Published on January 7, 2010 at 4:03 AM
BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has agreed that BioVex's ongoing OPTiM clinical study in unresectable Stage IIIb-IV melanoma be amended to include untreated (i.e., first line) patients as well as previously treated patients as defined in the original protocol.
This amendment has been agreed under the Special Protocol Assessment (SPA) procedure, thus maintaining the SPA status of the protocol. The amendment will expand the eligible pool of patients and allow patients to volunteer for the study as an alternative to, rather than only following, standard treatment approaches.
Source: BioVex Inc