EXECUTIVE SUMMARY

A Novel Biomarker for Diagnosis of Ulcerative Colitis and Colon Cancer

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 novel biomarker that predominates in human colon carcinoma and can be used for screening and detection of patients at risk of developing colon cancer, other colon related diseases, and ulcerative colitis.  Siuta Consulting has been retained by UMDNJ to identify potential partners for this biomarker.

BACKGROUND:  Tropomyosins are microfilament-associated proteins found in all eukaryotes and have been implicated in autoimmune diseases such as ulcerative colitis. To date, eight different isoforms (hTM1, hTM2, hTM3, hTMsma, hTM5a, hTM5b, hTM4, and hTM5) have been identified.  Although anti-tropomyosin autoantibodies have been detected in the sera of patients with ulcerative colitis, the autoantigen triggering the autoantibody response has not been definitively identified.  Previous studies have identified hTM5 as the predominant immunogen in ulcerative colitis patients, which is difficult to diagnose because its symptoms are similar to other intestinal disorders.  About 5% of patients with ulcerative colitis develop colon cancer.  The present invention identifies the autoantigen(s) that trigger ulcerative colitis and colon related diseases and dysfunction.

TECHNOLOGY:  A new isoform of tropomyosin, TC22, that predominates in human colon carcinoma has been identified and completely sequenced by Dr. Das.  Monoclonal antibodies, TC22-2, TC22-4, TC22-6 and TC22-7, specific for this distinctive protein have been generated.  A significantly large percentage (83%) of colon cancer tissues obtained from colon cancer patients showed strong reactivity with TC22-4 monoclonal antibody compared with normal colon epithelial cells or normal colonic mucosa tissue from patients with Crohn’s disease. 

Further, the amount of the TC22 protein was also found to be elevated in ulcerative colitis tissues.  Studies with GFP-TC22 revealed a weak interaction of the TC22 protein with actin filaments.  During mitosis, the alignment of mitotic spindle is guided by strength of the actin filament-tropomysoin interaction thereby influencing cellular proliferation.  The elevated expression of the TC22 isoform in colon cancer cells and its abnormal interaction with actin filaments implicate a role for TC22 protein in cellular proliferation and cancer.

Thus, this novel biomarker can be used for screening and detection of patients at risk of developing colon cancer , other colon related diseases, and ulcerative colitis.

PATENT STATUS:  The following United States and PTC Patent Applications have been published:

1. United States Patent Application 20070218066 entitled "Tropomyosin Isoforms, and Diagnostic and Therapeutic Uses Therefor" was filed on July 22, 2002 and published on September 20, 2007.  The corresponding PCT Patent Application has also been filed.

2. United States Patent Application 20070032426 entitled "Therapeutic and Diagnostic Methods for Ulcerative Colitis and Associated Disorders" was filed on August 7, 2006 and published on February 8, 2007.  The corresponding PCT Patent Application has also been filed.

3. United States Patent Application 20070025984 entitled "Treatment of Ulcerative Colitis with Tropomyosin Isoforms and Monoclonal Antibodies to Tropomyosin Isoforms" was filed on May 1, 2003 and published on February 1, 2007.  The corresponding PCT Patent Application has also been filed.

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