AmpliMed Corporation Announces Promising 1-year Survival Data from Phase I/II Study of Amplimexon(R) in Metastatic Malignan...( TUCSON Ariz. Jan. 3 /- AmpliMed t...),Health

TUCSON, Ariz., Jan. 3 /PRNewswire/ -- AmpliMed today reported one year survival results from a Phase I/II trial of its lead drug candidate, Amplimexon(R) (imexon for injection) in combination with dacarbazine in patients with unresectable stage III or stage IV metastatic malignant melanoma. Results from the full cohort of patients in both the Phase I and Phase II shows a 11.7 month overall mean survival for the entire patient set and a 22 month overall mean survival in the subset of patients with normal LDH levels. This compares favorably to historical controls of 8 months and 10 months, respectively, for patients treated with dacarbazine alone.

"The impact on overall survival demonstrated by Amplimexon in these trials is very promising and supports the need for a larger, randomized trial," said Ronald Garren, M.D., Chief Executive Officer of AmpliMed. "Amplimexon could represent a significant advance in the treatment of melanoma for which there have been no new treatments approved in the last decade."

Amplimexon is a small molecule drug that increases oxidative stress in tumor cells leading to mitochondrial damage and apoptosis. In preclinical in vitro and animal model studies it shows activity against human tumors including melanoma and is synergistic with alkylating agents including dacarbazine.

Fifty (50) patients were treated with Amplimexon at MTD (maximum tolerated dose) during the Phase II portion of the trial, receiving 250 mg/m2 of dacarbazine and 1,000 mg/m2 of Amplimexon for 5 consecutive days every 3 weeks. Phase II was designed to preliminarily evaluate the efficacy of the Amplimexon/dacarbazine combination in metastatic malignant melanoma, in addition to safety. The criteria utilized for efficacy evaluation was RECIST. A total of 68 patients were enrolled at 13 U.S. centers in the Phase I and Phase II portions of the study.

Clinical Trial Results. The drug combination of Amplimexon and dacarbazine was well tolerated,
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