WESTBOROUGH, MA, USA I November 13, 2013 I RXi Pharmaceuticals Corporation (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 first patient has been enrolled in a Phase 2 study with the anti-scarring product RXI-109. In this study (RXI-109-1301), patients with a long hypertrophic scar in the lower abdominal area are eligible to receive scar revision surgery and subsequent treatment with RXI-109 in one of two treatment regimens. Patients will receive RXI-109 or placebo on a blinded basis at the distal ends of their revised scar, leaving a central untreated section of the scar. Each patient’s revised scar area will provide the opportunity to compare the appearance of the revised areas after treatment with RXI-109 or placebo or when left untreated. This design allows for intra-subject comparison of the three revised scar segments, as such increasing the power of the study.
“The start of the first Phase 2 clinical study with RXI-109 is a very important step in bringing our first self-delivering (sd-rxRNA®) RNAi closer to the market,” said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, “Not only can the outcome of this first Phase 2 study create a novel treatment approach in an area where no FDA approved drugs exist; it should also confirm the clinical relevance of our proprietary sd-rxRNA approach for human diseases in a broader sense, creating numerous business development opportunities that could add substantial value to our company.”
In its public disclosures, the Company has indicated that two additional Phase 2 studies will be initiated in the near future. The first of these will evaluate the effect of RXI-109 on the recurrence of keloids after keloid revision surgery. The second study will evaluate the effect of RXI-109 on suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.
About Scarring
Skin scarring after surgery, trauma, or burns can cause debilitating aesthetic, functional and psychological effects. There are no FDA-approved therapeutics for treatment of post-operative scars. RXI‑109 has been shown in preclinical models to reduce CTGF, a growth factor essential in the wound healing cascade. Elevated levels of CTGF‑dependent signaling can prolong the tissue repair process and lead to pathological scarring.
About RXI-109
RXi Pharmaceuticals’ first clinical program involves RXI‑109, a self-delivering RNAi compound (sd‑rxRNA®) developed for the reduction of dermal scarring. RXI‑109 is designed to reduce the expression of CTGF, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trials of RXI‑109 showed excellent safety and tolerability with ascending single or multiple doses.
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.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (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 www.rxipharma.com.
SOURCE: RXi Pharmaceuticals
Post Views: 723
WESTBOROUGH, MA, USA I November 13, 2013 I RXi Pharmaceuticals Corporation (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 first patient has been enrolled in a Phase 2 study with the anti-scarring product RXI-109. In this study (RXI-109-1301), patients with a long hypertrophic scar in the lower abdominal area are eligible to receive scar revision surgery and subsequent treatment with RXI-109 in one of two treatment regimens. Patients will receive RXI-109 or placebo on a blinded basis at the distal ends of their revised scar, leaving a central untreated section of the scar. Each patient’s revised scar area will provide the opportunity to compare the appearance of the revised areas after treatment with RXI-109 or placebo or when left untreated. This design allows for intra-subject comparison of the three revised scar segments, as such increasing the power of the study.
“The start of the first Phase 2 clinical study with RXI-109 is a very important step in bringing our first self-delivering (sd-rxRNA®) RNAi closer to the market,” said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, “Not only can the outcome of this first Phase 2 study create a novel treatment approach in an area where no FDA approved drugs exist; it should also confirm the clinical relevance of our proprietary sd-rxRNA approach for human diseases in a broader sense, creating numerous business development opportunities that could add substantial value to our company.”
In its public disclosures, the Company has indicated that two additional Phase 2 studies will be initiated in the near future. The first of these will evaluate the effect of RXI-109 on the recurrence of keloids after keloid revision surgery. The second study will evaluate the effect of RXI-109 on suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.
About Scarring
Skin scarring after surgery, trauma, or burns can cause debilitating aesthetic, functional and psychological effects. There are no FDA-approved therapeutics for treatment of post-operative scars. RXI‑109 has been shown in preclinical models to reduce CTGF, a growth factor essential in the wound healing cascade. Elevated levels of CTGF‑dependent signaling can prolong the tissue repair process and lead to pathological scarring.
About RXI-109
RXi Pharmaceuticals’ first clinical program involves RXI‑109, a self-delivering RNAi compound (sd‑rxRNA®) developed for the reduction of dermal scarring. RXI‑109 is designed to reduce the expression of CTGF, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trials of RXI‑109 showed excellent safety and tolerability with ascending single or multiple doses.
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.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (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 www.rxipharma.com.
SOURCE: RXi Pharmaceuticals
Post Views: 723
