RXi Pharmaceuticals Corp. (RXII) announced today that The U.S. Food and Drug administration has cleared the CMC partial clinical hold, allowing the pivotal Phase 3 trial of NeuVax to commence.
NeuVax is expected to initiate its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax(TM) Treatment) study in the first half of 2012 under a Special Protocol Assessment (SPA).
RXi has made other significant developments in preparation for the Phase 3 trial initiation:
- Dr. Beth Mittendorf, Assistant Professor, Department of Surgical Oncology, University of Texas M. D. Anderson Cancer Center has been selected as a principal investigator for the trial. Dr. Mittendorf has been involved in cancer vaccine research for over 10 years, has lead numerous investigator sponsored studies, and has published extensively in the area of breast cancer immunotherapy.
- Conditional Institutional Review Board (IRB) approval from two key trial sites has been received to allow for initiation of the trial, with additional worldwide sites expected to open shortly. It is anticipated that the trial will encompass approximately 100 trial sites in the U.S., Canada, and Europe.
- RXi has engaged the Clinical Research Organization (CRO) Aptiv Solutions to manage the trial and clinical operations are on track for PRESENT to commence in the first half of next year.
RXi Pharmaceuticals Corporation
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Tamara McGrillen 508-929-3615
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics.