I don't know about you, but I am waiting very anxiously for today's presentation at the AUA conference from Dendreon about Provenge. It is an absolute shame that we have been put into the position that we needed to wait for more men to die before moving ahead. I am concerned that all of the [...]
Press Release: Dendreon Corporation (Nasdaq: DNDN) announced the following data presentations taking place at the American Urological Association's (AUA) Annual Meeting in Chicago, as well as a Dendreon-sponsored IMPACT data webcast conference call: (for those of us who will be unable to attend the session at AUA in Chicago) April 28, 2009, 2:20 p.m. CDT-"A [...]
As a follow up to yesterday's news about the positive results announced about Provenge, I have received a number of private emails asking questions about the treatment. I hope that the following will answer many of the questions people might still have about Provenge. • The other name for Provenge is sipuleucel-T. • Provenge is [...]
What great news has greeted us today. We can now hope that the FDA will quickly approve Provenge and we can get this sorely needed treatment ASAP. If Provenge gets approval from the FDA it will be the first cancer vaccine ever approved. Sadly it will be only the second approved treatment for prostate cancer! [...]
Last Friday's post included information about the recent appointment of Dr. Frank M. Torti as the Acting Director of the FDA. Dr. Torti has invited public comments about the future direction of the FDA. As a representative of Malecare, I have provided specific feedback to Dr. Torti. The following post includes my comments to him. [...]
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 [...]
