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, today reported its financial results for the quarter ended March 31, 2011.
“Our recent acquisition of NeuVax and focus on RXI-109 significantly advances RXi into a product development company with novel therapeutics addressing large unmet medical needs,” said Mark J. Ahn, PhD, President and Chief Executive Officer of RXi Pharmaceuticals. “We believe we currently have the people, pipeline and resources to realize the promise of our innovative product candidates for patients and shareholders.”
- Moved into Late-Stage Clinical Development with the Acquisition of Apthera, Inc. On April 13, 2011, RXi completed the acquisition of Apthera, Inc., a private biotechnology company developing an oncology pipeline of peptide-based immunotherapies. The acquisition provides RXi with a late stage product candidate, NeuVax ™(E75), a peptide-based immunotherapy for low-to-intermediate HER2+ breast cancer, not eligible for Herceptin® (trastuzumab), which is expected to enter Phase III clinical trials in the first half of 2012 under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). Phase II data after 36 months of treatment, as well as Phase III plans, will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in June 2011.
- Initiated Development Program for Dermal Anti-Scarring Product Candidate. RXi initiated its development program for RXI-109 with a goal of submitting an Investigational New Drug (IND) application in the second half of 2011. The company began manufacturing activities with a cGMP oligonucleotide manufacturer and is preparing a pre-IND package for submission to the FDA. Pending FDA review, the company intends to employ an innovative clinical trial design to study safety and tolerability as well as initial efficacy in its first clinical trial targeted for 2012. In this clinical trial, RXi plans to evaluate RXI-109 for the reduction of dermal scarring in planned surgeries.
- Completed $8.1 million public offering in Mar 2011. Net proceeds from this offering resulted in approximately $7.3 million to RXi. In addition, the company completed a separate offering of $12 million in April 2011 resulting in $10.9 million in net proceeds, bringing RXi’s total pro forma cash position to over $20 million. RXi was also granted approximately $1 million in grants. The company believes it has sufficient resources to initiate the clinical trials of its lead product candidates.
- Announced Positive Research Data from a collaboration with Generex Biotechnology Corporation. Initial results from the collaboration between RXi and Generex demonstrated success in using RXi's proprietary self-delivering rxRNA™ (sd-rxRNA™) compounds to silence genes up to 80% in hemopoietic cells. The ability to knock down expression of certain genes in isolated hemopoietic-derived cancer cells ( ex vivo) has the potential to convert them into specific immune-stimulants and opens the possibility for development of a new class of anticancer therapeutic vaccines.
- Presented New Preclinical RNAi Data on rxRNA Compounds. RXi announced new preclinical data using proprietary self-delivering RNAi (sd-rxRNA) compounds, including RXI-109, at the Keystone Symposia's Mechanism and Biology of Silencing conference held March 20-25, 2011 in Monterey, California.