[Federal Register Volume 75, Number 136 (Friday, July 16, 2010)]
[Notices]
[Pages 41501-41503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17428]


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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.

Novel Antigen for Use as Vaccine Against Nematode Infection

    Description of Invention: This invention describes a new vaccine 
against Strongyoides stercoralis, which establishes a parasitic 
infection that affects an estimated 100-200 million people worldwide. 
The potential for fatal disease associated with S. stercoralis 
infection and the difficulty in treating hyperinfection underscores the 
need for prophylactic vaccines against the disease. This vaccine uses 
S. stercoralis immunoreactive antigen (SsIR); a novel antigen capable 
of providing 70-90% protection for mice immunized with the antigen. In 
addition, sera from immunized mice have also been used to effectively 
protect na[iuml]ve mice from infection.
    The invention may also have potential use in diminishing allergic 
responses, as Strongyoides stercoralis infection has been shown to 
reduce the murine response to allergens. Consequently, SsIR may be used 
to immunize individuals and reduce the allergic response. The antigen 
may also be used to identify homologous antigens from other parasitic 
nematodes that may be important for vaccine development.
    Applications:

[[Page 41502]]

     Vaccines against S. stercoralis infection.
     Discovery and use of other anti-parasitic antigens for 
vaccines.
     Potential for allergy therapy.
    Development Status: Early stage.
    Market: 100-200 million worldwide.
    Inventors: Thomas B. Nutman (NIAID) and David Abraham (Thomas 
Jefferson University).
    Related Publication: Kerepesi LA, Keiser PB, Nolan TJ, Schad GA, 
Abraham D, Nutman TB. DNA immunization with Na+-K+ ATPase (Sseat-6) 
induces protective immunity to larval Strongyloides stercoralis in 
mice. Infect Immun. 2005 Apr;73(4):2298-2305. [PubMed: 15784574].
    Patent Status: U.S. Provisional Application No. 61/301,426 filed 04 
Feb 2010 (HHS Reference No. E-084-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301-435-5515; 
[email protected]; or Eric Odom; 301-435-5009; [email protected].
    Collaborative Research Opportunity: The Laboratory of Parasitic 
Diseases at NIAID is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact Thomas 
Nutman, Ph.D at [email protected] or Johanna Schneider, Ph.D at 
[email protected] for more information.

Mouse Model of Individual Unresponsive to Interferon

    Description of Invention: NIAID has developed a mouse model that 
produces very high levels of Interferon-alpha-receptor 2 (IFNAR2), both 
in liver cells and free-floating in serum.
    Chronic co-infection of HIV and hepatitis C virus (HCV) is 
associated with increased overall morbidity and mortality compared to 
those infected with just one virus. Recent data further suggests that 
co-infection is also associated with a more rapid progression of liver 
disease, higher HCV RNA viral levels, decreased cure rate of HCV, and 
increased toxicities of anti-HCV therapy. Finally, clinical trials have 
shown that many patients infected with both viruses do not respond to 
Interferon-based therapy. Research strongly suggests that non-
responding patients have an increased level of a free-floating form of 
IFNAR2, which could block Interferon activity.
    Resistance to Interferon therapy also occurs in other diseases, 
such as autoimmune diseases (e.g., lupus, scleroderma, psoriasis, 
vasculitis) and certain forms of cancer (e.g., Kaposi's sarcoma, 
follicular lymphoma). The various means by which resistance arises is 
currently being researched.
    Applications:
     Study of mechanisms of resistance to Interferon therapy in 
selected diseases, such as HCV/HIV co-infection and certain cancers.
     Study of Interferon-alpha in auto-immune diseases such as 
lupus, scleroderma, psoriasis, and vasculitis.
     Drug design and screening.
    Advantages:
     A model to screen, develop, and test drugs for HCV among 
HCV/HIV co-infected patients not responding to Interferon.
     A model for basic research, to study the biology and role 
of IFNAR2 and its function, along with the role of the Interferon 
receptor in the development of disease resulting from activation of the 
immune system.
    Development Status: Proof-of-principle studies showing that the 
mice represent HCV/HIV co-infected individuals not responding to 
Interferon treatment.
    Market: HIV/HCV co-infection is documented in one-third of all HIV-
infected persons in the United States, an estimated 250,000 people. 
Moreover, certain cancers (e.g., Kaposi's sarcoma, follicular lymphoma) 
normally treated with Interferon-alpha either show initial resistance 
or develop resistance during therapy, but the mechanism of resistance 
is highly complex; this mouse model will be useful in learning the 
paths through which resistance develops, and perhaps in designing 
strategies to overcome resistance. Finally, autoimmune diseases known 
to be caused (in whole or in part) by Interferon-alpha include lupus, 
scleroderma, psoriasis, and vasculitis.
    Inventors: Shyamasundaran Kottilil (NIAID), Howard Young (NCI), 
Michael Polis (NIAID), Anthony Suffredini (NIHCC).
    Patent Status: HHS Reference No. E-106-2009/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for non-exclusive Biological Materials 
Licensing.
    Licensing Contact: Susan Ano, Ph.D. 301-435-5515; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Laboratory of Immunoregulation, is 
interested in collaborative research directed toward molecular 
strategies for vaccine and antiviral development, and animal models of 
viral hepatitis C. Please contact William Ronnenberg at 301-451-3522 or 
[email protected] for more information.

Microwave-Assisted Freeze Substitution of Biological and Biomedical 
Samples

    Description of Invention: Freeze substitution fixation (FS) of 
hydrated samples frozen in vitreous ice provides exceptional 
preservation of structure for light and electron microscopy, and 
enables immunological detection of thermo-labile antigens that 
otherwise are damaged/destroyed by processing at ambient or elevated 
temperatures. Its use as a research tool or in clinical pathology has, 
however, been limited by the relatively lengthy periods required for 
passive diffusion of fixatives and organic solvents into the frozen 
hydrated material.
    The invention utilizes controlled microwave (MW) irradiation to 
accelerate the FS process; and comprises systems, devices and methods 
for microwave-assisted processing of samples under cryo-conditions. The 
entire MWFS procedure has been accomplished in less than 4 hours as 
compared to the approximately 2-5 days required for FS.
    Applications:
     Provides superior preservation and rapid turnaround in 
research and high throughput clinical laboratory settings.
     Applicable to a broad range of biological samples, 
hydrogels, and other hydrated materials.
     Processing for light and electron microscopy.
     Low-temperature synthetic and analytical chemistry.
    Advantages:
     Reduces processing periods from days to hours.
     Improves preservation, approaching native state.
     Enables uncomplicated, programmable operation.
     Provides excellent reproducibility.
    Development Status:
     Proof of concept with varied biological samples.
     Adaptation of existing equipment with manual processing.
     Proposed designs for instrumentation and automation.
    Inventors: David W. Dorward, Vinod Nair, Elizabeth R. Fischer, 
Bryan Hansen (NIAID).
    Patent Status: Filed PCT, Publication Number WO 2010/028164; 
Priority Date: 2008-09-05 (HHS Reference No. E-238-2008/2-PCT-01).
    Licensing Status: Available for licensing.

[[Page 41503]]

    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Research Technologies Branch, Electron 
Microscopy Unit, is interested in collaborative research to further 
develop, evaluate, or commercialize potential applications of this 
invention, including design and development of instrumentation for 
conducting MWFS. Please contact Barry U. Buchbinder, Ph.D., NIAID/OTD, 
at 301-594-1696 or [email protected], for more information.

Treatments for Smith-Lemli-Opitz Syndrome and Other Disorders of 
Cholesterol Biosynthesis

    Description of Invention: This technology provides methods for 
treating Smith-Lemli-Opitz Syndrome and other disorders of cholesterol 
biosynthesis.
    Smith-Lemli-Opitz Syndrome (SLOS) is an autosomal recessive 
disorder caused by an inborn error of cholesterol biosynthesis. It 
affects an estimated one in 20,000 to 60,000 newborns, and is most 
prevalent in Caucasians of Central European ancestry. It is 
characterized by distinctive facial features, microcephaly, mental 
retardation or learning disabilities, and behavioral problems, as well 
as malformations in many parts of the body, such as the heart, lungs, 
kidneys, gastrointestinal tract, and genitalia. However, the clinical 
manifestations of this disease can vary widely, ranging from relatively 
moderate symptoms to profoundly severe and life-threatening symptoms. 
At least 95% of SLOS patients present with some degree of mental 
retardation and learning disability.
    Biochemically, SLOS is caused by disruption of the DHCR7 gene, 
which is responsible for the final step in the production of 
cholesterol; this results in low cholesterol levels and an accumulation 
of toxic byproducts of cholesterol biosynthesis in the blood, nervous 
system, and other tissues. Supplementary dietary cholesterol is 
provided to SLOS patients, but is often of limited clinical benefit; 
because levels of byproducts remain high, they may interfere with the 
uptake of free cholesterol.
    Although some of the behavioral and learning problems are due to 
developmental problems, a portion of these symptoms are likely due to a 
biochemical disturbance. That biochemical disturbance is potentially 
treatable.
    In their recent work, the inventors have discovered that the 
accumulation in SLOS cells of the cholesterol precursor 7-DHC causes 
abnormal sphingolipid storage and transport, resulting in a cellular 
phenotype similar to that observed in the lysosomal storage disease 
Niemann-Pick type C (NPC). They have also discovered that treatment 
with inhibitors of sphingolipid biosynthesis corrects these 
abnormalities, and thus such inhibitors are of potential therapeutic 
benefit for the treatment of SLOS, as well as for other diseases 
exhibiting similar defects in sphingolipid trafficking.
    This technology claims compounds that inhibit sphingolipid 
biosynthesis for use in treating diseases which have a secondary 
Niemann-Pick type C disease-like cellular phenotype, including SLOS, as 
well as methods of treatment and pharmaceutical compositions.
    Applications: Development of therapeutics for Smith-Lemli-Opitz 
Syndrome and other diseases which have a secondary Niemann-Pick type C 
disease-like cellular phenotype, which includes inborn errors of 
cholesterol biosynthesis, Huntington's disease, cystic fibrosis, and 
autism.
    Development Status: In vitro studies have been performed using a 
sphingolipid biosynthesis inhibitor.
    Inventors: Forbes D. Porter et al. (NICHD).
    Related Publications:
    1. FD Porter. Malformation syndromes due to inborn errors of 
cholesterol synthesis. J Clin Invest. 2002 Sep 15; 110(6):715-724. 
[PubMed: 12235098]
    2. XS Jiang et al. Quantitative proteomic analysis of inborn errors 
of cholesterol synthesis: Identification of altered metabolic pathways 
in DHCR7 and SC5D deficiency. Mol Cell Proteomics. 2010 Mar 19; Epub 
ahead of print. [PubMed: 20305089]
    3. XS Jiang et al. Activation of Rho GTPases in Smith-Lemli-Opitz 
syndrome: pathophysiological and clinical implications. Hum Mol Genet. 
2010 Apr 1;19(7):1347-1357. [PubMed: 20067919]
    4. Tierney et al. Analysis of short-term behavioral effects of 
dietary cholesterol supplementation in Smith-Lemli-Opitz syndrome. Am J 
Med Genet A. 2010 Jan;152A(1):91-95. [PubMed: 20014133]
    Patent Status:
     U.S. Patent Application No. 12/666,279 filed 19 Jan 2010 
(HHS Reference No. E-206-2007/0-US-06).
     Related International patent applications.
    Licensing Status: Available for licensing.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
[email protected].
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Section on Molecular Dysmorphology, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this technology. Please contact Alan Hubbs, Ph.D. at 301-594-4263 or 
[email protected] for more information.

    Dated: July 12, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-17428 Filed 7-15-10; 8:45 am]
BILLING CODE 4140-01-P