Drug/indication: Synavive AR in rheumatoid arthritis (phase II trial)
Top-line results expected in third quarter 2012
The "SYNERGY" trial evaluates the efficacy of Synavive AR, a combination pill comprised of the cardiovascular drug dipyridamole and a very low dose of the steroid prednisone, in patients with rheumatoid arthritis. Synavive is being compared with placebo and against the individual components. The study's primary endpoint is reduction in c-reactive protein (measured by DAS28 scale); key secondary endpoints are reductions in signs and symptoms of rheumatoid arthritis, measured by ACR20, ACR50 and ACR70 scales.
Drug/indication: Palifosfamide in sarcoma (phase III trial)
Top-line results expected in the second half of 2012
"PICASSO III" compares palifosfamide plus doxorubicin to doxorubicin alone in patients with front-line metastatic soft-tissue sarcoma. The study's primary endpoint is improvement in progression-free survival (for accelerated approval) and overall survival (for full approval). Sources: TheStreet research; BioMedTracker, a provider of independent research on biotechnology and pharmaceutical developments; and company and analyst reports.