MediGene Decides on Extension of Clinical Development of Polyphenon(R) E Ointment to Additional Tumor Disease: Phase 2 Trial for
April 06 2004 - 11:48AM
PR Newswire (US)
MediGene Decides on Extension of Clinical Development of
Polyphenon(R) E Ointment to Additional Tumor Disease: Phase 2 Trial
for Actinic Keratosis In Preparation -- Initiation of clinical
phase 2 trial for actinic keratosis (precursor of skin cancer)
planned for the second quarter of 2004. MARTINSRIED, Germany and
SAN DIEGO, April 6 /PRNewswire-FirstCall/ -- The German-American
biotechnology company MediGene AG (Frankfurt, Prime Standard: MDG)
extends the clinical development ofits Polyphenon(R) E Ointment to
another tumor disease and is preparing the initiation of a clinical
phase 2 trial for the treatment of actinic keratosis, a precursor
of skin cancer. In this trial which is planned to start in the
second quarter of 2004,efficacy and safety of the Polyphenon(R) E
Ointment applied against actinic keratosis will be investigated.
The excellent data MediGene recently obtained in the phase 3 trial
of Polyphenon(R) E Ointment for the treatment of genital warts (see
our press release dated March 31, 2004) have been the basis for
this decision. The results of the new phase 2 trial are expected in
2005. 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 300 euro million
annually. Dr. Peter Heinrich, Chief Executive Officer of MediGene
AG, comments: "The extension of the clinical development of our
Polyphenon(R) E Ointment to the indication actinic keratosis will
be a further move in our strategy of expanding MediGene's tumor
drug pipeline, while focusing on the development of products close
to the market at the same time. We act on the assumption that our
Polyphenon(R) E Ointment has an immense potential for a number of
dermatological tumor diseases, such as actinic keratosis and basal
cell carcinoma, and we are just about to exploit this potential."
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 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. Details on the trial: The clinical
phase 2 trial on 60 patients showing the symptoms of multiple
actinic keratosis will be carried out in a total of 6 leading
clinical-dermatological centers in Germany and in Switzerland. The
patients will treat their actinic keratosis in a predefined area of
their skin, either on their heads or their 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 (no
disclosure to physician or patient during the trial). 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: Julia Hofmann,
Public Relations, +49-89-85-65-3324, Dr. Michael Nettersheim,
Investor Relations, +49-89-85-65-2946, Fax: +49-89-85-65-2920, both
of MediGene AG, ; Jonathan Fassberg, The Trout Group,
+1-212-477-9007, ext. 31, for MediGene AG
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