SOPHIA ANTIPOLIS, France, Sept. 11 NicOx S.A.(Eurolist: COX) today reported that TOPIGEN Pharmaceuticals Inc. has disclosedpromising 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, inaddition to certain anti-inflammatory effects, which could be beneficial inTOPIGEN's target indication of Chronic Obstructive Pulmonary Disease (COPD).TOPIGEN plans to initiate a phase 2 study in patients with COPD during thesecond 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 patientswith respiratory disease and confirm its potential for enhanced clinicalefficacy, as previously suggested by preclinical models of COPD. Thesepositive data demonstrate the potential of NicOx' technology in therespiratory area and the quality of our alliance with TOPIGEN, whose expertisein this therapeutic area has been invaluable. NicOx and TOPIGEN are excited bythis opportunity to develop an effective treatment for the millions of peoplesuffering from COPD and looks forward to the initiation of a new trial in thisindication 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 receiverepeated and ascending doses of either inhaled TPI-1020 or budesonide, aconventional corticosteroid which is used in respiratory disorders (see pressrelease of May 23, 2006). The top-line results of this trial revealed a goodsafety and tolerability profile, in addition to certain anti-inflammatoryeffects which could be beneficial in the treatment of COPD. TOPIGEN plans toinitiate 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 andrepresents the fourth leading cause of death in the United States. Thecellular mechanisms that are responsible for COPD pathology are not completelyunderstood. Chronic airflow limitation is believed to be a consequence of anabnormal recruitment of inflammatory cells such as neutrophils (cellsreleasing enzymes that destroy lung tissue) and is frequently a response toexposure to cigarette smoke. Smoking is the most important risk factorassociated with the development of COPD.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-drivenbiopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeuticareas of inflammation and cardio-metabolic disease. Resources are focused ontwo lead compounds, naproxcinod (formerly HCT 3012); in phase 3 developmentfor the treatment of signs and symptoms of osteoarthritis, and NCX 4016, inphase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leadingpharmaceutical companies, including Pfizer Inc. and Merck & Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a publiccompany listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
The elements included in this communication may contain forward-lookingstatements subject to certain risks and uncertainties. Actual results of thecompany may differ materially from those indicated in the forward-lookingstatements because of different risks factors described in the company'sdocument 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, In