The US FDA grants majority-owned subsidiary of Accentia Biopharmaceuticals, Biovest International, fast track status to BiovaxID, the company's personalized biologic therapeutic for follicular non-Hodgkin's lymphoma. The targeted anti-cancer immunotherapy, now undergoing pivotal phase 3 clinical trials at over 20 major medical centres throughout the US, showed extremely positive phase 2 results - more than 9 years after treatment 95% of BiovaxID treated of treated patients are still alive.
Granted fast track status for BiovaxID, Biovest is now eligible to submit a biologics license application (BLA) on a rolling basis, allowing the FDA to review sections of the BLA in advance of receiving the company's full submission, and permitting Biovest to apply for the expedited review of its BLA.
Steve Arikian, chairman and CEO of Biovest, commented, "We are extremely pleased at this very positive FDA action. This action by the FDA will help us bring BiovaxID to patients more quickly by allowing us to move our regulatory filing forward in stages. BiovaxID is not meant as a replacement for existing therapies, but rather as a complement. A premier example of a targeted therapeutic BiovaxID stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without causing damage to normal B-cell lymphocytes or to other cells."
Biovest is currently enrolling patients for its BiovaxID Phase 3 study. The study is being run in collaboration with the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA).
Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID, which is being developed as an automated vaccine
Non-Hodgkin's lymphoma, a cancer of the lymphatic system involving a type of white blood cell called a lymphocyte, is found in 65,000 new patients each year in the United States. And although good response rates are often seen with current treatments like chemotherapy, radiation, lymphocyte transplantation and monoclonal antibodies, the cancer invariably returns and is usually ultimately fatal.