Methods and assays which may be used to diagnose and follow the progression of cancers associated with c-Met expression

This invention described and claimed in these patent applications provide for methods and assays which may be used to diagnose and follow the progression of cancers associated with c-Met expression. The data supporting this application suggests that c-Met expression may be an appropriate biomarker in certain types of cancer. In particular, the applications describe a sensitive assay useful for monitoring levels of c-Met shed in the urine or blood. The assay was developed using commercially available reagents. The applications contain data, derived from patient samples, supporting the clinical utility of the assay. In particular, the data shows the use of the assay to detect levels of shed c- Met in patients with bladder cancer, renal cancers and prostate cancer. Data showing the applicability of the assay for glioblastoma was derived using murine models of cancer for glioblastoma. Data showing the applicability of the assay for breast cancer, melanoma and prostate cancer was derived using various human cell line model systems. HGF/met signaling has been most widely studied in settings related to cancer. It has been demonstrated to have a role in metastasis and angiogenesis. In addition to cancer, HGF activity has also been linked, through its role in apoptosis, to Alzheimer's disease and cardiovascular disease. These applications have not been published. The investigators presented their work in a poster session at the AACR Meeting April 16-20, 2005 (Abstract 2788) (http://www.abstractonline.com/viewer/viewAbstract.asp? CKey=%7bAD0F2047-14FA-4BEE-AE98-0DAF2F26EF1A% 7d&MKey=%7b218FF7E7-9F17-4030-9BB4- 8C029B0C9B4E%7d&AKey=%7b728BCE9C-121B-46B9- A8EE-DC51FDFC6C15%7d&SKey=%7bA5AFD1D5-1D83- 4F0E-9FD5-AC7119D62D8E). At this time there are no other publications related to this work. Dr. Bottaro's website is http://ccr.cancer.gov/Staff/Staff.asp?profileid=8410.

U.S. Provisional Application No. 60/734,993 filed 08 Nov 2005 (HHS Reference No. E-261-2005/0-US-01) and U.S. Provisional Application No. 60/780,626 filed 09 Mar 2006 (HHS Reference No. E-261-2005/1-US-01), entitled "Methods for Diagnosing and Monitoring the Progression of Cancer." At this time only U.S. Patent protection has been sought for this technology. There are no foreign counterpart patent applications. Inventors: Donald Bottaro and Pathirage G. Dharmawardana (both of NCI)

Licensees sought: Available for non-exclusive or exclusive licensing. Collaborative Research Opportunity: The National Cancer Institute, Urologic Oncology Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize HGF/c- Met signaling as it relates to tissue repair and regeneration, cancer, and other diseases. Please contact Brian W. Bailey, Ph.D. at (301) 451-2158 or bbailey@mail.nih.gov for more information.