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Novel noninvasive diagnostic technology for dynamic imaging of mitochondrial bioenergetics in breast cancer patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA210823-01
Agency Tracking Number: R41CA210823
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA15-270
Timeline
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-16
Award End Date (Contract End Date): 2019-08-14
Small Business Information
3502 GARDENVIEW RD
Pikesville, MD 21208-1507
United States
DUNS: 146202358
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 EREZ NEVO
 (443) 270-1600
 enevo@robinmedical.com
Business Contact
 EREZ NEVO
Phone: (443) 450-4030
Email: enevo@robinmedical.com
Research Institution
N/A
Abstract

Summary
Breast cancer is the second most common and the major cause of cancer related death of women in the USA
The last decade has witnessed major advancement of therapeutic drugs and tools while noninvasive diagnostic
imaging tools to measure interventions received much less attention Currently the mainstay of noninvasive
imaging in breast cancer relies primarily on anatomic imaging Metabolic imaging using FDG PET is a
successful diagnostic tool in several types of cancer but not in the setting of breast cancer The last decade has
also witnessed the revival of interest in the role of mitochondria in tumor invasiveness and as regulators of
cytotoxicity of first line chemotherapy agents Yet current tools for noninvasive investigations and diagnostics
of the mitochondrial function in cancer patients are limited to SPECT imaging agents Our recent preclinical
studies provided compelling evidence for the capacity of the PET imaging voltage sensor F
fluorobenzyltriphenylphosphonium FBnTP developed by the PI laboratory to potentially improve
management of breast cancer This includes improved early detection of early stage small vascularized
breast lesion with better functional and spatial resolution compared to FDG PET and SPECT imaging
Accurate D mapping of tumor proliferation an important prognostic factor in the clinical setting and
very early molecular level detection of treatment response directly at the core mechanism of cytotoxicity of
first line chemotherapy agents The technology supporting these utilities is based on our studies which
demonstrate that cellular uptake of FBnTP is directly proportional to the mitochondrial membrane potential
m of a cell m is the most comprehensive physiological endpoint of the organelle bioenergetics m
is a unique target that enables attaining the above goals m is significantly greater in certain types of
malignant cells including those of breast origin compared to normal cells resulting in a preferential
accumulation of FBnTP in tumor mass compared to healthy parenchyma m increases in highly
proliferating breast cancer cells whereas collapse of m coincides with the initiation of the irreversible phase
of the apoptotic cell death as induced by many first line chemotherapy agents in the breast cancer setting The
goal of this STTR Phase study is to establish proof of concept in patient samples under the approved IRB that
FBnTP is an effective imaging technology to detect breast lesions in women a prerequisite for future feasibility
studies of FBnTP as a surrogate marker of breast tumor invasiveness and response to therapeutic
interventions To improve commercial competitiveness FBnTP imaging will be carried out using breast
dedicated positron emission mammogram PEM a less costly technology compared to PET CT and MRI and
of better spatial resolution than PET Narrative
Breast cancer is most widespread and the second cause of cancer related mortality with an estimated
new diagnoses of advanced breast cancer in the USA in most of which will undergo chemotherapy but
only a minority will obtain complete response In recent years our laboratory focused on developing novel
imaging methods that will greatly improve management of breast cancer by predicting tumor response to
chemotherapy before treatment and determining the extent of response to chemotherapy shortly few days
after the start of the treatment regimen The present proposal aims at obtaining proof of principle in a small
cohort of patients of the capacity of the imaging biomarker to detect breast lesion in women a prerequisite for
future feasibility studies of the imaging method as a surrogate marker of breast tumor prognosis and response
to therapeutic interventions

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

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