Navigation Links
Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma
Date:3/2/2009

BERKELEY, Calif., March 2 /PRNewswire/ -- Aerovance Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate Aerovance's Phase IIb clinical trial, AeroTrial(TM), of inhaled dry powder Aerovant in patients with uncontrolled asthma.

Study initiation begins today in the United States for AeroTrial, a double-blind, randomized, placebo-controlled, Phase IIb dose-ranging study. Aerovance expects to enroll approximately 500 patients with moderate to severe asthma, in the United States and Europe, who are poorly controlled by the combination of inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). Patients will be randomly assigned to receive one of three Aerovant doses (1 mg, 3 mg or 10 mg) or placebo by inhalation twice daily for 12 weeks, during which time their standard ICS and LABA therapies will be gradually withdrawn. The primary endpoint is exacerbation incidence on Aerovant therapy as compared to placebo. Secondary endpoints include pulmonary function, time to exacerbation, daily peak expiratory flow (PEF) and symptom scores, immunoglobulin E (IgE) levels, and fractional concentration of expired nitric oxide (FeNO).

"Regulatory clearance and initiation of AeroTrial are significant milestones for Aerovance and potentially for patients living with uncontrolled asthma. The efficacy and safety data from our completed Aerovant studies are promising, and we are pleased to begin evaluation of this compound in a large number of moderate to severe asthmatics," said Mark Perry, Aerovance's president and chief executive officer. "Aerovant targets a root cause of asthma by blocking the signaling activity of two key cytokines, interleukin-4 (IL-4) and interleukin-13 (IL-13), critical in the progression of the disease. Our Phase IIa data suggest that targeted delivery to the lung is superior to systemic administration in blocking the asthmatic activities of IL-4 and IL-13 and has the potential to provide a breakthrough treatment for a patient population with few options."

AeroTrial is a late-stage clinical study using a dry powder formulation and follows positive clinical data from two Phase IIa studies in which Aerovant demonstrated significant benefit in asthmatics who were experimentally challenged with inhaled allergen (The Lancet 2007, 370: 1422-31). The dry powder formulation that will be used in AeroTrial was well tolerated in a recently completed Phase I study in asthmatics. By using a medication based on a protein occurring naturally in the body, AeroTrial seeks a non-steroidal solution to getting control of asthma. For more information, visit www.aerotrial.com.

Aerovant is a recombinant human IL-4 variant that is a potent inhibitor of the alpha subunit of the IL-4 receptor (IL-4R alpha), a shared component of both the IL-4 and IL-13 receptor complexes. Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer Pharmaceuticals Corporation in 2004.

Aerovance Inc. is a Berkeley, California-based biopharmaceutical company focused on the development and commercialization of first-in-class therapies for the treatment of respiratory and inflammatory diseases. For more information, visit www.aerovance.com.

Contact: Andreas Marathovouniotis or David Schull

Russo Partners

212-845-4235 or 212-845-4271

andreas.marathis@russopartnersllc.com

david.schull@russopartnersllc.com

Dave Happel

Aerovance Inc.

510-549-5525

dave.happel@aerovance.com


'/>"/>
SOURCE Aerovance Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Data Show Aerovances Aerovant(TM) Inhalation Powder is Well Tolerated in Asthma Patients
2. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
3. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
4. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
5. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
6. MedImmune Initiates Phase 2a Multi-Dose Study in Patients with Asthma
7. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
8. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
9. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
10. Prolexys Pharmaceuticals Initiates Phase 1 Study
11. Isis Initiates Phase 1 Study of ISIS 325568 Targeting Glucagon Receptor to Treat Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... -- Research and Markets has announced the addition of ... to 2025" report to their offering. ... The Global Cryostat Market is poised ... decade to reach approximately $3.5 billion by 2025. This ... given segments on global as well as regional levels presented in ...
(Date:3/23/2017)... 23, 2017 Executive ... through extensive primary research (inputs from industry experts, ... to present the analysis of global heart valve ... and Repair); Replacement Procedure By Technique (Mechanical, Bioprosthetic, ... (Surgical Devices, Balloon Valvuloplasty, Transcatheter Mitral Valve Repair ...
(Date:3/23/2017)... 23, 2017   BioSpace , the leading biotechnology ... with Indiana Biosciences Research Institute and over ... educational institutions to bring the state,s life sciences industry ... map, an artistic representation of the region,s booming biotechnology ... Vice President Mike Pence , a long-time advocate ...
Breaking Medicine Technology:
(Date:3/25/2017)... ... 25, 2017 , ... Getting earned media coverage meaningful for Garden Media Group's ... through the year, Garden Media aims to provide material helpful to clients’ goals and ... pitching client’s key messages to gain coveted media placements, Garden Media wows clients ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... to the military at the same time by providing Prehospital Trauma Life Support ... PHTLS is the world’s premier prehospital trauma education developed in cooperation with the ...
(Date:3/24/2017)... ... March 24, 2017 , ... Digital Scientists, a software innovation lab ... opening of a Greenville, South Carolina location. The lab has set up ... , “We’ve been working with South Carolina clients for years from our office here ...
(Date:3/24/2017)... ... 24, 2017 , ... Texas Physical Therapy Specialists (TexPTS) is pleased to ... Road. The clinic is the group’s 7th location in San Antonio and 23rd in ... will provide care from the clinic, which opened March 22, 2017. , ...
(Date:3/24/2017)... ... 24, 2017 , ... Shamanic healer and teacher Anahata Ananda ... Spiritual Awakening, proudly presents her Sacred Peru retreat with world famous shaman ... journey during the Summer Solstice will also be her final international retreat, Anahata ...
Breaking Medicine News(10 mins):