Personalized Cancer Vaccines Enter Advanced Clinical Trials

Impressive results in early clinical studies have prompted the [U.S.] Food and Drugs Administration (Rockville, MD, USA) to give a green light for phase II and phase III trials of a personalized cancer treatment for brain and prostate cancer.

The Northwest Biotherapeutics (Bethesda, MD, USA) "DCVax” treatment regimen begins with the collection of a patient's white blood cells in a single standard outpatient procedure called leukapheresis. Dendritic immune cells are isolated and then incubated for 10 days with biomarkers specific to the particular cancer that is growing in the patient. The dendritic cells are then harvested and returned to the patient's physician, who administers the "vaccine” by a simple injection into the skin in an outpatient setting.

The activated dendritic cells in the vaccine have been primed to educate the patient's other immune cells to aggressively and naturally seek out and kill cancer cells which display the same biomarkers that had been used to target the dendritic cells.

Preliminary results obtained by the company indicated that fully 85% of the patients treated with DCVax-Brain (specific for the aggressive brain tumor glioblastoma multiforme) lived longer than the usual 14.6 months median survival time. Furthermore, more than 20% of the patients treated with DCVax-Brain reached or exceeded the six-year survival mark. Under the standard of care treatment, less than 5% of glioblastoma multiforme patients are still alive after five years, and virtually no one is still alive at six years.

DCVax, is now being evaluated in a large, randomized, double blind, placebo controlled Phase II clinical trial. Results in preliminary trials showed that 80% of patients demonstrated a significant clinical response to the treatment, compared to just 25% - 30% of patients for chemotherapy. Furthermore, DCVax added years of survival for patients in these trials, compared to 10 weeks of added survival with typical chemotherapies. The personalized vaccine was found to be nontoxic with none of the serious side effects that are common to chemotherapy.

"DCVax is a cancer therapy game-changer, and a great improvement over chemotherapies both for extended survival and for quality of life,” said Linda Powers, chair of the board of Northwest Biotherapeutics. "DCVax will also be one of the first products to show that personalized medicines can be as economical - or more so - than mass produced off the shelf drugs for the healthcare system.”

Related Links:
[U.S.] Food and Drugs Administration
Northwest Biotherapeutics