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Development of Tumor Proliferation PET Tracer FLT using a Low Cost Single Dose Automatic Production and Quality Control Biomarker Generator System

Award Number: R44CA195831
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Development of Tumor Proliferation PET Tracer FLT using a Low Cost Single Dose Automatic Production and Quality Control Biomarker Generator System - DESCRIPTION (provided by applicant): Worldwide, a person dies from cancer every 5 seconds. Positron emission tomography (PET) is an effective tool that is critical in diagnosing cancer and monitoring treatment efficacy. PET imaging relies on use of short-lived radioisotopes. Commercial distribution of the most commonly used radio tracer, [18F]FDG, has resulted in 80% patient population coverage in the U.S, Western Europe and Japan. However, the "emerging world" (~85% of the world's population) still does not have ready access to [18F]FDG. ABT Molecular Imaging, Inc. (ABT) is focused on increasing PET access in the U.S. and worldwide. The firm's proprietary "Dose on Demand(tm)" Biomarker Generator (BG) greatly simplifies production of [18F]FDG. It also reduces the investment required by healthcare institutions to introduce PET diagnostics into new regions. The need for PET- related advances remains, however. The [18F]FDG biomarker is not the only one required for successful diagnosis/treatment monitoring of cancers. [18F]FLT has been shown to provide complementary information [18F]FDG regarding tumor proliferation in a range of cancers constituting 72% of all existing cases (see Comm. Plan Section A), yet it costs $3000-$4000/dose where available. [18F]FLT has shown so much promise that the National Cancer Institute has an established IND (11/2004) for [18F]FLT to actively encourage investigators to cross-file on (there are more than 350 clinical trials). The Fast Track SBIR project proposed here will provide the funding needed to develop and validate ABT's ability to automatically synthesize and perform automatic QC testing on [18F]FLT simplifying site IND submissions with ABT support. The envisioned ABT system will generate [18F]FLT for ~$250/dose using disposable dose-synthesis cards that can be used in-between [18F]FDG doses. The challenges to integrating [18F]FLT are (1) producing enough F-18 to account for the synthesis yield of [18F]FLT, (2) automating synthesis, and (3) automating QC tests of [18F]FLT on the BG system. For this Fast Track, ABT's PI, Dr. Khachaturian, will lead an expert R&D team of 12 in pursuing 3 Phase I and 3 Phase II Aims: (Aim 1) Validate the feasibility of increasing the amount of [18F] produced by the cyclotron from 1 to 1.7 [mCi/min]; (Aim 2) produce one unit dose of [18F]FLT (2.0-3.6 [mL], 2.5-5 [mCi]) with both US and EU precursors; and (Aim 3) pass the US and EU pharmacopeia quality controls tests. Phase I verification will fully validate proof of concept, such that Phase II development ca focus on ensuring consistent [18F]FLT yield and quality for manufacturing. The Phase II Aims are: (Aim 4) F-18 yield shall be >1.7 [mCi/min] at 3s for n = 4 targets and 20 runs/target; (Aim 5) 24 consecutive unit doses of [18F]FLT can be synthesized with both labeling precursors; and (Aim 6) 24 consecutive unit [18F]FLT doses will pass the US and EU pharmacopeia requirements. Phase III support will come from ABT's current investors and will enable the distribution of [18F]FLT, contingent upon receiving the NIH Fast Track support and meeting the Phase I and II R&D goals.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2020 ( Subtotal = -$559,125 )
2020	2017	ABT MOLECULAR IMAGING, INC.	3024 TOPSIDE BUSINESS PARK DR	LOUISVILLE	TN	37777	BLOUNT	USA	Cancer Detection and Diagnosis Research	000	3	3/2/2020	NON-COMPETING CONTINUATION	-$559,125
														Subtotal = -$559,125

Issue Date FY: 2017 ( Subtotal = $711,781 )
2017	2017	ABT MOLECULAR IMAGING, INC.	3024 TOPSIDE BUSINESS PARK DR	LOUISVILLE	TN	37777	BLOUNT	USA	Cancer Detection and Diagnosis Research	000	3	6/26/2017	NON-COMPETING CONTINUATION	$711,781
														Subtotal = $711,781

Issue Date FY: 2016 ( Subtotal = $843,368 )
2016	2016	ABT MOLECULAR IMAGING, INC.	3024 TOPSIDE BUSINESS PARK DR	LOUISVILLE	TN	37777	BLOUNT	USA	Cancer Detection and Diagnosis Research	000	2	6/7/2016	EXTENSION WITH OR WITHOUT FUNDS	$843,368
														Subtotal = $843,368

Issue Date FY: 2015 ( Subtotal = $222,828 )
2015	2015	ABT MOLECULAR IMAGING, INC.	3024 TOPSIDE BUSINESS PARK DR	LOUISVILLE	TN	37777	BLOUNT	USA	Cancer Detection and Diagnosis Research	000	1	5/14/2015	NEW	$222,828
														Subtotal = $222,828

Grand Total All Awards = $1,218,852

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Development of Tumor Proliferation PET Tracer FLT using a Low Cost Single Dose Automatic Production and Quality Control Biomarker Generator System

Award Number: R44CA195831

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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