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MDC-1231 for cancer prevention

Award Number: R42CA153662
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/19/2012
PERIOD OF PERFORMANCE END DATE: 08/31/2016

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MDC-1231 for cancer prevention - DESCRIPTION (provided by applicant): The chemoprevention of colon cancer has been hampered by either weak agents or significant side effects. It was recently shown that the combination of sulindac with difluoromethylornithine (DFMO) prevents nearly 70% of colon cancer, assessed as colon polyp recurrence. Sulindac, however, has frequent and significant side-effects that make its long-term application to cancer prevention problematic. Our phase I STTR assessed the potential role of our sulindac-like compound MDC-1231, also known as phosphosulindac (PS), in colon cancer prevention. PS has increased potency and safety compared to sulindac and acts synergistically with DFMO to prevent colon cancer with an efficacy of 91%. Our goal is to replace sulindac with PS in the successful combination with DFMO in order to develop a superior approach to colon cancer prevention. We have accomplished all the goals of the phase I grant. The goal of the present phase II application is to complete the preclinical development of PS and submit an FDA IND application. We propose five specific aims, some of them will be pursued in parallel and influence each other. Specific Aim #1: Complete the studies on the metabolism; perform PK/PD and biodistribution of the optimized oral formulation of PS. Specific Aim #2: Scale up the synthesis of PS under GMP conditions. Specific Aim #3: Develop an oral formulation of PS and determine its stability. Specific Aim #4: Perform toxicity studies of PS; they include animal toxicity and genotoxicity studies. Specific Aim #5: Prepare an IND protocol and package for FDA submission. The proposed work, if successful, will contribute greatly towards a realistic strategy for human colon cancer chemoprevention.


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: 2017 ( Subtotal = $0 )
2017	2013	MEDICON	12 BAYLOR CIR	WHITE PLAINS	NY	10605	WESTCHESTER	USA	Cancer Cause and Prevention Research	000	3	2/16/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $0 )
2015	2013	MEDICON INC	18 BLUEBERRY RIDGE ROAD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Cancer Cause and Prevention Research	000	3	9/10/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $0 )
2014	2013	MEDICON INC	18 BLUEBERRY RIDGE ROAD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Cancer Cause and Prevention Research	000	3	8/14/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $1,022,841 )
2013	2013	MEDICON INC	18 BLUEBERRY RIDGE ROAD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Cancer Cause and Prevention Research	000	3	8/30/2013	NON-COMPETING CONTINUATION	$1,022,841
														Subtotal = $1,022,841

Issue Date FY: 2012 ( Subtotal = $739,513 )
2012	2012	MEDICON INC	18 BLUEBERRY RIDGE ROAD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Cancer Cause and Prevention Research	000	2	9/19/2012	COMPETING CONTINUATION	$739,513
														Subtotal = $739,513

Grand Total All Awards = $1,762,354

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MDC-1231 for cancer prevention

Award Number: R42CA153662

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/19/2012

PERIOD OF PERFORMANCE END DATE: 08/31/2016

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