THE GMP-BASED DRUG SUBSTANCE SCTL DEVELOPMENT AIMING AT PREVENTION OF OPPORTUNISTIC INFECTIONS AFTER X-RAY- AND CHEMOTHERAPY OF CANCER. A SYNTHETIC COMBINATORIAL TETRAPEPTIDE LIBRARY SUBSTITUTION FOR CALF THYMUS EXTRACT

162 SCTL is the fully synthetic correlate of an enzymatic partially hydrolyzed extract from calf thymus, HTX. To exclude completely the transmission of bovine spongiformic ence pha litis (BSE) by the bovine thymus product a fully synthetic correlate of the active principles in the thymus tissue hydrolysate has been developed, namely SCTL. This synthetic peptide library has meanwhile substituted calf thymus extract preparations in seve ral cosmetics and drug products. The active principles of SCTL have been invented by the author but the application of the drug substance in cosmetic and pharmaceutical products has been exploited by others. For SCTL only limited pharmacological and toxicological data are available. Some interesting biological activities, though, have been shown for SCTL [Birr et al., 1987, 1998, 2003] which might explain to some extend the modes of action and its clinical effectiveness. In traditional European medicine the application calf thymus extract preparations in geriatric and immunodeficiency diseases has been practised for more than three centuries. In several countries traditional drug preparations and cosmetics from HTX have been used successfully. There are field reports on prevention of alopecia, opportunistic infections and cancer. Several publications report about the efficacy of the product in the reduction of hair loss secondary to cytostatic chemotherapy. But the mode of action of HTX , the partially hydrolyzed extract from calf thymus, is not known. Since biological effects on the proUDK 578.27+615.32