Brain Cancer Patients Living Longer After Personalized Vaccine Therapy
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Northwest Biotherapeutics, Inc. has released updated findings from a Phase I clinical trial of the personalized cancer vaccine, DCVax®-Brain, showing that patients are surviving twice as long with DCVax®-Brain as with either of the two therapeutics currently approved by the FDA for Glioblastoma multiforme (GBM), the most aggressive form of brain cancer.
Based upon these findings, FDA allowance has been received and Northwest Biotherapeutics has entered into an agreement with the University of California at Los Angeles (UCLA) to begin providing booster shots to clinical trial participants.
Dr. Linda Liau, Associate Professor of Neurosurgery and Director of the Malignant Brain Tumor Program at the UCLA School of Medicine, served as Principal Investigator for the trial.
Patients in the trial were newly diagnosed with GBM, which affects between 18,000 and 20,000 Americans each year. Beyond surgery to remove the brain tumor and radiation therapy, there are only two treatments for GBM currently approved by the FDA.
Those treatments have been shown in clinical trials to extend survival in GBM patients by only 2-3 months. In contrast, in the ongoing DCVax®-Brain Phase I clinical trial at UCLA, patients have experienced much longer extensions of survival, and longer periods before tumor recurrence.
Data from an earlier clinical trial at UCLA demonstrated that patient survival was twice as long for patients receiving DCVax®-Brain treatment than for patients receiving either of the two currently FDA-approved therapies.
"Findings such as these, where we are seeing over half of our patients with GBM alive after two years, and 4 of 10 patients alive after two and one-half years, with other patients still continuing toward the two-year and two and one-half year marks, present a unique opportunity for us to make a significant difference in the lives of these patients," stated Dr. Alton L. Boynton, President and Chief Operating Officer of Northwest Biotherapeutics.
"We believe that the results to date are particularly striking as the patients only received an initial series of injections and no booster shots. Now, with the FDA allowance and the agreement with UCLA, each patient will be able to receive up to five booster shots over the next 12 months."
"It is our hope that these booster injections will further enhance and sustain the patient's immune response in attacking the cancer and preventing or delaying its recurrence."
The DCVax®-Brain personalized vaccine in clinical development is a type of immunotherapy designed to stimulate a patient's own immune system to fight cancer.
Dr. Boynton explained, "Each of these patients has undergone tumor removal at surgery as part of the current standard of care."
"We use some of those tumor cells, and the dendritic cells drawn from a sample of the patient's blood, to teach the immune system to recognize the tumor cells as harmful so the body can work to eradicate them."
