FDA grants Clinical Data's PRX-8066 Orphan Drug Designation for pulmonary arterial hypertension

Nov 1 2010

Clinical Data, Inc. (NASDAQ: CLDA) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pulmonary arterial hypertension (PAH) to PRX-8066, the Company's selective serotonin 2B (5-HT_2B) receptor antagonist. The expression of 5-HT_2B receptors is elevated selectively in the pulmonary vasculature of PAH patients, and these receptors mediate abnormal cell growth and proliferation. Analyses of results from a Phase II study of PRX-8066 in pulmonary hypertension associated with chronic obstructive pulmonary disease (COPD) demonstrated its capacity to reduce elevated pulmonary pressures. Based on these results and findings from animal models, the Company is developing plans for the continued clinical development of PRX-8066 for patients with PAH.

“The scientific rationale and encouraging results of clinical studies of PRX-8066 in patients with pulmonary hypertension support further studies for this indication and potentially other disorders.”

"Obtaining Orphan Drug Designation is an important first step in developing our clinical program for PRX-8066," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "The scientific rationale and encouraging results of clinical studies of PRX-8066 in patients with pulmonary hypertension support further studies for this indication and potentially other disorders."

Blocking the activity of the 5-HT_2B receptor is predicted to alleviate symptoms and modify disease progression. PRX-8066 has demonstrated beneficial effects on pulmonary blood pressure in clinical studies and effects on vasodilatation and vascular remodeling of the pulmonary vasculature in animal models of disease.