Antiviral Efficacy of Butyrolactone Immunomodulators

Period of Performance: 01/01/1988 - 12/31/1988

$496K

Phase 2 SBIR

Recipient Firm

American Biotechnology CO.
7658 Standish Pl - Ste 107
Rockville, MD 20855
Principal Investigator

Abstract

THE BUTYROLACTONE (BLs) ARE SYNTHETIC IMMUNOMODULATORS WHICH ARE WATER SOLUBLE, RELATIVELY NON-TOXIC, CARBOHYDRATE COMPOSITIONS, THAT CAN BE ECONOMICALLY PRODUCED IN QUANTITY. THE DRUGS ARE ACTIVE WHEN ADMINISTERED BY ORAL, INTRAVENOUS OR INTRA-PERITONEAL ROUTES. THEY HAVE BEEN SHOWN TO ENHANCE RESPONSIVENESS OF A RANGE OF MURING T-LYMPHOCYTE DEPENDENT ACTIVITIES IN BOTH NORMAL AND IMMUNOCOMPROMISED ANIMALS. IN ADDITION, SELECT MEMBERS OF THE BLs STIMULATE INNATE IMMUNITY THROUGH ACTIVATION OF NATURAL KILLER (NK) AND POLYMORPHONUCLEAR NEUTROPHILS (PMNs). THIS SPECTRUM OF ACTIVITIES HAS BEEN TRANSLATED INTO PRE-CLINICAL NEUTROPHILS (PMNs). THIS SPECTRUM OF ACTIVITIES HAS BEEN TRANSLATED INTO PRE-CLINICAL RESEARCH IN THE AREAS OF ANTI-VIRAL AND ANTI-BACTERIAL THERAPY. UNDER A PHASE I SBIR THE COMPANY DEMONSTRATED THAT METHYL-FURYLBUTYROLACTONE COULD STIMULATE ANTIVIRAL IMMUNE MECHANISMS OF MICE INFECTED WITH LYMPHOCYTIC CHORIOMENINGITIS VIRUS (LCMV) WITHOUT ENHANCING VIRAL IMMUNOPATHOGENESIS OF THE ACUTE DISEASE. IN FACT, EVIDENCE FOR REDUCTION OF VIRUS YIELDS AND INCREASED SURVIVAL WERE OBSERVED. THE PHASE II PROJECT WILL EXPAND THE ANTIVIRAL STUDIES TO INCLUDE AN ARRAY OF VIRUSES WHICH SIMULATE DIVERSE PATHOGENIC MECHANISMS IN MAN. ALSO, THE COMPANY WILL TEST NEW BLs WHICH REGULATE INNATE AND ACQUIRE IMMUNITY. THE GOAL WILL BE TO CHARACTERIZE ANTIVIRAL EFFICACY OF A BUTYROLACTONE PRODUCT SETTING THE STAGE FOR A PHASE III PROJECT THAT WILL RESULT IN A MARKETABLE FDA APPROVED THERAPEUTIC.