CLINICAL TRIALS

Phase IIA trials in patients with COPD and cystic fibrosis have demonstrated the safety of inhaled heparin as a therapeutic approach.

A phase IIB clinical trial of inhaled heparin in COPD is in progress;

EudraCT number 2010-024168-16, sponsored by Casa di Cura Privata S. Raffaele Pisana, Rome.

The results should be available late 2013.

COPD is predominantly caused by cigarette smoking and inhalation of environmental factors, including wood smoke from cooking over open fires, and is believed to affect up to 10% of the world population. In 2009, the COPD market was estimated to be worth $7.2 billion and is projected to grow at a compound annual growth rate (CAGR) of 7.4% to reach $11.9 billion in 2016 [GlobalData.com]. The COPD market is growing significantly in most countries and it is expected that COPD will be the fourth leading cause of death worldwide by 2030.

There is a high level of unmet need for drugs that can reduce COPD exacerbation rates, slow or halt the progression of COPD, and improve lung function, exercise capacity and the quality of life in COPD patients. There are no specific treatments for COPD and the development of novel inhaled therapies based on the multiple pharmacological properties of heparin, both alone and in combination with other drugs, is expected to provide new treatment options for COPD patients worldwide, and will play a major role in the expansion of the COPD market in the coming years.

Ockham's commissioned on-going trial in patients with COPD support the efficacy and safety of this approach.