MDC-1231 for cancer prevention

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,803,865.00
Award Year:
2012
Program:
STTR
Phase:
Phase II
Contract:
2R42CA153662-02
Award Id:
n/a
Agency Tracking Number:
R42CA153662
Solicitation Year:
2012
Solicitation Topic Code:
NCI
Solicitation Number:
PA11-097
Small Business Information
18 Blueberry Ridge Rd, Setauket, NY, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
616767807
Principal Investigator:
BASIL RIGAS
(631) 444-9538
brigas@mediconinc.us
Business Contact:
BASIL RIGAS
(631) 444-9538
basil.rigas@stonybrook.edu
Research Institution:
STATE UNIVERSITY NEW YORK STONY BROOK

STONY BROOK UNIVERSITY
The Office of Sponsered Programs Melville Library Room 5501W
STONY BROOK, NY, 11794-
() -
Nonprofit college or university
Abstract
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% ofcolon 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 compoundMDC-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 PSin 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 ofPS 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. PUBLIC HEALTH RELEVANCE: Colon cancer is a major cause of cancer deaths in the US and worldwide. The prevention of colon cancer using pharmacological agents is now a realistic possibility, but new agents are urgently needed. We are proposing to develop a novel compound, phospho-sulindac, whichis potentially a highly effective and safe chemopreventive agent. The expected results will pave the way towards the completion of phospho-sulindac's preclinical evaluation, a required step prior to its testing in humans.

* information listed above is at the time of submission.

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