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:8/27/2014)... BIOEQUA, an innovative line of skin care ... handheld spray, has made its EQUA ESSENTIAL line available ... brand began with an unexpected discovery in an emergency ... that the application of nanospray technology allowed for liquid ... to skin's basal layer. This resulted in immediate absorption ...
(Date:8/27/2014)... State College, PA (PRWEB) August 27, 2014 ... Electromagnetic Simulation Software with new features for the ... release is an enhanced Biological Thermal Sensor, exclusive to ... is a specialty version of XFdtd, developed to calculate ... MATLAB® export functionality has been added to all versions ...
(Date:8/26/2014)... the thinnest-possible semiconductor, a new class of nanoscale ... , The University of Washington researchers have demonstrated ... be connected in an atomically seamless fashion known ... basis for next-generation flexible and transparent computing, better ... "Heterojunctions are fundamental elements of electronic and photonic ...
(Date:8/26/2014)... 2014 An analysis by Replikins, Ltd. of ... Mers CoV virus strains has revealed extensive conservation ... This conservation and sharing of specific Replikin gene structures ... candidate, as it did for the H5N1 influenza vaccine ... have been found to be effective (1,2). ...
Breaking Biology Technology:BIOEQUA'S EQUA ESSENTIAL Product Line Redefines Skin Care & Now Available in America 2Remcom Announces Enhanced Biological Thermal Sensor and Other Biomedical Features in XFdtd EM Simulation Software Update 2Remcom Announces Enhanced Biological Thermal Sensor and Other Biomedical Features in XFdtd EM Simulation Software Update 3Scientists craft atomically seamless, thinnest-possible semiconductor junctions 2
... ... Improvements. Producers, breed associations, livestock researchers and processing laboratories now have access to ... ability to accelerate breed improvements and verify parentage for cattle, sheep and swine. ... ...
... , ATLANTA, Jan. 8 With the ... might affect industrial boiler emissions, Georgia Power has decided to ... to biomass until the EPA rules are better defined in ... ) , The anticipated industrial boiler Maximum Achievable Control ...
... ... stage biopharmaceutical company focused on the development of novel vaccine candidates to treat chronic ... investor conference and will be attending the J.P. Morgan Healthcare Conference in San Francisco. ... Baltimore, MD ...
Cached Biology Technology:DNA Genotek Launches New Sample Collection Product to Accelerate Livestock Genetic Testing 2DNA Genotek Launches New Sample Collection Product to Accelerate Livestock Genetic Testing 3DNA Genotek Launches New Sample Collection Product to Accelerate Livestock Genetic Testing 4Georgia Power to Delay Plant Mitchell Conversion to Biomass 2Profectus Biosciences to Present at Key Investor Conference in January 2010 2Profectus Biosciences to Present at Key Investor Conference in January 2010 3
(Date:8/26/2014)... 2014 Oxygen ... Passware Analyst bekannt, einem neuen mobilen kriminaltechnischen ... Analysetools von Oxygen mit der Kennwortwiederherstellung und ... Das neue Tool kombinierte mobile Erfassung, Datenextraktion, ... Ablauf. Das neu hinzugekommene Modul für Kennwortwiederherstellung ...
(Date:8/25/2014)... is one of the most widespread causes of reduced ... United States are plagued by boron deficient soil and, ... their soil with boron; however, little is known about ... nutrient. Now, researchers at the University of Missouri have ... and reproduction in corn plants. Scientists anticipate that understanding ...
(Date:8/25/2014)... of biomolecule built like a nano-Christmas tree. Called a ... , It,s those ornaments that get all the glory. ... "tree" basically holds the sugars in place as they ... , Now a chemist at Michigan Technological University has ... deal more than a simple prop. , "We had ...
Breaking Biology News(10 mins):Oxygen Forensic Passware Analyst erfasst geschützte Mobilgerätedaten 2Researchers find boron facilitates stem cell growth and development in corn 2
... led by Northwestern Medicine scientists has identified how a defective ... disease known as Giant Axonal Neuropathy, or GAN. The finding ... Investigation . GAN is an extremely rare and ... systems of young children. Those affected show no symptoms at ...
... Health today announced that Vetsulin (porcine insulin zinc suspension), the ... is now available to veterinarians throughout the United States. ... from one in 1001 to one in 500, 2 and ... during the past 30 years.3 Today, along with proper diet ...
... cat, it instinctively avoids the feline or risks becoming dinner. ... the sense of smell, provides evidence that a single gene ... by neurobiologist Thomas Bozza has shown that removing one olfactory ... behavior. The gene, called TAAR4, encodes a receptor that responds ...
Cached Biology News:Rare, lethal childhood disease tracked to protein 2Merck Animal Health announces Vetsulin 2Cat and mouse: A single gene matters 2Cat and mouse: A single gene matters 3
... The H2OBIT™ is a fully licensed, high throughput, ... processing of up to 24 microplates. This equates ... plates. A robotic arm rapidly transfers ... resulting in temperature ramping times that are considerably ...
... ONE Ribonuclease is a 27kDa periplasmic enzyme ... of RNA to cyclic nucleotide monophosphate (NMP) ... of these intermediates to 3-NMPs (1). RNase ... known RNases that can cleave a phosophodiester ...
Porcine Pulmonary Artery Endothelial Cells (PPAEC) (>500,000 cells)...
...
Biology Products: