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Noninvasive Contrast Enhanced Early Detection of Melanoma Liver Metastasis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42CA183376-02
Agency Tracking Number: R42CA183376
Amount: $2,000,217.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-06-01
Award End Date (Contract End Date): 2020-05-31
Small Business Information
Marietta, GA 30068-1641
United States
DUNS: 078419511
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (404) 413-5520
Business Contact
Phone: (404) 429-1434
Research Institution
PO BOX 3999
ATLANTA, GA 30302-3999
United States

 Nonprofit college or university

Abstract The liver is the most common organ for metastasis of various cancersincluding pancreaticovariancolorectalgastric cancers and melanomaUveal melanoma metastasizes inof patients and upon metastasis targets the liver inof these casesThe most common primary malignant liver cancer worldwide is hepatocellular carcinomaHCCThe use of blind liver biopsy as a diagnostic tool for liver cancer has many limitations including risks associated with the procedure and sampling bias and it cannot be performed repeatedly for longitudinal studiesImproving noninvasive imaging methodology would be a significant advance in early detection of small primary cancers and liver metastases for precision medicineThere is a critical need to develop MRI contrast agents capable of detecting primary and metastatic liver cancers earlier in their development than currently possibleand to provide insight into the biology of metastases through biomarkers for precision treatmentWe have successfully met all of the proposed aims and milestones for Phase IThe main commercial goal of Inlighta Biosciences is to develop novel imaging reagents for preclinical and clinical applicationsOur concerted efforts in this Phase II application are directed towards non invasive earlier detection of uveal melanoma liver metastasis using novel protein contrast agents ProCAand its variant with capability to molecular imaging biomarker chemokine receptorCXCRan important biomarker for cell migration and tumor metastasisWe will obtain essential data required for filing IND applications for both reagents leading to clinical translationAimis to optimize and validate in vivo imaging capabilities of ProCAs in tumor detection assessing in mice and monkeyWe will also validate CXCRtargeting and monitor CXCRexpression levels in liver metastasis mouse modelsAimis to perform the safety and toxicity profiles protein contrast agents required for IND by determining serumcell and in vivo stabilityPK PDtoxicityand immunogenicitySuccess in our proposed studies will have immediate clinical implications in the diagnosis of liver metastasis from various cancersprimary liver cancerand other liver diseases Narrative Our proposed studies in precision imaging with unprecedented sensitivity and accuracy address major medical gaps including early detection of small lesion and biomarker expression especially for high risk patients and monitoring the dynamic changes of biomarkers during disease progression and following therapeutic treatmentSuccess in our proposed studies will have immediate clinical implications in the diagnosis of liver metastasis from various cancersprimary liver cancerand other liver diseasesaccurate staging following up of high risk patientsevaluating treatment effectand imageguided interventions

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

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