Cripto-1 is a gene that is currently thought to play an important role in several cancers, and is being developed in clinical trials as a cancer therapeutic. Presented in this invention is another use of Cripto-1 as a biomarker and possible therapeutic target for a variety of neurodegenerative diseases, including NeuroAIDS, Alzheimer's disease (AD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease (PD) and encephalitis. Cripto-1 and concomitant protein expression appears to be overexpressed by 20-fold or more in the brains of macaque monkeys and humans afflicted with NeuroAIDS. This expression is confined to neurons related to neurodegeneration. Inhibition of Cripto-1 may be associated with inhibiting the progression of these diseases via a disclosed method for inhibiting the expression or downstream signaling pathways mediated by Cripto-1. This inhibition can be achieved through the expression of various inhibitory oligonucleotides. Additionally, the development of antibodies against Cripto-1 has already been achieved for the detection of Cripto-1 in human pathological specimens.

It is estimated that by 2050, 14 million Americans will suffer from AD, representing national annual costs for caring and due to productivity lost of approximately $160 billion. Despite active research in this area, there remains urgent need to identify differentially expressed genes in and to develop methods for detecting neurodegenerative disease through assaying expression levels of specific genes. Currently, there are no drugs directed at inhibiting Cripto-1 as a therapeutic agent for AD or other neurodegenerative diseases. This invention holds the promise of market opportunities through pursuing development of Cripto-1 as a biomarker for diagnosis of and possible target for therapeutic intervention of these diseases.

U.S. Provisional Application No. 60/508,750 filed 03 Oct 2003 (HHS Reference No. E-075-2003/0-US-01)

PCT Application No. PCT/US04/32649 filed 01 Oct 2004 (HHS Reference No. E-075-2003/0-PCT-02), which published as WO 2005/033341 on 02 Jun 2005

U.S. Patent Application No. 10/574,645 filed 10 Aug 2006 (HHS Reference No. E-075-2003/0-US-03)

Inventors:
David S. Salomon (NCI) et al.

Licensees Sought:
Available for licensing.

Collaborative Research Opportunity:
The National Cancer Institute, Mammary Biology and Tumorigenesis Laboratory, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.