Drug Discovery & Development - February 04, 2011
RXi Pharmaceuticals Corporation, a leader in RNAi-based therapeutic discovery and development, announced further details regarding RXI-109, the company’s dermal anti-scarring candidate.
RXi has initiated its development program for RXI-109 with a goal of submitting an IND in the second half of 2011. The company is beginning manufacturing activities with an experienced cGMP oligonucleotide manufacturer to support its IND enabling toxicology program, and is preparing a pre-IND package for submission to the FDA. In addition, pending FDA review, the company intends to employ an innovative clinical trial design to study safety and tolerability as well as initial efficacy in its first clinical trial targeted for 2012. In this clinical trial, RXi plans to evaluate RXI-109 for the reduction of dermal scarring in planned surgeries. The company believes this clinical trial has the potential to generate a meaningful data set while keeping the trial size to a minimum.
“We are pleased with the progress the company is making with RXI-109 and continue to be on track to file an IND in the second half of this year,” said Pamela Pavco, Ph.D., Vice President of Pharmaceutical Development. “Our plans for the manufacturing and toxicology work are progressing nicely. By evaluating RXI-109's effect on scar formation in this proposed trial, not only will we be able to gather safety and tolerability data, we believe we may also be able to obtain an early histological assessment of clinical efficacy within the first year of initiating this trial.”
RXI-109 is a self-delivering RNAi compound (sd-rxRNA) designed to reduce the expression of CTGF (connective tissue growth factor). CTGF is known to be a critical regulator of several biological pathways involved in fibrosis and thus may be applicable in the treatment of numerous indications with a fibrotic component, including scar formation in the skin.
“As part of our anti-scarring program, we evaluated and screened multiple targets thought to be implicated in excessive fibrosis and selected CTGF,” said Anastasia Khvorova, Ph.D. RXi’s Chief Scientific Officer. “In addition to our work to identify and characterize RXI-109, there is supportive preclinical and recent clinical data in the literature showing that the modulation of CTGF plays an important role in the reduction of fibrosis and scarring. We are excited to be moving forward with our first development candidate that utilizes RXi’s proprietary sd-rxRNA technology platform.”
Date: February 3, 2011
Source: RXi Pharmaceuticals Corporation
RXi has initiated its development program for RXI-109 with a goal of submitting an IND in the second half of 2011. The company is beginning manufacturing activities with an experienced cGMP oligonucleotide manufacturer to support its IND enabling toxicology program, and is preparing a pre-IND package for submission to the FDA. In addition, pending FDA review, the company intends to employ an innovative clinical trial design to study safety and tolerability as well as initial efficacy in its first clinical trial targeted for 2012. In this clinical trial, RXi plans to evaluate RXI-109 for the reduction of dermal scarring in planned surgeries. The company believes this clinical trial has the potential to generate a meaningful data set while keeping the trial size to a minimum.
“We are pleased with the progress the company is making with RXI-109 and continue to be on track to file an IND in the second half of this year,” said Pamela Pavco, Ph.D., Vice President of Pharmaceutical Development. “Our plans for the manufacturing and toxicology work are progressing nicely. By evaluating RXI-109's effect on scar formation in this proposed trial, not only will we be able to gather safety and tolerability data, we believe we may also be able to obtain an early histological assessment of clinical efficacy within the first year of initiating this trial.”
RXI-109 is a self-delivering RNAi compound (sd-rxRNA) designed to reduce the expression of CTGF (connective tissue growth factor). CTGF is known to be a critical regulator of several biological pathways involved in fibrosis and thus may be applicable in the treatment of numerous indications with a fibrotic component, including scar formation in the skin.
“As part of our anti-scarring program, we evaluated and screened multiple targets thought to be implicated in excessive fibrosis and selected CTGF,” said Anastasia Khvorova, Ph.D. RXi’s Chief Scientific Officer. “In addition to our work to identify and characterize RXI-109, there is supportive preclinical and recent clinical data in the literature showing that the modulation of CTGF plays an important role in the reduction of fibrosis and scarring. We are excited to be moving forward with our first development candidate that utilizes RXi’s proprietary sd-rxRNA technology platform.”
Date: February 3, 2011
Source: RXi Pharmaceuticals Corporation
No hay comentarios:
Publicar un comentario