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NCI AND DAIICHI WILL DEVELOP SP-PG FOR KAPOSI's SARCOMA

Executive Summary

NCI AND DAIICHI WILL DEVELOP SP-PG FOR KAPOSI's SARCOMA under a recently finalized Cooperative Research and Development Agreement (CRADA), National Cancer Institute Laboratory of Tumor Cell Biology chief Robert Gallo reported June 18 at the International AIDS Conference in Florence, Italy. A sulfated polysaccharide peptidoglycan, SP-PG is a natural compound first produced by the Japanese firm Daiichi and later found by NCI researchers to have activity in the mouse model and in tissue cultures. The drug appears to prohibit the growth of Kaposi's sarcoma spindle cells. Gallo said the CRADA will enable NCI to obtain a more highly purified version of the compound in order to redo mechanism studies previously conducted with impure material. Under the agreement, Daiichi will carry out the remaining toxicology studies, and NCI will then begin clinical testing. Daiichi has had difficulty scaling up purification of the compound, Gallo noted, so NCI has received only a small amount of SP-PG so far. In a separate presentation June 18, Ann Collier, University of Washington, reported results of an ongoing Phase I study of AZT (Burroughs Wellcome's Retrovir) in combination with ddl (Bristol- Myers Squibb's Videx). Five combination regimens were compared: 150 mg AZT/90 mg ddI; 300 mg/334 mg; 600 mg/334 mg; 300 mg/500 mg; and 600 mg/500 mg. Of a total 55 patients, 37 completed 26 weeks of treatment. Collier said all treatment regimens were associated with an increase in CD4 cell count, with the median increase in the range of 50 cells. She noted that the initial increase was similar in all the groups, but the increase may be sustained longer in regimens with 600 mg AZT. When the combination regimens were compared to AZT alone, Collier said the trends in CD4 cell count were "similar if not better with the combination."
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