About Amplimexon® (imexon, inj.).

Amplimexon®, an anticancer drug with a novel mechanism of action, is minimally myelosuppressive only at the highest doses and overcomes multi-drug resistance.

The drug is a member of the cyanoaziridine class of compounds, and it is believed that it induces oxidative stress in cancer cells by reducing intracellular levels of 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 three 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. Maximum tolerated dose and schedule established as a result of the studies was a 45 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 enrolling a series of indication-directed clinical trials in which Amplimexon® is being administered in combination with currently available cancer chemotherapies including dacarbazine (DTIC®), gemcitabine (Gemzar®) and docetaxel (Taxotere®). Indications being studied include pancreatic adenocarcinoma, malignant melanoma, breast, lung and prostate cancer.

For more information on AmpliMed clinical trials, please click here.

Publications: Concerning Amplimexon and Amplizone

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