Drug Development

Phase III trial application filed for Multikine

Published in Medical Letter on the CDC and FDA, February 6th, 2005

Cel-Sci Corp. (CVM) has submitted a phase III clinical trial protocol to the U.S. Food and Drug Administration (FDA) for the use of its investigational immunotherapy drug Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity.

Additional information in support of and to provide the rationale for the phase III trial (final reports of clinical trials conducted with Multikine to date and manufacturing and testing information) was included with this submission.

The protocol was designed in consultation with a group of recognized experts in the field of head & neck cancer therapy to develop the conclusive evidence of the...

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Source: Medical Letter on the CDC and FDA (2005-02-06)

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