iTi Health — Department of Health and Human Services SBIR Phase I: Phase I - Topic 307 The long term objective of this work is to transform the clinical pra

Description

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.