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
Amount:
$249,330.00
Award Year:
2011
Program:
SBIR
Phase:
Phase I
Contract:
N43CO110121
Award Id:
n/a
Agency Tracking Number:
N43CO110121
Solicitation Year:
2011
Solicitation Topic Code:
NCI
Solicitation Number:
n/a
Small Business Information
1076 AUTUMN HILL CT, CROZET, VA, 22932-3140
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
Y
Duns:
964923747
Principal Investigator:
GREGFRALISH
(434) 298-4844
GFRALISH@ITIHEALTH.COM
Business Contact:
GREGFRALISH
(434) 298-4844
GFRALISH@ITIHEALTH.COM
Research Institute:
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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