MUNICH, Germany - Wilex AG and the Technical University of Munich have started a Phase III trial in high-risk patients with primary breast cancer to test the effectiveness of treatments following chemotherapy.
The randomized, multicenter trial has enrolled 540 patients and will investigate the outcome of using Docetaxel, a taxane compound from Aventis Pharma, in sequential application following chemotherapy with anthracycline. It will be conducted at up to 40 clinical sites across southern Germany, coordinated by the departments of gynecology at the Technical University of Munich (TUM) and the Ludwig-Maximilian University of Munich (LMU).
"This study allows us to combine expertise from three different areas to address the question of what to do with high-risk patients," Olaf Wilhelm, CEO of Wilex, told BioWorld International. "It's unclear today what the best treatment is. We do know now that with certain markers in the tumor, the prognosis for the patient differs. The question is whether we see indications of markers that can predict the response to the treatments."
The study will provide Wilex, of Munich, with clinical data on chemotherapy regimens that may serve as potential combination therapies for Wilex's uPA inhibitor WX-UK1, which is in Phase I clinical development. Aventis Pharma Deutschland GmbH, based in Frankfurt, Germany, is co-sponsoring the study. Marion Kiechle at TUM and Harald Sommer at LMU will direct the trial.
Recent observations have suggested that high-risk patients, according to their status with urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type-1 (PAI-1), can benefit from adjuvant systemic chemotherapy. For those patients, combination chemotherapy regimens can lead to improved patient outcome and prolonged survival.
"High-risk breast cancer patients can be identified by their uPA/PAI-1 levels in the primary tumor," said Nadia Harbeck, a breast cancer specialist at TUM. "It is of the utmost importance for these patients to find out whether they benefit from addition of Docetaxel to the standard anthracycline-containing adjuvant chemotherapy. This study offers a unique possibility to combine interesting clinical questions with up-to-date translational research."
The Wilex-TUM study thus will aim to evaluate the predictive value of the levels of uPA and PAI-1 in the primary tumor with respect to chemotherapy regimens containing Docetaxel. A secondary objective of the study is to look for new therapy response markers and targets.
"Wilex is developing cancer therapies by first identifying the prognostic markers that would indicate those patients most at risk of developing metastatic disease," Wilhelm said. "This clinical trial will provide us with data on chemotherapy regimens to be used in combination with our lead uPA inhibitor, WX-UK1, to target high-risk breast cancer patients. In addition, we hope that the collaboration will also be fruitful in identifying new predictive markers, tumor response markers and potential therapeutic targets."
Tumor levels of uPA and of PAI-1 are predictive factors for breast cancer patients, and patients with high levels of uPA and/or PAI-1 have a considerably poorer prognosis than patients with low levels.
Wilex was founded by clinical oncologists who identified prognostic markers that could recognize subpopulations of cancer patients at high risk of developing metastatic disease. The company is developing several therapies tailored to the medical needs of those patient populations. Wilex has three products in clinical trials, entailing both antibody and small-molecule therapies.