RXi Pharmaceuticals Presents Updated NeuVax (E75) Data At ASCO
- NeuVax™ (E75) presentation entitled “Sequential administration of trastuzumab and a CD8 T cell-eliciting HER-2/neu peptide vaccine in breast cancer patients compared to trastuzumab alone” at ASCO (American Society of Clinical Oncology).
- RXi to host panel entitled “Emerging Insights into Breast Cancer and Immunotherapy” which includes an update on NeuVax (E75) Phase II results in adjuvant breast cancer after 36 months of treatment.
WORCESTER, Mass.--(BUSINESS WIRE)--May 19, 2011 - RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted and immunotherapy technologies, will be presenting data from the NeuVax™ (E75) Phase II adjuvant breast cancer clinical trial at the 2011 annual meeting of The American Society of Clinical Oncology (ASCO) in Chicago.
The presentation, entitled “Sequential administration of trastuzumab and a CD8 T-cell-eliciting HER2/neu peptide vaccine in patients with breast cancer compared to trastuzumab alone” (Abstract #564), will be presented at the poster session “Breast Cancer HER2/ER” on Monday, June 6th from 1:00 – 5:00 PM CDT.
In addition, RXi will also be hosting a panel entitled “New Directions in Breast Cancer Therapeutics” on Sunday, June 5th, at 2:00 PM CDT at the Hyatt Regency McCormick Place. The panel presentation will include an update from the NeuVax Phase II clinical trial including the 36-month efficacy data, as well as Phase III plans. The 24 month landmark analysis was first presented at the ASCO Breast Cancer Meeting in October 2010.
About NeuVax™ (E75)
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 II 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 a Phase III clinical trial in the adjuvant setting for women with low-to-intermediate HER2+ status.
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.
RXi Pharmaceuticals has initiated development of clinical candidate RXI-109, a self-delivering RNAi compound (sd-rxRNA™) for the reduction of dermal scarring in planned surgeries. RXI-109 is designed to reduce the expression of CTGF (connective tissue growth factor), a critical regulator of several biological pathways involved in fibrosis, including scar formation in the skin. RXi is beginning manufacturing activities with an experienced cGMP oligonucleotide manufacturer to support its IND enabling toxicology program, and is preparing a pre-IND package for submission to the FDA. Pending FDA review, the company intends to use an innovative clinical trial design to study safety and tolerability as well as initial efficacy in its first clinical trial targeted for 2012.
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 RNA-targeted and immunotherapy technologies. 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.
Posted: May 2011