The trial will assess the safety of the formulation of BLP25 Liposome Vaccine (L-BLP25) that the companies expect to use in an upcoming phase III study. This formulation incorporates manufacturing changes intended to secure the future commercial supply of the vaccine.
Enrolment in the 20-patient trial is expected to be completed in the third quarter of 2005, with initial results anticipated before the end of the year.
Discussions over recent months with Health Canada have indicated that safety data from this phase II study will be needed before the authority will consider whether the product might be eligible for early approval based on survival data from an earlier phase IIb study.
“The start of this phase II trial is another step toward commencing our large, multi-national phase III study, which we hope to begin by the end of this year,” said Dr Alex McPherson, president and CEO of Biomira. “If appropriate data from this phase II trial are obtained, they may be used in discussions with Canadian regulatory authorities concerning the potential for early approval of this product candidate.”