SOURCE: TOPIGEN Pharmaceuticals, Inc.

November 19, 2007 12:34 ET

TOPIGEN Pharmaceuticals Begins Patient Dosing in Phase 2 Trial of TPI 1020 in COPD

Study to Assess Safety, Tolerability and Proof-of-Concept of TPI 1020 When Compared to Budesonide

MONTREAL--(Marketwire - November 19, 2007) - TOPIGEN Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in developing products for respiratory disorders, today announced that the first patients have been dosed in a Phase 2 trial, designed to evaluate the safety, tolerability and proof-of-concept of inhaled TPI 1020 in patients suffering from chronic obstructive pulmonary disease (COPD). TPI 1020 is a novel, anti-inflammatory respiratory drug licensed from NicOx S.A. for respiratory indications.

The randomized, double-blind, placebo and active-controlled, multi-center, Phase 2 trial is expected to enroll approximately 50 evaluable patients. The primary endpoint of this six-week study is to assess the general safety and tolerability of TPI 1020 versus budesonide as well as efficacy of TPI 1020 versus budesonide on sputum neutrophils counts. Neutrophils are inflammatory cells that are important in the pathology of COPD.

Paul K. Wotton, Ph.D., President and Chief Executive Officer of TOPIGEN, commented, "TOPIGEN is committed to developing innovative medicines for respiratory diseases, such as asthma and COPD, where there is a need for more effective treatment options to improve prognosis and quality of life. We are delighted that patient dosing has begun in this important Phase 2 proof-of-concept trial. Based on the very good safety profile and effect on inflammation seen in our recently completed Phase 2 study of TPI 1020 in asthmatic smokers, we plan to accelerate clinical development of the drug in COPD, and later in certain other respiratory disorders in which patients have abnormal levels of neutrophils. COPD will be the primary target indication for which we plan to seek eventual marketing approval."

Study Design Background

In this Phase 2 study, patients with COPD will be randomized to three arms which will receive inhaled doses of TPI 1020 (500 mcg bid), budesonide (800 mcg 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 safety endpoint of the trial is to determine the general safety and tolerability of inhaled TPI 1020 in COPD patients. The study will also compare the effect of TPI 1020 and budesonide on the change in sputum neutrophil counts between baseline and day 42. A secondary endpoint 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 endpoints 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), the amount of air that can be forcibly expelled from the lungs after breathing in as deeply as possible and Inspiratory Capacity (IC), the maximum volume of air that can be breathed in after breathing out normally. Blood cells and cytokines will also be studied in the trial.

About COPD

COPD is a disease characterized by persistent airflow limitation in the lungs. Today, it is the third leading cause of death in the U.S., 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 yet 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 cigarette smoke exposure. 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 associated 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 NicOx S.A.

NicOx is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammation and cardio-metabolic disease. Headquartered in Sophia-Antipolis, France, NicOx is a public company listed on the Eurolist of Euronext™, Paris. For more detailed information on NicOx, visit www.nicox.com.

About TOPIGEN

TOPIGEN is a privately held, clinical-stage company focused on developing new classes of inhaled drugs for respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma. TOPIGEN is actively progressing two drug candidates in Phase 2 trials for COPD and asthma, including TPI 1020, a novel anti-inflammatory, licensed from NicOx S.A. and TPI ASM8, which utilizes its proprietary mRNA-silencing technology. These drug candidates target multiple pathways and pro-inflammatory mediators involved in chronic pulmonary diseases.

Current venture investors include NovaQuest, MMV Financial, Inc., BDC Venture Capital, Fonds de solidarite FTQ, Desjardins Venture Capital, Caisse de Dépot et Placement du Québec (Caisse), T2C2/BIO 2000 and Lothian Partners 27 (sarl) SICAR. For more detailed information on TOPIGEN visit www.topigen.com.

Contact Information

  • Corporate Contact:
    Paul K. Wotton, Ph.D.
    President & CEO
    TOPIGEN Pharmaceuticals, Inc.
    (514) 868-0404
    Email Contact

    IR/PR Contact:
    Donna LaVoie or Tim Allison
    LaVoie Group
    (978) 745-4200 X103 or 102
    Email Contact or
    Email Contact