Healthcare Industry News: hemodialysis
News Release - February 21, 2006
Corgentech's Pivotal Phase 3 Trial of ALGRX 3268 Demonstrates Significant Pain Relief in Children Versus PlaceboCompany Plans to File New Drug Application with FDA in Mid-2006
SOUTH SAN FRANCISCO, Calif. and FORT MYERS, Fla., Feb. 21 (HSMN NewsFeed) -- Corgentech Inc. (Nasdaq: CGTK ) today announced that researchers presented pivotal Phase 3 trial results from the second of two Phase 3 trials demonstrating that children undergoing medical procedures requiring venipunctures and intravenous line placements treated with ALGRX 3268 experienced significantly superior pain relief in just one to three minutes versus those receiving placebo. Importantly, the study also showed ALGRX 3268 was well tolerated. The dataset, from which top-line data were reported in November 2005, was presented over the weekend at the Society for Pediatric Anesthesia Meeting in Fort Myers, Florida.
Corgentech plans to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in mid-2006 for ALGRX 3268, the first of three product candidates the company is developing for pain management. ALGRX 3268 utilizes a needleless injection system to locally deliver lidocaine into the skin to anesthetize the skin and relieve pain very rapidly. Approximately 18 million venipunctures and intravenous line placements occur each year in the largest children's hospitals and academic institutions in the United States.
"With an onset of action of one to three minutes, ALGRX 3268 provides a unique fast-acting, local anesthetic for reducing pain associated with peripheral venous access and intravenous insertion procedures in children," said Dr. Elliot J. Krane, principal investigator for the study and the director of pain management at the Lucile Packard Children's Hospital and professor of anesthesia and pediatrics at Stanford University School of Medicine. "Needlesticks are among the most distressing events for children undergoing medical treatments or procedures. In addition to being extremely fast-acting, ALGRX 3268 is well tolerated, which could make it an ideal new treatment to help physicians and nurses ease the pain and anxiety of their pediatric patients."
Study Details and Results
This second of two pivotal Phase 3 trials was conducted at nine centers in the United States and enrolled 535 patients, three to 18 years of age. Two hundred sixty-six patients received a placebo and 269 patients received ALGRX 3268 one to three minutes before undergoing medical procedures requiring venipuncture or intravenous line placement at the back of hand or antecubital fossa. The primary endpoint was pain upon needle insertion utilizing the FACES pain scale. Demographic characteristics, procedures performed, and sites of administration were evenly distributed across treatment groups.
The mean FACES score in the ALGRX 3268-treated patients was significantly lower than in the placebo group (p = 0.002). Similarly, the mean parental pain assessment score was significantly lower in the ALGRX 3268-treated patients than in the placebo group (p = 0.002).
These results are consistent with those reported in October from the first of these two pivotal Phase 3 trials, which employed an identical trial protocol and enrolled 574 pediatric patients. The primary endpoint of this study was also achieved and demonstrated that patients treated with ALGRX 3268 experienced statistically significantly less pain (p = 0.007) versus those treated with a placebo. ALGRX 3268 was well tolerated and demonstrated no significant safety issues in this study as well.
"We met the primary endpoints of two pivotal Phase 3 trials involving more than 1,000 patients, which we expect will enable us to obtain FDA approval for ALGRX 3268 in 2007," said John P. McLaughlin, chief executive officer of Corgentech. "Pain management is a critical underserved medical problem with few viable solutions for patients and caregivers. Poor pain management often leads to inferior healthcare outcomes, longer hospital stays, and additional expense. ALGRX 3268 represents an important near-term product opportunity that will serve as the cornerstone of a comprehensive portfolio of novel pain management treatments we plan to introduce to the market over the next three to five years."
Need for Fast-Acting Local Anesthetic
Local anesthetics for venipunctures and intravenous line placements are underutilized resulting in pain and anxiety for patients and their families. Topical local anesthetics are used in only approximately 10 percent of the tens of millions of these procedures because the currently available products require 10 to 60 minutes to relieve pain. ALGRX 3268, which provides significant pain relief in one to three minutes, may prove to be particularly useful in pediatric populations and emergency room settings, because it is easy to use and anesthetizes quickly -- generally in one minute -- potentially offering an important advantage over currently available therapies. With its fast onset-of-action, additional opportunities exist for ALGRX 3268 in the adult emergency room setting, hemodialysis and blood donation centers as well as physicians' offices and clinical laboratories.
Corgentech is a late-stage biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain and inflammation. The company has four drug candidates in clinical development for multiple potential indications, the most advanced of which, ALGRX 3268, has completed Phase 3 clinical trials. 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.
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