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:3/4/2015)... Lancée par l,Assistance ... en décembre 2011, l,étude collaborative française randomisée ... compare   l es microsphères en résine ... le carcinome hépatocellulaire avancé, a recruté plus de ...   ; les résultats sont attendus fin 2016. ...
(Date:3/3/2015)... and TORONTO, March 3, 2015 /PRNewswire/ - Aptose Biosciences ... new therapeutics and molecular diagnostics that target the underlying ... quarter and seventh-month period ended December 31, 2014. ... fiscal year end from May 31 to December 31. ... are reporting today are for the quarter and the ...
(Date:3/3/2015)... WASHINGTON , March 3, 2015 NASA astronaut ... his launch this month to spend a year living and ... live satellite interviews from 5:30 to 7 a.m. EDT Monday, ... Moscow as he completes the final weeks of ... by a video on NASA Television highlighting his mission training ...
(Date:3/3/2015)... ON , March 3, 2015 /PRNewswire/ - BIOREM Inc. (TSXV: ... $3.7 million.  The orders are for odour control projects in ... and Asia . "Bidding activity ... , President and CEO. "After a high volume year for bidding ... into the New Year.  The recent orders reflect the organization,s renewed ...
Breaking Biology Technology:Traitement du cancer primitif du foie : Recrutement terminé pour l'étude SARAH et résultats attendus fin 2016 2Traitement du cancer primitif du foie : Recrutement terminé pour l'étude SARAH et résultats attendus fin 2016 3Traitement du cancer primitif du foie : Recrutement terminé pour l'étude SARAH et résultats attendus fin 2016 4Traitement du cancer primitif du foie : Recrutement terminé pour l'étude SARAH et résultats attendus fin 2016 5Traitement du cancer primitif du foie : Recrutement terminé pour l'étude SARAH et résultats attendus fin 2016 6Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 2Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 3Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 4Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 5Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 6Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 7Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 8Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 9Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 10Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 11Aptose Biosciences reports results for the quarter and seven months ended December 31, 2014 12NASA Astronaut Scott Kelly Available for Interviews before One-Year Space Station Mission 2
... A longtime engineer at Wyle,s Houston-based operations has ... for his participation in developing a bioreactor, which enables ... outside the body, both in space and on Earth. ... and 26-year employee at Wyle,s Integrated Science and Engineering ...
... questions over a billion dollar industry by boldly claiming ... materials can be mass produced. In a ... journal Nanotechnology , Professor Mike Kelly, Centre for ... you cannot mass produce structures with a diameter of ...
... Harvest Technologies Corp. ( www.harvesttech.com ) announced today ... Heart Failure trial have been enrolled at Medanta-the Medicity ... intended to evaluate the safety and clinical effect of ... Congestive Heart Failure (CHF) when using a minimally invasive ...
Cached Biology Technology:Wyle Engineer Inducted Into Space Technology Hall of Fame for Work on Growing Human Cells in Space 2Limit to nanotechnology mass-production? 2Harvest Technologies Announces Initial Enrollment in Its REVIVE-1 Trial (REtrograde Vascular Infusion of BMAC to ImproVe Heart FailurE) 2
(Date:2/5/2015)... Carolina , 5. Februar 2015 /PRNewswire/ ... als spezialisiertes Logistikunternehmen und hat eine neue ... klinische Logistikfirma (Clinical Logistics Organization – CLO) ... neuen Kampagne lautet First , mit ... Foto: http://photos.prnewswire.com/prnh/20150205/173753 ...
(Date:2/5/2015)... , January 28, 2015 ... Analysis, Size And Segment Forecasts To 2020 has Been ... IR camera market is expected to reach USD 5.10 ... Grand View Research, Inc. IR cameras help identify the ... are expected to witness surging demand in medical imaging ...
(Date:1/22/2015)... 22, 2015 Research and Markets ( http://www.researchandmarkets.com/research/4trb7t/biometrics_a ) ... Global Market Overview" report to their offering. , ... ensure that an individual is who she/he is claiming to ... of a person,s unique physical characteristics, such as fingerprint, hand ...
Breaking Biology News(10 mins):Marken startet Kampagne mit Patienten im Mittelpunkt 2Marken startet Kampagne mit Patienten im Mittelpunkt 3IR Camera Market Worth $5.10 Billion By 2020: Grand View Research, Inc. 2IR Camera Market Worth $5.10 Billion By 2020: Grand View Research, Inc. 3Biometrics - A Global Market Overview 2Biometrics - A Global Market Overview 3
... enhance mental energy and well-being not only for healthy ... according to a July 15 panel discussion at the ... Food Expo held at McCormick Place. Bonnie Kaplan, ... University of Calgary, Alberta, Canada, said Monday vitamins and ...
... that have been recently published in Journal of ... (JGR-C), Journal of Geophysical Research-Solid Earth ... In this release: Why freshwater organisms ... of methane from thermokarst lakes, Low-cost solution optimizes water ...
... there was little doctors could do to help a patient ... important new discoveries about the deadly skin cancer. ... by any measure the most exciting time for melanoma research," ... Division of Dermatology and Cutaneous Sciences at Michigan State University,s ...
Cached Biology News:AGU journal highlights -- July 16, 2013 2AGU journal highlights -- July 16, 2013 3AGU journal highlights -- July 16, 2013 4AGU journal highlights -- July 16, 2013 5AGU journal highlights -- July 16, 2013 6AGU journal highlights -- July 16, 2013 7AGU journal highlights -- July 16, 2013 8AGU journal highlights -- July 16, 2013 9Tide is turning in skin cancer battle 2
...
...
...
... siSolutions siRNA Custom Synthesis Service ... duplex RNA to knockdown any ... (19 RNA base pairs with ... 27-mers, or other lengths of ...
Biology Products: