AMPLIMED BEGINS PATIENT ENROLLMENT FOR CANCER TRIAL
AmpliMed today announced that the it has begun to enroll patients in a new clinical trial that will evaluate its lead candidate, Amplimexon, in combination with the drug docetaxel (Taxotere), in patients with lung, breast and prostate cancer who have failed conventional therapy for their disease.
Docetaxel is an anticancer agent that interferes with the ability of cancer cells to divide. It is indicated for the treatment of patients with locally advanced or metastatic breast cancer after the failure of prior chemotherapy; in combination with prednisone for the treatment of hormone-refractory metastatic prostate cancer; as a single agent in patients with non-small cell lung cancer who have failed prior platinum-based chemotherapy; and in combination with cisplatin in previously untreated patients with non-small cell lung cancer. Prior studies have demonstrated that Amplimexon can potentiate the cytotoxic effects of docetaxel on tumor cells in vitro. This trial has been designed to determine patient tolerance of the combination of Amplimexon and docetaxel, and to provide guidance on a patient population for future clinical studies of the combination of the two drugs. Should the outcome prove positive, this may lead to the design of a randomized clinical trial to more rigorously evaluate the benefits of the combination.
The study is being conducted at The University of Texas M. D. Anderson Cancer Center in Houston, Texas. It is anticipated that approximately 30 patients will be enrolled in this study during the next 12 months, and the study is expected to continue for approximately 12 to 16 months.