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Topigen Pharmaceuticals Inc. Moves Novel Inhaled PDE Inhibitor, TPI 1100, Into Clinical Development for COPD


12/23/2008 9:44:08 AM

MONTREAL--(Marketwire - December 22, 2008) - TOPIGEN Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused in respiratory disorders, today announced that it has received a clinical trial approval (CTA) letter to move TPI 1100, a drug candidate for the treatment of chronic obstructive pulmonary disease (COPD), into clinical development in 2009. TPI 1100 is a novel, inhaled inhibitor against phosphodiesterases (PDEs), PDE 4 and PDE 7. PDEs are a group of enzymes that are validated targets for COPD.

In related news, TOPIGEN announced that it has reprioritized its pipeline candidates for COPD and will fund further development of TPI 1100 after determining that it is a more promising candidate for COPD than TPI 1020. This follows the results of a Phase II study that was recently completed for TPI 1020 in patients with COPD, which showed good safety and tolerability, but did not demonstrate the desired activity profile. TPI 1020 is a novel, anti-inflammatory respiratory drug licensed from NicOx S.A. for respiratory indications. Potential opportunities for TPI 1020 in other indications are currently being explored by NicOx and TOPIGEN under the ongoing collaboration agreement.

Mark Parry-Billings, Chief Executive Officer of TOPIGEN, commented, "PDE inhibition is a very exciting area with great potential in fighting inflammatory respiratory diseases. With regulatory approval to evaluate TPI 1100 in the clinic, we look forward to moving this product candidate through development. Our decision to not invest further in TPI 1020 for COPD reflects the systematic approach TOPIGEN will continue to take in focusing resources on the development programs with the greatest chance of achieving clear differentiation and value in the respiratory market. The Company remains committed to the treatment of COPD, which is estimated to affect 30 million people in the United States, Europe and Asia."

About TPI 1100

TPI 1100 is a novel, potent, selective and dual-acting RNA-silencing oligonucleotide against phosphodiesterase isoforms PDE4 and PDE7. The drug is designed to inhibit multiple gene expression pathways known to be linked to progressive airway inflammation and remodeling in COPD. Delivered topically via aerosol to the lungs and without the need for specialized formulation technologies, TPI 1100 represents a novel RNA-silencing therapy with a highly selective mechanism for reducing lung inflammation and is expected to be without the dose-limiting systemic side effects widely associated with known small molecule inhibitors. The drug utilizes TOPIGEN's proprietary FANA™ Technology, a new generation of oligonucleotide chemistry with potential for broad gene-targeting drug applications.

In May 2008, TOPIGEN representative Marylène Fortin, Ph.D., presented an abstract on TPI 1100 at the American Thoracic Society's 2008 International Conference, in Toronto, Canada, titled "TPI 1100: an inhaled antisense oligonucleotide (AON) against Phosphodiesterase (PDE) 4 and 7 with significant anti-inflammatory effects in a mouse model for COPD." In this presentation, TPI 1100 was compared with roflumilast, an orally active PDE 4 inhibitor. TPI 1100 was shown to reduce PDE 4B, 4D and 7A mRNA expression in cells from lung lavage and inhibited neutrophil recruitment. Moreover, TPI 1100 blocked the induction of the pro-inflammatory chemokines KC, MIP-2 and MIP-1alpha. In contrast, the effect of roflumilast on neutrophil recruitment was minimal, and no inhibition of chemokines was observed. For more information or for a copy of the abstract, please visit www.topigen.com.

About COPD

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 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) in 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 associated morbidity and mortality. Although current treatments improve quality of life and provide symptomatic relief in most patients, there is a need for better drugs to 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 for 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 Pharmaceuticals is developing a clinical pipeline of innovative therapeutics for respiratory diseases, including asthma and COPD. The Company's unique, multi-targeted oligonucleotide product candidates have compelling therapeutic profiles that address major unmet medical needs. Topigen's business strategy is to advance products through clinical proof of concept and out-license to partners for commercialization. www.topigen.com



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