Two monoclonal antibodies (MAbs) CBL1 and CT2 have proved to be clinically effective without major side effects in reversal of transplantation graft rejection and leukemia therapy. These clones will be expanded, MAbs purified, tested, sterilized, and placed in sterile 5 ml vials according to Food and Drug Administration (FDA) procedures. They will be sent for clinical trials to FDA-approved academic centers and hospitals. The long-term objective is to produce MAbs that will cure cancer.
Our specific aim i s to use MAbs raised by a new approach to immunization using special oncogenic virus-infected cells. These antibodies have been extensively screened and others would require further screening against normal and malignant tissues. One MAb appears to react to normal growth factor that is present only on the surface of activated or dividing cells. It will arrest the growth of cells in culture. Preliminary screening by immunoperoxidase binding to tissue shows one antibody that reacts with solid tumors and leukemia cells and another that binds only to some solid tumors. We have shown that two of these are suitable for tumor clinical trials (one is beginning at USC Cancer Center). Our other plans are to isolate and characterize the antigen, develop and ELISA test and determine if antigen levels in serum can be used as a diagnostic test for cancer. In phase I we would hope to isolate the antigen and develop and ELISA test and begin clinical trials. In phase II we hope that some of the antibodies may be demonstrated as suitable for a sensitive specific screening test for cancer and valuable in cancer therapeutics. (AG)
