OTHER FUNCTIONS - RandD BIOMEDICAL (BASIC RESEARCH)

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$199,969.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
N43CO120084
Award Id:
n/a
Agency Tracking Number:
N43CO120084
Solicitation Year:
2012
Solicitation Topic Code:
NCI
Solicitation Number:
n/a
Small Business Information
ACCELERATED MEDICAL DIAGNOSTICS, LLC, 2121 2ND ST, B-101, DAVIS, CA, 95616-5472
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
826929015
Principal Investigator:
PAUL HENDERSON
(925) 570-1615
PAUL@ACCELERATEDMEDDIAGNOSTICS.COM
Business Contact:
PAUL HENDERSON
(925) 570-1615
PAUL@ACCELERATEDMEDDIAGNOSTICS.COM
Research Institution:
Stub




Abstract
A. Background Information We developed a technology called PlatinDx that, based upon preclinical data, can potentially identify chemoresistance in breast cancer patients before they receive oxaliplatin therapy. PlatinDx utilizes tracing of subtherapeuticmicrodoses of 14C-labeled oxaliplatin with accelerator mass spectrometry (AMS), which has attomole (10-18 mole) sensitivity for 14C. We hypothesize that DNA damage caused by a single subtoxic microdose of oxaliplatin can predict patient outcomes suchas tumor shrinkage and survival. The goal of the project is to define the appropriate chemical (~1/100th the therapeutic dose) and radiochemical dose (a chest x-ray exposure) for the microdose composition, to establish protocols for the procedure and to gather preliminary clinical data. Breast cancer patients will receive a 14C-oxaliplatin microdose a few hours prior to normal biopsy. DNA will be isolated from white blood cells and left over tumor biopsy tissue. Drug-DNA damage levels will be measured by AMS and compared to outcomes such as tumor shrinkage, recurrence and severity of side effects. The data will be compared to ERCC1 expression and other biomarkers using the Response Genetics RT-PCR assay as a benchmark. The resulting feasibility data will allow the design of an SBIR Phase II diagnostics study. B. Phase I Technical Objectives The proposed Phase I clinical study will determine the feasibility of using [14C]oxaliplatin combined with AMS for clinical diagnostics trials using breast cancer patients. A clinical study is proposed due to substantial preclinical data (presented below). C. All patient recruitment for this SBIR Phase I study will be conducted by UC Davis. D. Experiments using accelerator mass spectrometry (AMS) will be performed by Accelerated Medical Diagnostics staff at the Lawrence Livermore National Laboratory.

* information listed above is at the time of submission.

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