WILEX successfully completed Phase I study in Healthy Volunteers with the oral MEK inhibitor WX-554
Munich, Germany, 18 January 2012. WILEX AG (ISIN DE0006614720 / WL6 / FSE) successfully completed a Phase I dose escalation study with the oral MEK inhibitor WX-554 demonstrating activity, safety and tolerance in healthy volunteers.
The trial aimed to determine pharmacokinetic and pharmacodynamic properties (MEK inhibition) of increasing single doses of WX-554. The study, which was conducted in Germany, tested three increasing dose levels, administered as capsules of WX-554 in four healthy male volunteers.
WX-554 showed very good bioavailability and inhibition of the MEK signal transduction pathway in a dose-dependent manner achieving long-lasting inhibition at 100 mg. The substance was safe and well tolerated. One subject at the highest dose level experienced skin rash, a known class effect of MEK inhibitors.
Dr. Paul Bevan, Head of Research and Development and member of the Executive Management Board of WILEX AG, commented: “We are delighted with the positive performance of WX-554 in this oral study. The results have enabled us to determine a rational dosing regimen for the next study in cancer patients, which will commence in the first quarter of 2012.”
The small-molecule MEK inhibitor is one of five oncology preclinical programmes obtained under the strategic alliance agreed with UCB in January 2009 and is being clinically developed by WILEX. Mitogen activated protein kinase (MEK) has been shown to play a central role in signal transduction. The MEK signalling pathway is over expressed in more than 30% of cancers, resulting in uncontrolled cell growth and proliferation. The first Phase I trial was successfully completed in the summer of 2010. The 25 volunteers in the dose escalation trial safely tolerated the intravenously administered WX-554.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company’s therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of research use only and in vitro diagnostic tests under the brand Oncogene Science. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. The wholly owned subsidiary Heidelberg Pharma AG gives WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. WILEX’s customers and partners include leading international pharmaceutical companies. ISIN DE0006614720 / WKN 661472 / Symbol WL6
Katja Arnold (CIRO)
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
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.