Conclusions from Holmberg & Sandmaier paperThis is an excerpt from the recent Holmberg and Sandmaier paper. It is
section 7, titled Conclusions:
The Theratope vaccine is well tolerated and has shown both in a
non-transplant and transplant clinical trial setting that it can
generate an immune response that appears to correlate with a survival
advantage to patients. The results of the Phase III study to determine
if the results from the Phase II studies are upheld remains to be
determined. Recently, the study closed to accrual with over 1000
patients enrolled. The Phase III study is a survival trial with final
analysis of data expected to commerce in mid-2003. However, Biomira
has planned two interim analyses of the Theratope vaccine trial to
take advantage of the potential to make Theratope vaccine available to
cancer patients as soon as possible, if statistical significance is
seen at either of these two earlier time points. The first of these
interim analyses is anticipated to be initiated in the third quarter
of 2001. 1n our opinion, if the Theratope vaccine is found to be
beneficial in the Phase Ill study, its uses will be immense, Not only
will it be used as consolidation therapy after completion of
conventional therapy or high dose therapy. But, one can envision that
it will be used as prophylactic therapy to vaccinate individuals with
a high risk for developing breast or ovarian cancer such as members of
families with brca1 and brca2 mutations or first-degree relatives with
the disease. Also, it will be an excellent candidate to use to
vaccinate normal donors who are going to donate their immune and stem
cells to siblings undergoing nonmyeloablative therapy for certain
solid tumours. such as breast cancer or ovarian cancer, Finally, it is
an ideal candidate to incorporate with other immunotherapy approach
such as IL-2 incubated PBSC and sequential IL-2 therapy as a way to
amplify further the immune responses seen after autologous
transplantation.
Your fellow investor,
DC Arnold