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FDA Requests Additional Phase 3 Trial for Cintredekin Besudotox in Glioblastoma Multiforme

WAUKEGAN, Ill.--(BUSINESS WIRE)--NEOPHARM, INC. (Nasdaq:NEOL - News) today announced that it has met with officials of the Office of Oncology of the FDA to discuss the Company's clinical trial data from its Phase 3 PRECISE trial for use of Cintredekin Besudotox in the treatment of recurrent glioblastoma multiforme (GBM).

Following presentation of the data by the Study's principal investigator, the Office of Oncology position was that an additional Phase 3 clinical trial for Cintredekin Besudotox in the treatment of GBM would be required before the FDA could accept the Company's application for approval. However, the Office of Oncology did encourage the Company to maintain a dialogue with the Agency regarding the pathway forward.

The Company is disappointed with the Office of Oncology's position, which, if implemented, would significantly delay the introduction of this therapy to GBM patients. The Company will consider its options to determine the best path forward and will communicate its plans when they are completed and approved by the Board of Directors.

Source: Neopharm

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