5-FLUOROURACIL THERAPEUTIC IMPLANT IN KAPOSI'S SARCOMA

MATRIX PHARMACEUTICAL, INC. IS FOCUSED ON DEVELOPMENT OF THE THERAPEUTIC IMPLANT (TI), A NOVEL INJECTABLE SUSTAINED-RELEASE DRUG PRODUCT. THE TI, A VISCOUS INJECTABLE GEL, IS COMPRISED OF A PROTEIN CARRIER MATRIX, VASOACTIVE TISSUE MODIFIER AND THERAPEUTIC AGENT. THE TI DELIVERING 5-FLUOROURACIL (5-FU), REFERRED TO AS 5-FU TI, WILL BE UTILIZED IN THIS STUDY. WE WILL EXAMINE THE FEASIBILITY OF UTILIZING THIS NEW TECHNOLOGY OF SITE-SPECIFIC TREATMENT WITH SUSTAINED DRUG RELEASE TO PROVIDE EFFECTIVE LOCAL TUMOR CONTROL TO PATIENTS WITH CUTANEOUS MANIFESTATIONS OF KAPOSI'S SARCOMA (KS). TWELVE PATIENTS WITH HISTOLOGICALLY-CONFIRMED, INDOLENT CUTANEOUS KS LESIONS WILL BE TREATED IN AN OPEN-LABEL, DOSE- COMPARISON STUDY EVALUATING THREE DOSES OF 5-FU TI AND A PLACEBO, ADMINISTERED UP TO TWO TIMES TO INDIVIDUAL LESIONS IN CONJUNCTION WITH A NO-TREATMENT CONTROL. PATIENTS WILL BE EVALUATED OVER SIX MONTHS FOR SAFETY (LOCAL AND SYSTEMIC TOXICITY) AND EFFICACY (LESION REGRESSION AND DURATION OF RESPONSE). THE 5-FU TI MAY PROVIDE AN EFFECTIVE LOCAL TREATMENT TO CONTROL INDIVIDUAL TUMORS IN KS PATIENTS. UPON SUCCESSFUL COMPLETION AND FAVORABLE RESULTS OF PHASE I STUDY, PHASE II SUPPORT WILL BE REQUESTED FOR ADDITIONAL PHARMACOLOGY, TOXICOLOGY, STABILITY AND CHEMISTRY STUDIES REQUIRED FOR FURTHER PRODUCT DEVELOPMENT AND MARKET INTRODUCTION.