EXECUTIVE SUMMARY

A Monoclonal Antibody for Screening and Diagnosis of

Precancerous Conditions of the Stomach

SUMMARY:  Dr. Kiron Das, Chief of Gastroenterology, Professor of Medicine, and the Director of the Crohn’s Disease and Colitis Center of New Jersey, Center of Excellence, at the University of Medicine & Dentistry of New Jersey (UMDNJ) has identified a monoclonal antibody, Das-1, that reacts specifically to a colonic epithelium protein called the colon epithelial specific protein (CEP) that can be used for screening and diagnosing patients with precancerous gastric intestinal metaplasia.  Siuta Consulting has been retained by UMDNJ to identify potential partners for this biomarker. 

BACKGROUND:  Gastric cancer is the seventh leading cause of cancer deaths in the United States and a major cause of death worldwide.  Annually, about 24,000 Americans are diagnosed with gastric cancer and approximately 700,000 worldwide.  Chronic gastritis, intestinal metaplasia, pernicious anemia, gastric polyps or Helicobacter pylori infection of the stomach are all considered to be risk factors for the development of gastric cancer.  Approximately 35-50% of the U.S. population is infected with H. pylori and 40-50% of infected subjects develop the precancerous condition known as intestinal metaplasia in the stomach.  Gastric intestinal metaplasia (GIM) is a change in the lining of the stomach whereby the lining is replaced by cells resembling the lining of the intestine.  Previous studies concerning whether GIM of the small intestinal or colonic phenotype predisposes gastric cancer have not yielded unequivocal results.

TECHNOLOGY:  Monoclonal antibody Das-1 reacts specifically with CEP of colon and Barret’s epithelium of the esophagus, which is a columnar metaplasitic change, but does not react with normal small intestinal, gastric, esophageal and gastric-esophageal junctional epithelium.  Das-1 antibody is also negative to esophagitis and squamous cell carcinoma.  Das-1 monoclonal antibody was tested in two groups of tissue samples.  When tested in patients without gastric cancer but with GIM, the antibody reacts strongly with GIM.  Furthermore, a large percentage of gastric cancer patients positive for GIM showed stronger reactivity with the monoclonal.  This revealed that the presence of colonic phenotype of GIM is strongly associated with gastric carcinoma and that Das-1 antibody can be used to screen and identify patients prone to develop gastric cancer.  Patients identified as more prone to develop gastric cancer could be followed closely by endoscopic examinations.  Subjecting only those patients who are at risk of developing gastric cancer would decrease the cost to healthcare significantly.

PATENT STATUS:  United States Patent Number 6,835,549 entitled "Immunoassay Method for the Diagnosis of Gastric Intestinal Metaplasia Associated with Gastric Carcinoma" issued on December 28, 2004.

LICENSE TERMS:  An exclusive or non-exclusive license is available.