[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