RXi Pharmaceuticals Announces Initiation of Second Double-Blind Vehicle Controlled Phase 1 Study Wit
Dec 5th 2012 6:50AM
Updated Dec 5th 2012 6:52AM
RXi Pharmaceuticals Announces Initiation of Second Double-Blind Vehicle Controlled Phase 1 Study With Its Anti-Scarring Compound, RXI-109
New study evaluates safety, tolerability and scar outcome after multiple dosing with RXI-109 or vehicle in healthy volunteers
WESTBOROUGH, Mass.--(BUSINESS WIRE)-- RXi Pharmaceuticals Corporation (OTC: RXII), today announced that dosing with their anti-scarring drug, RXI-109, for the management of surgical and hypertrophic scars and keloids has been initiated. Nine subjects (3 cohorts of 3) are participating in this dose escalation study during which intradermal injections of RXI-109 will be administered on 3 occasions over 2 weeks. Dose levels range from 2.5 to 7.5 mg per injection, and subjects will receive injections of RXI-109 and vehicle at small incisions on separate areas of their abdomen. Data on safety and tolerance will be collected and evaluated. The incisions will also be evaluated for possible drug effects on the scarring.
"We are pleased that, based on the excellent safety profile observed after single dosing with RXI-109, we have been able to move this quickly from the first into the second clinical study, which evaluates multiple doses per subject," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, "The speed with which we have been able to move this development forward is a testament to the safety of the drug, but also to the dedication of the team that executes this project. If we can continue at this pace, and assuming no unexpected hurdles, RXi Pharmaceuticals should be able to move into its first Phase 2 studies with RXI-109 in the second half of 2013."
Skin scarring after surgery, trauma, or burns can cause debilitating aesthetic, functional and psychological effects. There are no FDA-approved therapeutics for treatment of post-operative scars. RXI-109 has been shown in preclinical models to reduce CTGF, a growth factor essential in the wound healing cascade. Elevated levels of CTGF-dependent signaling can prolong the tissue repair process and lead to pathological scarring.
RXi Pharmaceuticals' first clinical program involves RXI-109, a self-delivering RNAi compound (sd-rxRNA®) developed for the reduction of dermal scarring. RXI-109 is designed to reduce the expression of CTGF, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trial of RXI-109 has shown excellent safety and tolerability with ascending single doses. This second trial uses multiple doses and evaluates safety and side effects of these doses, while also exploring possible effects of RXI-109 on the healing process.
RXi's sd-rxRNA oligonucleotides are designed for therapeutic use and have drug-like properties, such as high potency, target specificity, serum stability, reduced immune response activation, and efficient cellular uptake. These hybrid oligonucleotide molecules combine the beneficial properties of conventional RNAi and antisense technologies. This allows sd-rxRNAs to achieve efficient cellular uptake and potent, long-lasting intracellular activity.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (OTC: 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, which targets CTGF, entered into human clinical development 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
KEYWORDS: United States North America Massachusetts
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