About Amplimexon® (imexon, inj.)
an anticancer drug with a novel mechanism of action, is minimally
myelosuppressive, and only at the highest doses. It also overcomes multi-drug
The drug is a member of the cyanoaziridine class of compounds, and it induces oxidative stress in cancer cells by binding intracellular thiols, resulting in mitochodrial damage and apoptosis. It has also been shown in vitro and in vivo to synergize with several classes of anticancer drugs, including alkylating agents, antimetabolites and taxanes.
AmpliMed has completed five Phase I dose escalation studies in patients with a variety of refractory solid tumors and myeloma. For these studies, the toxic effects, pharmacokinetic behavior and maximum tolerated dose and schedule for Amplimexon was determined. The maximum tolerated dose and schedule established as a result of the studies was once or weekly for a 45-60 minute infusion, 5 days every two weeks, or 5 days every three weeks. The drug was well tolerated, with generally mild and manageable nausea, vomiting, constipation, diarrhea and fatigue being the most common side effects at the maximum tolerated doses.
AmpliMed is currently conducting a randomized phase II clinical trial in which Amplimexon® is being administered in combination with gemcitabine (Gemzar®) in metastatic pancreatic cancer. Additional studies being planned include malignant melanoma and lung cancer.
For more information on AmpliMed clinical trials, please click here.
Publications: Concerning Amplimexon and Amplizone