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GEN News Highlights : Sep 18, 2006

Adding Zadaxin to DTIC Chemotheraphy Doubled Malignant Melanoma Tumor Response

SciClone Pharmaceuticals and Sigma-Tau S.p.A released interim data showing that the addition of Zadaxin® to standard dacarbazine (DTIC) chemotherapy with or without interferon alpha in patients with stage IV malignant melanoma achieved double the overall tumor response as compared to the control group.

“We are pleased that the addition of Zadaxin at all tested doses increases tumor response for these patients with metastatic malignant melanoma,” notes Alfred R. Rudolph, M.D., COO of SciClone Pharmaceuticals. “Importantly, we intend to look at the survival and tumor response data together in early 2007 to determine the optimal dose and design for our planned Phase III trial, targeting regulatory approvals in the U.S. and Europe.”

Interim results from the ongoing Phase II trial included data on 463 of the total 485 patients in this five-arm, Phase II trial. All 463 patients have been evaluated according to RECIST criteria for overall tumor response, which includes partial and complete responses.

These interim data showed that all patients in the treatment arms containing Zadaxin had a higher response than those in the control arm. Of the 99 patients treated with 3.2 mg of Zadaxin in combination with DTIC, 12.1% achieved an overall response (complete and partial response), which was more than double the 5.3% response for the 95 patients in the control arm.

Of the 97 patients treated with 3.2 mg of Zadaxin, DTIC, and low-dose interferon alpha, 10.3% showed an overall response. Of the 97 patients receiving 1.6 mg of Zadaxin, DTIC, and low-dose interferon alpha, 7.2% showed an overall response.