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 [...]
I received an e-mail this morning from Leslie who was the producer and director of the short video I filmed about the Provenge issue at the FDA. (you can view the video at: Joel's Provenge Video Leslie asked that I sign a petition asking for a formal inquiry into the conflict of interest (COI) issues [...]
Today’s New York Times carried a story written by Reed Abelson entitled “Financial Ties Are Cited as Issue in Spine Study.” The story explained that some of the nation’s most prominent spine surgeons hailed as a medical breakthrough a study of nearly 240 patients with lower back pain. The doctors said that Prodisc, an artificial [...]