03-30497. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

ADDRESSES:

Licensing information and copies of any U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Human UGRP1 (Uteroglobin-Related Protein 1) Promoter and Its Use

Shioko Kimura and Tomoaki Nimi (NCI). PCT Application No. PCT/US02/19456 filed 18 Jun 2002 (with priority to 20 Jun 2001), which published as W0 03/000111 on 03 Jan 2003 (DHHS Reference No. E-058-2001/0-PCT-02). Licensing Contact: Susan Carson; [phone]; [e-mail].

Asthma is a genetically complex, multi-factorial disease affecting more than 17 million people in the United States alone and costing approximately US$6 billion to treat annually. Identification, mapping and linkage analyses of Single Nucleotide Polymorphisms (SNPs) have been increasingly used both to study the genetic etiology of asthma and to detect genetic loci contributing to asthma susceptibility. Researchers from the National Cancer Institute have described a novel gene, located in an asthma-susceptibility gene loci 5q31-34, named UGRP1 (uteroglobin-related protein 1) and an associated polymorphism that is significantly associated with asthma (Nimi et al. (2002) Am. J. Hum. Genet 70: 718-725).

UGRP1 is a homodimeric secretory protein of ~10 kDA and is expressed only in lung and trachea. The -112G/A polymorphism was identified in the human UGRP1 gene promoter and is responsible for a 24% reduction in the promoter activity in relation to the -112G allele, as examined by transfection analysis. In a case-control study using 169 Japanese individuals (84 with asthma and 85 unrelated healthy controls) those with a -112A allele (G/A or A/A) were 4.1 times more likely to have asthma than were those with the wild-type allele(G/G).

The invention describes the -112G/A polymorphism and the UGRP1 promoter region as well as methods for detecting polymorphisms present in the UGRP1 promoter which can be used as indicators for diagnosing or for predicting a predisposition to develop a respiratory disorder. The complex and polygenic nature of asthma suggests that this potential asthma susceptibility allele can be of great value not only to companies targeting respiratory diseases such as asthma but also to those more broadly involved in gene discovery, gene mapping, association-based candidate polymorphism testing, pharmacogenetics, diagnostics and risk profiling.

Dated: December 1, 2003.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.