RXII grabbed lows on news this morning.. (COMTEX) B: RXi Pharmaceuticals Provides Positive NeuVax(TM) Phase 3 Clini
cal Trial Update ( GlobeNewswire )
B: RXi Pharmaceuticals Provides Positive NeuVax(TM) Phase 3 Clinical Trial Updat
e ( GlobeNewswire )
Sep 12, 2011 (GlobeNewswire via COMTEX) ---- The CMC partial clinical hold
has been lifted by the FDA, allowing the
pivotal Phase 3 trial to commence.
-- RXi has assigned a principal investigator and initial IRB approvals
received--going to 100 trial sites in the US, Canada, and Europe.
-- CRO Aptiv Solutions has been engaged and international trial operations
are underway for the initiation of the Phase 3 PRESENT study in the
first half of 2012.
WORCESTER, Mass., Sept. 12, 2011 (GLOBE NEWSWIRE) -- RXi Pharmaceuticals
Corporation (Nasdaq:RXII), a biotechnology company focused on discovering,
developing and commercializing innovative therapies addressing major unmet
medical needs using targeted biotherapeutics, today announced a clinical
trial update on its lead program, NeuVax(TM) (E75 peptide vaccine with GM-CSF
adjuvant), a cancer immunotherapy targeted for low-to-intermediate HER2
expressing breast cancer patients not eligible for trastuzamab
(Herceptin(R)). RXi received official notification from the U.S. Food and
Drug Administration (FDA) that the Chemistry, Manufacturing, and Controls
(CMC) partial clinical hold has been lifted. RXi has satisfied all
requirements specified by the FDA and has initiated a clinical trial material
manufacturing plan to remain on schedule to meet the planned trial start
date. 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
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