Drug Development

IND submitted to U.S. FDA for trial of malignant melanoma therapy

Published in Medical Letter on the CDC and FDA, June 5th, 2005

BioVex, Ltd., has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to initiate a clinical trial in malignant melanoma of OncoVEX GM-CSF, its lead product candidate for the treatment of solid tumors.

OncoVEX GM-CSF is an oncolytic virus that selectively kills tumor cells. It also induces tumor cells to secrete GM-CSF, a powerful immune stimulator, potentially enhancing the destruction of both injected and metastatic tumor deposits.

"Submitting an IND for OncoVEX GM-CSF is a significant milestone for BioVex" said Gareth Beynon, CEO of BioVex. "We believe the combination of oncolytic activity with...

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Source: Medical Letter on the CDC and FDA (2005-06-05)

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