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This immuno-therapeutic experimental "vaccine" developed by scientists atthe University of South Alabama (USA) is intended to activate the body'simmune system against a cancer-specific protein to destroy the cancer cells.This immunizing protein, called the Oncofetal Antigen (OFA) or immatureLaminin Receptor Protein (iLRP), is a universal cancer antigen or proteinexpressed in all human cancer types tested by the USA scientists thus far.Notably, this specific protein is not expressed on normal cells and tissuesand thus is cancer-specific according to available assays.
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Those patients with disseminated breast carcinomas and meeting theclinical trial entrance criteria will be treated under the above referencedIND at the Southern Cancer Center (SCC) in collaboration with clinicians atthe Providence Cancer Center and other local oncology centers in and aroundMobile, Alabama.
The investigators will collect from each patient's blood a white bloodcell population called Dendritic Cells (DC). These cells are then exposed invitro to replicated iLRP, cultured, and reintroduced into the patient viasubdermal injection. The hope is that iLRP-sensitized DC will then recognizeiLRP as a foreign protein or antigen on cancer cells and, when reintroducedinto the body, will then, in turn, sensitize or introduce another group ofimmune cells known as T-killer lymphocytes, to the iLRP protein. The functionof T-killer cells is to recognize foreign substances and initiate theirdestruction. Once these killer cells are activated against the iLRP proteinon the cancer cells, it is further hoped that they will overwhelm and destroythe patients' breast cancer.
In a previous study recently undertaken in Austria, eleven advanced renalcell carcinoma patients who failed conventional therapy were treated with thistype of immunotherapy. These patients developed a cytotoxic responsesecondary to activation of their T-killer cells against the iLRP protein usingthe same type of technique as in the present study. Five of the 11 patientsare still alive with a median follow up of 46.7 months (range 33-54 months).The one-year survival rate was 90%; two-year survival rate - 54%; three-yearsurvival rate - 45%. Notably though, the patients suffered no serious sideeffects from the therapy where most of the effects were flu-like symptomssecondary to the desired immune response. This study is designed to determinewhether breast cancer patients will respond similarly and without toxicity.
This latest breast cancer study is the culmination of over 20 years oflaboratory study and research of OFA with the support of the NationalInstitutes of Health, including National Cancer Institute. The three seniorimmunobiologists, Drs. Joseph Coggin, Jim Rohrer and Adel Barsoum of theDepartment of Microbiology and Immunology at the University of South Alabama,will collaborate with the primary investigator, Dr. Paul Schwartzenberger,M.D., an SCC oncologist.
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