SLOW RELEASE LHRH ANALOG TO REDUCE SERUM TESTOSTERONE

AS A RESULT OF ADVANCES IN MODERN BIOTECHNOLOGY SELECTED LOWER MOLECULAR PEPTIDE HORMONES SUCH AS ANALOGS OF LUTEINIZING HORMONE RELEASE HORMONE (LHRH) HAVE FOUND UTILITY IN SUPPRESSING SERUM TESTOSTERONE TO VALUES FOUND IN SURGICALLY CASTRATED PATIENTS. FROM A PSYCHOLOGIC, SOCIAL AND EVEN ECONOMIC PERSPECTIVE, A LONGER-ACTING LHRH ANALOG IS CLEARLY PREFERABLE TO THE IRREVERSIBLE ALTERNATIVE, SURGICAL CASTRATION. A NUMBER OF DELIVERY SYSTEMS HAVE BEEN EVALUATED AND EVEN MARKETED WITHOUT, UNFORTUNATELY, DUE CONSIDERATION TO THE PRACTICAL LIMITATIONS TO PATIENT WELL-BEING THAT ATTEND SURGICALLY IMPLANTED "RODS" OR SOLVENT-CONTAINING MICROSPHERES. BASES ON OUR RECENT SUCCESSFUL PILOT TRIALS (IN RATS) USING AN ACTIVE SELECTED LHRH ANALOG, WE WILL INVESTIGATE THE POTENTIAL FOR AN INJECTABLE 90-DAY RELEASE SYSTEM THAT CAN BE DELIVERED VIA A CONVENTIONAL HYPODERMIC NEEDLE. SUCH A SYSTEM WILL CLEARLY OFFER THE PATIENT AN ACCEPTABLE ALTERNATIVE FOR SUPRESSING SERUM PRIOR TO CONDUCTING IN VIVO TESTING IN RATS. FEASIBILITY WILL BE ESTABLISHED WITH THE DEMONSTRATION OF WORK OF AN EFFICACIOUS INJECTABLE 90-DAY SYSTEM. PHASE II STUDIES WILL FOCUS ON OPTIMIZATION OF THE FORMULATION, WITH PHASE III INCLUDING CGMP PREPARATION OF MATERIAL FOR INITIAL CLINICAL TRIALS.