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MAP Pharmaceuticals Initiates Phase 2 Clinical Trial in Pediatric and Adolescent Patients With Asthma |
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02 Aug 2006 |
today announced the initiation and first patient dosing of a Phase 2 clinical trial evaluating MAP0010. MAP0010 is a proprietary nebulized formulation of budesonide for the inhalation treatment of asthma in both pediatric and adult populations.
MOUNTAIN VIEW, CA, USA | Aug 02, 2006 | MAP Pharmaceuticals today announced the initiation and first patient dosing of a Phase 2 clinical trial evaluating MAP0010. MAP0010 is a proprietary nebulized formulation of budesonide for the inhalation treatment of asthma in both pediatric and adult populations. This novel approach to therapy is intended to provide the same efficacy as the currently marketed nebulizer product, but with a lower dose delivered in less time.
The Phase 2 clinical trial will assess the efficacy of two doses of MAP0010 and will be conducted at multiple clinical sites in the United States as a randomized, double-blind, placebo-controlled study in approximately 225 pediatric and adolescent asthma patients. The primary endpoint for the study will be asthma control as assessed by changes in daily and evening asthma symptoms (coughing, wheezing, breathlessness) compared to placebo, with secondary endpoints that will evaluate changes in pulmonary function. Safety evaluations will be made throughout the duration of the clinical trial period.
"We are very pleased to see this program progress with a group of renowned clinical investigators who share our enthusiasm for the potential of this novel formulation for asthma treatment," said Dr. Stephen B. Shrewsbury, Vice President of Clinical and Regulatory Affairs at MAP. "We are optimistic that the unique features of our proprietary formulation will demonstrate significant delivery advantages and rapid therapeutic benefit to patients over existing asthma treatments."
Clinical data from a Phase 1 trial completed earlier this year with MAP0010 demonstrated that MAP's proprietary formulation is well-tolerated with no episodes of drug related adverse effects or bronchospasm. The resulting data supported initiation of this Phase 2 trial.
"We are encouraged by the results of our earlier Phase 1 clinical trial. Dosing patients in our Phase 2 trial is a significant achievement for our Unit Dose Budesonide program and it reinforces our goal at MAP Pharmaceuticals to develop therapies that provide convenient and differentiated patient advantages," said Timothy S. Nelson, CEO of MAP Pharmaceuticals. "By offering efficient delivery and a lower effective dose, we are striving to improve the lives of those patients suffering with asthma."
About Asthma
According to Datamonitor, a leading market research company, 41.5 million individuals are afflicted with asthma worldwide, 9.5 million of them are children. In some areas of the United States, the incidence of asthma in children is increasing at an alarming rate of more than 20% and the use of nebulized steroids is revolutionizing their treatment. Sales of nebulized steroids are expected to exceed $1.0 billion annually within the next few years.
Decision Resources reported in mid 2005 that the market for pulmonary treatment of asthma and COPD would expand from $8.4 billion in 2003 to $13.1 billion in 2013. This growth is due to increased incidence, the advent of combination therapy, as well as the rise of nebulized steroid treatment in pediatric patients.
About MAP Pharmaceuticals, Inc.
Located in Mountain View, California, MAP Pharmaceuticals is a specialty pharmaceutical company focused on the development of innovative therapies and inhalation delivery systems to treat a broad range of respiratory and systemic diseases. MAP's lead product candidates are a proprietary formulation of inhaled DHE for the treatment of migraines and a proprietary formulation of budesonide for the treatment of asthma in both pediatric and adult populations. Additional information about MAP Pharmaceuticals can be found on the MAP website at www.mappharma.com .
Source: MAP Pharmaceuticals, Inc |
