Wilex Starts Patient Enrollment in Rencarex® (WX-G250) Pivotal Phase III Trial in Renal Cell Carcinoma
Munich. Wilex AG, Munich, a privately held biopharmaceutical company dedicated to the development of novel cancer therapies, announced that the pivotal Phase III study with Rencarex® in renal cell carcinoma (RCC) has started enrolling patients.
The multi-center, global, randomized study has been designated ARISER (Adjuvant Rencarex Immunotherapy trial to Study Efficacy in non-metastasized Renal cell carcinoma) and is evaluating the efficacy of Wilex's antibody Rencarex® (WX-G250) versus placebo as an adjuvant therapy for patients with clear cell RCC.
Patients who are disease-free following the surgical removal of the kidney but who have a high risk of developing metastatic RCC will be enrolled in this study. The study is designed to detect a significant difference between the two treatment arms with respect to disease-free survival; patients will be followed-up long-term to determine overall survival statistics.
The trial will enroll approximately 612 patients in over 50 sites in Europe and the US. Patients in the treatment arm will be treated for 6 months with a once-weekly infusion of Rencarex®. Patients will be closely monitored with regular CT scans. Wilex has recently been granted IND approval for this Phase III trial by the US Food and Drug Administration.
Dr. Paul Bevan, Head of Research & Development and Member of the Executive Board of Wilex AG, said: "The goal of this Phase III study is to establish Rencarex® as a key treatment option in RCC. RCC is a therapeutic area with a high unmet medical need and, therefore, also a highly attractive niche market for new cancer therapies. For the patient group we are targeting in this study, non-metastasized RCC patients at high risk of developing metastasis after surgery, there is currently no approved treatment option at all."
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