015)... Aug. 04, 2015 ... has announced the addition of the ... and Service), Sub-Segment (Computer Forensics, Network Forensics, ... Types, Service, Vertical and Region - Global ... offering. By Component (Hardware, Software, ...
(Date:7/31/2015)... 31 de julho de 2015 A 10 ... ) será realizada pela BGI de 22-25 de outubro de ... A conferência está celebrando seu 10 o. ... ICG se tornou uma das reuniões mais influentes do ... científicos mais dinâmicos, entusiastas e prazerosos. ...
Breaking Biology News(10 mins):SMI Shows First Eye Tracking Upgrade for Augmented Reality Glasses 2SMI Shows First Eye Tracking Upgrade for Augmented Reality Glasses 3Digital Forensics Market - The Market Represents a Compound Annual Growth Rate (CAGR) of 11.3% From 2015 to 2020 2A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 2A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 3
... tree. Two years ago, a 71-year-old Indiana man impaled his ... wound caused an infection that led scientists to discover a new ... inside insects. On Oct. 15, 2010, Thomas Fritz, a retired ... apple tree outside his home near Evansville, Ind. As he ...
... for improved early disease screening, cancer staging, therapeutic assessment, and ... , director of Virginia Tech,s Center for Biomedical Imaging ... journal PLOS ONE . , The integration ... a new way of thinking in the biomedical imaging world" ...
... (NASDAQ: AWRE ), a global provider ... of Aware,s AccuRad REM Server with Nuance,s market-leading ... radiologists to automatically incorporate radiation exposure estimate information ... SB 1237, California,s mandate for inclusion of dose ...
Cached Biology News:Microbial 'missing link' discovered after man impales hand on tree branch 2Microbial 'missing link' discovered after man impales hand on tree branch 3Microbial 'missing link' discovered after man impales hand on tree branch 4Scanning innovation can improve personalized medicine 2Scanning innovation can improve personalized medicine 3Aware Enables Automated Delivery of Radiation Dose Information Through Integration With Leading Radiology Reporting System 2Aware Enables Automated Delivery of Radiation Dose Information Through Integration With Leading Radiology Reporting System 3
... Once again Guava is making flow cytometry accessible ... alike will appreciate the latest addition to Guavas ... EasyCyte Mini easy to use, surprisingly affordable, ... laser and 3-color detection. The Guava EasyCyte Mini ...
... Cell Lab Quantas unique combination of ... population resolution capabilities and accurate cell ... excitation wavelengths, including UV, allowing flexible ... multi-color applications typically only achievable with ...
... monoclonal antibody irreversibly crosslinked to protein G-agarose ... PDH complex from heart mitochondria. Also included ... for control immunocapture. ,The pyruvate dehydrogenase complex ... from small amounts of tissue. This facilitates ...
... Protein/antibody delivery using PULSin may be superior ... example, unlike traditional transfection, with PULSin you ... level and time course of proteins in ... provide more information than traditional RNA interference ...
Biology Products: