RXi Pharmaceuticals Presented an Update on the Company's Dermatology and Ophthalmology Franchises
MARLBOROUGH, Mass., Sept. 11, 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 the Company's President & CEO, Dr. Geert Cauwenbergh, presented at the Rodman & Renshaw 16th Annual Global Investment Conference on Wednesday, September 10, 2014. Dr. Cauwenbergh provided early interim data from their first Phase 2a clinical trial (RXI-109-1301) as well as other advancements in the Company's dermatology and ophthalmology franchises.
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Clinical Trial Update
In the Company's first Phase 2a trial (RXI-109-1301), eight patients in each of two cohorts were enrolled and have reached the one month post-surgery observation point. Because this trial was designed with an adaptive protocol, it provides the ability to review early data and optimize future cohorts and/or trials. While one month is an early time point to evaluate scar formation, assessments of 1-month post surgery photographs by 11 blinded evaluators suggest that delayed treatment with RXI-109 (Cohort 2) is better than immediate treatment (Cohort 1). In Cohort 2 only, there was a statistical preference for RXI-109 treated scars by both comparative observations (RXI-109 treated- vs. placebo-treated scars) and by evaluation of the scars using a visual analog scale. Based on these early observations, the dosing regimen in this study can be fine-tuned and we can more rapidly move forward to an optimized treatment for prevention of scarring after surgery. Additional results to date show that RXI-109 is well tolerated with no systemic side effects. Local effects are mild and similar to those seen in the Company's prior Phase 1 clinical trial (erythema, occasional burning or stinging sensation). Evaluation of the 3, 6 and 9 month time points in this and the other ongoing Phase 2a trials will provide continued insight into dosing regimen, and give further guidance for future study design.
"Our progress in the past few months has been remarkable, both in advancing our RXI-109 clinical program and in expanding the development potential within our dermatology and ophthalmology franchises," said Dr. Geert Cauwenbergh, President and CEO. He added that, "The interim findings in the first Phase 2a trial with RXI-109 are of significant help in accelerating the evaluation of the best treatment regimen for patients with hypertrophic scars, allowing for additional patients to be included in cohorts with a more effective dosing regimen and saving time and costs by eliminating less optimal treatment schedules."
New Targets for sd-rxRNA® in Dermatology
The Company also announced that collagenase and tyrosinase were selected as new discovery stage targets for their self-delivering platform. For each of these two targets, we have identified potent sd-rxRNA compounds for further evaluation. These two targets are important for various diseases in skin. e.g., photo aging, wound healing, hyperpigmentation as well as in other disease areas (including osteo- and rheumatoid arthritis, acne scarring, blistering skin disorders, corneal erosions and endometriosis and certain neurological cancers).
Ophthalmology Franchise Update
As part of the ongoing ophthalmology program, the Company filed a request for a pre-IND meeting with the FDA in advance of filing an IND for RXI-109 for diseases in the eye. IND-supporting toxicology studies are in progress to support RXI-109 being developed as a treatment for ocular scarring.
In addition, the Company announced that a potent anti-VEGF sd-rxRNA has been identified, which may be considered for development in age-related macular degeneration (AMD) alone or in combination with RXI-109 to block both the neovascular and the scarring component of AMD. The VEGF compound is based in part on the target sequence of Bevasiranib, the siRNA compound acquired along with additional RNAi assets from OPKO Health, Inc.
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
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