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Advance Early Detection of Lupus Nephritis with ClearGold

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK123943-01
Agency Tracking Number: R41DK123943
Amount: $288,365.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-19
Award End Date (Contract End Date): 2020-08-31
Small Business Information
2209 NEW COLLEGE LN
Plano, TX 75025-5512
United States
DUNS: 080371860
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MENGXIAO YU
 (214) 799-3250
 clearnanopi@gmail.com
Business Contact
 JIE ZHENG
Phone: (214) 779-3250
Email: clearnanomed@gmail.com
Research Institution
 UNIVERSITY OF TEXAS DALLAS
 
800 WEST CAMPBELL, AD15
RICHARDSON, TX 75080-3021
United States

 Nonprofit college or university
Abstract

SummarySystemic lupus erythematosusSLEor lupus is an autoimmune disease that impacts more thanmillion people worldwideincludingmillion AmericansNearlyof these patients will develop lupus nephritiswhich can cause kidney failureAs a resultits financial burden to individual patient can reach $yearmuch higher than many other diseases because of kidney transplantationAlthough early treatment of lupus nephritis can significantly slow down or even prevent the disease progression to kidney failureproteinuriaour current gold standard for screening lupus patientsis not sensitive and accurate enough for early detection of lupus nephritisWhile new biomarkers or exogenous renal function markers are being developed or tested in clinical trials for early diagnosis of lupus nephritistheir sensitivity and accuracy are comparable to those of proteinuriaAs a resulteven todayproteinuria remains the gold standard and there are strong unmet needs for early detection and accurate monitoring of kidney damages in the lupus patientsTo address this unmet needClearNano Incis developing a test agentnamedClearGoldthat can be used to detect lupus nephritis much earlier and more accurately than proteinuriaIn this applicationwe aim to address two key questionsHow accurate this method is in detection of lupus nephritisHow early this method can identify lupus nephritis in comparison with proteinuria in the mouse modelThe success will validate the competitive advantages of ClearGold over proteinuria in the early detection of kidney damages in the lupus mouse modelwhich will lay down a solid foundation for clinical translation ofClearGoldThrough these studieswe believe that a long standing challenge in the early detection of kidney damages in the lupus nephritis can be eventually addressed with ourClearGoldtest agentwhich represents a $Billion market opportunity NarrativeThe financial burden of individual lupus nephritis patients can reach $yearmuch higher than many other diseases due to the kidney failure and transplantationAlthough early treatment of lupus nephritis can significantly slow down or even prevent the disease progression to kidney failureproteinuriaour current gold standard for screening lupus patientsis not sensitive and accurate enough for early detection of lupus nephritisTo address this unmet needClearNano Incis developing a test agentnamedClearGoldthat can be used to detect lupus induced kidney damages much earlier and more accurately than proteinuriaIn this phase I applicationwe will validate this technology in lupus mouse model and lay down a solid foundation for clinical translation ofClearGoldwhich represents a $Billion market opportunity

* Information listed above is at the time of submission. *

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