In this single-arm, Phase 2 study, patients with follicular B-cell Non-Hodgkin's Lymphoma (NHL) in continuous first clinical remission six months following PACE chemotherapy were treated with a series of subcutaneous vaccinations of BiovaxID. BiovaxID is comprised of tumor-derived Id protein (tumor antigen) conjugated to KLH as a carrier protein administered with GM-CSF (granulocyte macrophage colony stimulating factor).
With a median follow-up of 9.2 years, 45 percent of patients remained in continuous first clinical remission at their most recent follow-up (either in 2004-2005), and the overall survival rate was 95 percent. Furthermore, median disease free survival for the patient cohort was 96.5 months (8.0 years). Based on historical data these results suggest a clinically significant advance over current expectations of disease progression.
"The results of this Phase 2 study compare very favorably with chemotherapy alone and with CHOP-R where the median disease-free-survival is 2.2 years and 6.9 years respectively. The ongoing Phase 3 trial of BiovaxID vs. non-specific immune stimulation should help to clarify the role of vaccine therapy in patients with follicular lymphoma," said Barry Gause, M.D., co-investigator for the clinical trial at the National Cancer Institute (NCI).
"We are encouraged by these long term follow-up data from our Phase 2 study," said Angelos Stergiou, M.D., Director of Product Development, Accentia Biopharmaceuticals. "These results underscore the potential of BiovaxID as a promising personalized therapeutic vaccine for folli
Contact: Sherran Brewer