RXi Pharmaceuticals Announces mRNA Data of an Additional Cohort in the Second Phase 1 Multi-Dose Study with RXI-109, Extending the Dose Response Following Treatment in the Initial 2-week Period
WESTBOROUGH, Mass., Dec. 4, 2013 /PRNewswire/ -- RXi Pharmaceuticals Corporation (OTCQX: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced additional results from their second placebo-controlled Phase 1 study with RXI‑109, an sd-rxRNA® compound that targets Connective Tissue Growth Factor (CTGF), and is being developed for the treatment of abnormal dermal scars such as hypertrophic scars and keloids in conjunction with scar revision surgery.
In this study, subjects received small skin incisions in their abdomen and were treated with three intradermal doses of RXI‑109 over a 2-week period. The dose escalating portion of the study consisted of four cohorts of three healthy volunteers each. An additional 5th cohort was also added at the highest dose, in which the treatment period was delayed by two weeks. Subjects received RXI‑109 on one side of the abdomen, and placebo on the other side. Subjects were monitored for safety and local and systemic side effects over a total study period of 84 days. Multiple dermal injections were well tolerated at all doses, and treatment with RXI‑109 resulted in dose-dependent silencing of CTGF mRNA in the treated areas. In the additional 4th cohort of this study, three doses of 10 mg dose per incision over the initial 2-week period following the incision averaged approximately 50% reduction of CTGF mRNA expression compared to placebo when measured three days after the last dose. In the 5th cohort, where the dosing period with 10 mg RXI-109 per incision was delayed by 2 weeks after the incisions were made, no additional benefit was seen on mRNA reduction. Both treatment regimens were safe and well tolerated. However, delay of dosing resulted in fewer local skin effects for both placebo and active.
Based on the excellent safety profile shown in Phase 1, a Phase 2 study was initiated in November 2013 in which subjects will receive multiple doses of RXI-109 in conjunction with revision surgery on existing hypertrophic scars. Additional studies in hypertrophic scars and keloids are planned.
Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals said that, "We are pleased with the outcome of our completed second Phase 1 study. The results show that multiple intradermal injections of RXI‑109 are well tolerated with minimal and mild side effects". He added that, "The addition of a 4th cohort at a higher dose has confirmed the dose related suppression of CTGF mRNA when RXI-109 is administered shortly after the surgical incisions are made, with 50% reduction with the highest dose compared to 9%, 43% and 43% reduction of CTGF mRNA for the 2.5, 5, and 7.5 mg doses, respectively. The fact that the already mild side effect profile observed with the drug seems to be even lower when the treatment is delayed for two weeks after the incisions, supports our decision to have immediate and delayed treatment groups included in our ongoing Phases 2 study for treatment of pre-existing hypertrophic scars in the lower abdominal area".
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (OTCQX: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, self-delivering RNAi platform. Therapeutics that use RNA interference, or "RNAi," have great promise because of their ability to down-regulate, the expression of a specific gene that may be over-expressed in a disease condition. Building on the pioneering work of scientific founder and Nobel Laureate Dr. Craig Mello, a member of the RXi Scientific Advisory Board, RXi's first RNAi product candidate, RXI‑109, targets connective tissue growth factor (CTGF) to reduce dermal scarring (fibrosis), entered into human clinical trials in June 2012. For more information, please 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 future expectations, planned and future development of RXi Pharmaceuticals Corporation's products and technologies. Forward-looking statements about expectations and development plans of RXi's products involve significant risks, and uncertainties: risks that RXi may not be able to successfully develop its candidates, or that development of RNAi-based therapeutics may be delayed or not proceed as planned, or that we may not develop any RNAi-based product; risks that the development process for our product candidates may be delayed, risks related to development and commercialization of products by our competitors, risks related to our ability to control timing and terms of collaborations with third parties, and the possibility that other companies or organizations may assert patent rights preventing us from developing our products. Actual results may differ from those contemplated by these forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.
RXi Pharmaceuticals Corporation
Tamara McGrillen, 508-929-3646
SOURCE RXi Pharmaceuticals Corporation