AmpliMed Corporation Announces Promising 1-year Survival Data from Phase I/II Study of Amplimexon(R) in Metastatic Malignan... (with only 10.8 percent of patients showi...)

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AmpliMed Corporation Announces Promising 1-year Survival Data from Phase I/II Study of Amplimexon(R) in Metastatic Malignant Melanoma

Date:1/3/2008

with only 10.8 percent of patients showing myelosuppression and only 7 patients having serious adverse events likely related to the study drug. An objective response plus stable disease rate of 30.9 percent was observed for all treated patients (N = 68). The median overall survival of all patients was 11.7 months compared to approximately 8 months for dacarbazine treated historical controls. There was a minimum patient follow up of 1 year.

Subsets of patients having a normal serum LDH or alternatively an elevated LDH were also analyzed for median overall survival. The median overall survival of the 31 patients in the Amplimexon/dacarbazine group with a normal LDH was 22.5 months compared to 10 months for a dacarbazine monotherapy historical control group having a normal LDH. The median survival was 4.8 months for patients having an elevated LDH, no different than the historical control group receiving dacarbazine monotherapy.

"In addition to the positive survival advantage observed for patients with less advanced disease, I am particularly impressed with the relatively infrequent side-effects of Amplimexon across the entire set of patients treated, even when administered with full dose standard chemotherapy," said Evan M. Hersh, M.D., Chief Medical Officer of AmpliMed Corporation. "We look forward to evaluating Amplimexon in a larger, confirmatory trial and are excited by the potential this product candidate may offer to patients with malignant melanoma the most serious form of skin cancer."

About Metastatic Melanoma

Metastatic melanoma is the most deadly form of skin cancer, afflicting approximately 8,000 patients per year in the U.S. Based on statistics from the American Cancer Society, melanoma represents about 5% of all skin cancers, but causes almost 75% of all skin cancer related deaths. Whereas localized melanomas are largely curable by surgery, metastatic melanoma has a poor prognosis and there are few effective treatments. This
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