Biomira and Merck KGaA Commence BLP25 Liposome Vaccine Phase II Safety Study
Biomira Inc. and Merck KGaA announced the start of a Phase II, single-arm, multi-centre, open label study of BLP25 Liposome Vaccine (L-BLP25). The trial will assess the safety of the formulation of L-BLP25 that the Companies expect to use in the upcoming Phase III study. This formulation incorporates manufacturing changes intended to secure the future commercial supply of the vaccine. Enrollment of the 20-patient trial involving men and women with non-small cell lung cancer (NSCLC) from eight clinical trial sites in Canada is expected to be completed in the third quarter of 2005, with initial results anticipated before the end of 2005.
Data obtained in 2004 from the NSCLC Phase IIb trial showed the greatest survival advantage in vaccinated patients with Stage IIIB locoregional (LR) disease. The new Phase II trial will include patients with unresectable Stage III disease. Thus, Stage IIIB LR patients will be included as well as, for the first time, patients with Stage IIIA disease. All patients in the Phase II trial must have demonstrated either stable disease or a clinical response after primary therapy of combined modality treatment (chemotherapy and radiation therapy). These same criteria are to be used for the planned Phase III trial.
Discussions over recent months with Health Canada indicate that safety data from this Phase II study will be needed before Health Canada will consider whether the product might be eligible for early approval based on survival data from the earlier Phase IIb study. The Companies, given recent feedback obtained from the US FDA, will not pursue early approval in the US. Nonetheless, the Companies are encouraged by the helpful comments from the US FDA regarding the clinical registration plans.
Other news from the department business & finance
