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NEOTROPIX GETS FDA APPROVAL TO START SVV-001 TRIAL

May 17, 2006

Neotropix has announced that the FDA has approved its nvestigational new drug (IND) application for its first cancer drug candidate, Seneca Valley Virus (SVV-001).

A dose-escalating Phase I study will determine if SVV-001 can be systemically administered safely to patients with certain types of advanced neuroendocrine cancers, including small cell lung cancer. The study will also examine the distribution of the virus in the body, the elimination of it from the body, the immune response to the virus, and whether it affects the patients' tumors. At the end of the trial, the company will select an optimal dose for further clinical studies.