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news.Antigenics has reported that follow-up data from a Phase I/II investigator-sponsored trial of cancer vaccine, Oncophage, in recurrent, high-grade glioma showed that 11 out of 12 patients exceeded the historical median benchmark of 6.5 months survival from time of recurrence.
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The study showed that all 12 treated patients demonstrated a significant immune response after vaccination with Oncophage. Patients with minimal residual disease at time of first vaccination were more likely to survive beyond nine months compared with patients with significant residual disease.
The investigator-sponsored Phase I portion of this Phase I/II study was designed to establish the feasibility, safety and activity of Oncophage vaccination in patients with recurrent, high-grade glioma, a cancer of the central nervous system. The trial involved two cohorts of six patients, both receiving a minimum of four Oncophage injections: the first cohort received biweekly vaccinations; the second cohort received weekly vaccinations. Using three different techniques, patients were monitored for immune response before and after Oncophage treatment.
According to investigators, no adverse events or toxicity identified were considered attributable to the vaccine. A tumor-specific immune response was detected in all 12 patients. Researchers plan to submit the findings for peer-review publication by year-end. Based on these results, the Phase II portion of this study was launched in early October 2007.
Derived from each individual’s tumor, Oncophage is designed to program the body’s immune system to target cancer cells of that patient.