Jefferson Medical College is now home to a unique cancer vaccine processing facility. It is the only one of its kind in Philadelphia, and perhaps the nation.
AVAX Technologies, Inc., of Kansas City, Mo.--which has exclusive rights to a Jefferson-based vaccine against malignant melanoma--is building the vaccine laboratory to increase quantities of the vaccine for future testing and use. The lab is a so-called “clean lab,” which means it meets strict federal Food and Drug Administration (FDA) standards.
“If a company wants to produce a vaccine to market, the work must be done in an approved facility. It’s called a GMP--’Good Medical Practices’--lab,” explains medical oncologist David Berd, M.D., who created the vaccine technology. “It essentially will be an industrial lab in an academic facility.”
Dr. Berd, professor of medicine at Jefferson’s Kimmel Cancer Center and Jefferson Medical College, Thomas Jefferson University, and his colleagues are hoping that the $200,000 laboratory will help step up the production of the potentially life-saving cancer vaccine.
The current vaccine is autologous, meaning that it’s prepared from a patient’s own cancer cells. Each vaccine is custom-made for the patient. Before injecting the cells into patients, the cells are inactivated and treated with a chemical, dinitrophenyl, which chemically modifies them. The modified cells apparently appear foreign enough to the body’s immune system for it to react against them.
Malignant melanoma is the deadliest form of the skin cancer. It is the fastest growing cancer in the United States and is the fifth most common cancer among Americans. According to the American Cancer Society, 40,300 new cases will be diagnosed in 1997; 7300 Americans will die from the disease.
The vaccine treatment appears to be effective in prolonging the survival of patients with malignant melanoma. In the June 1997 issue of the Journal of Clinical Oncology, a leading cancer research publication, Dr. Berd reported the results of treatments on patients with melanoma spread to a single lymph node site (stage III disease). The vaccine treatments were started after the lymph nodes had been removed. Of 62 patients, 36 were still alive after a median follow-up time of 55 months. The projected 5-year relapse-free and overall survival rates for these patients were 45 percent and 58 percent respectively. This compares favorably with the 15- to 25-percent survival rates reported in patients treated with surgery alone.
Dr. Berd and his colleagues will participate in a Phase III trial to test the effectiveness of the vaccine on patients with disease that has spread to the lymph nodes. The five-year trial, already underway, will compare the effectiveness of an autologous melanoma vaccine to the standard treatment, which is alpha interferon. The trial will involve 250 patients seen at institutions in several major cities. If the trial is successful, then AVAX will ask the FDA for approval to allow it to market the vaccine.
The lab, he notes, is the first of its kind in Philadelphia and perhaps in the nation. The new lab will not be limited to vaccines for melanoma. Dr. Berd currently is testing a similar vaccine for ovarian cancer.
Dr. Berd explains that many labs are working on generic cancer vaccines, but few have attempted autologous vaccines because of the technical difficulty involved in producing a vaccine for each individual patient. “We expect to show that our autologous cancer vaccine is not only effective, but also practical and applicable to large numbers of patients at sites throughout the country,” he says.