Corgentech and AlgoRx Complete Enrollment for Phase 1/2 Trial of Avrina(TM), New Drug Candidate for Eczema
06 12월 2005 - 9:00PM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif. and SECAUCUS, N.J., Dec. 6
/PRNewswire-FirstCall/ -- Corgentech Inc. (NASDAQ:CGTK) and AlgoRx
Pharmaceuticals, Inc. today announced that enrollment has been
completed for the second of two multi-center 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 15 million adults and children
in the United States. This trial is being conducted in Australia
and Switzerland and enrolled approximately 120 patients. The first
trial, being conducted at multiple sites in the United States,
enrolled approximately 75 patients. The multi-center, randomized,
double-blind, placebo-controlled trial is evaluating the safety and
tolerability of once-a-day versus twice-a-day applications of
Avrina to the skin of adult patients with mild-to-moderate eczema.
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). "We look forward to reporting data in the first
quarter of 2006 from this robust Phase 1/2 clinical program for
eczema, which enrolled approximately 200 patients across both
studies," said Daniel J. Gennevois, M.D., vice president, medical
affairs at Corgentech. "Avrina may have the potential to provide
durable, long-lasting inflammation reduction while providing
patients with more convenient dosing regimens and fewer side
effects." Study Details This Phase 1/2 study, which was conducted
at multiple sites in Australia and Switzerland enrolled
approximately 120 individuals randomized in parallel to one of
three groups divided between patients receiving Avrina once a day,
patients receiving Avrina twice a day and patients receiving
placebo. Study participants are applying the study drug for 28 days
to targeted areas of the skin and are then being followed for 14
days after the final treatment. The trial will assess the safety
and tolerability of Avrina. Periodic physician assessments of the
targeted areas will be made 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 in October of 2005
of approximately 75 patients randomized in parallel to one of three
active treatment dose groups or a control group. Patients applied
the study drug twice daily for 21 days to targeted areas of the
skin and are being followed for 28 days after the final treatment.
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. Clinical trials will demonstrate
whether results obtained in preclinical studies will be indicative
of future results. About Corgentech Corgentech is a
biopharmaceutical company focused on the development and
commercialization of novel therapeutics for significant unmet
medical needs. Corgentech and private company, AlgoRx
Pharmaceuticals, Inc., recently announced that they have signed a
definitive agreement to merge and create a late-stage company that
will be focused on developing and commercializing products for pain
management and inflammation. For more information on the company
and its technologies, please visit http://www.corgentech.com/.
About AlgoRx AlgoRx is a private, emerging pharmaceutical company
focused on developing and commercializing a diversified portfolio
of pharmaceutical product candidates to address pain, a large and
under-served market. AlgoRx's portfolio of pain management drug
candidates includes ALGRX 3268, which has completed Phase 3
clinical trials, ALGRX 4975, which is in Phase 2 clinical trials,
and ALGRX 1207, which is soon to enter the clinic. AlgoRx is based
in Secaucus, NJ. For more information on the company and its
technologies, please visit http://www.algorx.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, Avrina clinical results forecasts of
product development, FDA filings, benefits of the proposed merger,
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 the companies 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 10-K/A for the year ended
December 31, 2004 and most recently filed Form 10-Q. Corgentech and
AlgoRx undertake no obligation and do 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. Additional Information and Where to Find It Corgentech
Inc. has filed a registration statement on Form S-4, and Corgentech
and AlgoRx Pharmaceuticals, Inc. have filed a related joint proxy
statement/prospectus, in connection with the merger transaction
involving Corgentech and AlgoRx. Investors and security holders are
urged to read the registration statement on Form S-4 and the
related joint proxy statement/prospectus because they contain
important information about the merger transaction. Investors and
security holders may obtain free copies of these documents and
other documents filed with the SEC at the SEC's web site at
http://www.sec.gov/. In addition, investors and security holders
may obtain free copies of the documents filed with the SEC by
contacting Corgentech Investor Relations at the email address: .
Corgentech, AlgoRx and their directors and executive officers may
be deemed to be participants in the solicitation of proxies from
the stockholders of Corgentech and AlgoRx in connection with the
merger transaction. Information regarding the special interests of
these directors and executive officers in the merger transaction is
included in the joint proxy statement/prospectus of AlgoRx and
Corgentech described above. Additional information regarding the
directors and executive officers of Corgentech is also included in
Corgentech's proxy statement for its 2005 Annual Meeting of
Stockholders, which was filed with the SEC on April 27, 2005. This
document is available free of charge at the SEC's web site at
http://www.sec.gov/ and from Investor Relations at Corgentech as
described above. DATASOURCE: Corgentech Inc. CONTACT: Jennifer Cook
Williams, Senior Director, Investor Relations of Corgentech,
+1-650-624-9600, or Web site: http://www.algorx.com/ Web site:
http://www.corgentech.com/
Copyright
Corgentech (NASDAQ:CGTK)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Corgentech (NASDAQ:CGTK)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024