When I provided testimony at the FDA in support of the application for approval of the vaccine Provenge®, I had the opportunity of meeting some of the representatives of the biotech company Antigenics (AGEN). Since I am also a renal cancer survivor they initially approached me asking if I would be willing to meet them back in New York. I am always interested in meeting people in the industry.
Upon our return to NYC, I went to their offices and met with the Public Relations Director and their President. They explained their vaccine does differ significantly from Provenge®. Instead of using blood products to construct their vaccine, Oncophage®, they utilize the surgically removed tumor to create the vaccine.
At this time, as with Dendreon (the biotech company that has developed Provenge®), their numbers were not yet up to the demands of the FDA.
Even though it has been 11 years in development the Oncophage product has not yet won approval from the US Food and Drug Administration (FDA). The Phase III trial, completed in 2006 did not show sufficient efficacy when the entire sample population was analyzed. However, the Russian regulators approved the drug on the basis of a subset of that Phase III data, relating to patients with less advanced cancer who demonstrated a more effective response to the treatment.
This situation highlights a huge challenge that most cancer vaccines have not yet figured how how to deal with in the United States. Vaccines are designed to generate an immune response that will make the body’s own defenses turn on tumor cells. The problem is that cancer patients who enter the clinical trials have reached the advanced stages of disease when the toll of the cancer itself, and the various treatments used to treat it, has damaged their immune systems irreparably.
Dendreon elected to continue their phase III trials in the United St