Diagnosis and Therapeutic Monitoring of Cancer Using Beta-Catenin Splice Variants

Background:
The National Cancer Institute, Division of Cancer Epidemiology and Genetics is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a method of diagnosing or monitoring therapeutic efficacy in the treatment of carcinomas through the evaluation of beta-Catenin splice variant status. Therapeutic application of this technology is currently being evaluated in pre-clinical experiments; an additional abstract on this application is available relating to this aspect of the technology.

Technology:
The technology measures the level of one or more pairs of transcripts or the protein products of these transcripts and the cellular localization of the transcripts or proteins. The primary transcripts or protein products useful in this method are those of the B-Catenin gene (CTNNB1). In particular, the levels of the 16A and 16B CTNNB1 splice variant transcripts are of importance in carrying out the methods of this patent application. Other gene transcripts or protein products that may be evaluated in conjunction with CTNNB1 16A and 16B to provide additional diagnostic information include WAF1 (p21) and cMYC.

Further R&D Needed:
Evaluating various isotypes in a variety of cell types in cancers and pre-neoplastic cells, with access to a broad range of cell samples representing normal, pre-neoplastic, and invasive tissues.

Value Proposition-Solution:

• Diagnostics: Methodology useful in evaluating the status of pre-neoplastic lesions as well as tumor tissue. Consequently, the methods can be used to track the progression or regression of disease in many cell and tissue types from normal to dysplasia to cancer.
• Biological Materials: Biological materials related to this technology including a series of recently established aptamers capable of specific binding to the CTNNB1 protein.

R&D Status:
Therapeutic: Early patient data is found in the article in Genes Chromosomes & Cancer Therapeutic use of siRNA: Pre-clinical .

Patent Status:
PCT application filed 10 Feb 2006 and published as WO 2006/086772

Related Publication(s):
MJ Roth et al. beta-Catenin splice variants and downstream targets as markers for neoplastic progression of esophageal cancer. Genes Chromosomes Cancer. 2005 Dec;44(4):423-428. [PubMed abs]

Contact Information:
John D. Hewes, Ph.D., NCI Technology Transfer Center
Phone: 301-435-3121
E-mail: Hewesj@mail.nih.gov

Reference:  #541 LH