MUNICH, Germany, June 15 /PRNewswire/ -- Wilex AG, Munich, a privately held biopharmaceutical company dedicated to the development of novel cancer therapies, today announced that the pivotal Phase III study with Rencarex(R) 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(R) (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 the 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(R). 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(R) 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."
Background on Rencarex(R)
Rencarex(R) (WX-G250) is a highly specific IgG1 monoclonal antibody that binds to a cell surface antigen, the MN-antigen (also called G250-antigen or CA IX), which is found on 95% of clear Renal Cell Carcinoma (RCC) cells but not on normal tissue. Wilex received Orphan Drug Status from FDA and EMEA for Rencarex(R) for use in RCC, which provides for the granting of marketing exclusivity to Wilex for 7 years in the USA and for 10 years in the EU after receiving marketing approval. Rencarex(R) has completed clinical Phase II trials in RCC in which it showed strong enhancement of patient long term survival together with an excellent safety profile. Rencarex(R) is partnered with Esteve S.A. (Barcelona) for co-development and marketing in Southern Europe.
Background on Renal Cell Carcinoma
Renal Cell Carcinoma (RCC) is the most common form of kidney cancer and the 10th most common cancer in the US. More than 150,000 people are newly diagnosed with RCC worldwide each year. In the US and Europe, RCC accounts for more than 33,000 deaths each year. To date, neither radiation, chemo- nor hormonal therapy could prolong the survival of metastatic RCC patients. Currently there is no treatment approved in the adjuvant setting for nephrectomized RCC patients at high risk of metastatic relapse after surgery.
Background on Wilex AG (http://www.wilex.com/)
Wilex, founded in Munich (Germany) in 1997, is a leading European biopharmaceutical company focusing on the development of novel cancer therapies for the treatment of various tumors including renal cell, breast, gastric, and colon cancer. Wilex has three compounds in clinical trials, two in pre-clinic, and three in research. The Company has two therapeutic platforms: antibodies and small molecules.