Study Supports Possible Use of Leukine(R) as a Potential Adjuvant Therapy for High-Risk Melanom...(L-2 in 45patients who had undergone pote...),Health

Date:6/5/2008

L-2 in 45 patients who had undergone potentially curative surgery. In the first year of treatment, Leukine was administered subcutaneously at 125mcg/m2/day for 14 consecutive days, followed by IL-2 subcutaneously at nine million IU/m2/day for four days. The patients then received no treatment for 10 days. Patients with resected large metastases that yielded approximately 100 X 106 tumor cells also received autologous whole cell vaccine starting at the second Leukine cycle.

During the second year of treatment, each patient received Leukine alone two times per week. In patients who experienced resected recurrence, the same adjuvant therapy was re-administered.

Follow-up ranged from one - 50 months (median 15.9). At the end of the trial, 32 of the original 45 patients were alive [9/13 stage IV, 16/25 stage III, and 7/7 stage II (3B/4C)]. The survival data were expressed by Kaplan- Meier, and showed disease-free survival of .60 [95 percent CI], and overall survival of .64 [95 percent CI] at 21 months. There was no statistical difference in survival by Log Rank between those who received only Leukine versus those treated by Leukine and IL-2 (p=.8), and there was no increase in the number of dendritic cells during or after Leukine administration in the 11 patients who donated blood for dendritic cell counts.

About Leukine(R)

Leukine(R) (sargramostim) is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the United States in 1991, and is marketed by Bayer HealthCare Pharmaceuticals. Leukine is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults (greater than or equal to 55 years) with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the U.S. for use in
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SOURCE Bayer HealthCare Pharmaceuticals Inc. Copyright©2008 PR Newswire. All rights reserved

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