SOUTH SAN FRANCISCO, Calif., Feb. 9 /PRNewswire-FirstCall/ -- Corgentech Inc. today announced that it has completed patient enrollment in three Phase 2 clinical trials of ALGRX 4975-one of three mid- to late-stage non-opioid pain management drug candidates the company is developing-to evaluate this novel agent’s ability to reduce post-surgical pain. The market for patients treated for post-surgical pain in the United States alone is more than $1.7 billion.
“In multiple clinical trials to date, ALGRX 4975 has been shown to reduce post-surgical, neuropathic and musculoskeletal pain for weeks to months after a single administration,” stated Patricia Richards, M.D., Ph.D., vice president, clinical research at Corgentech. “There is a major unmet need for well-tolerated, long-acting pain relievers that could reduce the need for opioid medications, and we look forward to sharing the results of all these trials in the second quarter of 2006.”
Study Details
The three trials each enrolled approximately 40 patients who have either undergone cholecystectomy, hernia repair or total knee replacement surgery. The Phase 2 trials in hernia repair and cholecystectomy, or gallbladder removal, which is also a model for abdominal surgeries, were each conducted at single clinical sites. The Phase 2 trial in total knee replacement patients was conducted at two clinical sites. In all three trials, patients were randomized to receive either ALGRX 4975 or placebo, which was administered before closure of the surgical wound to reduce post-surgical pain, and thus reduce the need for opioid drugs and hasten recovery time.
How ALGRX 4975 May Address Need for Fast-Acting, Long-Acting Local Anesthetic
ALGRX 4975 is a novel non-opioid drug candidate being developed in multiple mid-stage clinical trials for site-specific, moderate to severe pain. It is long-acting and designed to provide pain relief to patients for weeks or months after just a single treatment. ALGRX 4975, a VR1 agonist, is based on capsaicin and acts as a C-neuron anesthetic. The product is administered locally at the site of pain and selectively reduces pain in nerve endings so does not affect other nerve fibers important for other sensory or motor skills. In addition to the post-surgical studies underway, ALGRX 4975 is being evaluated in a Phase 2 study for Morton’s neuroma, a neuropathic condition of the foot, and in a Phase 2 trial for tendonitis. In a Phase 2 study of bunionectomy patients, ALGRX 4975 demonstrated months of pain relief following bunionectomy surgeries.
Opioid drugs, such as morphine, are currently the most commonly used agents to relieve pain in neuropathic, post-surgical and musculoskeletal pain conditions but are associated with significant side effects including respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use. In clinical studies to date, ALGRX 4975 has not demonstrated similar side effects and has been shown to be well tolerated. Additionally, it has been shown that pain in the hospital is associated with increased length of stay, longer recovery times and poorer patient outcomes. By safely decreasing a patient’s level of pain with fewer side effects and associated complications, ALGRX 4975 may have the potential to reduce length of hospital stay and the need for opioids.
About Corgentech
Corgentech is a late-stage biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain management and inflammation. The company has four drug candidates in mid- to late-stage clinical trials for multiple potential indications, the most advanced of which has completed Phase 3 clinical trials and is expected to be submitted for FDA approval during 2006. Corgentech is based in South San Francisco, CA. For more information on the company, please visit www.corgentech.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 Corgentech 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 Corgentech’s Form S-4 as well as Corgentech’s Form 10-K/A for the year ended December 31, 2004 and most recently filed Form 10-Q.
Corgentech 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.
Corgentech
CONTACT: Jennifer Cook Williams, Vice President, Investor Relations ofCorgentech, +1-650-624-9600, or investors@corgentech.com
Web site: http://www.corgentech.com/
