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Anesiva Starts Phase 1 Clinical Study of 1207, New Topical Local Anesthetic

Posted on: Wednesday, 25 October 2006, 09:01 CDT

SOUTH SAN FRANCISCO, Calif., Oct. 25 /PRNewswire-FirstCall/ -- Anesiva, Inc. announced today that it has commenced Phase 1 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.

"Preclinical data suggest that 1207 could offer rapid and deep-penetrating relief as a topical treatment for neuropathic pain, or potentially for surgical incision pain prior to dermatological surgery," said Daniel J. Gennevois, M.D., vice president of medical affairs at Anesiva. "With 1207 entering the clinic, we now have three novel products in various stages of advanced development, each of which offers the promise to address significant unmet medical needs in the pain market."

1207 -- Novel Anesthetic Properties

1207 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, aching 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. In preclinical testing, topical administration of 1207 demonstrated a long duration of action and deep, rapid penetration. Other potential applications for 1207 include pre-procedural use in dermatological surgery and post-surgical incision pain.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. In addition to 1207, the company has two other drug candidates in development for multiple pain-related indications, the most advanced of which, Zingo(TM), has completed Phase 3 clinical trials. The second product in the pipeline, 4975, has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com/.

Forward Looking Statements

This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect,""estimate,""project,""budget,""forecast,""anticipate,""intend,""plan,""may,""will,""could,""should,""believes,""predicts,""potential,""continue," and similar expressions are intended to identify such forward-looking statements. Forward- looking statements in this press release include, without limitation, projected timing of FDA filings and clinical data announcements and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward- looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended June 30, 2006.

Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.

Anesiva, Inc.

CONTACT: Jennifer Cook Williams, Vice President, Investor Relations, ofAnesiva, Inc., +1-650-624-9600 or investors@anesiva.com

Web site: http://www.anesiva.com/

Source: PRNewswire-FirstCall

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