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FDA lifts hold on RXi breast cancer vaccine trial

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Grant Zeng, CFA

FDA lifts hold on RXi breast cancer vaccine trial

On September 12, 2011, RXi Pharmaceuticals Corporation (RXII - Free Report) announced a clinical trial update on its lead program, NeuVax (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).

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 III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study in the first half of 2012 under a Special Protocol Assessment (SPA).

•    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.

Along with the clinical trial hold lift, RXi has made other significant developments in preparation for the Phase III 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.

•    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.

We think RXi is making great progress in the advancement of its lead candidate NeuVax™ for breast cancer. We maintain our Outperform rating on RXII and reiterate our 12-month price target of $2.5 per share.

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