[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56774-56775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19649]
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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.
Hepatitis C Virus Cell Culture System
Description of Technology: Hepatitis C virus (HCV) infection causes
chronic liver disease and is a major global health problem with an
estimated 170 million people affected worldwide and 3-4 million new
cases every year. Therapeutic advances will be greatly aided by the
ability of researchers to successfully replicate and characterize the
virus in vitro. The study of HCV replication has, however, been
hindered by the lack of an efficient virus culture system. One
approach, using cell culture adaptive mutations in the viral RNA has
been found to significantly enhance HCV virus production, but it has
been difficult to define which stage of the viral lifecycle is affected
by a given adaptive mutation.
NIH researchers have now developed a single-cycle virus production
system that allows the stage of the viral lifecycle affected by a
specific adaptive mutation to be determined. They have isolated a
unique subclone of Huh 7 Hepatoma cells, S29, that permits HCV
replication and infectious virion release, but is resistant to
infection by HCV. This permits the use of single cycle growth studies,
and removes the confounding effects of virus re-infection allowing
progress to be made on structure/function studies, or on studies of the
effects of drugs on replication and virus assembly.
Applications: HCV drug discovery; HCV single-cycle virus studies;
HCV structure/function studies.
Market: HCV research.
Inventors: Suzanne U. Emerson, Robert H. Purcell, Rodney Russell
(NIAID).
Patent Status: HHS Reference No. E-324-2007/0--Research Tool.
Patent protection is not being sought for this technology.
Licensing Status: Available for licensing.
Licensing Contact: Chekesha S. Clingman, Ph.D.; 301/435-5018;
[email protected].
Use of CpG Oligodeoxynucleotides To Induce Epithelial Cell Growth
Description of Invention: Wound repair is the result of complex
interactions and biologic processes. Three phases have been described
in normal wound healing: acute inflammatory phase, extracellular matrix
and collagen synthesis, and remodeling. The process involves the
interaction of keratinocytes, fibroblasts and inflammatory cells at the
wound site. The sequence of the healing process is initiated during an
acute inflammatory phase with the deposition of provisional tissue.
This is followed by re-epithelialization, collagen synthesis and
deposition, fibroblast proliferation, and neovascularization, all of
which ultimately define the remodeling phase. These events are
influenced by growth factors and cytokines secreted by inflammatory
cells or by the cells localized at the edges of the wound.
Tissue regeneration is believed to be controlled by specific
peptide factors which regulate the migration and proliferation of cells
involved in the repair process. Thus, it has been proposed that growth
factors will be useful therapeutics in the treatment of wounds, burns
and other skin disorders. However, there still remains a need for
additional methods to accelerate wound healing and tissue repair.
This application claims methods of increasing epithelial cell
growth. The methods include administering a therapeutically effective
amount of a CpG oligodeoxynucleotide (ODN) to induce epithelial cell
division. Also claimed are methods of inducing wound healing. The
method includes treating the wound with a CpG oligonucleotide, thereby
inducing wound healing. The wound can be any type of wound, including
trauma or surgical wounds. The CpG ODN can be applied systemically or
locally.
[[Page 56775]]
Application: Induction of wound healing through use of CpG
oligodeoxynucleotides.
Developmental Status: CpG oligonucleotides have been synthesized
and preclinical studies have been performed.
Inventors: Dennis Klinman and Takahashi Sato (NCI).
Patent Status: U.S. Provisional Application filed 06 Sep 2007 (HHS
Reference No. E-242-2007/0-US-01).
Licensing Status: Available for exclusive or nonexclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
[email protected].
Collaborative Research Opportunity: The Laboratory of Experimental
Immunology of the National Cancer Institute is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize methods of
increasing epithelial cell growth. Please contact John D. Hewes, Ph.D.
at 301-435-3121 or [email protected] for more information.
Flexible, Polyvalent Antiviral Dendritic Conjugates for the Treatment
of HIV/AIDS
Description of Technology: This technology describes the design and
synthesis of flexible, polyvalent, antiviral conjugates of less than
200 kDa for the treatment of HIV/AIDS. These conjugates are mimetic of
D1D2-Ig[alpha]tp, a high-molecular-weight (1 MDa) CD4-immunoglobulin
fusion construct with extreme HIV neutralizing potency. Cryo electron
microscopy suggests that the extreme potency of D1D2-Ig[alpha]tp is due
to polyvalent presentation of a gp120-binding ligand on a flexible
scaffold. The current prototype for the technology is a conjugate
comprising soluble, two-domain human CD4 covalently linked to a
flexible poly(ethylene glycol)-PAMAM dendrimer scaffold. The construct
is designed to retain a high degree of flexibility and polyvalence,
and, at less than 200 kDa, is similar in size to successful antibody
therapeutics currently on the market. Because it retains the key
determinants of potency and the human CD4 moieties of D1D2-Ig[alpha]tp,
this conjugate is expected to have the following unique set of HIV
antiviral properties: (1) IC90 infectivity neutralization
values in the nanomolar range against HIV primary isolates; (2) lack of
susceptibility to viable escape mutations, because the ligand is CD4,
and because CD4-independence evolves concomitantly with constitutive
exposure of neutralization-sensitive, highly conserved coreceptor
binding site epitopes; (3) indefinite control of HIV viral replication,
without the need for combination therapy, arising from properties (1)
and (2); (4) improved HIV viral replication control when used in
combination with other Highly Active Antiretroviral Therapy (HAART);
(5) improved prevention of seroconversion when used in combination with
other HAART shortly following known exposure to HIV.
Applications: Novel therapeutics for the treatment and prevention
of HIV infection.
Development Status: Synthesis and characterization in progress.
Inventors: Sriram Subramaniam and Adam Bennett (NCI).
Publication: AE Bennett et al. Cryo electron tomographic analysis
of an HIV neutralizing protein and its complex with native viral gp
120. J Biol Chem., in press; published online ahead of print June 28,
2007.
Patent Status: U.S. Provisional Application No. 60/932,464 filed 31
May 2007 (HHS Reference No. E-213-2007/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Sally Hu, Ph.D.; 301/435-5606; [email protected].
Collaborative Research Opportunity: The Laboratory of Cell Biology
of the National Cancer Institute is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize Flexible, Polyvalent Antiviral
Dendritic Conjugates for the Treatment of HIV/AIDS. Please contact John
D. Hewes, Ph.D. at 301-435-3121 or [email protected] for more
information.
Monoclonal Antibodies to Fusion-Active Conformations of GP41
Description of Technology: This technology describes three novel
monoclonal antibodies, 2F12, 9C5 and 11B8, which were derived against
an HIV gp41 heptad-repeat entry inhibitor that mimics a structure of
the HIV envelope protein fusion intermediate. These antibodies
recognize the fusion-intermediate and six-helix conformations of gp41
and are useful tools for high-throughput screening assays (HTS) to
identify novel HIV-1 inhibitors. Since the drugs identified in the
assays using these monoclonal are expected to inhibit HIV infection in
a different manner than current antiretroviral drugs, these antibodies
may serve as valuable tools for screening for new drugs that may have
activity against HIV strains that are resistant to currently available
antiretroviral drugs.
Applications: Research tool.
Development Status: In vitro data available .
Inventors: Carol D. Weiss and Russell A. Vassell (CBER/FDA).
Related Publication: S Jiang et al. A screening assay for antiviral
compounds targeted to the HIV-1 gp41 core structure using a
conformation-specific monoclonal antibody. J Virol Methods. 1999
Jun;80(1):85-96.
Patent Status: HHS Reference No. E-124-2007/0--Research Tool.
Patent protection not being pursued for this technology.
Licensing Status: Available for non-exclusive licensing as
biological material.
Licensing Contact: Sally Hu, Ph.D.; 301/435-5606; [email protected].
Dated: September 27, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-19649 Filed 10-3-07; 8:45 am]
BILLING CODE 4140-01-P