The AmpliMed study will determine the maximum tolerated doses of Amplimexon (imexon injection) as well as its toxicity in combination with gemcitabine (marketed by Eli Lilly as Gemzar) in patients with advanced pancreatic adenocarcinoma, in preparation for subsequent phase II clinical trials.
Data on tumor response and clinical benefit will also be collected and compared against historical control data in order to help establish the parameters for future clinical development.
Amplimexon has a unique way of attacking cancer cells that appears to avoid bone marrow toxicity and drug resistance that limits the usefulness of other chemotherapies. Amplimexon appears to do this by causing the disruption of mitochondria, the energy producing factories of the cancer cell, resulting in the leakage of toxic substances which kill cancer cells.
“This is the first protocol specifically designed to establish the patient tolerance of a combination of Amplimexon and a commonly prescribed cancer chemotherapeutic,” said Dr Evan Hersh, vice president for clinical affairs and chief medical officer of AmpliMed. “Preclinical findings in models of resistant pancreatic cancer have suggested that the combination of Amplimexon and gemcitabine may be significantly more effective than either drug alone and well tolerated.”