AmpliMed® to Present Positive Phase I Study Results for Amplimexon® (imexon for inj.) in Patients with Advanced Solid Tumors

Data from the Phase I study show that Amplimexon is well tolerated and provides objective evidence of antitumor activity. The multicenter study involved 49 patients with a variety of solid tumors including melanoma, pancreatic, ovarian, colon, uterine, lung and prostate cancers. Patients were administered a range of doses from 20-1000 mg/m2/day of Amplimexon as a 30 minute infusion daily X 5 days every two weeks. The maximum tolerated dose (MTD) of this schedule of administration was determined to be 875 mg/m2/day. Pharmacokinetic studies revealed peak blood levels of imexon at the MTD that were well in excess of those shown to have antitumor effects in preclinical testing. Pharmacodynamic studies showed a correlation between a decrease in the plasma levels of cystine, a thiol-containing compound, and blood levels of imexon, providing additional support for the theory that imexon exerts its effects in part by binding thiols in cells and causing increased intracellular anti-oxidant levels.