D_SOW_NNMT_HGS2.pdf
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9.0.0.2.20101008.1.734229 Statement of Work for Services (SOW) General Information:
Title of Project:
Statement of Need and Purpose:
Background Information and Objective:
Period of Performance:
Scope of Work:
General Requirements:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:
Specific Requirements:
Level of Effort:
Government Responsibilities:
Delivery or Deliverables:
Reporting Requirements:
Other Considerations:
Travel:
Key Personnel:
Information System Security Plan:
Data Rights:
Section 508:
Publications and Publicity:
Confidentiality of Information:
Evaluating NNMT inhibitors in high grade serous ovarian cancer mouse model Metastasis in all cancer, specifically ovarian cancer remains a grave unmet medical need. NNMT is a methyltransferase that has been implicated towards causing metastasis in high grade serous (HGS) ovarian cancer. In a collaboration with the National Cancer Institute (NCI) and Univ of Chicagom, the National Center for Advancing Translational Sciences (NCATS) has developed a series of potent and selective NNMT inhibitors that we would like to evaluate in a mouse model of high grade serous (HGS) ovarian cancer for proof of concept.
NNMT is a methyltransferase, a metabolic enzyme that transfers a methyl group from SAM to nicotinamide. Its activity is upregulated in the tissue surrounding high grade serous ovarian tumors in patients. Proof of concept animal experiments by silencing or knocking out the gene and with unoptimized small molecule inhibitors has shown promising results in inhibiting metastasis to the omentum. In collaboration with the NCI and University of Chicago, the NCATS has developed exquisitely potent selective and orally bioavailable small molecule inhibitors of NNMT. The NCATS would like to demonstrate proof of concept with lead compounds in multi-week study in HGS ovarian cancer mouse model.
12 months with periodic updates after award Contractor shall perform the following:
1. Receive compounds and instructions to formulate key compounds from NCATS
2. Develop the HGS-2 mouse model of ovarian cancer
3. Conduct a validation study in two groups of FVP mice and B6 mice (N=20)
4. Conduct an efficacy study with the following design (N=40, 10 in each group).
Group 1: Vehicle control p.o. qd Group 2: Compound 1 @ TBD dose p.o. qd Group 3: Cisplatin @ TBD dose i.p. qw Group 4: Compound 1 @ TBD dose p.o. qd + Cisplatin @ TBD dose i.p. qw
5. Treatment shall be three to four weeks
6. Body weight shallbe monitored throughout study
7. Imaging shall be done once a week.
8. 20 omental tumor samples shall be collected from groups 2 and 4 and cut into 2 pieces, one for PK analysis of compound, metabolites and one for FACS analysis with TBD markers NCATS will supply compound, formulation, exposure study details and a study design to the contractor Periodic reports via calls and emails showing progress in each individual model are required.
Progress reports and meetings every 3-4 weeks between key personal at contractor site and NCATS. Reports shall cover progress in dosing, efficacy readouts, exposure, metabolite formation, clinical chemistry and histology.
N/A Samarjit Patnaik; patnaiks@mail.nih.gov; Matthew Hall; hallma@mail.nih.gov; Ke Kong; ke.kong@nih.gov N/A Data belongs to NCATS N/A Contractor shall not publish any information without informing NCATS. All information is confidential and NCATS will solely determine date for publication or publicity or patenting.
All information shared between NCATS and contractor is confidential. The time or method for publication will be determined by NCATS.
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| Enter the title of your project.: |
| Include a general narrative of the need of the project and the desired results.: |
| Include a brief history of the project, the importance of the project, and the overall program objectives.: |
| Specify base period of performance. If applicable, specify option periods (not to exceed sixty (60) months,) or options for additional quantities.: |
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