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news.Northwest Biotherapeutics has received FDA clearance to proceed with phase I clinical testing of its personalized therapeutic cancer vaccine, DCVax-LB, in non-small cell lung cancer.
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DCVax-LB is an extension of the DCVax personalized cancer vaccine that has already shown significant delay in disease progression and in extension of survival in clinical trials in primary brain cancer and prostate cancer.
DCVax is a therapeutic vaccine, which is used to treat patients who already have cancer. DCVax is a personalized treatment: it is made from a patient’s own dendritic cells that have been “educated” to teach the immune system to recognize and kill cancer cells bearing the biomarkers of the patient’s tumor.
The clinical endpoints of the trial will be progression-free survival (i.e., delay in progression of the cancer) and overall survival.
“The same DCVax platform can be used for the treatment of many different tumor types, since it incorporates all of the biomarkers from the patient’s tumor,” said Dr Alton Boynton, president of Northwest Biotherapeutics.
“DCVax-LB offers several key advantages over existing FDA-approved treatments. To date, DCVax product candidates have shown no toxicity, and have been compatible with other standard therapeutic regimens, including chemotherapy and radiotherapy. In addition, clinical data on delay in disease progression and extension of survival in brain and prostate cancer to date are remarkable.”
Lung cancer kills over 160,000 in the US each per year as compared to 30,350 deaths per year for prostate cancer. Existing treatments for non-small cell lung cancer include surgery and radiation therapy, which are used in various combinations. These treatments have significant adverse side effects, and have had little effect on survival.