[Federal Register Volume 73, Number 104 (Thursday, May 29, 2008)]
[Notices]
[Pages 30952-30954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11919]


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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.

[[Page 30953]]

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.

Telomerase Suppressor Compositions and Methods for Diagnosis and 
Treatment of Cancer

    Description of Technology: Lung cancer is responsible for one-third 
of all cancer related deaths. Although tobacco smoking is a major cause 
of lung cancer, epidemiological studies have provided evidence for the 
involvement of genetic factors in the disease onset. For now there are 
no reliable markers for the early lung cancer diagnostics and no 
effective treatment except resection of the tumor on early stages. As a 
result, it is difficult to diagnose lung cancer without invasive 
methods and before significant progression of the disease has occurred.
    NIH inventors have recently discovered that a gene called CCDC36 
(LELA1) is frequently inactivated in patients with non-small cell lung 
cancer (NSCLC). In many instances of lung cancer, particularly early 
onset NSCLC, one copy of CCDC36 will be lost due to the chromosomal 
deletion while the other will be inactivated by promoter methylation. 
This results in reduction or loss of CCDC36 gene expression. In 
addition, several single nucleotide polymorphisms (SNPs) found in the 
gene appeared to be associated with the early onset NSCLC. CCDC36 gene 
replacement could be utilized as a potential therapeutic strategy.

Applications

    Detection of SNPs associated with early onset NSCLC can be 
potentially used to diagnose predisposition.
    Detection of chromosomal loss of CCDC36 and/or its methylation 
status in lung cancer can be used to diagnose NSCLC.
    Treatment of NSCLC using CCDC36-based therapeutics.

Advantages

    Early detection of NSCLC has the potential to improve prognosis of 
lung cancer patient.
    Non-invasive nature of the test is beneficial to patient comfort.

Benefits

    There is no current genetic test for early onset NSCLC, providing 
an excellent market opportunity.
    Developing a diagnostic test for lung cancer will have significant 
social benefits, allowing the early detection and treatment of lung 
cancer patients.
    Inventors: Tatiana Dracheva et al. (NCI).
    Patent Status: PCT Application No. PCT/US2008/059800 filed 09 Apr 
2008 (HHS Reference No. E-265-2007/0-PCT-01).
    Licensing Status: Available for licensing.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Laboratory of Human Carcinogenesis is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
``Unique Genetic Changes in CCDC36 Gene That Are Associated with Early 
Onset Lung Cancer.'' Please contact John D. Hewes, Ph.D., at 301-435-
3121 or [email protected] for more information.

Muramyl Dipeptide as a Therapeutic Agent for Inflammation

    Description of Technology: The nucleotide-binding oligomerization 
domain 2 (NOD2) protein plays a key role in innate immunity as a sensor 
of muramyl dipeptide (MDP), a breakdown product of bacterial 
peptidoglycan. Bacterial peptidoglycan promotes the innate immune 
response through the activation of Toll-like receptor 2 (TLR2), which 
ultimately provokes inflammation. Activation of NOD2 by MDP negatively 
regulates the activity of TLR2, and thus reduces inflammation.
    The inventors have demonstrated that administration of MDP prevents 
the development of experimental colitis in mice. They have also 
determined that MDP reduces pro-inflammatory cytokine production from 
multiple Toll-like receptors, and that this reduction arises from the 
induction of IFN regulatory factor 4 (IRF4). The technology includes 
methods of treating or preventing inflammation associated with an 
autoimmune disorder, particularly inflammatory bowel disease, via 
administration of muramyl peptide; also included are methods of 
reducing symptoms characteristic of inflammation via administration of 
muramyl peptide.
    Applications: This technology has potential as an anti-inflammatory 
therapy for autoimmune or other inflammation-associated diseases, 
particularly inflammatory bowel diseases such as Crohn's disease and 
ulcerative colitis.
    Market: Approximately 1.8 million people suffer from inflammatory 
bowel disease in the major pharmaceutical markets. In the United States 
alone, there are approximately 300,000 to 500,000 people with 
inflammatory bowel disease, as estimated by the National Institute of 
Diabetes and Digestive and Kidney Diseases, NIH.
    Development Status: In vivo data are available in an experimental 
colitis mouse model, and in vitro data supporting mechanism of action 
also are available.
    Inventors: Warren Strober et al. (NIAID).
    Relevant Publication: T. Watanabe et al. Muramyl dipeptide 
activation of nucleotide-binding oligomerization domain 2 protects mice 
from experimental colitis. J Clin Invest. 2008 Feb;118(2):545-559.
    Patent Status: PCT Application No. PCT/US2007/086117 filed 30 Nov 
2007 (HHS Reference No. E-110-2006/0-PCT-02).
    Licensing Status: This technology is available for exclusive or 
non-exclusive licensing.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
[email protected].
    Collaborative Research Opportunity: The NIAID Laboratory of Host 
Defenses, Mucosal Immunity Section, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize this technology. Please 
contact either Rosemary Walsh or Charles Rainwater at 301-496-2644 for 
more information.

Treatment and Diagnosis of Cancer, Diabetes and Other Disorders Using 
Adrenomedullin Peptides and Antibodies

    Description of Technology: Adrenomedullin (AM), a 52-amino acid 
regulatory peptide, is expressed in a wide range of tissues, and has a 
variety of biological roles. AM was initially identified as a 
vasodilator, and the effects of AM and its fragments in the 
cardiovascular system have been widely studied. AM also has important 
effects on renal function, cell growth, glucose

[[Page 30954]]

metabolism, and regulation of hormone secretion, and has antimicrobial 
activity.
    This technology claims AM peptides and antibodies, which would be 
useful in the development of a therapeutic or for diagnostics use. Also 
claimed are methods of inhibiting tumor cell growth using AM peptides, 
in particular in a patient suffering from a lung tumor. Claims are also 
directed to methods of treating a subject with AM-associated 
conditions, including diabetes, pregnancy, neurological disease, 
inflammation, or bone development. Finally, methods are claimed for 
diagnosing or monitoring a disease where AM levels are altered.
    Also available is a murine monoclonal antibody, MoAb-G6, which was 
raised against an AM peptide. This antibody neutralizes AM bioactivity, 
and reacts with the processed form of AM, but not the preprohormone. 
This antibody would be useful not only for research use, but also as 
part of a diagnostic assay for measurement or detection of AM.

Applications

    Peptide- or antibody-based therapeutics for cancer, diabetes, 
inflammation or other AM-associated disease.
    Diagnostic tools for the detection of AM-positive tumors or other 
AM-associated conditions.
    Research use of AM peptides and antibodies.
    Development Status: This technology is currently in the pre-
clinical stage of development.
    Inventors: Frank Cuttitta et al. (NCI).

Related Publications

    1. A Martinez et al. Regulation of insulin secretion and blood 
glucose metabolism by adrenomedullin. Endocrinology. 1996 
Jun;137(6):2626-2632.
    2. E Zudaire et al. The central role of adrenomedullin in host 
defense. J Leukoc Biol. 2006 Aug;80(2):237-244.
    3. E Zudaire et al. Adrenomedullin is a cross-talk molecule that 
regulates tumor and mast cell function during human carcinogenesis. Am 
J Pathol. 2006 Jan;168(1):280-291.

Patent Status:

    U.S. Patent Serial No. 6,320,022 issued 20 Nov 2001 (HHS Reference 
No. E-206-1995/3-US-04).
    U.S. Patent Serial No. 7,101,548 issued 05 Sept 2006 (HHS Reference 
No. E-206-1995/3-US-10).
    U.S. Patent Application No. 11/517,599 filed 05 Sept 2006 (HHS 
Reference No. E-206-1995/3-US-11).
    Foreign counterparts in Australia, Canada, France, Germany, Great 
Britain, and Japan.

Related Technologies

    HHS Reference No. E-256-1999/0--Determination of Adrenomedullin-
Binding Proteins.
    HHS Reference No. E-294-2002/0--A New Target for Angiogenesis and 
Anti-Angiogenesis Therapy.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Angiogenesis Core Facility is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize Use of Adrenomedullin Peptides and 
Antibodies in the Treatment and Diagnosis of Cancer, Diabetes and other 
Disorders. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

    Dated: May 21, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-11919 Filed 5-28-08; 8:45 am]
BILLING CODE 4140-01-P