MARLBOROUGH, Mass., Aug. 31, 2015 /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering and developing innovative therapies primarily in the areas of dermatology and ophthalmology, today announced that the 30-day review period following the filing of the Company's Investigational New Drug (IND) for ocular indications with the U.S. Food and Drug Administration (FDA) has passed and the IND is now active.
As outlined in the Company's Second Quarter Earnings Call on August 12, 2015, preparations are ongoing for the initiation of a Phase 1/2 trial in Ophthalmology to evaluate the safety and clinical activity of RXI-109 to prevent the progression of the scarring component of retinal diseases. The process to obtain approval from the Investigational Review Board (IRB) is underway. If the current plan is acceptable to the IRB, a multi-dose, dose-escalating trial will initiate early in the fourth quarter of this year.
This Phase 1/2 study will be the Company's first clinical trial with RXI-109 in Ophthalmology. RXI-109-1501 will focus on patients with advanced age-related macular degeneration or advanced wet AMD. RXI-109 is a self-delivering RNAi (sd-rxRNA®) compound developed to target connective tissue growth factor (CTGF), a key regulator in scar formation. The goal is to block the formation of sub-retinal scarring that is secondary to the neovascular disease of wet AMD in order to preserve vision for a longer period of time.
"As mentioned during our earnings call a few weeks ago, we are pleased to be moving forward one of our seven key initiatives for shareholder value creation," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "Progressing the clinical program for RXI-109 in ophthalmology is a major step in our approach to demonstrate the value of our self-delivering RNAi technology to alleviate diseases in patients who today have little hope for improvements in their advanced disease states. Overall, we are pleased to be advancing RXI-109 for both Dermatology and Ophthalmology, and look forward to initiating additional targeted programs using our self-delivering RNAi platform in these two therapeutic areas."
Currently, there are three ongoing Phase 2a trials evaluating the effect of RXI-109 on scar formation in the skin after surgical revision of hypertrophic scars or keloids. Approximately 100 subjects have been treated with RXI-109 by intradermal injection in all trials to date. RXI-109 has proven to be safe and well tolerated in that target population. The Company expects to provide further updates on its Dermatology and Ophthalmology clinical programs in the coming months.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering and developing innovative therapeutics primarily in the areas of dermatology and ophthalmology that address high-unmet medical needs. Our discovery and clinical development programs are based on siRNA technology, as well as immunotherapy agents. These compounds include, but are not limited to, our proprietary, self-delivering RNAi (sd-rxRNA®) compounds for the treatment of dermal and ocular scarring. It also includes an immunomodulator, Samcyprone™, a proprietary topical formulation of diphenylcyclopropenone (DPCP), for the treatment of such disorders as alopecia areata, warts, non-malignant skin tumors and cutaneous metastases of melanoma.
RXi's novel, self-delivering RNAi (sd‑rxRNA®) compounds 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. sd-rxRNAs have been shown, in vitro and in vivo, to achieve efficient spontaneous cellular uptake and potent, long-lasting intracellular activity.
RXI-109, an sd-rxRNA compound, is the Company's first clinical development candidate. RXI-109 silences Connective Tissue Growth Factor (CTGF), which plays a key role in tissue regeneration and repair and is initially being developed to reduce or inhibit scar formation in the skin and in the eye. RXI-109 is currently being evaluated in Phase 2a clinical trials in dermatology. The Company's sd-rxRNA technology platform is broadly protected by multiple issued patents and numerous patent applications.
RXi's robust pipeline, coupled with an extensive patent portfolio, provides for product and business development opportunities across a broad spectrum of therapeutic areas. We are committed to being a partner of choice for academia, small companies, and large multinationals. We welcome ideas and proposals for strategic alliances, including in- and out-licensing opportunities, to advance and further develop strategic areas of interest. Additional information may be found on the Company's website, 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: our ability to successfully develop RXI-109, Samcyprone™ and our other product candidates (collectively "our product candidates"); the future success of our clinical trials with our product candidates; the timing for the commencement and completion of clinical trials; our ability to enter into strategic partnerships and the future success of these strategic partnerships; and our ability to deploy our sd-rxRNA® technology through partnerships, as well as the prospects of these partnerships to provide positive returns. Forward-looking statements about expectations and development plans of RXi's product candidates and partnerships involve significant risks and uncertainties, including the following: risks that we may not be able to successfully develop and commercialize our product candidates; risks that product development and clinical studies may be delayed, not proceed as planned and/or be subject to significant cost over-runs; risks related to the development and commercialization of products by competitors; risks related to our ability to control the timing and terms of collaborations with third parties; and risks that other companies or organizations may assert patent rights preventing us from developing or commercializing our product candidates. Additional risks are detailed in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors." Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our 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