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Study Supports Possible Use of Leukine(R) as a Potential Adjuvant Therapy for High-Risk Melanoma Patients
Date:6/5/2008

- Phase II Data Indicate Overall and Disease-Free Survival -

WAYNE, N.J., June 5 /PRNewswire/ -- Results from an adjuvant trial in high-risk melanoma patients demonstrated that a majority of patients treated with Leukine(R) (sargramostim) achieved disease-free and/or overall survival. These findings, which indicate Leukine's potential in this cancer setting, were released at the 44th annual meeting of the American Society of Clinical Oncology (ASCO).

Results from the Phase II study (ASCO abstract #20027) show that 60 percent of the 45 high-risk patients enrolled in the trial experienced disease-free survival and 64 percent of patients achieved overall survival at 21 months.

"Previous findings suggest that sargramostim may be a potential adjuvant therapy for high-risk melanoma patients," said E. George Elias M.D., Ph.D., Director of Maryland Melanoma Center. "The percentage of patients who achieved disease-free and overall survival in this trial provides further evidence that sargramostim may prove to be a viable treatment option for this patient population and that further study in Phase III trials are needed."

In this trial, adjuvant therapy with Leukine and a synergistic cytokine, IL-2, was generally well-tolerated in patients with high-risk melanoma following potentially curative surgery. Each patient received two years of adjuvant therapy: year one with Leukine and IL-2 and year two with only Leukine. Toxicities were mild to moderate and no hospitalizations were required.

"These data, particularly the overall survival rates, are encouraging, even though preliminary, and indicate Leukine's potential as a treatment in this setting," said Paul MacCarthy, M.D., FRCPI, vice president and head of U.S. Medical Affairs for Bayer HealthCare Pharmaceuticals.

Clinical Trial Overview

This Phase II trial was a single-arm, open-labeled study to evaluate the safety, tolerability and treatment efficacy of Leukine and I
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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