TAS::75 0849::TAS SBIR TOPIC 307 PHASE I NOVEL IMAGING AGENTS TO EXPAND THE CLINICAL TOOLKIT FOR CANCER DIAGNOSIS, STAGING, AND TREATMENT

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N43CO110121
Agency Tracking Number: N43CO110121
Amount: $249,330.00
Phase: Phase I
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NCI
Solicitation Number: N/A
Small Business Information
ITI HEALTH
1076 AUTUMN HILL CT, CROZET, VA, 22932-3140
DUNS: 964923747
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 GREG FRALISH
 (434) 298-4844
 GFRALISH@ITIHEALTH.COM
Business Contact
 GREG FRALISH
Phone: (434) 298-4844
Email: GFRALISH@ITIHEALTH.COM
Research Institution
 Stub
Abstract
Phase I - Topic 307 The long term objective of this work is to transform the clinical practice of diagnosing and treating pancreatic cancer through the development of a targeted imaging reagent. The 5-year survival rate for patients diagnosed with pancreatic cancer is less than 5%. Those with respectable disease have a much greater likelihood of survival, however 80% of patients are diagnosed with metastatic disease thus, ineligible for potentially curative surgery. Therefore, iTi Health is developing an imaging produce that can recognize the newly identified biomarker plectin-1, which is specifically expressed in the early through metastatic stages of pancreatic cancer. An extensive preclinical data set was recently presented to the FDA Divisions of Medical Imaging Products. Encouragingly, the Division provided a concrete road-map for advancing this promising product to the clinic and expressed marked enthusiasm for the product and the biomarker. At the conclusion of funding, feasibility of this product will have been demonstrated by accomplishing the following aims: a.) developing a detailed clinical development plan for PTP-01; b.) directly addressing the FDA-suggested experiments to support an IND filing and clinical testing. Specific milestones include and IND-ready preclinical package as well as a fully developed plan for advancement to clinical testing.

* information listed above is at the time of submission.

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