NORTHWEST BEGINS BRAIN CANCER THERAPY TRIAL

Northwest Biotherapeutics announced that the first two patients in its pivotal Phase II clinical trial have undergone surgery for newly diagnosed glioblastoma multiforme (GBM), which is the first step in the preparation of the company's DCVax-Brain treatment.

The DCVax-Brain treatment consists of three initial immunizations at two-week intervals, followed by four booster injections at two- and four-month intervals for the remainder of year one, and thereafter semiannual maintenance injections for an additional two years. DCVax-Brain showed no toxicity in previous studies in more than 100 patients.

The trial is based on two Phase I studies that included both newly diagnosed (early-stage) and recurrent (late-stage) GBM patients. DCVax-Brain has doubled the time to progression and the overall survival time in both the early- and the late-stage patients. The data for those trials continue to mature.

In the newly diagnosed GBM patients, DCVax-Brain has increased the time to recurrence or progression of disease as described in Kaplan Meier plots from 8.1 months with standard of care treatments to 18.1 months. Kaplan Meier plots also showed that DCVax-Brain increased median overall survival from 17 months with standard of care treatments to 33.8 months. Ten of the 19 patients remain alive for periods ranging to date from 10 to 80 months. Similarly, in recurrent patients, DCVax-Brain has increased median survival from 6.4 months for historical controls receiving standard of care to 13.2 months for patients receiving DCVax-Brain.

DCVax-Brain uses patients' own tumors, surgically removed as part of the standard of care, to prepare a mix of their personal cancer biomarkers. These personal cancer biomarkers are then loaded into the patients' dendritic cells and injected back into the patients through a simple intra-dermal injection at various intervals over a three-year period.