SOUTH SAN FRANCISCO, Calif., Oct. 4 /PRNewswire-FirstCall/ -- Anesiva, Inc. today announced that the first patient has been treated in a Phase 2 study of the company's compound Adlea(TM) (formerly 4975) for post-operative pain in patients who undergo total hip replacement surgery, also called Total Hip Arthroplasty (THA). Adlea is a long-acting, non-opiate analgesic drug candidate designed to provide pain relief for weeks to months after a single local application during the surgical procedure.
"Hip replacement surgery can involve a long recovery time -- sometimes up to six months -- which is frequently accompanied by post-operative pain from the procedure," said John P. McLaughlin, chief executive officer of Anesiva. "We believe Adlea may help alleviate the resulting pain for patients without the troubling side effects that other treatments such as opiates and COX-2 inhibitors can cause. We believe that these benefits can help patients recover faster and complete their rehabilitation more successfully after surgery."
The trial will enroll approximately 160 patients, randomized to receive either a single 15-mg dose of Adlea or placebo instilled into the surgical wound prior to closure. The trial will evaluate safety, tolerability, pharmacokinetics, and the ability of Adlea to reduce post-operative pain following total hip replacement surgery.
Anesiva previously announced positive data from a Phase 2 study showing that a single treatment with Adlea in patients undergoing total knee replacement surgeries produced significant reduction in pain on ambulation on the first post-operative day and significantly less pain on follow-up visits at two weeks. Adlea-treated patients also had numerically lower mean pain scores at pre-specified time intervals over the first two weeks post-surgery in the study while pharmacokinetic data demonstrated that most patients (19 of 25) had detectable plasma Adlea levels for less than 12 hours (presented at the American Pain Society meeting in May 2007). This short duration of systemic exposure associated with the long duration of pain relief following a single Adlea dose may potentially represent a huge advantage in risk-benefit ratio with Adlea use relative to the conventional systemically active analgesics on the market. As expected, the study also met its primary objective of demonstrating safety and tolerability.
Anesiva's goal is to initiate clinical trials of Adlea for two lead indications in the coming months: management of acute post-operative pain associated with orthopedic surgeries and management of osteoarthritis pain in the knee. These include a Phase 2 trial in arthroscopic shoulder surgery, a Phase 2 / 3 trial in osteoarthritis of the knee, and a Phase 3 trial in Total Knee Arthroplasty (TKA). Anesiva also recently initiated a Phase 2 trial in TKA.
How Adlea May Address The Need for Long-Duration, Well-Tolerated Pain Relief
Adlea 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, Adlea does not affect other nerve fibers necessary for sensory or motor sensations and proprioception.
Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. Its short duration of systemic exposure (hours) relative to the long duration of analgesia (weeks to months) resulting from a single treatment of Adlea is particularly important in this typically elderly and vulnerable patient population and may also potentially offer a safer treatment option in the management of chronic osteoarthritis pain. Importantly, the prolonged analgesic effect resulting from a single or stepped dose, localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opiates (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction). In clinical studies to date, Adlea has been shown to be well tolerated.
About Total Hip Replacement
Total hip replacement is performed in patients with late-stage degenerative hip disease. A number of conditions and diseases can cause the cartilage surfaces of the hip joint's ball-and-socket components to degenerate, which leads to pain, stiffness, and disability. According to the American Academy of Orthopedic Surgeons, more than 193,000 total hip replacements are performed each year in the United States, and this number will increase by an estimated 174 percent to 572,000 by the year 2030.
About Anesiva and its Diverse Portfolio 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 one FDA-approved product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, to reduce pain associated with peripheral venous access procedures in children three to 18 years of age. The second product in Anesiva's pipeline, Adlea(TM) (formerly 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: the timing and results of our clinical trials, whether Adlea will provide pain relief for weeks to months, whether Anesiva is able to manufacture our products on commercially reasonable terms, whether Anesiva can commercially release new products successfully and the degree to which these products 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, 2007.
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.
