Our studies are based upon the previous isolation and partial purification of thymosin fraction 5, a family of polypeptides isolated from calf thymus, and the demonstration that these polypeptides can partially or fully reconstitute immune function in thymic-deprived animals and in humans with a number of primary immunodeficiency diseases or cancer. Of major potential importance to the goals of the National Cancer Program in the cancer treatment area is the recent completion of the first Phase II randomized trials, conducted by Dr. Richard Schulof here at The George Washington University Medical Center, showing that synthetic thymosin alpha?l?, when given in conjunction with radiotherapy of the lung, significantly prolonged the disease-free interval and resulted in early immune reconstitution. This is the first successful prospective-randomized trial of immunotherapy in lung cancer using a synthetic thymic hormone. Two Phase III confirmatory trials by RTOG and MAOP are currently underway with thymosin alpha 1. Our research has the following overall objectives: (1) to continue the chemical characterization, including amino acid sequence analysis, of the biologically active peptide components of thymosin that have immunoreconstitutive or immunoregulatory effects; (2) to develop and standardize large-scale procedures for the production of the biologically active peptides in thymosin adequate for human use; (3) to develop functional radioimmunoassays for the biologically active thymosin peptides; and (4) to determine in relevant in vitro and in vivo animal models the efficacy of these peptides in alleviating specific immunological defects. (HF)
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