• Cytopia Ltd., of Melbourne, Australia, filed an investigational new drug application with the FDA for its orally active JAK2 inhibitor CYT387. The company hopes to conduct a Phase I/II trial in patients with myelofibrosis.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., successfully completed its open-label multidose, multiday, observational safety study of Dyloject in the U.S. The objective of the study was to evaluate the safety of Dyloject following I.V. bolus administration of multiple doses over multiple days in patients ages 18 to 85 with acute postoperative pain. A total of 856 patients successfully completed the study, receiving at least eight doses of Dyloject over a 48-hour period. The company said it plans to file a new drug application for Dyloject in the fall, at the same 37.5-mg dose used in the study.

• Resolvyx Pharmaceuticals Inc., of Bedford, Mass., initiated the first human trial evaluating an oral resolvin therapeutic, RX-10001, in a Phase I study of asthma and inflammatory diseases. RX-10001 is a synthetic form of RvE1, a naturally occurring resolvin shown in animal studies to activate the body's own off-switch mechanisms for inflammation and to promote healing.

• YM BioSciences Inc., of Mississauga, Ontario, said its licensee, Daiichi-Sankyo Co. Ltd., of Tokyo, started enrolling patients in a Phase II trial of nimotuzumab in combination with radiation therapy/cisplatin/vinorelbine in first-line curative intent patients with Stage III non-small-cell lung cancer. The trial is designed to evaluate the treatment completion rate and numerous secondary endpoints including response rate, progression-free survival and the overall survival rate at 12 months and 18 months, as well as toxicity.