Corgentech Phase 2 Trial of ALGRX 4975 Meets Primary Endpoint of Decreased Pain for Tendonitis Patients
09 3월 2006 - 9:00PM
PR Newswire (US)
Statistically Significant, Sustained Pain Reduction Versus Placebo
in Patients with 'Tennis Elbow' SOUTH SAN FRANCISCO, Calif., March
9 /PRNewswire-FirstCall/ -- Corgentech Inc. (NASDAQ:CGTK) today
reported positive clinical data from a Phase 2 clinical trial
showing that ALGRX 4975-one of three non-opioid pain management
drug candidates the company is developing-demonstrated sustained,
statistically significant pain relief over placebo in patients with
tendonitis of the elbow. The 45-patient study met its primary
endpoint-response to ALGRX 4975 in treating pain induced by wrist
dorsiflexion four weeks after patients were treated with a single
injection of ALGRX 4975 or placebo. At week four, 64 percent (14 of
22) of patients treated with ALGRX 4975 were considered
"responders," versus 30 percent (seven of 23) of patients treated
with placebo (p=0.0256). A responder was defined as having no or
slight pain upon wrist dorsiflexion (0 or 1) on a 0-4 scale. For
patients treated with ALGRX 4975, a statistically significant
improvement in the responder analysis was maintained eight weeks
after treatment compared to placebo, and the trend for ALGRX 4975
patients to have lower pain scores was maintained from two to 12
weeks. Secondary endpoints also favored the ALGRX 4975-treated
group. Additionally, ALGRX 4975 was well tolerated at all time
points during the 24-week study. Complete results of this trial
will be presented at the upcoming 25th Annual Scientific Meeting of
the American Pain Society in May 2006. "ALGRX 4975 is a
highly-differentiated product that could fill an important unmet
need for an efficacious, non-opioid, long-acting pain reliever,"
stated James Z. Huang, president of Corgentech. "ALGRX 4975 has
demonstrated its ability to provide pain relief to patients
experiencing post-surgical, neuropathic and musculoskeletal pain
for weeks to months after only a single administration. We look
forward to reporting clinical results next quarter from three
additional Phase 2 trials of ALGRX 4975 for three diverse
post-surgical indications." Study Details The randomized,
double-blind, placebo-controlled Phase 2 trial enrolled 45 patients
with elbow tendonitis or "tennis elbow" across two centers.
Patients received either an injection of ALGRX 4975 or placebo
preceded by an injection of a local anesthetic into the site of
pain. With the average duration of symptoms for tendonitis patients
being six to 12 weeks, pain scores were monitored for 12 weeks
following the single dose of ALGRX 4975 or placebo. About
Tendonitis -- A Condition Affecting One to Three Percent of Adults
in the U.S. Elbow tendonitis is a relatively common condition
affecting one to three percent of the adult population in the
United States. Although commonly called "tennis elbow," only about
five percent of all cases are related to playing tennis. The
majority of cases are occupation-related and the condition can lead
to a loss of work and productivity, with an estimated seven percent
of industrial workers affected at some point in their working
career. In addition to immobilization, a variety of treatments
exist including non-steroidal anti-inflammatory drugs, local
corticosteroid injections, and more recently, shock wave therapy.
However, nothing has been convincingly proven to provide
long-lasting pain relief for patients with this painful condition.
The average duration of symptoms is six to 12 weeks, but
occasionally patients may have persistent symptoms lasting many
months. Surgery is sometimes required for patients having severe
symptoms lasting greater than six months. How ALGRX 4975 May
Address Need for Fast-Acting, Long-Duration Pain Relief 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 provides 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 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. ALGRX 4975 is being evaluated in
multiple Phase 2 trials for a variety of pain management
indications. Corgentech recently completed enrollment for three
Phase 2 trials of ALGRX 4975 for the reduction of post-surgical
pain following hernia repair, total knee replacement and
cholecystectomy for which data are expected in the second quarter
of 2006. ALGRX 4975 demonstrated pain relief in a Phase 2 trial for
post-surgical pain in patients undergoing bunionectomy, and in a
Phase 2 trial for the neuropathic foot condition Morton's neuroma,
a statistically significant decrease in foot pain was measured
following a single administration of ALGRX 4975. 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, 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 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, Vice President, Investor Relations, of Corgentech
Inc., +1-650-624-9600, or Web site: http://www.corgentech.com/
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