Corgentech Presents Clinical Data From Phase 1/2 Trial of Avrina(TM), Drug Candidate for Eczema
March 06 2006 - 7:00AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., March 6 /PRNewswire-FirstCall/ --
Corgentech Inc. (NASDAQ:CGTK) today presented clinical data from
one of 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
this U.S.-based trial to evaluate anti-inflammatory drug effect,
and as previously reported in a top-line data announcement last
month, the lowest dose evaluated was the most efficacious. The dose
of 0.25% almost achieved statistical significance (p=0.059) in the
analysis of the combined eczema score (designated primary efficacy
endpoint) at day 22, despite the small patient population (n=23). A
statistically significant reduction in change from baseline for the
total symptom score (p=0.035) and for the excoriation score
(p=0.007) was also observed at day 22 in the 0.25% dose group. At
two weeks follow-up after drug discontinuation, a pattern of
continued efficacy in these parameters and at this lower dose group
suggests a potential disease-modifying or skin healing effect. The
primary endpoint of this trial was to establish the safety and
tolerability profile of Avrina, and Avrina was shown to be safe and
well tolerated. These data were presented over the weekend at the
American Academy of Dermatology Meeting in San Francisco, CA. "We
are analyzing the data and meeting 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. "Avrina is one of four product candidates in our
advanced product pipeline, which is focused on pain management and
inflammation. Corgentech's most advanced product candidate, ALGRX
3268, has completed Phase 3 trials and is expected to be submitted
to the FDA for product approval mid-year." Study Details The Phase
1/2 trial was conducted at multiple clinical sites in the United
States and completed enrollment of approximately 75 patients with
mild to moderate eczema in October 2005. The trial was randomized,
double-blind and placebo-controlled, and 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.
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. 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 and inflammation. The company has
four drug candidates in clinical development for multiple potential
indications, the most advanced of which, ALGRX 3268, has completed
Phase 3 clinical trials. 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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