New drug Amplimexon

AmpliMed has begun enrollment of patients in a phase Ib trial to evaluate its lead candidate, Amplimexon, as a stand-alone therapy in patients with multiple myeloma.

The patients being enrolled in the trial have disease which has begun to progress following at least two prior therapeutic campaigns, either conventional or experimental.

Cell-based studies have shown that Amplimexon induces programmed cell death (apoptosis) in certain myeloma cell lines and in fresh myeloma cells taken from patients.

According to the company, Amplimexon may have the potential to slow or prevent the progression of myeloma without causing further bone marrow damage in patients in whom prior therapy has already caused serious damage.

This clinical trial has been designed to determine the tolerance of escalating doses of Amplimexon in this patient population, and to provide guidance on dosing for future clinical studies in multiple myeloma patients. Once the maximum tolerated dose has been established, the study will continue as a phase II study.

Should the outcome prove positive, this may lead to the design of a randomized clinical trial to more rigorously evaluate the benefits of the drug in this patient population.

Amplimexon has a unique way of attacking cancer cells that appears to avoid serious bone marrow toxicity and drug resistance that limits the usefulness of other chemotherapies. According to AmpliMed, the dug appears to kill cancer cells 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.

"While there are many new drugs under development to address earlier stages of multiple myeloma, the safety profile of Amplimexon coupled with its potency against myeloma cells in culture suggests that it may have particular value in patients with preexisting bone marrow damage, who have progressed despite prior treatment," said Robert Ashley, chairman, president and CEO of AmpliMed.