Corgentech Completes Patient Enrollment in Three Phase 2 Clinical Trials of Post-Surgical Pain Drug Candidate
09 2월 2006 - 9:00PM
PR Newswire (US)
Company Plans to Announce Clinical Data in Second Quarter of 2006
SOUTH SAN FRANCISCO, Calif., Feb. 9 /PRNewswire-FirstCall/ --
Corgentech Inc. (NASDAQ:CGTK) today announced that it has completed
patient enrollment in three Phase 2 clinical trials of ALGRX
4975-one of three mid- to late-stage non-opioid pain management
drug candidates the company is developing-to evaluate this novel
agent's ability to reduce post-surgical pain. The market for
patients treated for post-surgical pain in the United States alone
is more than $1.7 billion. "In multiple clinical trials to date,
ALGRX 4975 has been shown to reduce post-surgical, neuropathic and
musculoskeletal pain for weeks to months after a single
administration," stated Patricia Richards, M.D., Ph.D., vice
president, clinical research at Corgentech. "There is a major unmet
need for well-tolerated, long-acting pain relievers that could
reduce the need for opioid medications, and we look forward to
sharing the results of all these trials in the second quarter of
2006." Study Details The three trials each enrolled approximately
40 patients who have either undergone cholecystectomy, hernia
repair or total knee replacement surgery. The Phase 2 trials in
hernia repair and cholecystectomy, or gallbladder removal, which is
also a model for abdominal surgeries, were each conducted at single
clinical sites. The Phase 2 trial in total knee replacement
patients was conducted at two clinical sites. In all three trials,
patients were randomized to receive either ALGRX 4975 or placebo,
which was administered before closure of the surgical wound to
reduce post-surgical pain, and thus reduce the need for opioid
drugs and hasten recovery time. How ALGRX 4975 May Address Need for
Fast-Acting, Long-Acting Local Anesthetic 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 designed to provide 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
selectively reduces pain in nerve endings so does not affect other
nerve fibers important for other sensory or motor skills. In
addition to the post-surgical studies underway, ALGRX 4975 is being
evaluated in a Phase 2 study for Morton's neuroma, a neuropathic
condition of the foot, and in a Phase 2 trial for tendonitis. In a
Phase 2 study of bunionectomy patients, ALGRX 4975 demonstrated
months of pain relief following bunionectomy surgeries. Opioid
drugs, such as morphine, are currently the most commonly used
agents to relieve pain in neuropathic, 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 four 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 during 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 CONTACT: Jennifer Cook
Williams, Vice President, Investor Relations of Corgentech,
+1-650-624-9600, or Web site: http://www.corgentech.com/
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