Corgentech Reports Clinical Data From Phase 1/2 Trials of Avrina(TM), Drug Candidate for Eczema
February 07 2006 - 5:00PM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., Feb. 7 /PRNewswire-FirstCall/ --
Corgentech Inc. (NASDAQ:CGTK) today reported clinical data from two
Phase 1/2 clinical trials of Avrina, Corgentech's NF-kappaB Decoy
drug candidate for the treatment of atopic dermatitis, a chronic
skin disease also known as eczema that affects about 52 million
adults and children in the United States, Europe and Japan.
Exploratory analysis of efficacy was conducted in these trials to
evaluate anti-inflammatory drug effect, and in both trials the
lowest dose evaluated was the most efficacious. The dose of 0.25%,
which was studied only in the U.S. trial, almost achieved
statistical significance (p=0.059) in the analysis of the combined
eczema score despite the small patient population. The primary
endpoint of these trials was to establish the safety and
tolerability profile of Avrina. Preliminary review of the available
safety data indicate that topical application of Avrina in the dose
ranges studied in both trials was safe and that Avrina was well
tolerated in the most efficacious dose of 0.25%. It is expected
that Avrina clinical data will be presented at the American Academy
of Dermatology Meeting in San Francisco, CA in early March 2006.
"The clinical data suggest that we need to explore lower doses of
Avrina to fully establish its clinical benefit in the treatment of
eczema. We will continue to analyze the data and meet with clinical
investigators expert in atopic dermatitis to quickly define our
plans for the potential future development of this product
candidate," stated Daniel J. Gennevois, M.D., vice president,
medical affairs at Corgentech. "This data announcement is one of
many clinical milestones we expect to announce over the coming
months from our pipeline of four product candidates for pain
management and inflammation. Other expected milestones include the
filing of our New Drug Application (NDA) for our lead product
candidate, ALGRX 3268, as well as multiple Phase 2 clinical data
announcements from another pain product candidate, ALGRX 4975."
Study Details Both Phase 1/2 trials enrolled patients with
mild-to-moderate eczema and were multi-center studies that were
randomized, double-blind and placebo-controlled. Periodic physician
assessments of the targeted areas were made in both trials to
measure the degree of symptom severity as well as patient
evaluations of itchiness. The Phase 1/2 trial in the United States
completed enrollment of approximately 75 patients in October 2005.
The patients were randomized in parallel to one of three active
treatment dose groups evaluating doses of 0.25%, 0.5% and 1.0% or a
control group. Patients applied the study drug twice daily for 21
days to targeted areas of the skin and were followed for 28 days
after the final treatment. The ex-U.S. Phase 1/2 trial, which was
conducted at multiple sites in Australia and Switzerland, completed
enrollment of approximately 120 individuals in December 2005. The
patients were randomized in parallel to one of three groups divided
between patients receiving a 1.0% dose of Avrina once a day, twice
a day and patients receiving placebo. Study participants applied
the study drug for 28 days to targeted areas of the skin and were
then followed for 14 days after the final treatment. Avrina is a
highly selective and potent inhibitor of the transcription factor,
NF-kappaB, which is implicated in inflammatory diseases such as
eczema, asthma and inflammatory bowel disease (IBD). About Eczema
Characterized by itchiness, redness and thickening of the skin,
eczema is often associated with elevated levels of immunoglobulin E
(IgE) and a personal or family history of allergies, allergic
rhinitis and asthma. While topical corticosteroids are currently
used to treat eczema, their chronic use is limited due to the
potential for significant side effects. Topical calcineurin
inhibitors have also shown potential in the treatment of this
disease; however these potent immunosuppressive agents have yet to
produce long-term safety data. In preclinical studies, Avrina was
efficiently delivered to intact skin using several
easy-to-manufacture, inexpensive formulations and was effective in
reducing the swelling and inflammation associated with eczema with
minimal side effects. About Corgentech Corgentech is a late-stage
biopharmaceutical company focused on the development and
commercialization of novel therapeutic treatments for pain
management and inflammation. 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,
+1-650-624-9600, or Web site: http://www.corgentech.com/
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