E8-1244. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by an agency of the U.S. Government and are 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 the 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.

Diagnosis and Treatment of Barrett's Esophagus and Associated Esophageal Adenocarcinoma

Description of Invention: Barrett's esophagus is a condition in which the normal esophageal tissue lining has been replaced by an abnormal lining of gastric and intestinal tissue resulting from chronic gastroesophageal reflux disease. Patients have an increased risk of developing esophageal adenocarcinoma, which is often detected at later stages and is associated with poor prognosis. Survival rates are very low ranging from 10% in Europe to 16% in the United States.

Available for licensing are microRNA (miRNA) biomarkers that show differential expression in the adenocarcinoma diagnosis and Barrett's esophagus status, and they can predict diagnosis and Barrett's esophagus with accuracies of 71.4% and 74.7%, respectively. Thus, these miRNA biomarkers that may predispose individuals to Barrett's esophagus and/or esophageal adenocarcinoma could provide a means for earlier detection and help in better identifying treatment options.

Applications:

Method to diagnose and treat Barrett's esophagus and esophageal adenocarcinoma.

miRNA pharmaceutical compositions to treat Barrett's esophagus.

Advantages: Early diagnostic that can more accurately stratify patients for increased survival rates and appropriate treatments.

Development Status: The technology is currently in the pre-clinical stage of development.

Market: Esophageal cancer is the 8th most common cancer and 6th most common cause of cancer worldwide.

Survival rate of esophageal cancer is 10% to 16% in Europe and United States respectively.

miRNA technologies have an emerging market, and in 2007, it was worth an estimated 23 million dollars in the U.S. and it has a projected annual growth rate of 100%.

Inventors: Ewy Mathe (NCI), Curtis C. Harris (NCI), et al.

Patent Status: U.S. Provisional Application No. 60/979,300 filed 11 Oct 2007 (HHS Reference No. E-008-2008/0-US-01).

Licensing Status: Available for non-exclusive licensing.

Licensing Contact: Jennifer Wong; 301-435-4633; [e-mail].

Collaborative Research Opportunity: The Laboratory of Human Carcinogenesis at the National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods to diagnose and treat Barrett's esophagus and esophageal carcinoma. Please contact John D. Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Mouse Model for Obesity and Type 2 Diabetes Due to Inactivation of ANKRD26 Gene

Description of Invention: Obesity and type II diabetes are major health hazards both in the United States and internationally. The incidence of obesity has been steadily increasing, underscoring the need to identify and develop effective treatments. As a result, there has been a strong effort to create animal models to help study these diseases.

NIH inventors have created a new mouse model for obesity and type II diabetes. In this model, both copies of the ANKRD26 gene are inactivated by the insertion of a marker gene (beta-galactosidase) into the open reading frame of the gene. The resulting knockout mouse exhibits extreme obesity, increased organ and body size, and acquired insulin resistance. The mouse also expresses the marker gene, thereby allowing the monitoring of ANKRD26 expression patterns.

Applications:

Study and identify treatments for obesity and type II diabetes.

Examine ANKRD26 expression under various conditions.

Study the progression of obesity and type II diabetes in a specific genetic background.

Advantages:

Distinct phenotype from other mouse models for obesity and type II diabetes allows broader study of the diseases when used in combination with other mouse models.

Distinct phenotype allows the study of obesity in a previously unidentified genetic background.

Benefits: Obesity can increase the susceptibility to other health conditions such as cardiovascular disease. It has been reported that billions of tax dollars a year are spent in the treatment of obesity-attributable conditions. The use of this animal model could result in social benefit, in terms of both health and financial concerns, by leading to the development of new methods of treating obesity. Furthermore, the incidence of obesity has more than doubled over the past 10 years, suggesting that the discovery of new treatments would result in strong financial returns.

Inventor: Ira Pastan (NCI).

Publication: TK Bera et al. A model for obesity and gigantism due to disruption of the Ankrd26 gene. Proc Natl Acad Sci USA. 2008 Jan 8;105(1):270-275.

Patent Status: HHS Reference No. E-156-2007/0—Research Tool. Patent protection is not being sought for this technology.

Licensing Status: Available for licensing.

Licensing Contact: David A. Lambertson, PhD; 301-435-4632; [e-mail].

Photosensitization by Nuclear Receptor-Ligand Complexes and Cell Ablation Uses Thereof

Description of Invention: Androgen receptors (AR) mediate the effects of male steroid hormones and contribute to a wide variety of physiological and pathophysiological conditions. Prostate cancer development and progression are mediated through AR, a ligand-dependent transcription factor, and it is present in all stages of prostate carcinoma. Increased levels of PSA, an AR-induced prostate tumor-specific protein, are indicative of prostate cancer. Benign, non-cancerous conditions are also AR-dependent and can be therapeutic targets as well.

This technology is a method to cause AR-induced cell death (apoptosis) through photoactivation of a non-steroidal androgen receptor antagonist 1,2,3,4-tetrahydro-2,2-dimethyl-6-(trifluoromethyl)-8-pyridono[5,6-g] quinoline (TDPQ). Upon TDPQ binding to AR, a highly potent photocytoxic reaction induced once the TDPQ-AR complex is exposed to visible light irradiation of a specific wavelength. The inventors have cell-culture results demonstrating that cell death is a function of TDPQ, AR and light irradiation. This treatment method can potentially target AR-containing cancerous cells, while sparing nearby cells that lack AR.

The process has been extended to other nuclear receptors by choice of other photoactivatable ligands for these receptors. Certain suitable ligands are marketed drugs.

Applications: Therapeutic compounds to treat AR related conditions such as prostate cancer, baldness, hirsutism, and acne.

Potential therapeutics for progesterone and glucorticoid receptor ligand related conditions such as breast and brain cancers, lymphoma, leukemia and arthritis.

Method to treat androgen, progesterone, and glucorticoid receptor related conditions.

Market: Prostate cancer is the second most common type of cancer among men, wherein one in six men will be diagnosed with prostate cancer.

An estimated 218,890 new cases of prostate cancer and 27,050 deaths due to prostate cancer in the U.S. in 2007.

Hirsutism affects approximately 5% of adult women in the United States.

Hair loss and acne industries are worth several billions of dollars.

Development Status: The technology is currently in the pre-clinical stage of development.

Inventors: William T. Schrader et al. (NIEHS).

Publications:

1. B Risek et al. Androgen Receptor-Mediated Apoptosis is Regulated by Photoactivatable AR Ligands. Presented at the Annual Meeting of the Endocrine Society in Toronto, Canada in June 2007.

2. B Risek et al. Photocytotoxic Properties of the Non-Steroidal Androgen Receptor Antagonist TDPQ. Presented at the Annual Meeting of the Endocrine Society in Boston, MA in June 2006.

Patent Status: U.S. Provisional Application No. 60/926,218 filed 24 Apr 2007 (HHS Reference No. E-108-2007/0-US-01).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Jennifer Wong; 301-435-4633; [e-mail].

Antibodies and Polypeptides Specific to AAMP-1: Diagnostic and Therapeutic Uses Thereof

Description of Invention: Angio-associated migratory cell protein (AAMP-1) was first isolated from a human melanoma cell line as a motility-associated cell protein. AAMP-1 contains two immunoglobin domains, six WD40 repeats, and a heparin-binding domain. In vitro, over expression of AAMP-1 promotes tumor cell invasion and metastasis as well as angiogenesis. AAMP-1 was later found to be over expressed in endothelial cells, cytotrophoblasts, and poorly differentiated colon adenocarcinoma cells found in lymphatics. In addition, gene expression studies have shown that AAMP-1 is over expressed in breast and gastrointestinal tumors. The issued patents claim proteins, polypeptides, and recombinant polyclonal antibodies specific to AAMP-1 and their use in diagnostic and therapeutic applications.

Applications: The antibodies specific to AAMP-1 can detect formalin-fixed antigen and SDS-denatured antigen. These antibodies can be used for detailed expression studies of AAMP-1 in different cancer cell lines.

The antibodies could also be used to detect AAMP-1 in patient's sera as a useful diagnostic marker for multiple carcinomas including high nuclear grade ductal carcinoma in situ (Clinical Cancer Research Dec 2002 8:3788-95).

Claimed proteins and polypeptides could also be used to promote cell adhesion to a substrate, promote tissue acceptance of prostheses, and promote wound healing.

Development Status: This technology is currently in the pre-clinical stage of development.

Market: Estimated new cases and deaths from breast cancer in the United States in 2007: New cases: 178,480 (female); 2,030 (male); Deaths: 40,460 (female); 450 (male).

Inventors: Marie Beckner, Henry Krutzsch and Lance Liotta (NCI).

Publications:

1. ME Beckner et al. AAMP, a newly identified protein, shares a common epitope with alpha-actinin and a fast skeletal muscle fiber protein. Exp Cell Res. 1996 Jun 15;225(2):306-314.

2. A Adeyinka et al. Analysis of gene expression in ductal carcinoma in situ of the breast. Clin Can Res. 2002 Dec;8(12):3788-3795.

Patent Status: U.S. Patent No. 6,274,134 issued 14 Aug 2001 (HHS Reference No. E-084-1991/1-US-01); Australian Patent No. 684,806 issued 23 Apr 1998 (HHS Reference No. E-084-1991/1-AU-05); Australian Patent No. 668,134 issued 26 Apr 1996 (HHS Reference No. E-084-1991/0-AU-03) and Japanese Patent No. 3,715,313 issued 9 November 2005 (HHS Reference No. E-084-1991/1-JP-04).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Surekha Vathyam, PhD; 301-435-4076; [e-mail].

Dated: January 16, 2008.

Steven M. Ferguson,

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