RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, presented Phase 2 efficacy results for NeuVax™ in combination with trastuzumab (Herceptin®; Genentech/Roche) at the American Society of Clinical Oncology (ASCO) annual meeting. The poster entitled, “Sequential administration of trastuzumab and a CD8 T cell-eliciting HER-2/ neu peptide vaccine in breast cancer patients compared to trastuzumab alone,” was presented during the “Breast Cancer HER2/ER” poster session on Monday, June 6, 2011. RXi is developing NeuVax, a CD8 T-cell eliciting immunotherapy, for the adjuvant treatment of low to intermediate HER2 expressing breast cancer. Data from the E75 Phase 2 breast cancer trial and another CD8 T cell eliciting peptide were analyzed, and the control arms of each trial were combined for this analysis. Of 187 patients enrolled in the E75 trial, 108 received vaccine and 79 were in the control arm. Of the vaccine treated patients 15 received Tz. A total of 32 patients in the combined control arms received Tz (trastuzumab). The recurrance rate for the control arm was 12.5% (4/32), comparable with reported rates of similarly staged and treated patients. The recurrance rate for the NeuVax +Tz arm was 0% – no patients receiving vaccine after adjuvant Tz relapsed. A total of 30 patients were treated with Tz followed by vaccine, with zero patients recurring (0/30, p=0.06). “These preliminary results indicate the potential for immunotherapy combined with Tz therapy for the improved treatment HER2 3+ breast cancer patients. The results of this trial clearly warrant a randomized Phase 2 study with NeuVax in combination with trastuzumab to confirm efficacy and safety in a larger population,” stated COL George E Peoples, MD, FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, MD Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center (BAMC).
“We are excited that the data presented by Dr. Peoples may provide another indication for NeuVax in the treatment of HER2 3+ breast cancer patients,” commented Mark J. Ahn, PhD, CEO and President of RXi Pharmaceuticals. “In addition, our Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study is expected to commence in the first half of next year in women with low-to-intermediate HER2+ status in the adjuvant setting.”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 3 clinical trial in adjuvant therapy of 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.
About RXI-109RXi 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 targeted biotherapeutics. For more information, visit www.rxipharma.com. Forward-Looking Statements 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.