• Actelion Ltd., of Allschwil, Switzerland, reported data showing that in mildly symptomatic pulmonary arterial hypertension patients with WHO functional Class II PAH, bosentan (Tracleer) prevented clinical deterioration by significantly delaying time to clinical worsening, and it reduced the number of patients worsening to WHO functional Class III/IV disease. A significant reduction in pulmonary vascular resistance and a positive trend in increasing the 6MWD also were observed. Those data were published in The Lancet.

• Oncolytics Biotech Inc., of Calgary, Alberta, is starting a Phase II trial of intravenous Reolysin in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers that are refractory to standard therapy or for which no standard therapy exists. The 14-patient, open-label study will measure tumor response and duration of response as its primary objectives. The secondary objective is to determine the safety and tolerability of Reolysin when administered in combination with chemotherapy drugs.

• Pharmaxis Ltd., of Sydney, Australia, said it reached an agreement with the FDA on a special protocol assessment for a Phase III trial of Bronchitol in bronchiectasis. The study will randomize 350 patients to receive either Bronchitol or placebo for 52 weeks. The primary endpoints are defined as a reduction in frequency of exacerbations and improvement in quality of life, while secondary endpoints include time to first exacerbation and duration of exacerbation. Additional secondary endpoints will measure antibiotic use, sputum volume, exercise tolerance and lung function. Pharmaxis previously received agreements on the trial design from European regulators. Pending successful results, the study will serve as the basis for marketing applications in both the U.S. and Europe. Bronchitol, which has fast-track and orphan drug status in the U.S., also is in development for improving mucus clearance in patients with cystic fibrosis and other acute and chronic pulmonary conditions.

• YM BioSciences Inc., of Mississauga, Ontario, said the FDA removed the clinical hold on AeroLEF, allowing YM to resume the expansion of the Phase II trial into the U.S. AeroLEF is being developed for the management of acute pain by delivering a formulation of inhaled, nebulized, free-and-liposome-encapsulated fentanyl. The FDA cleared the Phase II protocol in June 2007 but imposed a clinical hold in January with a request for additional safety information, specifically data relating to certain patients who appeared to experience oxygen desaturation in earlier studies. (See BioWorld Today, Jan. 18, 2008.)