The Food and Drug Administration (FDA) is one of the major governmental entities that has a significant, direct and immediate affect on any of us who has any illness. All men with prostate cancer have had their life and their deaths impacted by the FDA. This impact has not been on just a few of [...]
At 9 am this morning, Dendreon Corporation (Nasdaq: DNDN) announced the long awaited interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT (Immunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B). The clinical trial is designed to assess the safety and efficacy of the investigational active cellular immunotherapy Provenge® (sipuleucel-T) in men with metastatic [...]
Dendreon Corporation (Nasdaq: DNDN), the company that is testing Provenge a potential vaccine for prostate cancer, has started a second of two new Phase 2 trials. The multicenter trial, called ProACT (PROstate Active Cellular Therapy), is enrolling 120 men with metastatic, androgen independent prostate cancer. The trial protocol calls for all men to receive active [...]
According to Philip M. Arlen, M.D., director of the Clinical Research Group for the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, at the National Cancer Institute, "Vaccines, if and when they are approved, can be safely and effectively combined with other therapies, including hormones. There appears to be an advantage in overall [...]
Yesterday, Dendreon Corp (DNDN) announced that the FDA has agreed to allow them to amend the trial design of its Provenge cancer vaccine. The change in the design will accelerate the expected timing of the final study results by about one year. According to Dendreon, the interim results of the impact study are still expected [...]