RXi Pharmaceuticals to Present New Data in its First Phase 2a Clinical Trial with RXI-109

MARLBOROUGH, Mass., Oct. 7, 2014 /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that a review of the first two enrolled patients' clinical photographs in the first Phase 2a clinical trial (RXI-109-1301), indicate that treatment with the Company's lead clinical candidate, RXI-109, may be effective in suppressing recurrence of hypertrophic scars at the 3-month time point. Patients will continue to be monitored through 9 months to evaluate if this outcome persists over time.

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On September 10^th of this year, the Company announced that based on early 1-month observations, the dosing regimen in these trials can be fine-tuned, allowing the Company to more rapidly move forward with treatment optimization for the prevention of scarring after surgery. Today's presentation will provide 3-month photographs from the first two patients enrolled in study RXI-109-1301 that indicate treatment with RXI-109 shows a clinical benefit. The safety information in this ongoing study to date, continues to confirm that RXI-109 is well tolerated with no overt systemic side effects.  Local effects are mild and similar to those seen in the Company's prior Phase 1 clinical trials (erythema, occasional, transient burning or stinging sensation). Complete 3-month results from this trial are expected to be available in Q1 2015.

"We are encouraged by the preliminary results in this trial," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. "To date, our Phase 2a studies are providing us with exactly the information for which such studies are intended, early information on dosing requirements and observation of a clinical effect of the drug. Having this information in hand now should save money and time going forward in our clinical development as we will incorporate these learnings into future clinical protocols."

The presentation will be webcast today, Tuesday, October 7, 2014 at 10:00 a.m. PST, at the 13^th Annual BIO Investor Forum. The webcast will be available on the "Investors" section of the Company's website, www.rxipharma.com. 

About the BIO Investor Forum

The 13^th Annual BIO Investor Forum is an international investor conference focused on private and emerging public biotech companies. This Forum also draws business development executives from leading global pharmaceutical and established biotechnology companies. The meeting will take place October 7-8, 2014 at the Palace Hotel in San Francisco, California.

About RXI-109 Clinical Trials

RXi Pharmaceuticals' first clinical program involves RXI‑109, an sd-rxRNA compound, developed for the reduction of dermal scar formation. RXI‑109 is designed to reduce the expression of connective tissue growth factor (CTGF), a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trials with RXI‑109 (RXI-109-1201 and RXI-109-1202) showed excellent safety and tolerability with ascending single and multiple doses, as well as dose-dependent effects on the CTGF protein and on the mRNA that controls production of this protein.

In November 2013, the Company started its first Phase 2a study (RXI-109-1301) in patients who had pre-existing hypertrophic scars present on their lower abdomen for at least one year. In that study, the patients undergo scar revision surgery, after which they are treated with RXI-109 on one end of the scar and placebo on the opposite end of the scar.  In April of this year, the Company began its second Phase 2a study (RXI-109-1401) for RXI-109 treatment to prevent recurrence of keloids in patients undergoing keloidectomy (removal of keloid). Patients with two keloids of similar size and location are eligible for the study. After keloidectomy, the lesions are closed and one is treated with RXI-109, and the other is treated with placebo. As is the case for the study in hypertrophic scars, patients will be followed for several months (clinically and with photographs) after the end of treatment. 

The Company's third Phase 2a study (RXI-109-1402) was initiated in July 2014 for RXI-109 for the reduction of recurrence of hypertrophic scars following elective scar revision surgery. In this study, patients with either one long hypertrophic scar, or two scars comparable in length, anatomical location and characteristics, are eligible to receive scar revision surgery.  For a single scar, a portion of the revised scar segment will be treated with RXI-109 and a comparably sized length on the opposite end of the excised scar segment will be left untreated. If two scars are revised, one revised scar segment will be treated with RXI-109 and one scar will be left untreated after revision surgery. This third Phase 2a study will follow patients for nine months. Investigator and independent reviewer assessments will be used to evaluate the effectiveness of RXI-109 in preventing scar formation. Reviewers will evaluate and compare the appearance of the revised areas after treatment with RXI-109 or when left untreated. 

All three Phase 2a trials incorporate a within-subject comparison of revised sites treated with RXI-109 vs. control sites.  This is a powerful study design because it decreases the potential impact of variability due to patient-to-patient healing characteristics.

About RXi Pharmaceuticals Corporation

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, self-delivering RNAi (sd-rxRNA®) platform. Therapeutics that use RNA interference, or "RNAi," have great promise because of their ability to down-regulate the expression of specific genes that may be over-expressed in disease conditions. 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, a self-delivering RNAi compound (sd-rxRNA), entered into human clinical trials in June 2012 and is currently being evaluated in Phase 2 clinical trials to reduce the formation of dermal scars (fibrosis).  RXI-109 is designed to reduce the expression of connective tissue growth factor (CTGF), a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin.  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. For more information, please visit 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 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:  the risk that we may not be able to successfully develop our 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 products; risks that the development process for our product candidates may be delayed, risks related to the development and commercialization of products by our competitors, the risk related to our ability to control the 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.

Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
[email protected]

SOURCE RXi Pharmaceuticals Corporation