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Barvarian Nordic Provides A Long Anticipated Update on Their Randomized Phase 3 trial of Prostvac VF

Barvarian Nordic (BN) released some outstanding news a few days ago. According to BN they hope to complete the enrollment in their phase 3, double blind, randomized, placebo controlled, international clinical trial of their cancer vaccine, Prostvac VF. The trial known as PROSPECT is scheduled to be completed with in the next 12 months, unless [...]

The New Yorker Magazine Publishes A Great Article on Immunotherapy

For those who might be interested in the April 23, 2012 edition of The New Yorker Magazine, Jerome Groopman has written an excellent article on the history and current state of Immunotherapy. The article is entitled "The T-Cell Army" and it is on page 24. Not only does the article review the history (going all [...]

A New Controversy Surrounding Provenge Continues To Complicate The Decision To Use It

According to an article written by Reuters some doctors have raised doubts about the efficacy of Provenge, known scientifically as sipuleucel-T. Prostate cancer vaccine Provenge has long incited passions unlike any other cancer therapy and the story seems to continue even to today. The current issue has been raised by Marie Huber, a trained scientist [...]

Dendreon Has Three Posters At ASCO That Add New And Great News For Men With Advanced Prostate Cancer

The American Society of Clinical Oncologists (ASCO) posted on Wednesday the abstracts from the Genitourinary Conference which is scheduled for February 2-4 in San Francisco, California. Dendreon, the creator of the immunotherapy Provenge for men with metastatic castrate resistant advanced prostate cancer has three very interesting and informative posters which will appear at the conference. [...]

Bavarian Nordic Initiates Pivotal Phase 3 Trial of PROSTVAC® Prostate Cancer Immunotherapy

Bavarian Nordic A/S (BAVA) announced on November 15, that its subsidiary, BN ImmunoTherapeutics has started the pivotal Phase 3 trial of PROSTVAC® for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The trial is being conducted under a Special Protocol Assessment agreement with the FDA. Notice this trial has the same criteria as [...]

A Look at the Status of Cancer Vaccines – Emerging Treatments

From very early on, researchers and doctors have dreamed of using the body’s own immune system to fight cancer. The big question has been why doesn’t the immune system attack the tumor cells that invade healthy tissue? The really good news is that finally science is catching up with this vision. Therapeutic cancer vaccines that [...]

Dendreon Gets FDA Approval for Extra Work Stations at their New Jersey Factory

On March 10th (my birthday) Dendreon announced that it has obtained clearance of its new work stations from the FDA. The result of this clearance is the quadrupling the output from the New Jersey factory where it makes sipuleucel-T (Provenge). When Dendreon obtained FDA clearance in April of 2010, it had extremely limited manufacturing capabilities [...]

The FDA Has Granted A Special Protocol Assessment for Phase 3 Trial of PROSTVAC® – An On the Horizon Drug

Bavarian Nordic A/S today announced that they have received a letter of concurrence from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 study required for product registration for its product candidate, PROSTVAC®, for the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer [...]

Great News – Second Vaccine Shows Improved Survival in Prostate Cancer

Is there going to be a competitor to Provenge once it is approved? This is a very interesting question as a second investigational vaccine has shown a significant survival advantage in men with asymptomatic metastatic castration-resistant prostate cancer. There were just released updated results from a phase II trial of PROSTVAC-VF/Tricom vaccine. The trial had [...]

Cell Genesys Halts VITAL-2 GVAX Trial in Advanced Prostate Cancer

As my regular readers probably have noted from prior posts, I am a strong advocate for research and the development of a prostate cancer vaccine. A cancer vaccine is different from the more “common” types of vaccines that are familiar to us. The “common” vaccines (i.e. tetanus or polio) are administered prior to having an [...]

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