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Journal of Clinical Oncology Publishes Leukine(R) Study Demonstrating Positive Survival Outcomes in Patients with High-Risk Melanoma
Date:6/30/2008

- Phase II Trial Shows Increase in Mature Dendritic Cells -

WAYNE, N.J., June 30 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals today confirmed that results of a Phase II trial were published in the July 1 edition of the Journal of Clinical Oncology. The study showed that Leukine(R) (sargramostim) demonstrated a median overall survival of 65 months and increased mature dendritic cells in high-risk melanoma patients. Dendritic cells are special antigen-presenting cells that help the immune system recognize cancer cells and are the most effective antigen-presenting cells known. Study authors concluded that this increase in dendritic cell counts may also correlate with delayed recurrence of disease.

"These data provide early signals that Leukine may offer clinical benefit in this patient group by increasing and differentiating dendritic cells and perhaps by benefiting patients who have lowered baseline levels of dendritic cells," said Dr. Adil Daud, first author of the study and Associate Professor, Director, Clinical Research, University of California, San Francisco Melanoma Center. "Patients who experienced an increase of dendritic cells were more likely to demonstrate delayed disease recurrence."

In this Phase II prospective trial, 42 patients with resected high-risk (Stage IIIB, IIIC or IV) melanoma were treated with Leukine (125 mcg/m2/day for 14 consecutive days followed by 14 days of no treatment). This regimen was repeated for 13 cycles unless patients had unacceptable toxicity or showed evidence of disease recurrence. Patients had no evidence of disease at the start of the trial as measured by imaging. Patients underwent restaging every four months. The most common adverse events found in the study were injection site reactions (88 percent), pain (61 percent), arthralgia/myalgia (61 percent), fatigue (61 percent), flu-like symptoms (39 percent) and insomnia (27 percent).

Of the 42 enrolled patients, 39 were av
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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