TPI-1020 Trial For Chronic Obstructive Pulmonary Disease Promising

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TPI-1020 Trial

TOPIGEN Pharmaceuticals has disclosed promising top-line results from its first phase 2 clinical study for TPI-1020, a new chemical entity licensed from NicOx which is a novel respiratory anti- inflammatory.

These results showed a good safety and tolerability profile, in addition to certain anti-inflammatory effects, which could be beneficial in TOPIGEN's target indication of Chronic Obstructive Pulmonary Disease (COPD). TOPIGEN plans to initiate a phase 2 study in patients with COPD during the second half of 2007 (see TOPIGEN's press release enclosed).

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Damian Marron, Vice-President of Corporate Development at NicOx, declared: "These results indicate that TPI-1020 is safe and well tolerated in patients with respiratory disease and confirm its potential for enhanced clinical efficacy, as previously suggested by preclinical models of COPD. These positive data demonstrate the potential of NicOx' technology in the respiratory area and the quality of our alliance with TOPIGEN, whose expertise in this therapeutic area has been invaluable. NicOx and TOPIGEN are excited by this opportunity to develop an effective treatment for the millions of people suffering from COPD and looks forward to the initiation of a new trial in this indication later this year."

This trial was initiated in May 2006 and was a 21-day, multi-center, double blind trial in asthmatic smokers who were randomized to receive repeated and ascending doses of either inhaled TPI-1020 or budesonide, a conventional corticosteroid which is used in respiratory disorders (see press release of May 23, 2006). The top-line results of this trial revealed a good safety and tolerability profile, in addition to certain anti-inflammatory effects which could be beneficial in the treatment of COPD. TOPIGEN plans to initiate a phase 2 trial for TPI-1020 in COPD during the second half of 2007.

About COPD

COPD is characterized by persistent airflow limitation in the lungs and represents the fourth leading cause of death in the United States. The cellular mechanisms that are responsible for COPD pathology are not completely understood. Chronic airflow limitation is believed to be a consequence of an abnormal recruitment of inflammatory cells such as neutrophils (cells releasing enzymes that destroy lung tissue) and is frequently a response to exposure to cigarette smoke. Smoking is the most important risk factor associated with the development of COPD.

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