Heidelberg Pharma AG

Legal Proceedings Report • Jul 3, 2008

News Details

Corporate | 3 July 2008 14:11

WILEX AG: Phase III ARISER study with RENCAREX: patient recruitment successfully completed

WILEX AG / Miscellaneous

Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.

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PRESS RELEASE

Phase III ARISER study with RENCAREX: patient recruitment successfully
completed

Munich, 3 July 2008. Munich-based biopharmaceutical company WILEX AG (ISIN
DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today announced
that it has successfully completed patient recruitment in the Phase III
ARISER trial with its drug candidate RENCAREX®. The international
double-blind trial is testing RENCAREX® for use as adjuvant therapy of
clear cell renal cell carcinoma. The trial is being carried out in more
than 150 centres in North and South America as well as Europe. The trial
examines whether RENCAREX® could prolong disease free survival and overall
survival in comparison to placebo. A total of 856 patients are taking part
in the trial, of which 583 were recruited in Europe and 273 in North and
South America. 203 patients were enrolled in the study centres in the US,
which represents 24% of the total. Patients who are at present still
undergoing the pre-enrolment screening process will also be able to
participate in the trial if they meet the inclusion criteria. This means
that the final number of patients in the trial may still increase. The drop
out rate at currently 4.2% remains low. This again suggests that the
treatment is well tolerated and the regimen of weekly injections
acceptable.

We reported on the positive outcome of the interim analysis for futility in
December 2007. The next milestone in the trial will be when 343 relapses
have occurred.

Dr. Paul Bevan, Head of Research and Development and Member of the
Executive Management Board at WILEX, said: 'The number of relapses we have
recorded currently stands at over 180. This is within the timeframe
projected last December. We therefore believe that we will reach the next
milestone early in 2009. WILEX will continue to closely monitor the relapse
rate.'

When this next milestone is reached, the study protocol specifies that all
patient data will be analysed centrally to enable the Independent Data
Monitoring Committee to carry out an interim analysis for efficacy of
RENCAREX®. This interim analysis will evaluate whether RENCAREX® is
significantly superior to placebo with regard to disease-free survival. The
data will remain blinded to WILEX. If the result is positive, the analysis
may provide the basis for filing for approval in Europe.

About the ARISER study
The international, multicentre, randomised trial called ARISER (Adjuvant
RENCAREX Immunotherapy trial to Study Efficacy in non-metastasised Renal
cell carcinoma) examines the efficacy of the antibody RENCAREX® in
comparison to placebo in the treatment of clear cell renal cell cancer
patients after complete or partial surgical removal of the affected kidney
in patients with no detectable metastases. This cancer belongs to one of
the particularly aggressive indications, for which no FDA or EMEA approved
drug exists today. RENCAREX® aims to inhibit these malignant kidney tumours
from further growth and recurrence and to help destroy cancer cells and
thereby prolong the disease-free survival of patients. Patients are given
weekly injections of RENCAREX® for a period of six months.

About WILEX
WILEX is a biopharmaceutical company based in Munich and is listed at the
Frankfurt Stock Exchange at the Regulated Market / Prime Standard. WILEX’s
mission is to develop drugs and diagnostic agents with a low side effect
profile and targeted treatment of different types of cancer as well as for
early detection of tumours. The Company's product candidates are based on
antibodies and small molecules. WILEX has an attractive product pipeline
which includes both drug and diagnostic candidates: The substances
RENCAREX® and REDECTANE® are currently undergoing a Phase III registration
trial. The substance WX-671 (developed under the name MESUPRON®) is
currently in a Phase II programme. Based on this pipeline, WILEX's aim is
to achieve profitability within a few years through the consistent
commercialisation of its products and in the long term to finance its
research and development programmes from its operating business.
Website: http://www.wilex.com

This communication contains certain forward-looking statements relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will' 'should' 'future', 'potential' or similar expressions or by a
general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to
place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
03.07.2008 Financial News transmitted by DGAP

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Language: English
Issuer: WILEX AG
Grillparzerstr. 10
81675 München
Deutschland
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart

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