Anesiva, Inc. (Nasdaq: ANSV) announced today clinical data from a Phase 1 safety study of product candidate 1207, which was being tested as a topical anesthetic for treatment of neuropathic patients. 1207 achieved the primary endpoint of the study of safety and tolerability. In the studied population of healthy volunteers, no clear anesthetic effect of 1207 was demonstrated.
"While we are disappointed that we did not see positive efficacy in this trial, our primary focus is on our two most advanced pain product candidates -- Zingo(TM), for which we recently filed a New Drug Application, and 4975, which is expected to enter pivotal trials later this year," stated John P. McLaughlin, chief executive officer of Anesiva. "Based on the results of the Phase 1 trial of 1207, we are no longer pursuing the clinical development of this drug."
The Phase 1 study enrolled a total of 24 adult healthy male volunteers in six dose-escalating cohorts at a single clinical center in Australia. In addition to safety data, the randomized, double-blind, placebo-controlled study measured sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.
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. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been submitted for the most advanced product, Zingo(TM). 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 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 September 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.
http://www.anesiva.com/
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