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www.fdanews.com/articles/63546-anesiva-launches-phase-i-study-of-topical-anesthetic

ANESIVA LAUNCHES PHASE I STUDY OF TOPICAL ANESTHETIC

October 30, 2006

Anesiva announced it has initiated Phase I clinical testing of product candidate 1207, a new topical local anesthetic for the potential treatment of numerous pain conditions, including neuropathic pain.

The study, designed to assess the safety of 1207, will enroll 24 adult healthy male volunteers in up to six dose-escalating cohorts in Australia. In addition to safety data, the randomized, double-blind, placebo-controlled study will measure sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.

The drug candidate is a new chemical entity with novel anesthetic properties that provide pain relief by binding to the fast sodium channel on neurons responsible for transmitting pain signals from nerve endings to the brain. Specifically, 1207 binds to the fast sodium channel on both A nerve fibers responsible for transmitting immediate adaptive pain signals and C nerve fibers responsible for transmitting longer-term, dull, throbbing pain signals.

By interrupting the communication channel of both A fibers and C fibers, 1207 is designed to provide effective topical pain relief with a faster onset and longer duration of action than currently marketed pain products, according to the company. In preclinical testing, topical administration of 1207 demonstrated a long duration of action and deep, rapid penetration. Other potential applications for 1207 include preprocedural use in dermatological surgery and postsurgical incision pain.