Alfacell plans to complete NDA filing by mid-2007 for Onconase in malignant mesothelioma

By Lisa Kerner

Charlotte, N.C., June 22 - Alfacell Corp. said it has completed most of the key requirements of the Chemistry, Manufacturing and Controls (CMC) section of its rolling New Drug Application for Onconase in unresectable malignant mesothelioma.

It expects to file the CMC submission by the end of the third quarter and the NDA no later than mid-2007. Onconase has already been granted orphan-drug designation in Europe and Australia as well as fast-track status by the Food and Drug Administration.

Onconase, from Alfacell's proprietary ribonuclease technology platform, has been shown to target tumor cells while sparing normal cells.

Alfacell is conducting a phase 1/ 2 study of Onconase in non-small cell lung cancer.

Bloomfield, N.J.-based Alfacell discovers and develops novel therapeutics for cancer, using its proprietary RNase technology platform.

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