Date: 2012-01-18
Type of information:
phase: 1
Announcement: completion of the study
Company: Wilex (Germany)
Product: WX-554
Action mechanism: WX-554 is a small-molecule MEK inhibitor. The product 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.
Disease:
Therapeutic area: Cancer - Oncology
Country: Germany
Trial details: The trial aimed to determine pharmacokinetic and pharmacodynamic properties (MEK inhibition) of increasing single doses of WX-554. The study was conducted in Germany and it has tested three increasing dose levels, administered as capsules of WX-554 in four healthy male volunteers.
Latest
news: * On January 18, 2012, Wilex has announced that it has successfully completed a Phase I dose escalation study with the oral MEK inhibitor WX-554 demonstrating activity, safety and tolerance in healthy 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. Another study will commence in the first quarter of 2012.* On September 15, 2011, Wilex has announced the start of another Phase I trial with the small-molecule MEK inhibitor WX-554. The study is being conducted in healthy volunteers at a single site in Germany. The trial aims to determine safety, pharmacokinetic and pharmacodynamic properties of various single doses of WX-554. Studies in cancer patients are expected to commence early next year. The oral Phase I programme follows the successfully completed Phase I study with an intravenous formulation and will therefore also deliver an estimate of the bioavailability of the drug candidate. 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.
The German Federal Institute for Drugs and Medical Devices (BfArM) approved this Phase I trial with the WX-554 in August 2011. WILEX expects study data in the first quarter of 2012.
