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www.fdanews.com/articles/81536-neopharm-investigators-present-preliminary-cancer-trial-data

NEOPHARM INVESTIGATORS PRESENT PRELIMINARY CANCER TRIAL DATA

October 10, 2005

NeoPharm has announced the presentation of initial safety data from a Phase I study of cintredekin besudotox in the treatment of newly diagnosed malignant glioma patients at the 55th Annual Meeting of the Congress of Neurological Surgeons, currently being held in Boston.

The main objective of the study is to assess the safety and tolerability of cintredekin besudotox administered via convection-enhanced delivery followed by radiation therapy with or without Temozolomide in patients with newly diagnosed malignant glioma. The secondary objective is to determine the maximum-tolerated concentration, and the tertiary endpoint is to assess response to therapy as measured by overall survival.

Twelve patients have been enrolled in the study to date. Adverse events (AEs) considered related to cintredekin besudotox were consistent with AEs observed in Phase I studies of cintredekin besudotox administered as monotherapy in patients with recurrent malignant glioma.