SOUTH SAN FRANCISCO, May 1 /PRNewswire-FirstCall/ -- Anesiva, Inc. announced today that it will present additional Phase 2 data on 4975 for the treatment of post-surgical pain associated with total knee replacement surgeries. The poster presentation will take place at the 26th Annual Scientific Meeting of the American Pain Society being held May 2-5 at the Washington Convention Center in Washington, D.C.
The presentation information is as follows: -- Poster #781: Enduring and well-tolerated analgesia for total knee arthroplasty postsurgical pain produced by a single, rapidly-eliminated, intraoperative instillation of 4975 -- Poster Display Times: May 3, 2007: 9:30 a.m. - 11:30 a.m. and 2:30 p.m. - 6:15 p.m.* May 4, 2007: 9:30 a.m. - 12:00 p.m. and 3:00 p.m. - 6:15 p.m. * Author-attended session from 4:45 p.m. - 6:15 p.m. on May 3rd
Top-line data from the Phase 2 study demonstrated that treatment with 4975 resulted in significant reduction in pain on first ambulation on first day post-surgery and reduction in "pain right now" as well as "worst pain in past 24 hours" on Brief Pain Inventory at two weeks post-surgery. Additionally, 4975 was shown to be well tolerated. Further results of the study presented at the American Academy of Pain Medicine Meeting showed a trend toward lower concomitant morphine usage in the 4975-treated group over the placebo group, one of the exploratory endpoints. This is an important finding, as an advantage of 4975 is its potential to reduce the need for opioid drugs, which are well known to have side effects such as sedation, respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use.
A follow-on Phase 2 clinical trial in approximately 80 patients undergoing knee replacement surgeries is expected to begin during the first half of 2007. The trial will evaluate a higher dose of 4975 than that used in the previous study. Anesiva plans to initiate a Phase 3 trial in knee replacement surgery patients in the second half of 2007.
About Total Knee Replacement Surgery
Total knee replacement surgeries (also known as total knee arthroplasty) are performed on patients with end-stage osteoarthritis of the knee. These patients have disabling pain which imposes severe limitations on their mobility, and knee replacement is performed with the goal of restoring or improving patients' quality of life. There were an estimated 470,000 total knee replacement procedures performed in the United States in 2005, and the number of replacements will continue to grow as the average age of the U.S. population increases and as these individuals conduct more active lives. The American Academy of Orthopedic Surgeons projects that approximately 3.5 million of these procedures will be done each year by 2030.
How 4975 May Address Need for Long-Duration, Well-Tolerated Pain Relief
4975 is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, 4975 does not seem to affect other nerve fibers necessary for motor functions or other functional sensations, such as those needed to sense temperature or pressure.
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 filed 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 Form 10-K for the year ended December 31, 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 of Investor Relations, ofAnesiva, Inc., +1-650-624-9600, investors@anesiva.com
Web site: http://www.anesiva.com/
