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Elesclomol Study Shows Significant Improvement in Progression-Free Survival for Chemotherapy-Naive Patients With Metastatic Melanoma
Date:5/20/2008

elanocytes, the cells that make skin pigment, or melanin - spreads to other parts of the body.(2,3) In the U.S. alone, the percentage of people who develop melanoma - the deadliest form of skin cancer - has more than doubled in the past 30 years, and about 60,000 people are diagnosed with melanoma and 8,000 will die from it in 2008.(4,5,6) Worldwide, approximately 132,000 new diagnoses are made each year.(7) Currently, there are no approved therapies that have been shown to improve survival for patients with metastatic melanoma.(8)

Phase II Trial of Elesclomol and Paclitaxel in Stage IV Metastatic Melanoma: A Subgroup Analysis By Prior Chemotherapy (Abstract # 9036) Presentation date/time: May 31, 2008, 2:00 PM - 6:00 PM

This retrospective subgroup analysis of a randomized, double-blind, active-controlled, Phase II trial in patients with stage IV metastatic melanoma evaluated the rates of progression-free survival and overall survival for the combination of elesclomol and paclitaxel versus paclitaxel alone in patients who received one prior chemotherapy treatment with those who were chemotherapy-naive. A total of 81 patients evaluated in this analysis either received 213 mg/m2 of elesclomol co-infused with 80 mg/m2 paclitaxel or 80 mg/m2 of paclitaxel alone in four-week cycles (once weekly for three weeks and one week's rest) until disease progression.(1)

Patients who had not received prior chemotherapy and were given a combination of elesclomol and paclitaxel (n=24), compared to patients who were given paclitaxel alone (n=8):

-- Experienced a 69 percent reduction in the risk of progression or death

-- Lived an average of almost six months longer (15.9 months versus 10.0

months)

-- Had a longer median progression-free survival (7.1 months versus 1.8

months; p=0.020).(1)

"Metastatic melanoma is an aggressive disease, and patients currently have few treatment options," said investigator David
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SOURCE GlaxoSmithKline; Synta Pharmaceuticals Corp.
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