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


Applied Clinical Trials

Results Demonstrating Encouraging Anti-Tumor Activity and Minimal Toxicity Presented at European Organization for Research and Treatment of Cancer (EORTC)

Prague, Czech Republic and Tucson, Ariz. – 9 November 2006 – AmpliMed® today reported final results from the Phase I trial of its lead drug candidate, Amplimexon® (imexon for inj.), in patients with advanced solid tumors. The results are being presented by Tomislav Dragovich, MD, PhD, Assistant Professor of Medicine of the Arizona Cancer Center and lead investigator of the study, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which is being held this week in Prague, Czech Republic.

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.

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