SOUTH SAN FRANCISCO, Calif., May 18 /PRNewswire-FirstCall/ -- Corgentech Inc. today announced that positive safety and efficacy data from one of two pivotal Phase 3 studies of its lead product candidate, 3268, will be presented at the Society of Academic Emergency Medicine Annual Meeting in San Francisco later this week. Data from the study demonstrated that 3268, a fast-acting local anesthetic, provided a statistically significant reduction in pain compared to placebo when administered just one to three minutes prior to venipuncture and intravenous (IV) line placement procedures in children. The Company has also reported positive safety and efficacy data from the second Phase 3 trial studying 3268.
Details on the presentation are as follows:
When: Saturday, May 20, 2006, 11:00 a.m. to 12:00 p.m.
Session: Oral Papers, Pediatrics
Title: Local Analgesia within 1 to 3 minutes for Pediatric
Venipuncture and Peripheral Venous Cannulation Procedures
Using the Needle Free System 3268. Abstract # 362.
Presenter: William T. Zempsky, M.D., Associate Professor, Department
of Pediatrics, University of Connecticut; Associate
Director, Pain Relief Program, Connecticut Children's
Medical Center, Hartford, CT.
"Children who enter a hospital emergency department often experience great fear and anxiety associated with or in anticipation of needlestick procedures," said Dr. Zempsky. "We have clear guidelines now from multiple professional organizations advocating the use of topical anesthetics in children to reduce the pain of venipuncture and IV procedures whenever possible. Dr. Zempsky is co-author of a recent American Academy of Pediatrics Clinical Report on the relief of pain and anxiety in pediatric patients in emergency medical systems. The report encourages the use of painless topical anesthetics prior to all non-emergent invasive procedures in the emergency department including venous access procedures.
Zempsky continued, "The routine use of currently marketed topical anesthetics is limited as these products are inconvenient, requiring up to 60 minutes to offer benefit. With an onset of action of one to three minutes, 3268 could easily be incorporated into procedures and allow emergency medical personnel to comply with these guidelines without interrupting the clinical care of patients."
Topical local anesthetics for venipunctures and IV placements are an underserved market. 3268 is a needlefree system that delivers lidocaine powder into the epidermis and provides analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in pediatric populations and busy emergency room settings, means the product can be incorporated into the procedure allowing uninterrupted care, an important advantage over current options.
In hospitals in the United States, approximately 18 million venous access procedures occur each year in pediatric patients alone. In addition to the pediatric hospital population, opportunities exist for 3268 in the adult hospital setting, hemodialysis and blood donation centers as well as physicians' offices and clinical laboratories.
"We believe that 3268 represents an important near-term product opportunity that will serve as the cornerstone of a comprehensive portfolio of novel pain management treatments," said John P. McLaughlin, chief executive officer of Corgentech. "We are making excellent progress in our preparation of a New Drug Application (NDA) for 3268, which we plan to file with the FDA in the summer."
Statistically Significant Reduction in Pain
The Phase 3 was conducted at six leading children's hospitals in the United States and enrolled 574 patients, three to 18 years of age. Patients received treatment with 3268 or placebo (an identical device but without drug) one to three minutes before venipuncture or intravenous line placement at the back of hand or antecubital fossa. The primary endpoint was child-rated pain (using the FACES pain scale) upon needle insertion.
The mean FACES score in patients treated with 3268 prior to needle insertion was significantly lower than patients treated with placebo (p = 0.007). Similarly, when parents assessed their child's pain during the procedure, the mean parental observational pain assessment score was significantly lower in patients treated with 3268 compared to those patients treated with placebo (p<0.001).
These results are consistent with those presented in February from a similar pivotal Phase 3 trial, which employed an identical trial protocol and enrolled 535 pediatric patients at nine clinical centers in the United States. The primary endpoint of that study was also achieved and demonstrated that patients treated with 3268 experienced a statistically significant reduction in pain (p = 0.002) upon needle insertion compared to placebo. 3268 was well tolerated and no clinically significant safety issues were observed in either study.
Corgentech 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 four drug candidates in clinical development for multiple potential indications, the most advanced of which, 3268, has completed Phase 3 clinical trials. To reflect the company's core focus on novel pain management therapies, the board of directors recently voted to change the company name to Anesiva. If approved by stockholders at the annual meeting on June 21, 2006, the name change will become effective immediately thereafter. Corgentech is based in South San Francisco, CA.
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 quarterly report on Form 10-Q for the quarter ended March 31, 2006.
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.