FDA approves trial for SKCC breast cancer vaccine

The Federal Drug Administration announced Friday approval of a Phase 1 clinical trial designed to study a breast cancer vaccine developed at the Sidney Kimmel Cancer Center.

According to SKCC President and CEO Dr. Albert Deisseroth, “This vaccine will be administered for recurrent breast cancer and is the first cancer vaccine to be specifically designed for the aged immune system which often fails to respond to vaccinations for infectious diseases as well as cancer.”

“If the vaccine is able to suppress the growth of established breast cancer, it is very likely that it will be of use in preventing the development of breast cancer in families genetically predisposed to this disease, ” said Joy Hamer, RN, OCN and SKCC's Director of Clinical Development and Regulatory Affairs.

Dr. Deisseroth's vaccine has been in development for more than seven years, and during that entire period, the work has been supported by the Breast Cancer Research Foundation of New York City. The Breast Cancer Research Programs of the Department of Defense and the State of California have also supported the work which began when Dr. Deisseroth was at Yale University, prior to joining SKCC.

According to Dr. Deisseroth, this vaccine is unique from all other approaches in its two-pronged approach:

First, it is designed to boost the response of the aged immune system by replacing a potent immunostimulatory signal which is missing in older people. Health experts estimate that only 20 percent of individuals over the age of 50 develop immunity from standard vaccines, such as common flu vaccines. Women with breast cancer are often immune-impaired for several reasons. The average breast cancer patient is 50-60 years old. Additionally, those with recurrent disease are frequently immune-suppressed both by previous chemotherapy and by their disease burden.

Secondly, the target of the vaccine, MUC-1, is part of cancers of the breast, colon, lung, ovary and prostate where its over expression predicts for shortened survival and resistance to therapy. The MUC-1 in the cancer cells has a structure different from that in normal cells, making it a tumor specific target. Moreover, the function of MUC-1 changes in the cancer cell so as to make the cancer more resistant to chemotherapy and radiation.

Pre-clinical animal studies conducted by the Deisseroth laboratory have shown that the vaccine boosts immunity within 14 to 21 days, and that the immunity lasts for at least a year.

“Cancer vaccines symbolize the mission of the SKCC: The use of laboratory discoveries for the development of directions of therapy and diagnosis that are less toxic and more effective than standard chemotherapy,” Dr. Deisseroth says.

The trial, which is for women whose breast cancer has recurred after surgery, and is stable after having only partially responded to salvage chemotherapy, will be available for patient entry in the first quarter of 2008.

Founded in 1990, the Sidney Kimmel Cancer Center is a non-profit research institute dedicated to the development of advanced biological cancer treatments, such as gene therapy, tumor vascular target therapy, vaccine therapy and immunotherapy, and to making those treatments readily available to patients. For more information, visit www.skcc.org or contact Leslie Greve at 858-450-5990, Ext. 243.