WILEX completes Phase I program with anti-cancer drug WX-671 in healthy volunteers and holds clinical Phase Ib study in cancer patients now

07 August 2006

Munich (Germany). WILEX AG, a privately held biopharmaceutical company dedicated to the development of novel cancer therapies, today announced that it has started a first clinical Phase Ib study with its new anti-cancer drug WX-671 in cancer patients. This step follows the recent completion of the clinical Phase I study program with WX-671 in healthy volunteers.

WX-671 is an oral serine protease inhibitor targeting the urokinase Plasminogen Activator system (uPA system) which has been shown to play a key role in metastasis and primary tumor growth of breast cancer and various other solid tumors. WX-671 is an oral pro-drug of WILEX’s investigational drug WX-UK1, which, in intravenous form, is currently being studied in Phase I trials in cancer patients.

In this Phase Ib study, WX-671 will be administered to patients with head & neck cancer before surgery. The study will evaluate safety, tolerability and pharmacokinetics of the drug.

In a recently completed Phase I study, WX-671 was administered in multiple rising doses to healthy male volunteers to investigate safety, pharmacokinetics and oral bio-availability of the drug. WX-671 was safe and well tolerated at all dose levels tested. In addition, the compound showed good oral bio-availability and conversion of the oral drug WX-671 into the active drug WX-UK1. The placebo controlled, double-blind study had been initiated in Q4 2005.

Dr. Paul Bevan, Head of Research and Development and Member of the Executive Board of WILEX, said: “We are pleased that WX-671 has shown excellent safety and tolerability in the clinical Phase I study program with healthy volunteers. The start of clinical Phase Ib studies with WX-671 in cancer patients means another significant step forward in the development program of this compound. In addition, it further strengthens our novel anti-metastatic uPA inhibitor program for the treatment of breast, pancreatic and various other cancers. We plan to progress WX-671 into Phase II development by the end of 2006.”

Background on WILEX’s uPA inhibitor program

WILEX’s uPA inhibitor program is one of the most promising new non-cytotoxic approaches in cancer therapy to specifically block tumor metastasis and primary tumor growth. The uPA (urokinase-type Plasminogen Activator) system has been shown to play a key role in tumor cell invasion and metastasis and in primary tumor growth of various solid tumors including breast, ovarian, gastric, and pancreatic cancer. The uPA system is an extra-cellular enzyme system expressed on certain aggressive metastasizing solid tumors. The uPA system enables tumor cells to degrade their surrounding tissue (i.e. the extracellular matrix), to invade into healthy tissue and blood vessels and thus to migrate and form new tumors at distant sites. WILEX is developing several compounds to inhibit the uPA system. In addition to its drug candidates in clinical development,
WX-UK1 and WX-671, WILEX is conducting several research programs targeting components of the uPA system.

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