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A PET Diagnostic for Imaging Bacterial Infection

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EB029860-01
Agency Tracking Number: R41EB029860
Amount: $221,273.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIBIB
Solicitation Number: PA19-270
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-07-21
Award End Date (Contract End Date): 2021-07-20
Small Business Information
Setauket, NY 11733-2249
United States
DUNS: 079480664
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (631) 632-7907
Business Contact
Phone: (631) 632-7952
Research Institution
W5510 Frank Melville Jr. Memorial Library
United States

 Nonprofit College or University

Bacterial infections such as those of prosthetic joints, bones (osteomyelitis) and heart valves (infective
endocarditis) are difficult to diagnose and treat, and are a major cause of mortality, morbidity and health care
costs. The long-term goal of our program is to develop a positron emission tomography (PET) radiotracer that
can be used for non-invasive PET imaging to detect and localize bacterial pathogens in humans. This radiotracer
will serve as a non-invasive diagnostic to accurately identify bacterial infections and inform on bacterial load
during chemotherapy, thereby identifying and improving treatment outcomes of patients with infectious diseases.
We have synthesized a novel radiotracer, CC-001, that is selectively taken up by bacteria including clinically
relevant strains of Staphylococcus aureus. We have shown that CC-001 accumulates at the site of S. aureus
infection in a soft tissue infection model of disease. Significantly, CC-001 can distinguish bacterial infection from
inflammation unlike the widely used clinical PET tracer 2-deoxy-2-[18F]fluoro-D-glucose ([18F]FDG). The object
of this Phase I STTR is to validate CC-001 in a preclinical model of infection and perform studies in preparation
for an investigational new drug submission. In Aim 1 we will demonstrate that CC-001 can detect and image S.
aureus in a preclinical model of infective endocarditis and that this radiotracer can quantify bacterial load as a
function of antibiotic treatment. In Aim 2 we will perform dosimetry studies in order to assess the projected
radiation exposure at a clinically relevant human dose. We will also demonstrate that CC-001 does not display
any adverse effects at 100 and 1000 times the projected human dose in mice. Thus, we will show that radiation
burden and toxicity resulting from the dose of radiotracer proposed for clinical studies is within the acceptable
range based on data from the U.S Food and Drug Administration. This Phase I STTR will pave the way for a
Phase II STTR in which we will gather additional preclinical data and subsequently transition into clinical trials.PROJECT NARRATIVE
Many human bacterial infections including those of the heart, are difficult to detect and treat due to their location
in the human body and are a serious cause of morbidity and health care costs. To meet this unmet medical need,
we will validate a radiotracer that can detect and localize bacterial pathogens in humans using positron emission
tomography imaging. This radiotracer can serve as a non-invasive diagnostic and inform on bacterial load during
chemotherapy, thereby identifying and improving treatment of patients with infectious diseases.

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

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