extract:
Interim progression free survival data show a favourable trend toward patients receiving CVac staying in remission longer than those in the observational standard of care (OSC) group. Combining overall data of first and second remission, the median progression free survival time (as of the date of data cut-off) is 421 days for non-randomized CVac, 365 days for CVac, and 321 days for OSC. The first seven patients on the study were not randomized and all seven were assigned to receive CVac in accordance with the trial design.
Safety data to date indicate that CVac is very well tolerated as compared to observational standard of care (OSC). Preliminary intracellular cytokine staining (ICS) data in three CVac treated patients have shown a potent cytotoxic T cell response specific to mucin 1, while untreated patients did not show the same immune response. In the near term, upon completion of the analysis, the Company will release ICS data from a cohort of seven patients that have been followed for an extended period
of time. Over the next year, Prima will have ICS data on all patients enrolled on the CAN-003 trial.
CVac may be expected to confer increasing clinical benefit to patients as observation continues; the immune system takes time to build up its strongest response against tumor cells. Interim progression free survival and immune monitoring data from the CAN-003 trial demonstrate an early
profile similar to other successful immunotherapy products to treat cancer such as PROVENGE® and YERVOY®. While the CAN-003 data are interim stage and in a small cohort of patients, these data indicate that there are no impediments to moving the CVac clinical development program forward.
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