MediGene Initiates Phase 2 Clinical Trial of Polyphenon(R) E Ointment for the Treatment of Actinic Keratosis on Schedule
April 29 2004 - 11:24AM
PR Newswire (US)
MediGene Initiates Phase 2 Clinical Trial of Polyphenon(R) E
Ointment for the Treatment of Actinic Keratosis on Schedule
Expanding Market Potential for Polyphhenon(R) E MARTINSRIED,
Germany and SAN DIEGO, April 29 /PRNewswire-FirstCall/ -- Today the
German-American biotechnology company MediGene AG (Frankfurt, Prime
Standard: MDG) initiated a phase 2 clinical trial of Polyphenon(R)
E Ointment for the treatment of actinic keratosis, a precursor of
skin cancer. With the enrolment of the first patient the company
has achieved the extension of the clinical development of its
Polyphenon(R) E Ointment to another skin tumor disease, as
announced on April 6, 2004. In this trial, the efficacy, safety and
tolerability of the Polyphenon(R) E Ointment on actinic keratosis
will be investigated. The results of this trial are expected in
2005. Up to now, MediGene has been developing Polyphenon(R) E
Ointment for the treatment of genital warts and has achieved
excellent results in a phase 3 clinical trial in March 2004. The
extension of clinical development to actinic keratosis will
increase the sales potential of Polyphenon(R) E Ointment by
approximately euro 200 million to more than euro 300 million
annually. Trial design: Six leading clinical-dermatological centers
in Germany and in Switzerland will carry out the phase 2 clinical
trial on 60 patients showing the symptoms of multiple actinic
keratosis. The patients will treat their actinic keratosis in a
defined area of their skin, either on their heads or faces, by
applying Polyphenon(R) E Ointment daily. Important objectives of
the trial are the verification of efficacy of the Polyphenon(R) E
Ointment applied against actinic keratosis, as well as insights
into safety and tolerability. The trial is placebo-controlled, i.e.
a control group of patients will receive a placebo. The trial will
be randomized (random assignment of treatment) and double-blinded
(both physician and patient are not informed whether the drug or a
placebo is administered). Actinic keratosis & Polyphenon(R) E
Ointment: Actinic keratoses are hornification disorders caused by
excessive exposure of the skin to the sun, which may develop into
malignant spinocellular carcinoma. Scientific research indicates
that infection with certain human papilloma viruses (HPV) may also
be involved in the onset and development of skin tumors such as
actinic keratosis. Numerous findings indicate that the catechines
in our Polyphenon(R) E Ointment inhibit basic functions of HPV,
counteract specific changes in tumor cells and, moreover, stimulate
the immune system. The active substance in Polyphenon(R) E Ointment
is a defined extract from green tea leaves. This press release
contains forward-looking statements that involve risks and
uncertainties. The forward-looking statements contained herein
represent the judgement of MediGene as of the date of this release.
These forward- looking statements are no guarantees for future
performance, and the forward- looking events discussed in this
press release may not occur. MediGene disclaims any intent or
obligation to update any of these forward-looking statements.
MediGene(TM) is a trademark of MediGene AG; Polyphenon(R) E is a
trademark of Mitsui Norin; Eligard(R) is a trademark of Atrix.
About MediGene: MediGene AG is a publicly quoted (Frankfurt: Prime
Standard), German- American biotechnology company located in
Martinsried, Germany and San Diego, USA. MediGene has the most
mature drug development pipeline in the German biotech industry and
possesses innovative platform technologies. With Eligard(R) for the
treatment of prostate cancer, MediGene is the first German biotech
company with an approved drug on the verge of market launch.
MediGene's core competence lies in research and development of
novel approaches for the treatment of various tumor diseases. Thus
MediGene focuses on indications of high medical need and economic
opportunities. DATASOURCE: MediGene AG CONTACT: Public Relations,
Julia Hofmann, +49-89-85-65-3324, or Investor Relations, Dr.
Michael Nettersheim, +49-89-85-65-2946, or, , both for MediGene AG,
Fax: +49-89-85-65-2920
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