PITTSBURGH, PA, USA I May 1, 2014 I Complexa, Inc., an inflammatory and metabolic disease-focused biopharmaceutical company announced today that it has initiated the first human clinical trial of lead product candidate CXA-10. The initial target indication is for the treatment of acute kidney injury related to the administration of contrast imaging agents in high-risk patients. This Phase I trial is designed to assess CXA-10’s safety and pharmacokinetics. Through the use of various biomarkers, the study will also demonstrate CXA-10’s mechanism of action and document target organ engagement that will further illuminate its regulation of critical inflammatory pathways.
“We are pleased to have advanced CXA-10 to a Phase I clinical trial, a significant milestone in the development of this innovative next generation inflammatory and metabolic control technology,” commented Complexa President and CEO, Josh Tarnoff. “After more than a decade of studying CXA-10, we believe this compound has the potential to become an important advance in the treatment of kidney injury.”
This advancement of CXA-10 to human clinical trials follows extensive demonstration of efficacy in multiple preclinical animal models, as well as completion of expanded pharmacokinetic and toxicology assessments.
CXA-10, and related drug candidates in Complexa’s portfolio utilize the body’s own endogenous signaling pathways to promote defense and repair responses, which can be applied to a number of underserved, life-threatening inflammatory-based diseases. Complexa identified acute kidney injury as the lead proof-of-technology indication due to the significant unmet need in this patient population.
Complexa also continues its work on oral chronic treatments and intends to file an IND with the FDA for oral administration of CXA-10 in the treatment of chronic kidney disease later this year. Development programs in other inflammatory, neurodegenerative and metabolic-related therapeutic categories are also under active evaluation.
About Complexa
Complexa, Inc. is a platform biopharmaceutical company researching and developing endogenous human cell signaling technologies targeting an array of prevalent inflammatory and metabolic diseases. The company’s proprietary technology involves the synthesis and therapeutic applications of endogenous nitro-fatty acids (NFAs) and additional structure/function-related mediators that are designed to treat various diseases. NFAs are cell signaling agents that regulate major inflammatory signaling pathways (e.g., Nrf2, NFkB and HSF). Capitalizing on their identification and synthesis of these endogenous signaling mediators, Complexa’s technologies act to amplify the existing anti-inflammatory and metabolic signaling mechanisms that promote the resolution and repair of acute and chronic tissue injury and disease.
SOURCE: Complexa
Post Views: 461
PITTSBURGH, PA, USA I May 1, 2014 I Complexa, Inc., an inflammatory and metabolic disease-focused biopharmaceutical company announced today that it has initiated the first human clinical trial of lead product candidate CXA-10. The initial target indication is for the treatment of acute kidney injury related to the administration of contrast imaging agents in high-risk patients. This Phase I trial is designed to assess CXA-10’s safety and pharmacokinetics. Through the use of various biomarkers, the study will also demonstrate CXA-10’s mechanism of action and document target organ engagement that will further illuminate its regulation of critical inflammatory pathways.
“We are pleased to have advanced CXA-10 to a Phase I clinical trial, a significant milestone in the development of this innovative next generation inflammatory and metabolic control technology,” commented Complexa President and CEO, Josh Tarnoff. “After more than a decade of studying CXA-10, we believe this compound has the potential to become an important advance in the treatment of kidney injury.”
This advancement of CXA-10 to human clinical trials follows extensive demonstration of efficacy in multiple preclinical animal models, as well as completion of expanded pharmacokinetic and toxicology assessments.
CXA-10, and related drug candidates in Complexa’s portfolio utilize the body’s own endogenous signaling pathways to promote defense and repair responses, which can be applied to a number of underserved, life-threatening inflammatory-based diseases. Complexa identified acute kidney injury as the lead proof-of-technology indication due to the significant unmet need in this patient population.
Complexa also continues its work on oral chronic treatments and intends to file an IND with the FDA for oral administration of CXA-10 in the treatment of chronic kidney disease later this year. Development programs in other inflammatory, neurodegenerative and metabolic-related therapeutic categories are also under active evaluation.
About Complexa
Complexa, Inc. is a platform biopharmaceutical company researching and developing endogenous human cell signaling technologies targeting an array of prevalent inflammatory and metabolic diseases. The company’s proprietary technology involves the synthesis and therapeutic applications of endogenous nitro-fatty acids (NFAs) and additional structure/function-related mediators that are designed to treat various diseases. NFAs are cell signaling agents that regulate major inflammatory signaling pathways (e.g., Nrf2, NFkB and HSF). Capitalizing on their identification and synthesis of these endogenous signaling mediators, Complexa’s technologies act to amplify the existing anti-inflammatory and metabolic signaling mechanisms that promote the resolution and repair of acute and chronic tissue injury and disease.
SOURCE: Complexa
Post Views: 461
