Corgentech Reports Phase 2 Trial Results for 4975 in Hernia Repair Pain
25 3월 2006 - 6:05AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., March 24 /PRNewswire-FirstCall/ --
Corgentech Inc. (NASDAQ:CGTK) today reported clinical results from
a Phase 2 trial of 4975, the company's novel, long-acting,
non-opioid drug candidate being developed in multiple mid-stage
clinical trials for site-specific, moderate to severe pain. The
41-patient, randomized, double-blind, parallel-group, placebo-
controlled European study was designed to measure the effectiveness
of 4975 in treating pain induced by surgical repair of an inguinal
(groin) hernia as measured one and four weeks after surgery.
Patients were given either a single dose of 4975 or placebo, which
was instilled (dripped by syringe) into the wound over
approximately one minute prior to wound closure. All patients in
both the treatment and placebo arms received paracetamol
(acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs:
ibuprofen) for one week following surgery, a mandated standard of
care in Denmark where the trial was conducted. While 4975 was well
tolerated at all time points during the study, there was no
significant difference in pain score in the drug versus control
arm. "We believe that concomitant administration of pain killing
drugs may have confounded the results of this trial since the
results are inconsistent with data obtained from multiple previous
Phase 2 trials of 4975 that demonstrated significant, sustained
pain reduction versus placebo in other indications," stated Daniel
J. Gennevois, M.D., vice president of medical affairs at
Corgentech. "Several aspects of this study's design were different
from other studies we have conducted. Mainly, paracetamol and
NSAIDs were systematically administered to both the treatment and
placebo arms for a week. Therefore, the pain score for the placebo
arm during the first week after surgery was quite low, making it
difficult to show a drug effect of 4975 during the first week when
the pain should be the most intense. The pain scores were
sufficiently low on the visual analog scale (VAS) of one to 100
(4975 group = 14.4, placebo group = 17.5) that most clinicians
would deem there to be clinically insignificant pain or no pain at
all." This small pilot Phase 2 study is one of multiple Phase 2
studies of 4975 either ongoing or completed that are evaluating the
use of this long-acting, non-opioid for pain management in several
different indications, of which five already have demonstrated
significant pain reduction and a favorable safety profile. The
indications include tendonitis of the elbow, post-surgical pain in
patients undergoing bunionectomy and neuropathic foot condition
Morton's neuroma. Phase 2 studies of 4975 for total knee
replacement and cholecystectomy have completed enrollment, and data
are expected in the second quarter of 2006. How 4975 May Address
Need for Fast-Acting, Long-Duration Pain Relief 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 provides pain relief to patients for weeks or
months after just a single treatment. 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 reduces pain by
selectively acting on nerve endings expressing VR1 receptors, but
does not affect other nerve fibers important for other sensory or
motor sensations. Opioid drugs, such as morphine, are commonly used
agents to relieve pain in 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, 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, 4975 may
have the potential to reduce length of hospital stay and the need
for opioids. About Inguinal Hernia Repair A hernia develops when
the outer layers of the abdominal wall weaken, bulge, or actually
rip. The hole in this outer layer allows the inner lining of the
cavity to protrude and to form a sac. Most hernias in adults result
from strain on the abdominal muscles, which have been weakened by
age or by congenital factors. Inguinal (groin) hernias account for
80 percent of all hernias and are more common in men than
women-about 25 percent of men and two percent of women develop an
inguinal hernia in their lifetime. In surgical repair, an incision
is made over the hernia and the bulging tissue or organ is replaced
inside the muscle wall, and a mesh is applied over the weakness and
sewn in place. Over half a million operations to repair hernias
were done in the U.S. last year, the vast majority of which were
done under local anesthesia. 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 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 in
mid-2006. Corgentech is based in South San Francisco, CA. For more
information on the company, please visit
http://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. DATASOURCE: Corgentech Inc. CONTACT: Jennifer
Cook Williams of Corgentech Inc., +1-650-624-9600, or ; or Daryl
Messinger of WeissComm Partners, +1-415-999-2361, or , for
Corgentech Inc. Web site: http://www.corgentech.com/
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