NicOx Announces TOPIGEN Initiates Phase 2 Proof of Concept Study in COPD fo...(sto TPI 1020 in North America with an op...),Health

Date:11/20/2007

s to TPI 1020 in North America with an option to obtain rights to the rest-of-world from NicOx at a later date. TOPIGEN will manage and fund development activities through to product registration and NicOx stands to receive an undisclosed share of future revenues and up to euro 52.9 million in potential milestones and commercial success fees.

Study design and endpoints

The trial is a 6-week, multi-center, double blind, placebo and active- controlled study, where about 50 patients with COPD will be randomly allocated to three arms. Each arm will receive inhaled doses of TPI 1020 (500ug bid), budesonide (800ug bid), a conventional corticosteroid commonly used in respiratory disorders, or placebo. Eligible patients will be smokers or ex- smokers between 40 and 80 years old with an established clinical history of mild to moderate COPD as defined by the Standards for the Diagnosis and Management of patients with COPD.

The primary outcome measures of the study are the effect of TPI 1020 and budesonide on the change in sputum neutrophil counts between baseline and day 42 and the safety and tolerability of inhaled TPI 1020 in COPD patients. A secondary outcome will also measure the change in sputum neutrophil counts between baseline and day 21. Neutrophils are immune cells implicated in COPD pathology and previous in vivo studies have suggested that TPI 1020 is more effective than budesonide at inhibiting the infiltration and subsequent activation of neutrophils in the lungs.

Additional secondary outcome measures will follow the effect of TPI 1020 and budesonide on the change in three standard spirometry measurements between baseline and days 21 and 42. Spirometry is used to assess the volume of air that can be moved in and out of the lungs. The three parameters which will be followed in the trial are: Forced Expiratory Volume 1 (FEV1), the volume of air that can be breathed out during the first second of forced exhalation; Slow Vital Capacity (SVC),
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