Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Munich-based biopharmaceutical company, Wilex has announced that the FDA approved an investigational new drug application for a clinical Phase II trial with its drug candidate WX-671.
Subscribe to our email newsletter
The study will evaluate the efficacy of WX-671 in combination with the chemotherapeutic agent capecitabine (Xeloda) in patients with HER2-receptor negative metastatic breast cancer. The trial is supported under the agreement number DAMD17-03-1-0634 by the US Department of Defense Breast Cancer Research Program.
The study will be conducted in 114 patients in approximately 40 centres in six countries. The Fox Chase Cancer Center (FCCC) in Philadelphia, a member of the Eastern Cooperative Oncology Group (ECOG), will be the lead centre in the US. The study is a randomized, double blind Phase II trial in patients with metastatic breast cancer. Patients will receive daily doses of WX-671 for three weeks in one of the two treatment groups, while the other treatment group will receive placebo. All patients will receive daily capecitabine concomitantly for the first two weeks of every cycle. The treatment cycles will be continued until progression or unacceptable toxicity.
Progression free survival is defined as a primary endpoint of the trial. The study will also evaluate the overall survival and the objective response rate. The start of patient recruitment is expected in second quarter of 2008.
Paul Bevan, head of R&D and member of the executive management board at Wilex, said: “We will switch to the oral pro-drug WX-671, which is converted into WX-UK1 in the body, because it is more convenient for the patients getting oral therapy. This will facilitate the long-term treatment of patients.”