RXi Pharmaceuticals Provides Positive NeuVax™ Phase 3 Clinical Trial Update
- 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, MA (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™ (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 3 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).
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.
"Our extensive progress to date, including the timely lifting of the clinical hold and significant headway with site IRBs, is testament to the team's operational excellence and its commitment to meeting program timelines," said Mark J. Ahn, President and CEO of RXi. "NeuVax is now the cornerstone for building a strong oncology pipeline as we continue to build momentum within the oncology community and look forward to presenting additional NeuVax data at key clinical meetings this Fall."
About NeuVax™ (E75)
RXi is also pursuing development of a cancer vaccine for breast cancer. NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study. The Phase 3 trial is expected to commence in the first half of 2012.
According to the National Cancer Institute, over 200,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for Human Epidermal growth factor Receptor 2 (IHC 1+, 2+ or 3+). Only 25% of all breast cancer patients, those with HER2 3+ disease are eligible for Herceptin® (trastuzumab; Roche-Genentech) which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2 positive patients (HER2 1+ and 2+) who achieve remission with current standard of care, but have no available HER2 targeted adjuvant treatment options to maintain their disease free status.
About RXi Pharmaceuticals Corporation
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. For more information, visit www.rxipharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the future expectations, plans and prospects of the development of RXi Pharmaceuticals Corporation's products. These forward-looking statements about future expectations, plans and prospects of the development of the Company's products are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in the Company's most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. The Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
SOURCE: RXi Pharmaceuticals Corporation
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