Topigen Pharmaceuticals Inc, a clinical-stage biopharmaceutical company focused in respiratory disorders, 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."

TPI 1100 is a novel, potent, selective and dual-acting RNA-silencing oligonucleotide against phosphodiesterase isoforms PDE4 and PDE7.

NicOx is a product-driven biopharmaceutical company dedicated to the development of nitric oxidedonating drugs for unmet medical needs.

Topigen Pharmaceuticals is developing a clinical pipeline of innovative therapeutics for respiratory diseases, including asthma and COPD.