Corgentech Pain Drug, 4975, Demonstrates Statistically Significant Pain Reduction After Knee Replacement Surgeries
14 June 2006 - 10:00PM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., June 14 /PRNewswire-FirstCall/ --
Corgentech Inc. (NASDAQ:CGTK) today reported positive, top-line
clinical data from a Phase 2 clinical trial in total knee
replacement surgeries showing that 4975, the company's novel,
long-acting, non-opioid drug candidate being developed for
site-specific, moderate-to-severe pain, demonstrated pain reduction
at all pre-specified time intervals in the study, including
statistically significant pain relief at day one (p=0.0273) and at
day 14 (p=0.0071). The difference in average daily pain scores
between the 4975-treated group (n=25) and the placebo group (n=25)
on day one was statistically significant and showed a relative
difference in pain on first ambulation of 24 percent. On a
numerical rating scale of zero to 10, the average pain score for
the treated group was 5.4 compared with the placebo group's average
of 7.1. It is noteworthy that this difference was detected despite
all patients being on concomitant morphine. On day 14, the
patients' "worst pain in the previous 24-hour period" using the
Brief Pain Inventory form showed a relative difference of 34
percent with the average pain scores being 3.9 and 5.9 for the
treated group and placebo group, respectively. The analysis of
additional exploratory efficacy endpoints favored the 4975 group
over the placebo group including average daily pain scores at
multiple time points: day 1, day 2, days 1-2, days 3-7, days 8-14,
days 1-14 and days 3-14. In addition, the measure of pain
interference with activities favored the 4975 group over the
placebo group at most of the time points measured. The preliminary
data showed that 4975 was safe and well tolerated. Total knee
replacement (also known as total knee arthroplasty) is performed in
patients with end-stage osteoarthritis of the knee. These patients
have disabling pain which imposes severe limitations on their
mobility, and knee replacement is performed with the goal of
restoring or improving patients' quality of life. There were an
estimated 470,000 total knee replacement procedures performed in
the United States in 2005, and the number of replacements will
continue to grow as the average age of the U.S. population
increases and as these individuals conduct more active lives. The
American Academy of Orthopedic Surgery projects that approximately
3.5 million of these procedures will be done each year by 2030.
"4975 has demonstrated its ability to provide relief of acute and
chronic pain to patients experiencing post-surgical, neuropathic
and musculoskeletal pain for weeks to months after only a single,
local administration. Unlike opioids, which have systemic side
effects including nausea, vomiting, constipation and respiratory
depression, 4975 appears to have a more favorable safety profile,"
said Daniel J. Gennevois, M.D., vice president of medical affairs
at Corgentech. "Leveraging the positive data from the knee
replacement trial in conjunction with the large body of 4975
clinical data collected to date, we look forward to discussing the
data with regulators as we advance the clinical development of
4975." The Phase 2 study involved 50 knee replacement surgery
patients who were randomized to receive either a single dose of
4975 or placebo, which was dripped by syringe into the wound prior
to closure. Post-operatively, patients self-administered
intravenous morphine via patient controlled analgesia (PCA) pump to
achieve satisfactory analgesia. Additionally, after PCA was
discontinued, patients could receive supplemental
hydrocodone/acetaminophen as needed to manage their pain. Phase 2
Trial of 4975 for Cholecystectomy Surgery The company also reported
that in a Phase 2 trial of 4975 in 44 patients undergoing
cholecystectomy (gall bladder removal) surgeries, the trial did not
show a difference in pain scores between those receiving 4975 and
those receiving placebo. The patients were randomized to receive
either a single dose of 4975 or placebo, which was dripped by
syringe into the surgical wound prior to closure, and both
treatment groups received concomitant pain medications. Preliminary
data show that 4975 was safe and well tolerated in this study.
While both the knee and cholecystectomy trials were in surgical
settings and included similar concentrations of 4975, it is
possible that the extent of contact between the drug and the
relevant tissues in the cholecystectomy surgeries may not have been
maintained at a level sufficient to provide therapeutic benefit. In
future trials, the company will continue to explore additional
routes of administration that will enable optimal drug
distribution, including direct injection into the relevant tissues.
How 4975 May Address Need for Long-Duration, Well-Tolerated Pain
Relief 4975 is long-acting, with the potential to provide pain
relief for weeks or months after just a single treatment. It is a
non-opioid TRPV1 agonist based on capsaicin. Its unique mechanism
of action provides a long-lasting, localized effect on C-fibers,
and blocks the transmission of aching, throbbing pain caused by
major surgical procedures. Because it selectively acts on nerve
endings, 4975 does not affect other nerve fibers necessary for
sensory or motor sensations, such as those needed to sense
temperature or pressure. In clinical studies to date, 4975 has not
had the side effects often associated with other pain medications
and has been shown to be well tolerated. Opioid drugs, such as
morphine, which are commonly used agents to relieve pain in
post-surgical and musculoskeletal pain conditions, have significant
side effects including sedation, respiratory depression, euphoria,
and nausea and vomiting during acute use, and constipation and
physical dependence during chronic use. About Corgentech 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, and the stock is anticipated to
trade under the Nasdaq symbol: ANSV. 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 clinical development 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. DATASOURCE: Corgentech Inc. CONTACT: Jennifer Cook
Williams, Vice President, Investor Relations, of Corgentech Inc.,
+1-650-624-9600, or ; or media, Daryl Messinger of WeissComm
Partners, +1-415-999-2361, or , for Corgentech Inc. Web site:
http://www.corgentech.com/
Copyright
Corgentech (NASDAQ:CGTK)
Historical Stock Chart
From May 2024 to Jun 2024
Corgentech (NASDAQ:CGTK)
Historical Stock Chart
From Jun 2023 to Jun 2024