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Wilex and Fox Chase Cancer Center Embark on Second Phase of Breast Cancer Clinical Trial Using Oral Agents to Target Tumor Cell Invasion and Metastasis

Department of Defense Breast Cancer Research Program continues its support of innovative collaboration to accelerate development of potential anti-cancer drug

PHILADELPHIA (November 16, 2009) – Fox Chase Cancer Center researchers are recruiting patients for a clinical trial that may offer hope for women with metastatic breast cancer. The first phase of this study began five years ago in Philadelphia and evaluated the safety of a novel compound WX-UK1. The drug showed promise in its ability to target tumor cell invasion and metastasis with no additional toxicities. Phase II will evaluate a new drug, WX671 (the active ingredient is WX-UK1) as first-line therapy for women with Her2-negative metastatic breast cancer. 

This study marks the continuation of an innovative collaboration between the U.S. government (Department of Defense Breast Cancer Research Program), an academic research center (Fox Chase) and a biotech firm (Wilex AG, Munich, Germany) to move a laboratory discovery to the clinic to benefit patients.

“In this multi-site study, we will determine whether adding an investigative drug, WX-671, to the standard chemotherapy (capecitabine) improves patient outcomes,” said Lori J. Goldstein, MD, principal investigator of this study and director of Fox Chase's Breast Evaluation Center and director of the Breast Cancer Research Program at Fox Chase. WX-671 aims to reduce the invasive and metastatic properties of tumors and slow down their growth by blocking a certain system in the tumor. “In this study both drugs will be given orally, which is much more convenient for the participants,” Goldstein added.

The active ingredient (WX-UK1) in the study drug has already been given in combination with capecitabine to 23 patients with advanced cancers.
“The phase I trial results showed the drug combination had no additional toxicities and proved some activity against the disease,” Goldstein said. “The DOD-Wilex-Fox Chase collaboration shows how government, private industry, and academia work together to bring promising research from the laboratory to the clinic quicker than traditional avenues.”

Background on Wilex AG
WILEX is a biopharmaceutical company based in Munich and is listed at the Frankfurt Stock Exchange at the Regulated Market / Prime Standard. The Company was founded in 1997 by a team of physicians and oncologists from the Technical University of Munich. WILEX’s mission is to develop drugs with a low side effect profile and targeted treatment of different types of cancer as well as diagnostic agents for specific detection of tumors.  

Background on the U.S. Department of Defense Breast Cancer Research Program
The Department of Defense (DoD) Breast Cancer Research Program (BCRP) is a biomedical research program that the United States Congress directs to be performed by the DoD. The DoD 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 is US$150 million. For further information please visit:

Fox Chase Cancer Center, part of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence four consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship, and community outreach.  For more information, call 1-888-FOX CHASE or (1-888-369-2427).

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