RXi Pharmaceuticals Announces Completion of Enrollment of Phase 1/2 Clinical Trial with RXI-109 for Retinal Scarring

Wednesday, June 21, 2017 Drug News
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Study RXI-109-1501 is evaluating the safety and clinical activity of RXI-109 to prevent the progression of retinal scarring, a harmful component of numerous retinal diseases

MARLBOROUGH, Mass., June 21, 2017 /PRNewswire/ --

RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, announced today the completion of enrollment in its Phase 1/2 study RXI-109-1501.  This multi-center, multi-dose, dose escalation trial is being conducted in patients with advanced neovascular or 'wet' age-related macular degeneration (AMD) where retinal scarring can result in continued vision loss. RXI-109 is a self-delivering RNAi (sd-rxRNA®) compound developed to target connective tissue growth factor (CTGF), a key regulator of scar formation.

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"We are very pleased with the progress of this clinical trial and happy to report that RXI-109 has been well tolerated with no drug related issues occurring to date," said Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals.  He continued, "The completion of enrollment is an important study milestone as this means that we are likely to finish patient follow-up before year end, as planned and previously communicated."  

The primary endpoint for RXI-109-1501 is to evaluate the safety and tolerability of RXI-109, but in the study other endpoints are included to assess RXI-109's potential for clinical activity using numerous assessments to monitor ocular health and visual acuity.  In this Phase 1/2 study, each subject receives a total of four doses of RXI-109 at one month intervals.  RXI-109 is administered by intravitreal injection in one eye only.  The dosing period (3 months) is followed by a four month observation period. Several dose levels are evaluated in a small number of subjects in this first trial in order to establish safety information and to help determine the dosing regimen for continued study.   

About RXi Pharmaceuticals

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a clinical-stage company developing innovative therapeutics that address significant unmet medical needs. Building on the pioneering discovery of RNAi, scientists at RXi have harnessed the naturally occurring RNAi process which can "silence" or down-regulate the expression of a specific gene that may be overexpressed in a disease condition. RXi developed a robust RNAi therapeutic platform including self-delivering RNA (sd-rxRNA) compounds that selectively block the expression of any target in the genome, thus providing applicability to many therapeutic areas. Our current programs include cell-based immunotherapy, dermatology, and ophthalmology. RXi's extensive patent portfolio provides for multiple product and business development opportunities across a broad spectrum of therapeutic areas and we actively pursue research collaborations, partnering and out-licensing opportunities with academia and pharmaceutical companies. Additional information may be found on the Company's website, 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: 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.

Contact

RXi Pharmaceuticals CorporationTamara McGrillen508-929-3646tmcgrillen@rxipharma.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/rxi-pharmaceuticals-announces-completion-of-enrollment-of-phase-12-clinical-trial-with-rxi-109-for-retinal-scarring-300477263.html

SOURCE RXi Pharmaceuticals Corporation



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