Patients with a diagnosis of stage three or four malignant melanoma who have not been previously treated with chemotherapy for their metastatic disease are being recruited.
Melanoma is the most serious form of skin cancer, the company says. During the past decade the incidence of melanoma cases has increased more rapidly than any other form of cancer.
Dacarbazine is a chemotherapeutic agent that interferes with the growth of cancer cells. It is one of only two drugs approved for sale in the US as first-line therapy for the treatment of metastatic malignant melanoma.
Previous studies have demonstrated that Amplimexon can increase the cytotoxic effects of dacarbazine (DTIC) on tumor cells in vitro and in animal models of melanoma tumor growth.
The present trial has been designed to determine patient tolerance of the combination of Amplimexon and DTIC while comparing the use of the two treatments to DTIC alone. If this proves successful, further clinical trials are planned.
The study is being conducted at six research centers across the US. It is anticipated that approximately 60 patients will be enrolled in the phase I and phase II components combined during the next 12 months.