Prochymal is currently in clinical trials for the treatment of chronic obstructive pulmonary disease, or COPD, a form of lung disease characterized by limitation or obstruction of airflow in the airway, encompassing both emphysema and chronic bronchitis. COPD is the fourth-leading cause of death in the U.S. with an estimated 12 million Americans diagnosed with the disease. COPD has no known cure, thus current therapeutic intervention is aimed at providing relief of symptoms. Preclinical and clinical data suggest that Prochymal’s unique mechanism of action may provide a first-in-class treatment option with the ability to reverse the underlying disease.
The six-month interim evaluation in the Phase II trial evaluating Prochymal in patients with moderate to severe COPD demonstrated product safety. Prochymal also significantly decreased the levels of CRP compared to placebo in those patients with elevated CRP at the time of study entry (p<0.05). CRP is a protein found in the blood in response to inflammation and is often elevated in inflammatory diseases such as GvHD and Crohn’s disease, and has been found to correlate with clinical parameters of disease activity. Although there is substantial preclinical evidence, this study provides the first well-controlled objective data confirming the systemic anti-inflammatory effects of Prochymal in humans.