Hoag Participating in Clinical Trial for Aggressive Brain Cancer

Monday, April 23, 2012

Hoag Participating in Clinical Trial for Aggressive Brain Cancer

Brain Cancer Vaccine for Local Brain Cancer Patients now available as a research option in Orange County

NEWPORT BEACH, CA – Hoag Memorial Hospital Presbyterian today announced that itsNeurosciences Institute is the first Orange County-based center to begin enrolling patients in a new late-stageclinical trial for an aggressive form of brain cancer: Glioblastoma multiforme (GBM).

Led locally by Hoag and Christopher Duma, MD, FACS, Program Director of Hoag Neurosciences Institute Brain Tumor Program, the FDA-authorized, Phase II trial is sponsored by Northwest Biotherapeutics.

TheDCVax®-L personalized cancer immune therapy is an experimental therapeutic “cancer vaccine” which has been under development by Northwest Biotherapeutics for a decade. (In contrast to a “preventive vaccine”, a “therapeutic vaccine” is an immune treatment administered to treat a disease that a patient already has, and is intended to help the patient’s own immune system to attack the cancer). The purpose of this clinical study is to determine if DCVax®-L can cause an immune response against a patient’s GBM cancer cells, and can slow the growth and recurrence of GBM to extend overall survival. This investigational, personalized vaccine is made from master immune cells drawn from the patient’s own blood, and biomarkers from the patient’s own tumor tissue which together may stimulate a specific immune response and may cause an extension of the time until the brain cancer recurs, and extension of survival.

“At Hoag, we are always looking for new advanced treatment options for the brain tumor patients in our community,” said Dr. Duma.

Hoag is one of a select number of centers nationally currently enrolling in phase II of the trial. In priorsmall clinical trials, the patients who received DCVax®-L showed a median survival of approximately 3 years, as compared to the median survival of 14.6 months seen in patients who received today's standard of care (surgery, radiation and chemotherapy). The current study is for newly-diagnosed patients and is randomized. All patients will receive standard of care. Approximately 160 patients will receive the DCVax®-L treatment, and 80 patients will receive a placebo (an inactive substance), in addition to the standard of care. If a patient’s condition in the placebo group worsens, they will be given the option to receive the DCVax®L treatment.

Key to this study is that potential GBM patients must be identified prior to their initialbrain tumor surgery? in order to consent to the collection of brain tumor tissue for manufacture of their personalized vaccine.

Brain cancer is diagnosed in about 200,000 patients per year with approximately 40,000 being primary brain cancer. Approximately 60% of primary 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. There are currently few treatment options that significantly influence disease outcome for GBM patients, and a typical survival rate for the disease is 14.6 months.

GBM is a fast-growing tumor that occurs in the central nervous system and can seriously impair brain function. This type of tumor most often occurs in adults between age 45 and 70. Symptoms can include headaches, seizures, difficulty learning or comprehending information, personality changes or paralysis.

For more information on the DC-Vax®- Brain for Glioblastoma (GBM) clinical trial,click here.

About Hoag Neurosciences Institute (HNI)

Hoag Neurosciences Institute ( hoag.org/neurosciences) coordinates clinical neuroscience specialists, dedicated facilities and the latest technology to provide individualized patient management under the following programs:Memory and Cognitive Disorders,Brain Tumors,Stroke,Epilepsy,Pain,Movement Disorders, and Neurobehavioral Disorders. HNI also houses the Multiple Sclerosis, Voice and Swallowing, and Sleep Centers and is becoming a regional referral center for all brain and spinal disorders.