SOPHIA ANTIPOLIS, France, Sept. 11 /PRNewswire/ -- NicOx S.A. (Eurolist: COX) today reported that TOPIGEN Pharmaceuticals Inc. 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).
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.
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.
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 of reference.
TOPIGEN Pharmaceuticals to Advance TPI 1020 Into Phase 2 Development for COPD
Phase 2a Study Results Confirm Drug's Safety, Tolerability when Compared with
Budesonide; Potential for Enhanced Clinical Efficacy in COPD
MONTREAL, Sept. 11 /PRNewswire/ -- TOPIGEN Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in respiratory disorders, today announced the successful completion of a Phase 2a safety trial with TPI 1020 in smokers with asthma.
TOPIGEN also announced plans to initiate a Phase 2 clinical trial of TPI 1020 in chronic obstructive pulmonary disease (COPD) in the second half of 2007. TPI 1020 is a novel anti-inflammatory respiratory drug licensed from NicOx S.A.
The primary objective of this Phase 2a study was to confirm the general safety, tolerability and pharmacodynamic activity of inhaled TPI 1020 in smokers with asthma. The study evaluated equimolar doses of TPI 1020 and budesonide at two dose levels for 21 days in a comparative, randomized design in 27 asthmatic smokers. TPI 1020 was very well tolerated. In addition, the study demonstrated the potential for unique anti-inflammatory effects on prognostic indicators that are believed to be relevant in COPD, which will be evaluated further in the planned Phase 2 study in COPD patients.
Paul K. Wotton, Ph.D., President and Chief Executive Officer of TOPIGEN, commented: "The data we have seen in this Phase 2a safety trial are very encouraging and confirm the preclinical findings of the drug in our own COPD models. The multiple modes of anti-inflammatory activity give us confidence to progress the development of TPI 1020 in COPD."
Mark Parry-Billings, Ph.D., Chief Development Officer of TOPIGEN, added: "Assuming that TPI 1020 continues to show similar characteristics in future clinical studies, we may have a compound with a unique efficacy profile for use in COPD, a progressive disease associated with high morbidity and mortality for which there is currently no cure. TPI 1020 may also have potential efficacy in other lung diseases that would benefit from these anti- inflammatory effects."
Michele Garufi, Chairman and Chief Executive Officer of NicOx, said: "We are very pleased with the Phase 2a data generated by TOPIGEN, which have confirmed the safety of TPI 1020 and its potential to be efficacious in the treatment of COPD. These positive results are also a testament to our excellent collaboration with respiratory development partner, TOPIGEN. We look forward to the continued progress of this compound and to the initiation of the COPD trial later this year."
Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation in the lungs. Today, it is the fourth 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 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 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(TM), Paris. For more detailed information on NicOx, visit http://www.nicox.com.
TOPIGEN is a privately held, clinical-stage biopharmaceutical 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, licensed from NicOx S.A. and TPI ASM8, which utilizes its proprietary mRNA-based chemistry. 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.
|SOURCE NicOx S.A.|
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