BioWorld International Correspondent
MUNICH, Germany - The U.S. Department of Defense Breast Cancer Research Program has awarded its first biotechnology clinical partnership to Wilex AG and the Fox Chase Cancer Center.
The award nets Wilex, of Munich, $3.9 million to support clinical development of WX-UK1 in two clinical trials at Fox Chase, of Philadelphia, that will investigate antimetastatic treatment of patients with advanced breast cancer.
The DOD program aims to establish partnerships between the biotechnology industry and academic institutions that will accelerate clinical development of novel compounds that have the potential to make substantial improvements in breast cancer therapies or prevention.
"We had always planned trials in the United States for WX-UK1," Olaf Wilhelm, CEO of Wilex, told BioWorld International. "This is now financially supported.
"We have structured the program with Fox Chase as a Phase I/II trial," Wilhelm said. "It will be developed in combination with chemotherapy. We know from our previous Ia trial that the compound is safe. Nevertheless, we have to do the Phase I parts with increasing doses to look at the compound's safety together with chemotherapy."
The company's drug candidate is a non-cytotoxic compound being developed for antimetastatic treatment of patients with breast cancer and other solid tumors. It is a small molecule that inhibits serine proteases and the urokinase-type plasminogen activator (uPA) system, which have been shown to play a key role in metastasis and primary tumor growth of solid cancers. It also is being tested as a single agent in a Phase I/II trial in Germany. Wilex obtained investigational new drug approval from the U.S. FDA for WX-UK1 in May 2003.
Wilhelm said that the compound has several promising aspects. "We are a strong believer in combination therapy," he said. "WX-UK1 has shown an additive effect in animal models and workings against metastasis. We will also be looking at how it could add to standard care in second- and third-line therapy. It may be able to not only help attack the primary tumor but also work to prevent metastasis, which is one of the biggest dangers in breast cancer."
The award from the DOD will cover the entire cost of the trial. While Wilex had an existing relationship with Fox Chase, this is its first work with the Department of Defense. "The department had an open call for programs last year," Wilhelm said. "A couple were selected to submit a full application," and Wilex is the first to receive an award.
In response to a grassroots campaign, the United States Congress allocated specific funds for breast cancer research in the Department of Defense budget. Congress cited the department's long history of medical research, dating back to smallpox research in the 1780s, and deemed its administrative structure flexible and speedy enough to respond quickly to changing needs and priorities. The Department of Defense Congressionally Directed Medical Research Programs now administers programs funding breast cancer, prostate cancer, ovarian cancer, chronic myelogenous leukemia, neurofibromatosis, and tuberous sclerosis research.