Researchers To Present Positive Phase I Study Results For AmpliMed Corporation's(TM) Amplimexon(R) (imexon inj.) In Patients With Advanced Solid Tumors

TUCSON, Ariz.--(BUSINESS WIRE)--Nov. 16, 2005-- Scientists See Preliminary Evidence of Anti-Tumor Activity and Minimal Toxicity AmpliMed(TM) today announced that preliminary results of its Phase I trial of its lead drug candidate, Amplimexon(R) (imexon inj.), in patients with advanced solid tumors will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which is being held this week in Philadelphia. The multi-center study involved 48 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/m(2)/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/m(2)/day. Results showed that Amplimexon was well tolerated and there was preliminary evidence of antitumor activity. Several Phase I/II studies both in combination with chemotherapy and as monotherapy are underway, and combination chemotherapy Phase II and III studies are planned. Dr. Tomislav Dragovich, MD, Ph.D, assistant professor of Medicine at the Arizona Cancer Center, and the lead investigator of the study, will present the results during a poster presentation on November 17th in Philadelphia. An important experimental finding in the Phase I study was a significant dose-related reduction in the plasma levels of sulfur-containing compounds (thiols) in patients administered Amplimexon. This is consistent with previous findings in cell culture that suggest that the drug acts by reducing thiol levels in cancer cells, leading to a build up in toxic reactive oxygen species (ROS) inside the cancer cell and ultimately to programmed cell death, or apoptosis. In a second poster at the same meeting, Dr. Amanda F. Baker of the University of Arizona Cancer Center reports the results of experiments designed to explore the changes in gene expression in patients' white blood cells exposed to Amplimexon. The findings of this study also help support the hypothesis that Amplimexon acts by increasing ROS levels in cancer cells. The data suggests that cells exposed to Amplimexon upregulate the expression of those genes that are associated with the response to oxidative stress, which would be the reaction that would be anticipated if Amplimexon was causing an increase in intracellular ROS levels.