Corgentech Announces Scientific Presentation of Pivotal Phase 3 Data Demonstrating Significant Pain Reduction Associated With F
18 5월 2006 - 9:30PM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., May 18 /PRNewswire-FirstCall/ --
Corgentech Inc. (NASDAQ:CGTK) 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
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