TOPIGEN

May 23, 2006 12:04 ET

TOPIGEN Initiates Phase II Program of TPI-1020 in Respiratory Disorders

MONTREAL and PARSIPPANY, NJ--(CCNMatthews - May 23, 2006) -

Program to Commence in Asthmatic Smokers

TOPIGEN Pharmaceuticals Inc., an emerging biopharmaceutical company specializing in respiratory disorders, today announced it has initiated a Phase II clinical trial of TPI-1020 in asthmatic smokers. This study is part of an overall clinical plan for the development of TPI-1020, an inhaled corticosteroid for chronic obstructive pulmonary disease (COPD).

This 21-day, multi-center, randomized, double-blind study will evaluate repeated and ascending doses of either TPI-1020 or budesonide in two treatment groups of 15 subjects per group. The primary objective of the trial is to assess the general safety, tolerability and pharmacodynamic activity of inhaled TPI-1020 in smokers with asthma. Secondary objectives will assess preliminary efficacy measurements.

"TPI-1020 is part of an exciting new class of nitric oxide (NO)-donating therapeutics, and it targets the underlying inflammation involved in certain lung disorders," said Dr. Louise Proulx, Vice President of Product Development at TOPIGEN. "Our preclinical and clinical observations suggest that the drug has broad potential to provide effective therapy for airway diseases, such as COPD and certain asthma indications. The goal of our program is to develop a medication that inhibits the recruitment of inflammatory cells or neutrophils and is more effective than leading conventional corticosteroids in treating patients with COPD."

About TPI-1020

TPI-1020 is a novel, inhaled NO-donating derivative of budesonide. Budesonide is a widely prescribed, multi-billion dollar corticosteroid, marketed worldwide by AstraZeneca under the name Pulmicortr. TOPIGEN licensed North American rights for the compound from NicOx S.A. for respiratory diseases with an option for worldwide rights (see press release dated October 27, 2005). When compared to budesonide, TPI-1020 was shown in preclinical studies to significantly block the recruitment of inflammatory cells (neutrophils) in rodent models of airway inflammation and pulmonary disease. Neutrophils are immune cells that play a central role in the pathology and exacerbations of COPD.

Clinical and preclinical studies on the drug were previously conducted by NicOx and included experiments in models of COPD. These in-vivo studies suggested that TPI-1020 is more effective than budesonide alone in protecting against bronchoconstriction and in inhibiting the infiltration and subsequent activation of neutrophils in the lung tissue. The results of clinical studies indicated that TPI-1020 was well tolerated, with a promising trend in activity and pharmacokinetic profile.

About COPD

Chronic obstructive pulmonary disease (COPD) is a disease of the elderly characterized by persistent airflow limitation of the lungs. Today, it is the fourth leading cause of death in the US after heart disease, cancer and cerebrovascular diseases, accounting for more than 120,000 deaths annually. 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 response to exposure to cigarette smoke. Smoking is the most important risk factor associated with the development of COPD. Acute exacerbations are the most common complication and a primary contributor to the morbidity and mortality. The disease is often associated with other significant disorders, notably asthma and heart disease. Although current treatments improve quality of life and provide symptomatic relief in some patients, there are no drugs available that can slow the progressive decline in lung function.

About TOPIGEN

TOPIGEN is a privately held biopharmaceutical company focused on developing new classes of inhaled drugs for respiratory disorders. TOPIGEN's pipeline includes small molecule and RNA-based therapeutics. The Company's Phase II products and research programs are uniquely focused on inhibiting multiple inflammatory pathways at the cellular site of lung inflammation. By topically targeting multiple affected airway receptors with its drugs, the Company expects to improve outcomes for many patients with respiratory diseases. This approach has shown promising preclinical and clinical results in inhibiting the underlying inflammation associated with many pulmonary conditions such as asthma, COPD and allergic rhinitis. For more detailed information on TOPIGEN visit www.topigen.com.


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