[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21638-21640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9641]
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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.
New Mouse Strain With Conditional Deletion of SMAD7: Analysis of
Disease Processes Involving Immunological, Fibrotic or Cardiovascular
Indications
Description of Invention: SMAD7 conditional knockout mice are
available for licensing. SMAD7 can be knocked out by breeding with CRE-
recombinase transgenic mice with a variety of promoters to yield tissue
or cell type-specific deletions of SMAD7. SMAD7 has been shown to play
a role in bone morphogenesis, cardiovascular tissue generation, immune
regulation and fibrosis. Therefore, these mice provide a unique model
to examine the role of the SMAD7 gene in disease processes that involve
immunological, fibrotic, or cardiovascular components. Specifically,
these mice may represent a novel model of Scleroderma, a disease with
both an immunological and fibrotic component.
Applications:
Mouse model of Scleroderma.
Means of studying bone morphogenesis and cardiovascular
tissue generation.
Means of studying the role of SMAD7 in immune regulation.
Inventors: Marilyn Diaz (NIEHS).
Related Publication: Dong C, Zhu S, Wang T, Yoon W, Li Z, Alvarez
RJ, Dijke P, White B, Wigley FM, Godschmidt-Clermont PJ. Deficient
Smad7 expression: A putative molecular defect in scleroderma. Proc Natl
Acad Sci USA. 2002 Mar 19;99(6):3908-3913. [PubMed: 11904440]
Patent Status: HHS Reference No. E-040-2010/0--Research Material.
Patent protection is not being pursued for this technology.
Licensing Status: This technology is available as a research tool
under a Biological Materials License.
Licensing Contact: Steve Standley, Ph.D.; 301-435-4074;
[email protected].
Collaborative Research Opportunity: The NIEHS is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact Dr. Elizabeth M. Denholm,
[email protected], for more information.
A Method of Reducing Cholesterol Biosynthesis With Specific MicroRNAs
Description of Invention: This technology is directed to the
discovery of specific microRNAs that target and downregulate enzymes
within the cholesterol biosynthetic pathway and is currently being
tested in vivo.
Briefly, microRNAs regulate the translation of messenger RNAs
(mRNAs)
[[Page 21639]]
into protein. The inventors have discovered a set of specific microRNAs
that downregulate the expression of multiple enzymes in the cholesterol
biosynthetic pathway. Importantly, this technology may provide the
benefits of cholesterol lowering therapies to patients that are not
suited for statin-based treatments. Statins block the cholesterol
biosynthetic pathway at a single enzymatic step and may result in the
deleterious build-up of a metabolic intermediate. In contrast, this
technology simultaneously targets the expression of multiple enzymes
required for cholesterol biosynthesis and thus may avoid the build-up
of metabolic intermediates. The reduction of cholesterol biosynthesis
has been indicated for improved cardiovascular health and lowers the
risk for heart disease, heart attack, and stroke.
Potential Applications and Advantages:
A method of reducing cellular cholesterol biosynthesis.
A method of reducing systemic cholesterol in a subject.
May be effective for patients not suited for statin-based
treatment.
Targets multiple enzymes in the cholesterol biosynthetic
pathway simultaneously.
Development Status: Early stage.
Market: According to the Centers for Disease Control (CDC),
approximately one in every six adults has high cholesterol and
individuals with high total cholesterol have approximately twice the
risk of heart disease in comparison to individuals with optimal levels.
Inventors: Kasey Vickers and Alan Remaley (NHLBI).
Publication: Vickers KC and Remaley AT. MicroRNAs in
atherosclerosis and lipoprotein metabolism. Curr Opin Endocrinol
Diabetes Obesity. 2010 Apr;17(2):150-155; DOI 10.1097/
MED.0b013e32833727a1. [PubMed: 20150807]
Patent Status: U.S. Provisional Application No. 61/280,170 filed 30
Oct 2009 (HHS Reference No. E-142-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, MHPM; 301-435-4521;
[email protected].
Collaborative Research Opportunity: The National Heart, Lung and
Blood Institute, Pulmonary Vascular Medicine Branch, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
microRNA regulation of the cholesterol biosynthetic pathway. Please
contact Dr. Denise M. Crooks at 301-435-0103, [email protected] for
more information.
Moraxella Catarrhalis Lipooligosaccharide Based Conjugate Vaccines for
the Prevention of Otitis Media and Respiratory Infections
Description of Invention: Moraxella catarrhalis is one of the three
leading causative agents of otitis media in children. This is due in
part to the current immunizations of children with Streptococcus
pneumoniae polysaccharide and conjugate vaccines to prevent otitis
media. The proportion of otitis media caused by pneumococcal strains
covered by the vaccines have decreased while those caused by Moraxella
catarrhalis and nontypeable Haemophilus influenzae have significantly
increased. At some point during early childhood, otitis media affects
more than 80% of children under 6 years of age. Otitis media can lead
to deafness and language or learning deficits. In adults, Moraxella
catarrhalis is a major cause of bronchopneumonia and exacerbation of
existing chronic obstructive pulmonary disease for chronic heavy
smokers or elderly patients with chronic pulmonary disease. Moraxella
catarrhalis infections can be treated with antimicrobial agents;
however, the emergence of antibiotic resistance makes vaccines against
Moraxella catarrhalis an attractive alternative to antimicrobial drugs.
There are currently no Moraxella catarrhalis vaccines on the market.
The subject technologies are conjugate vaccines against Moraxella
catarrhalis. The vaccines are comprised of isolated
lipooligosaccharides (LOS) from which esterified fatty acids have been
removed to produce detoxified LOS or from which lipid A has been
removed to produce a detoxified oligosaccharide (OS) covalently linked
to an immunogenic carrier such as tetanus toxoid, and adjuvants such as
alum. The vaccines can potentially be used as a vaccine component in a
combination vaccine containing other pediatric vaccine components.
Applications: Vaccines for the prevention of respiratory infections
and otitis media caused by Moraxella catarrhalis.
Advantages:
Novel vaccine candidates.
LOS is a conserved antigen.
Development Status: In vitro and in vivo (mouse animal model) data
is available and can be provided upon request.
Market:
Pediatric vaccines.
Preventative vaccines.
Inventors: Xin-Xing Gu (NIDCD) and John Robbins (NICHD).
Related Publications: Manuscripts in preparation, available upon
request under a confidential disclosure agreement.
Patent Status:
U.S. Patent 6,685,949 issued 03 Feb 2004 (HHS Ref. No. E-
264-1997/0-US-13).
U.S. Patent 7,641,906 issued 05 Jan 2010 (HHS Ref. No. E-
217-2001/0-US-06).
Licensing Status: Available for licensing.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
[email protected].
Collaborative Research Opportunity: The National Institute on
Deafness and Other Communication Disorders, Vaccine Research Section,
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize the subject technology. Please contact Brian W. Bailey,
Ph.D. at 301-594-4094 or [email protected] for more information.
Nontypeable Haemophilus Influenzae Lipooligosaccharide Based Conjugate
Vaccines for the Prevention of Otitis Media and Respiratory Infections
Description of Invention: Nontypeable Haemophilus influenzae is one
of the leading causative agents of otitis media in children and
accounts for 11% of pneumonia cases in children. This is due in part to
the current immunizations of children with Streptococcus pneumoniae
polysaccharide and conjugate vaccines to prevent otitis media. The
proportion of otitis media caused by pneumococcal strains covered by
the vaccines have decreased while those caused by nontypeable
Haemophilus influenzae have significantly increased. At some point
during early childhood, otitis media affects more than 80% of children
under 6 years of age. Otitis media can lead to deafness and language or
learning deficits. In adults, nontypeable Haemophilus influenzae causes
respiratory tract infections primarily in persons with chronic
obstructive pulmonary disease, one of the most common lung diseases.
Exacerbation of chronic obstructive pulmonary disease in the elderly is
the fourth leading cause of death in the United States. Otitis media
can be treated with antibiotics; however, the emergence of antibiotic
resistance makes vaccines against nontypeable Haemophilus influenzae an
attractive alternative to those classes of drugs. The
[[Page 21640]]
current Haemophilus influenzae type b conjugate vaccines have no
protective effect against nontypeable strains.
The technologies described herein are conjugate vaccines against
nontypeable Haemophilus influenzae. The vaccines are comprised of
lipooligosaccharides (LOS) from which esterified fatty acids have been
removed from lipid A to form detoxified LOS conjugated to an
immunogenic carrier such as tetanus toxoid, and an adjuvant such as
alum. In vivo data in the Chinchilla animal model are available. The
vaccines can be potentially used as a component in a combination
vaccine with other pediatric vaccine components.
Applications: Vaccines for the prevention of respiratory infections
and otitis media caused by nontypeable Haemophilus influenzae.
Advantages:
Novel vaccine candidates.
Conserved antigen.
Development Status: In vitro and in vivo data can be provided upon
request. Data is also available from a phase I clinical trial with a
representative vaccine showing safety and immunogenicity in adults.
Market:
Pediatric vaccines.
Preventative vaccines.
Inventors: Xin-xing Gu (NIDCD), John Robbins (NICHD), et al.
Related Publication: W Hong et al. Protection against nontypeable
Haemophilus influenzae challenges by mucosal vaccination with a
detoxified lipooligosaccharide conjugate in two chinchilla models.
Microbes Infect. 2010 Jan;12(1):11-18. [PubMed: 19782149]
Patent Status:
U.S. Patent 6,207,157 issued 27 Mar 2001 (HHS Ref. No. E-
228-1995/1-US-01).
U.S. Patent 6,607,725 issued 19 Aug 2003 (HHS Ref. No. E-
228-1995/1-US-02).
U.S. Patent 7,641,906 issued 05 Jan 2010 (HHS Ref. No. E-
217-2001/0-US-06).
Licensing Status: Available for licensing.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
[email protected].
Collaborative Research Opportunity: The National Institute on
Deafness and Other Communication Disorders, Vaccine Research Section,
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize the subject technology. Please contact Brian W. Bailey,
Ph.D. at 301-594-4094 or [email protected] for more information.
Dated: April 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-9641 Filed 4-23-10; 8:45 am]
BILLING CODE 4140-01-P