This is the first of two clinical trials with Wilex's compound WX-UK1 at Fox Chase funded by a US$ 3.9 million grant from the U.S. Department of Defense (DoD) Breast Cancer Research Program to study the potential of this agent as a breast cancer therapeutic in the USA.
WX-UK1 is a non-cytotoxic small molecule that belongs to a new class of drugs. In animal models, WX-UK1 blocks tumor cell invasion, metastasis and primary tumor growth by inhibiting the urokinase Plasminogen Activator (uPA) system.
"The pre-clinical research with WX-UK1 provided strong data warranting a clinical trial to pursue the possible benefit this drug may have in the treatment of breast cancer," said Lori J. Goldstein, M.D., principal investigator of this study and director of Fox Chase's Breast Evaluation Center and leader of the Breast Cancer Research Program at Fox Chase. "The DOD-Wilex-Fox Chase collaboration is an example of how government, private industry, and academia can work together to bring promising research from the laboratory to the clinic quicker than traditional avenues."
"Unlike conventional chemotherapeutic agents, WX-UK1 is focused on a biological target directly connected to cancer progression, and, therefore offers an entirely new mechanism of action," said Prof. Olaf G. Wilhelm, MD, Chief Executive Officer of Wilex. "It is our goal to develop WX-UK1 for use in combination with chemotherapy. With Fox Chase Cancer Center, we have a highly experienced and capable partner for the clinical development of WX-UK1 in the USA".
The open label dose escalation Phase I study will evaluate the safety and biological activity of WX-UK1 in combination with the oral chemotherapeutic agent capecitabine (Xeloda®) in up to 54 patients with advanced solid tumors. The maximum tolerated dose (MTD) of WX-UK1 in combination with capecitabine (Xeloda®) will be determined. In addition, pharmacokinetics and pharmacodynamics of the treatment regimen will be investigated.
Xeloda® is a registered trademark of F. Hofmann la Roche.
Background on WX-UK1
Wilex is developing WX-UK1, a novel non-cytotoxic drug candidate, for the anti-metastatic investigational treatment of patients with breast cancer and other solid tumors. WX-UK1 is a synthetic small molecule inhibitor of serine proteases and the Urokinase-type Plasminogen Activator (uPA), which have been shown to play a key role in metastasis and primary tumor growth of breast, gastric, colon cancer, and various other solid tumors. In pre-clinical studies, WX-UK1 significantly reduces metastasis formation and primary tumor growth. In a clinical Phase Ia trial with healthy volunteers conducted in Germany, WX-UK1 was safe and well tolerated at all doses tested. WX-UK1 is currently being tested as a single agent in two Phase I trials in cancer patients in Germany. In September 2003, Wilex and Fox Chase Cancer Center were awarded the first Biotechnology Clinical Partnership Award worth $3.9 million from the U.S. Department of Defense (DoD) Breast Cancer Research Program. This award supports two clinical trials with WX-UK1 in patients with advanced solid tumors (Phase I) and advanced breast cancer (Phase II) at Fox Chase.
Background on Fox Chase Cancer Center (www.fccc.edu/research/pid/goldstein/)
Fox Chase Cancer Center is an independent, nonprofit institution devoted to improving cancer treatment and prevention. Fox Chase's mission is to reduce the burden of human cancer through the highest-quality programs in research and patient care, including cancer prevention, treatment, early detection and education. Fox Chase's 100-bed hospital is the fourth largest in the US devoted entirely to cancer care. Fox Chase was one of the nation's first comprehensive cancer centers designated by the US National Cancer Institute in 1974. In an effort to contribute to the reduction of both the incidences of breast cancer and the morbidity and mortality due to the disease, Fox Chase has developed a multidisciplinary Breast Cancer Program encompassing basic, clinical, and prevention and control research. Clinical research involves investigational agents for all stages of disease.
Background on Wilex AG (www.wilex.com)
Wilex AG, based in Munich (Germany), is a leading European biopharmaceutical company focusing on the development of novel cancer therapies for the treatment of various tumors including renal cell cancer, breast, gastric, and colon cancer. Therapies are tailored to the individual needs of cancer patient subpopulations in order to provide effective and well tolerated treatment. Wilex has a well-balanced product portfolio with three compounds in clinical trials, two in pre-clinic, and three in research. The Company has two therapeutic platforms: antibody-based and small molecule-based therapies. Wilex was founded in 1997 by clinical oncologists from the Technical University of Munich.
Background on the U.S. Department of Defense Breast Cancer Research Program
The DoD Breast Cancer Research Program (BCRP) is a biomedical research program that the United States Congress directs to be performed by the Department of Defense (DoD). The Department of Defense has designated the United States Army Medical Research and Materiel Command to administrate the program. The BCRP was established in 1992 with the overall goal to promote research directed toward eradicating breast cancer. The Congressional appropriation for 2003 year is BCRP is US$150 million. For further information please visit: http://cdmrp.army.mil.