DCVax®-L is an experimental autologous cellular therapy designed to create a specific immune response against a patientís cancer. DCVax®-L utilizes a patientís own dendritic cells (DC), and an extract of the patientís own tumor cells to achieve an immune response. The tumor from surgery is shipped to a manufacturing facility, as are blood cells, in order to prepare the DCVax®-L. DCVax®-L is then shipped frozen to the clinic for administration to the patient. DCVax®-L is usually manufactured in sufficient quantities for treatment of at least one year, and often for two or more years.
Brain Cancer Facts
Brain cancer is diagnosed in about 200,000 patients per year with approximately 40,000 being primary brain cancer, and the remainder the result of metastasis from other distant primary cancers such as breast, lung and colon. Approximately 60% of brain cancers are diagnosed as astrocytoma of which there are four forms, grade I through IV. Glioblastoma multiforme (GBM) is the most aggressive and lethal form of astrocytoma and is classified as grade IV. Brain tumors are the leading cause of solid tumor cancer death in children under the age of 20.
Glioblastoma multiforme represents about 50% of the astrocytoma, and is the most lethal form of brain cancer for which there are currently few treatment options that significantly influence disease outcome. In the United States, the incidence of GBM is about 10,000 -12,000 cases per year, prevalence is approximately 25,000, and there is no gender or age bias as well. Worldwide, the incidence and prevalence is approximately double that number. Survival at one year is about 28%, at two years 8% and at five years < 3%.
Standard of Care
Patients newly diagnosed with GBM are generally eligible for surgery, and following surgery receive a regime of external beam radiation therapy with a median survival outcome of about 10-12 months. Over the last two or three years, several chemotherapy drugs were approved as adjuvant therapy to surgery and radiation. First is the Gliadel Wafer that is inserted into the cranial cavity at the time of surgery, and which continuously, and locally delivers the chemotherapeutic agent carmustine over the next several weeks to the remaining tumor cells in the cranium. Studies by Brem et al show a survival advantage of about 2 months, survival improving from a median of 10.1 months for surgery + radiation to 12.6 months for surgery + radiation + Gliadel Wafer. The second approach uses the drug temozolomide following surgery, and concomitant with radiation and post radiation. This regime showed a survival advantage also of about 2 months, from 12.1 to 14.6. Clearly, there is an unmet medical need for improved treatment outcomes for patients with GBM.