Navigation Links
RXi Pharmaceuticals Announces mRNA Data of an Additional Cohort in the Second Phase 1 Multi-Dose Study with RXI-109, Extending the Dose Response Following Treatment in the Initial 2-week Period

WESTBOROUGH, Mass., Dec. 4, 2013 /PRNewswire/ -- RXi Pharmaceuticals Corporation (OTCQX: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced additional results from their second placebo-controlled Phase 1 study with RXI‑109, an sd-rxRNA® compound that targets Connective Tissue Growth Factor (CTGF), and is being developed for the treatment of abnormal dermal scars such as hypertrophic scars and keloids in conjunction with scar revision surgery.

(Logo: )

In this study, subjects received small skin incisions in their abdomen and were treated with three intradermal doses of RXI‑109 over a 2-week period.  The dose escalating portion of the study consisted of four cohorts of three healthy volunteers each.  An additional 5th cohort was also added at the highest dose, in which the treatment period was delayed by two weeks. Subjects received RXI‑109 on one side of the abdomen, and placebo on the other side. Subjects were monitored for safety and local and systemic side effects over a total study period of 84 days. Multiple dermal injections were well tolerated at all doses, and treatment with RXI‑109 resulted in dose-dependent silencing of CTGF mRNA in the treated areas. In the additional 4th cohort of this study, three doses of 10 mg dose per incision over the initial 2-week period following the incision averaged approximately 50% reduction of CTGF mRNA expression compared to placebo when measured three days after the last dose. In the 5th cohort, where the dosing period with 10 mg RXI-109 per incision was delayed by 2 weeks after the incisions were made, no additional benefit was seen on mRNA reduction.  Both treatment regimens were safe and well tolerated.  However, delay of dosing resulted in fewer local skin effects for both placebo and active.    

Based on the excellent safety profile shown in Phase 1, a Phase 2 study was initiated in November 2013 in which subjects will receive multiple doses of RXI-109 in conjunction with revision surgery on existing hypertrophic scars. Additional studies in hypertrophic scars and keloids are planned.  

Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals said that, "We are pleased with the outcome of our completed second Phase 1 study.  The results show that multiple intradermal injections of RXI‑109 are well tolerated with minimal and mild side effects". He added that, "The addition of a 4th cohort at a higher dose has confirmed the dose related suppression of CTGF mRNA when RXI-109 is administered shortly after the surgical incisions are made, with 50% reduction with the highest dose compared to 9%, 43% and 43% reduction of CTGF mRNA  for the 2.5, 5, and 7.5 mg doses, respectively. The fact that the already mild side effect profile observed with the drug seems to be even lower when the treatment is delayed for two weeks after the incisions, supports our decision to have immediate and delayed treatment groups included in our ongoing Phases 2 study for treatment of pre-existing hypertrophic scars in the lower abdominal area".

About RXi Pharmaceuticals Corporation

RXi Pharmaceuticals Corporation (OTCQX: 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, targets connective tissue growth factor (CTGF) to reduce dermal scarring (fibrosis), entered into human clinical trials in June 2012.  For more information, please visit

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: 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

SOURCE RXi Pharmaceuticals Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
2. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
3. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
4. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
5. Icahn Issues Statement Regarding Amylin Pharmaceuticals
6. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
7. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Jazz Pharmaceuticals Announces First Quarter 2012 Financial Results Conference Call On May 8, 2012
10. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
11. Avanir Pharmaceuticals To Present at Three Conferences In May
Post Your Comments:
(Date:11/24/2015)... leader in LCD screen protection and glare-elimination technology, is providing a vital solution to health care ... electronic documentation system. Photo - ... ... ... A study in 2013 by the National Institutes of Health found that ...
(Date:11/24/2015)...   Renowned UAE nutritionist ... advice and insights on supplements and healthy diet ing ... of Dubai residents are not consuming enough fruits ... femMED launches comprehensive solutions for women , s most common ... are not consuming enough to keep themselves healthy. A local expert addressed how ...
(Date:11/24/2015)... BRISTOL, Pa. , Nov. 24, 2015 /PRNewswire/ ... primarily for the medical research, clinical diagnostic and ... Kord-Valmark, a leading manufacturer of quality petri dishes. ... to offer clients a platform of products that ... and manufactured with the highest quality.  ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... Dr. Todd S. Afferica, a noted general ... many of his patients. Dr. Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in ... time the doctor uses other traditional cutting tools, such as the scalpel and high-speed ...
(Date:11/24/2015)... ... 24, 2015 , ... ThirdLove, the fast-growing bra company that ... offering 40% off select bras and underwear styles, now through Saturday, November 28th. ... technology and the latest fashion, quickly becoming the next generation of luxury bras. ...
(Date:11/24/2015)... ... November 24, 2015 , ... The hospitals and ... several aspects of orthopedic care. They have received recognition for excellence from various ... care. , Becker's Hospital Review selected hospitals for inclusion based on national ...
(Date:11/24/2015)... ... November 24, 2015 , ... Brillouin Energy Corp. ... is the developer of renewable energy technologies capable of producing commercially useful amounts ... today that its WET™ and HHT™ Boiler System reactor core modules were presented ...
(Date:11/24/2015)... ... November 24, 2015 , ... The American Association of Poison ... poison centers through donations on Tuesday, Dec. 1, 2015. Since 2012, the Tuesday ... inspires people to collaborate in improving their local communities and help give back ...
Breaking Medicine News(10 mins):