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NicOx Announces TOPIGEN Initiates Phase 2 Proof of Concept Study in COPD for TPI 1020
Date:11/20/2007

SOPHIA ANTIPOLIS, France, Nov. 20 /PRNewswire/ -- NicOx S.A. (Eurolist: COX) today announced that TOPIGEN Pharmaceuticals Inc. has dosed the first patients in a phase 2 proof of concept study for TPI 1020 in Chronic Obstructive Pulmonary Disease (COPD) - see TOPIGEN press release attached. This new study is expected to provide the first assessment of TPI 1020's potential activity in COPD. TPI 1020 is a new chemical entity and novel anti- inflammatory licensed by TOPIGEN from NicOx for COPD and other respiratory disorders.

This new clinical study follows the recent announcement of promising top- line results from a phase 2a study in asthmatic smokers, where TPI 1020 showed a good safety and tolerability profile, in addition to certain anti- inflammatory effects which could be potentially beneficial in COPD (see press release of September 11, 2007). COPD is a respiratory disease caused by chronic inflammation of the lungs and bronchi and represents the third-leading cause of death in the United States (see NOTE).

Pascal Pfister, Chief Scientific Officer at NicOx, said: "We believe TPI 1020, which has a novel mechanism of action due to NicOx technology, could have the potential to bring real benefits to people suffering from COPD, based on data that has been observed in preclinical studies and the recently reported asthmatic smoker safety study. The progression of the TPI 1020 program is a testament to TOPIGEN's expertise in the respiratory therapeutic area, as well as the broad potential of NicOx' technology, and we see this collaboration as a validation of our strategy of partnering with leading biopharmaceutical companies outside our key therapeutic domains. We look forward to the results of this phase 2 proof of concept study, which should provide an important assessment of the compound's activity."

Under the terms of the agreement signed between NicOx and TOPIGEN in October 2005, TOPIGEN acquired the development and commercialization rights 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), 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.

NOTE:

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.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) 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. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.

NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck & Co., Inc.

NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).

The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company's document de reference. 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, Nov. 20 /PRNewswire/ -- 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. 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 http://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 Depot et Placement du Quebec (Caisse), T2C2/BIO 2000 and Lothian Partners 27 (sarl) SICAR. For more detailed information on TOPIGEN visit http://www.topigen.com.


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SOURCE NicOx
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