AmpliMed has announced preliminary results of its Phase I trial of Amplimexon (imexon injection) in patients with advanced solid tumors.

The multicenter 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 mg to 1,000 mg of Amplimexon as a 30-minute daily infusion. Results showed that Amplimexon was well-tolerated and there was preliminary evidence of antitumor activity.

There was also 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 buildup in toxic reactive oxygen species inside the cancer cell and ultimately to programmed cell death, or apoptosis.