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TOPIC 345: PREDICTIVE BIOMARKERS OF PROSTATE CANCER PATIENT SENSITIVITY FOR RADIATION LATE EFFECTS

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N91019C00031
Agency Tracking Number: N44CA190031
Amount: $1,903,095.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: N/A
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
1 RESEARCH CT, STE 450
ROCKVILLE, MD 20850-6252
United States
DUNS: 078720415
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Scott Grindrod
 (434) 409-8865
 scott.grindrod@shuttlepharma.org
Business Contact
 Scott Grindrod
Phone: (434) 409-8865
Email: scott.grindrod@shuttlepharma.org
Research Institution
N/A
Abstract

To address the goals of developing ""predictive biomarkers of adverse reactions to radiation treatment""we propose to perform a multi site analytic validation of the product""metabolite panel kit""developed in the Phase I SBIR effortResults of plasma metabolite analysis in defined cohorts of patients treated with SBRT for prostate cancer will be tested for precisionaccuracy and reproducibility in three independentgeographically distributed testing laboratoriesClinical samples obtained from patients with prostate cancers and samples spiked with known quantities of metabolites will be distributed for analytic validation of Shuttle s metabolite ""kit""The data derived in the Phase I effort have defined metabolite panels for potential use as predictive biomarkers of radiation late effectsherewe propose three technical objectivesTo manufacturemetabolite panel ""kits"" and analysis softwareTest and validate the performance of kits and software at three independent sites andWith the assistance of regulatory consultant and FDA inputdesign an expanded multi institutional validation clinical trial to test the metabolite panel kit for use as a potential ""metabolite biomarker"" for clinical applicationDemonstration of proof of principle in patients with prostate cancer may support development and commercialization of the metabolite biomarker product

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

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