FDA Grants Orphan Drug Status For Personalized Lymphoma Vaccine

In case you can’t see from where you’re sitting, I’m doing the happy dance. Why?

Because Biovest International, Inc. (Other OTC: BVTI) announced TODAY that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest's personalized lymphoma vaccine. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market.

Twenty years in the making, this new drug is a patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine evokes the power of each patient's immune system and primes it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. In the vaccine's cancer target, B-cell lymphoma, the process is made possible by the presence of a hallmark surface antigen of the cancer cells that is not present in non-cancerous tissue.

By priming the immune system with this antigen in the form of an autologous vaccine, the vaccine induces a powerful immune response against the cancerous cells that in many cases results in pronounced, complete cancer clearance. Because each dose of Biovest's vaccine is derived from individual patient's cancerous cells, the vaccine is a true targeted, customized therapy.
By the way, there is a new free webcast on Agressive B-Cell non-Hodgkin lymphoma at http://www.presentme.com/audio2009/20091024LRFReiman/