Heidelberg Pharma AG

Regulatory Filings • Jan 25, 2008

News Details

Corporate | 25 January 2008 09:18

WILEX AG: Phase I study with uPA inhibitor WX-UK1 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 INFORMATION

Phase I study with uPA inhibitor WX-UK1 successfully completed

Munich, 25 January 2008. The Munich-based biopharmaceutical company WILEX
AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) has
successfully completed a Phase I dose escalation study with its drug
candidate WX-UK1 in combination with the chemotherapeutic agent
Capecitabine (Xeloda®, Hoffmann La Roche AG, Basle, Suisse) in patients
with advanced solid tumours. The study was conducted as a single centre
trial at Fox Chase Cancer Center, Philadelphia, PA (USA), and funded under
the agreement number DAMD17-03-1-0634 by the US Department of Defense
Breast Cancer Research Program.

25 patients were treated with the combination of both substances. Patients
received once weekly infusions of WX-UK1 for three weeks at various fixed
doses and daily capecitabine concomitantly for 2 weeks. This three-week
cycle was repeated until progression or toxicity. The maximum number of
treatment cycles was 15 (eleven months). Twenty-three patients completed at
least one treatment course with an average of 4.5 treatment courses.

The combination therapy was safe and well tolerated. The typical
capecitabine-related adverse events were observed and no apparent changes
in the frequencies or intensities of these side effects were reported.
There was no increased rate of adverse events, nor of increased intensity
associated with co-administration of WX-UK1. No serious adverse events
related to WX-UK1 were reported. Pharmacokinetic analysis showed no
significant reciprocal drug-drug interactions. WX-UK1 showed dose-linear
pharmacokinetic profile over the dose range tested.

In this difficult to treat patient population with advanced metastatic
tumours and no standard efficacious treatment options, combination therapy
with WX-UK1 showed encouraging effects in several patients including
evidence of prolonged stable disease and in 3 patients, 2 of whom had
metastatic breast cancer, partial responses.

'These effects are particularly noteworthy as all three patients showed
disease progression at the time of study entry', comments Dr. Paul Bevan,
Head of Research & Development and Member of the Executive Management Board
of WILEX AG. 'The results of the trial confirm our therapeutic approach of
long term treatment of various types of cancer with anti-metastatic uPA
inhibitors. Treatment of eleven months with 46 infusions confirms that the
combination of our drug candidate with Capecitabine was safe and well
tolerated. With this trial our Phase I-programme with uPA inhibitors is
completed. A Phase II study with WX-671, an oral pro-drug of WX-UK1, is
currently underway.'

About the uPA programme
WILEX’s late stage multi-product portfolio includes two drug candidates,
WX-UK1 and WX-671, which are being developed as part of the Company’s
urokinase-type Plasminogen Activator programme ('uPA programme'). In this
programme WILEX is developing various compounds that inhibit the uPA
system. The uPA system plays a key role in the growth, spread and
metastasis of various malignant tumours. The Company expects that drug
candidates which emerge from the uPA programme may be used for the
treatment of patients with tumours such as breast, pancreatic, ovarian,
gastric and colon cancer.

WILEX successfully completed Phase I studies with WX-UK1 and WX-671. The
compounds were found to be safe and well tolerated. WX-671 can be
administered orally and is converted into WX-UK1 in the body. This
facilitates the long-term treatment of patients. Therefore, the Company
decided to investigate the efficacy of WX-671 in two Phase II trials. After
a positive outcome from these Phase II trials, the Company intends to test
WX-671 in different types of cancer.

About WILEX
WILEX is a biopharmaceutical Company based in Munich founded in 1997 by a
team of physicians and oncologists from the Technical University of Munich.
WILEX is focused on the development of new cancer therapies based on
antibodies and small molecules. The therapeutic approach of WILEX targets
the prevention of growth, spread and the metastasis of malignant tumours
and the destruction of malignant tumours in the body. The late stage
multi-product portfolio includes both drug and medicinal product candidates
as well as research candidates. Currently the following compounds are in
clinical development: WX-G250 (development name: RENCAREX®), WX-671, WX-UK1
and CA9-SCAN. The company’s strategy is to develop WILEX into a
commercially successful biopharmaceutical company with a broad portfolio of
new drugs and medical products for the treatment of cancer. WILEX AG has
been listed in the Regulated Market / Prime Standard of the Frankfurt Stock
Exchange
ISIN DE0006614720 / WKN 661472 / Symbol WL6

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
general discussion of strategy, plans or intentions of the Company. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial condition, performance, or achievements, or industry results, to
be materially different from any future results, performance 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.
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.
25.01.2008 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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