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Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain,Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the,Knee

- Pain Reductions Observed at Eight Weeks Sustained up to 12 Weeks and Drug Remains Very Well Tolerated -

SOUTH SAN FRANCISCO, Calif., July 02, 2007 /PRNewswire-FirstCall/ -- Anesiva, Inc. today announced preliminary longer-term, follow-up results from a Phase 2 study showing that a 1mg treatment with Adlea(TM) (formerly 4975) in patients with moderate-to-severe osteoarthritis of the knee produced substantial reductions in pain that persisted for up to 12 weeks.

"The positive preliminary results from this knee pain study further strengthen our belief that Adlea will prove to be a safe and effective drug in multiple osteoarthritis indications," said John P. McLaughlin, chief executive officer of Anesiva. "We are on-track to advance Adlea into late-stage trials in various indications this summer, including a Phase 2/3 trial for osteoarthritis of the knee."

Fifty-five patients with osteoarthritis of the knee were randomized to receive either: (I) a single injection of 1 mg of Adlea (n=36) or (II) three stepped ascending weekly doses totaling 1 mg of Adlea (n=19). At baseline prior to treatment, approximately three quarters of the patients had moderate pain while the other quarter had severe or extreme pain. As was previously reported, patients treated with Adlea demonstrated a 61 percent reduction in mean pain intensity from baseline to week one, and the analgesic effect was sustained at all subsequent weeks to the last scheduled in-clinic assessment at week eight, at which time a 64 percent reduction in pain from baseline was reported. At week 12, pain reductions were sustained. A cohort of 50 patients showed a 65 percent reduction from baseline pain scores. Forty two percent of the patients reported "no pain," 44 percent had "mild pain," and only 14 percent reported "moderate" or "severe" pain. The lengthy duration of clinical benefit is consistent with the known mechanism of action that suggests treatment with Adlea administered as a single injectio
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