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by inhalation twice daily for 12 weeks, during which time their standard ICS and LABA therapies will be gradually withdrawn.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:2/10/2016)... India , February 10, 2016 ... The "Personalized Medicine, Targeted Therapeutics and Companion Diagnostic ... Trends, Technologies, Participants, and Environment" research report indicates ... worth over $149 billion by 2020 growing at ... up of companion diagnostics and targeted therapeutics and ...
(Date:2/9/2016)... Feb. 9, 2016  Landauer, Inc. (NYSE: LDR ... measurement and monitoring, outsourced medical physics services and high ... its fiscal 2016 first quarter ended December 31, 2015. ... Fiscal 2016 First Quarter Highlights , Revenue of ... quarter of 2015 , Domestic Radiation Measurement services revenues ...
(Date:2/9/2016)... , Feb. 9, 2016  Jazz Pharmaceuticals plc ... report its 2015 fourth quarter and full year financial ... of the financial markets.  Company management will host a ... p.m. EST/9:30 p.m. GMT to discuss fourth quarter and ... and financial update and guidance for 2016 financial results. ...
Breaking Medicine Technology:
(Date:2/9/2016)... Altamonte Springs, FL (PRWEB) , ... February 09, ... ... nation’s leading innovative specialty pharmacies, announces today the continuation of the ‘Pay It ... donations for each prescription referral received at our specialty pharmacy. , “Since ...
(Date:2/9/2016)... ... , ... The Journal of Pain Research has published the commentary ... As corresponding author Dr John F. Peppin says “Terminology matters, yet little attention has ... patients. ‘Chronic cancer pain’ and ‘chronic non-cancer pain’ are replete in the literature; ...
(Date:2/9/2016)... ... February 09, 2016 , ... ... to expand access to affordable hearing aids , increase industry transparency, and ... in the United States. , “For the average consumer, the hearing aid industry ...
(Date:2/9/2016)... Maui, Hawaii (PRWEB) , ... February 09, 2016 , ... ... to Maui to lead a photographic adventure on the island, June 14-19, 2016, hosted ... Unforgettable Events series. , After a successful debut in 2015, the ...
(Date:2/9/2016)... ... February 09, 2016 , ... i2i Systems, an early innovator and developer of ... in the latest KLAS report, Population Health Management 2015: How Far Can Your Vendor ... population health management (PHM). The latest KLAS Report, leveraging over 200 user interviews, ...
Breaking Medicine News(10 mins):