Sample Letter of Intent
Opportunity: Pancreatic cancer is one of the most prevalent forms of cancer. According to the National Cancer Institute, more than 45,000 cases will be diagnosed in 2013, ranking twelfth on the list of cancers, but it will also cause more than 38,000 deaths, ranking fourth. One year survival rates for the disease are 25%, but at five years, only 6% or so survive. Cancers caught early enough may be operable and survival rates increase, but the difficulty detecting the disease results in cases that are inoperable and often metastatic. Further, little progress has been made developing effective treatments, and the result has been modest increases in lifespan, but little progress toward treatments that produce durable disease remission.
Proposed Solution: We propose to develop a simple blood test for a protein marker that is a reliable predictor of pancreatic cancer at early stages. With it, we will provide physicians and patients with a simple test for the disease that will allow detection at early stages when surgical treatments are still options and reasonably effective.
Preliminary Data: Our laboratory has performed protein analysis of 57 human pancreatic tumor specimens representing Stages 2, 3 and 4 of the disease and identified a marker on the surface of the cell named PCA1 (for Pancreatic Cancer Antigen 1) that is present in tumor samples, but is undetectable in normal pancreatic tissue. Assay of human tissue panels did not detect appreciable amounts of the molecule in other tissues, and it was barely detectable in blood. We recently reported in the Proceedings of the National Academy of Science that PCA1 was detected with a monoclonal antibody to PCA1 in 65% of the tumor samples that were tested, and in assays of a subset of the positive tumors, could be detected in 50% of ELISA assays of the serum samples from the same patient. During the course of this project, we propose to significantly expand the population of tumors and serum samples that are tested to better define the reliability of a PCA1 assay to identify pancreatic cancer, and which stages of the disease it can detect. We recognize that for diagnostic purposes testing tumor samples will not help in disease diagnosis, but the simultaneous testing of matched serum samples will allow us to assess how presence in serum correlates with PCA1-‐positive tumor samples. Further, it is our hope that this analysis will help establish the statistical parameters and protein levels that are diagnostic for the presence of pancreatic cancer in a patient.
Time to Market: At the end of this project, we expect that further work will need to be done with additional tumor and serum samples to definitively establish the statistical parameters and diagnostic reliability of the test. In addition, the clinical testing kit will need to be developed and produced to clinical diagnostic specifications. With this, if successful, we estimate that the test could be submitted for FDA 510K approval in three to four years.
Budget: We estimate that the budget for a one year project will be approximately $95,000.
Current IP: Details of PCA1 were submitted to Drexel’s Office of Tech Commercialization after publication in PNAS, and the University filed a provisional patent application. We have accumulated additional information that has not yet been disclosed to OTC.