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.Dendreon has completed enrollment of 500 patients for the Phase III clinical trial of Provenge, the company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer.
Subscribe to our email newsletter
The primary endpoint of the study is overall survival and time to objective disease progression is a secondary endpoint. The company currently expects an interim analysis for overall survival to be performed in the second half of 2008.
The Immunotherapy for Prostate Adenoarcinoma treatment (IMPACT) study is a double-blind, randomized, placebo-controlled phase III trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving Provenge versus placebo.
Mitchell Gold, president and CEO of Dendreon, said: “The completion of enrollment of over 500 patients into the IMPACT study is a major achievement for the organization, as the data from this trial may provide the FDA with the additional clinical data they need for the approval of Provenge. Men with late stage prostate cancer currently have few appealing treatment options available to them. We believe Provenge has the potential to offer both oncologists and urologists a well tolerated treatment option for their patients that has the ability to extend survival.”