[Federal Register Volume 73, Number 17 (Friday, January 25, 2008)]
[Notices]
[Pages 4603-4605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1244]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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: 301/496-7057; fax: 301/402-0220. 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which the normal esophageal tissue lining has been replaced by an 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; 
[email protected].
    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 [email protected] 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,

[[Page 4604]]

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; 
[email protected].

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; 
[email protected].

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.

[[Page 4605]]

    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; 
[email protected].

    Dated: January 16, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-1244 Filed 1-24-08; 8:45 am]
BILLING CODE 4140-01-P