[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13344-13346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5356]
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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.
Device for Simulating Explosive Blast Trauma
Description of Technology: NIH scientists have developed a novel
device to simulate the effects of pressure waves resulting from
explosions or blasts on biological tissue. This methodology allows
real-time monitoring of tissue damage while it is occurring and can
track the secondary effects of pressure damage after tissue insult.
This tool is well-adapted for investigating traumatic brain injury and
organ damage resulting from explosion pressure waves, such as in
military combat.
[GRAPHIC] [TIFF OMITTED] TN06MR12.002
Potential Commercial Applications:
Real-time monitoring of tissue damage from primary blast
pressure
Real-time monitoring of tissue damage from secondary
effects of blast pressure, such as tissue shearing against surfaces
Can monitor tissue through both live imaging and assaying
cell viability
Can measure pressure effects on various tissues
Competitive Advantages:
Allows differentiation of primary and secondary blast
pressure effects on tissue damage
Employs multiple methods to assess cell viability
Possesses high temporal resolution
Development Stage: Prototype.
Inventors: Rea Ravin, Paul Blank, Alex Steinkamp, Joshua
Zimmerberg, Sergey Bezrukov, and Kim Lee Mcafee (all of NICHD).
Intellectual Property: HHS Reference No E-068-2012/0--U.S.
Provisional Application No. 61/590,209 filed 24 Jan 2012.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
[email protected].
Small-Molecule Inhibitors of Human Galactokinase for the Treatment of
Galactosemia and Cancers
Description of Technology: Lactose, found in dairy products and
other foods, is comprised of two simple sugars, glucose and galactose.
In galactosemia,
[[Page 13345]]
where galactose is not properly metabolized, build-up of toxic
compounds, such as galactose-1-phosphate, can lead to liver disease,
renal failure, cataracts, brain damage, and even death if this disorder
is left untreated. Currently, the only treatment for galactosemia is
elimination of lactose and galactose from the diet, but in some cases
this is not sufficient to avoid long-term complications from the
disorder.
This technology describes selective small-molecule inhibitors of
human galactokinase, which inhibit the first step in galactose
metabolism. These compounds could be used to treat galactosemia by
eliminating the build-up of toxic metabolites in brain, liver and other
tissues, and could form the basis for the first effective treatment for
this disorder.
These inhibitors are also promising candidates for the treatment of
certain cancers, such as PTEN/AKT misregulated cancers. The inventors
have already shown that the inhibitors are cytotoxic for several cancer
cell lines.
Potential Commercial Applications:
Treatment of galactosemia
Treatment of certain cancers, such as PTEN/AKT
misregulated cancers
Competitive Advantages:
There is currently no effective treatment for classic
galactosemia, where dietary restriction cannot prevent long-term
complications in some cases.
Cancer therapeutics based on these inhibitors are
predicted to have minimal side-effects.
Development Stage:
Early-stage
In vitro data available
Inventors: Matthew Boxer et al. (NCATS).
Intellectual Property: HHS Reference No. E-240-2011/0 -- PCT
Application No. PCT/US2011/053021 filed 23 Sep 2011.
Licensing Contact: Tara L. Kirby, Ph.D.; 301-435-4426;
[email protected].
Collaborative Research Opportunity: The National Center for
Advancing Translational Sciences is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize Small-Molecule Inhibitors of Human
Galactokinase for the Treatment of Galactosemia and Cancers. For
collaboration opportunities, please contact Lili M. Portilla, MPA at
[email protected].
The Cancer Stem Cell Finder: A Novel Reporter Construct Which Uses
Transposition and Green Fluorescent Protein Expression To Identify
Cancer Stem Cells
Description of Technology: Scientists at the National Institutes of
Health (NIH) have designed a novel reporter construct which can be used
to identify, monitor, and allow for the manipulation of cancer stem
cells (CSCs). CSCs are a subset of poorly differentiated tumor cells
expressed at low frequency within a tumor and are resistant to
conventional chemotherapies. CSCs have high metastatic potential and
give rise to new tumors that spread cancer throughout the body. These
characteristics make CSCs prime targets for developing new therapeutic
agents to eradicate cancer.
The reporter construct is a novel expression vector composed of the
Sleeping Beauty transposon plasmid and a Nanog promoter linked to green
fluorescent protein (GFP). Nanog is a transcription factor that is
overexpressed in embryonic stem (ES) cells and tumors that resemble ES
cells. When introduced into a population of tumor cells, the Nanog-GFP-
Sleeping Beauty transposon construct is able to integrate into tumor
cell DNA via transposition. If the transposed cell is a CSC, the Nanog
transcription factor overexpressed in that CSC will bind to the Nanog-
promoter in the reporter construct to drive GFP expression within the
cell. Thus, CSCs can be isolated based on their selective expression of
the GFP label. The NIH scientists have utilized their reporter
construct to identify small populations of CSCs in mouse and human
breast cancer cell models.
Potential Commercial Applications:
Identify CSCs with high metastatic potential in patients
to target with therapeutic intervention
Screen therapeutic drug candidates to identify their
effectiveness against CSCs in comparison to more highly differentiated
tumor cells
Investigate genes, surface proteins, and other markers
responsible for CSC ``stem-ness'' to develop CSC diagnostics and
identify therapeutic candidates to stop or reverse the properties
contributing to the high metastatic potential of these cells
Identify transcription factors/genes activated in the tumor
microenvironment that trigger metastasis
Competitive Advantages:
The reporter construct is validated to identify CSCs in
both human and mouse tumor cell populations
Researchers and clinicians can monitor the ``stem-ness''
of a tumor cell population to predict the metastatic potential of a
tumor
CSCs are identified in vivo in somatic cells via GFP
labeling without utilizing a virus for transfection
CSCs can be isolated, monitored, and traced via their GFP
label in both in vitro and in vivo experimentation
Facilitates the generation of a large quantity of CSCs for
further study
Development Stage:
Early-stage
Pre-clinical
In vitro data available
In vivo data available (animal)
Inventors: Rachel L. de Kluyver (formerly NCI), Jimmy K. Stauffer
(NCI), Thomas J. Sayers (SAIC-Frederick).
Intellectual Property: HHS Reference No. E-215-2011/0 -- Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Samuel E. Bish, Ph.D.; 301-435-5282;
[email protected]
Collaborative Research Opportunity: The Cancer and Inflammation
Program, NCI, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize Nanog promoter driven GFP constructs for the
easy identification and isolation of cancer stem cells. For
collaboration opportunities, please contact John Hewes, Ph.D. at
[email protected].
Genes and Autoantibodies To Diagnose and Treat Sj[ouml]gren's Syndrome
Description of Technology: Sj[ouml]gren's syndrome (SS) is a
chronic autoimmune disease of unknown etiology that targets salivary
and lacrimal glands and may be accompanied by multi-organ systemic
manifestations. To date, no specific diagnostic test has been developed
for SS and, as a result, SS is often underdiagnosed and undertreated.
In order to further understand the immunopathology of SS and
uncover both therapeutic and diagnostic targets, researchers at NIH
compared gene expression profiles of salivary glands with severe
inflammation to those with mild or no disease. Results from these
studies identified target genes that were further characterized in
tissues, serum and in cultured cell populations by real time PCR and
protein analyses. Among the most highly expressed SS genes were genes
associated with myeloid cells, including members of the mammalian
chitinase family. In addition to genes, the researchers have also
identified autoantibodies that have increase levels in SS patients. The
gene expression levels and autoantibodies
[[Page 13346]]
identified in the research represent both promising means for
diagnosing SS earlier in disease progression as well as therapeutic
targets to treat SS.
Potential Commercial Applications:
Diagnosis of Sj[ouml]gren's syndrome
Treatment of Sj[ouml]gren's syndrome
Competitive Advantages: The genes and autoantibodies identified in
this technology may lead to one of the first diagnostic tests for
Sj[ouml]gren's syndrome.
Development Stage:
Early-stage
In vitro data available
Inventors: Sharon M. Wahl (NIDCR), et al.
Publications:
1. Greenwell-Wild T, et al. Chitinases in the salivary glands
and circulation of patients with Sj[ouml]gren's syndrome: macrophage
harbingers of disease severity. Arthritis Rheum. 2011
Oct;63(10):3103-3115, doi: 10.1002/art.30465. [PMID 21618203]
2. Katsifis GE, et al. Systemic and local interleukin-17 and
linked cytokines associated with Sj[ouml]gren's syndrome
immunopathogenesis. Am J Pathol. 2009 Sep;175(3):1167-1177. [PMID
19700754]
3. Moutsopoulos NM, et al. Lack of efficacy of etanercept in
Sj[ouml]gren syndrome correlates with failed suppression of tumour
necrosis factor alpha and systemic immune activation. Ann Rheum Dis.
2008 Oct;67(10):1437-1443. [PMID 18198195]
4. Mavragani CP, et al. Augmented interferon-alpha pathway
activation in patients with Sj[ouml]gren's syndrome treated with
etanercept. Arthritis Rheum. 2007 Dec;56(12):3995-4004. [PMID
18050196]
5. Katsifis GE, et al. T lymphocytes in Sj[ouml]gren's syndrome:
contributors to and regulators of pathophysiology. Clin Rev Allergy
Immunol. 2007 Jun;32(3):252-264. [PMID 17992592]
Intellectual Property:
HHS Reference No. E-140-2011/0 -- U.S. Provisional
Application No. 61/476,192 filed 15 April 2011
HHS Reference No. E-140-2011/1 -- U.S. Provisional
Application No. 61/556,729 filed 07 November 2011
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
[email protected].
Bacterially Expressed Influenza Virus Recombinant HA Proteins for
Vaccine and Diagnostic Applications
Description of Technology: Pandemic H1N1 influenza virus is a
recently emergent strain of influenza virus that the World Health
Organization (WHO) estimates has killed at least 14,711 people
worldwide. Avian influenza viruses are emerging health threats with
pandemic potential. Due to their global health implications, there has
been a massive international effort to produce protective vaccines
against these influenza virus strains. Currently, influenza virus
vaccines are produced in chicken eggs, a production method that is
disadvantaged by lengthy vaccine production times and by inability to
meet large-scale, global demands.
The subject technologies are specific recombinant HA proteins from
H1N1, H5N1, and other strains of influenza virus produced in bacteria.
The HA proteins properly fold, form oligomers, bind fetuin, agglutinate
red blood cells and induce strong neutralizing antibody titers in
several in vivo animal models. The key advantages of this technology
are that expression of these proteins in bacteria reduces the vaccine
production time and offers the ease of scalability for global usage, an
issue with current production methods. The recombinant HA proteins can
also be used for diagnostic applications.
Potential Commercial Applications:
Vaccines for the prevention of influenza infection
Diagnostics for influenza virus specific antibodies
Competitive Advantages:
Novel vaccine candidates
Rapid production time
Ease of scalability
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Hana Golding and Surender Khurana (FDA).
Publication: Khurana S, et al. Recombinant HA1 produced in E. coli
forms functional oligomers and generates strain-specific SRID potency
antibodies for pandemic influenza vaccines. Vaccine. 2011 Aug
5;29(34):5657-5665. [PMID 21704111].
Intellectual Property: HHS Reference No. E-032-2010/1--PCT
Application No. PCT/US2010/055166 filed 02 Nov 2010.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
[email protected].
Potent, Easy To Use Targeted Toxins as Anti-Tumor Agents
Description of Technology: The invention discloses synthesis and
use of novel derivatives of 2-[2'-(2-aminoethyl)-2-methyl-ethyl]-l,2-
dihydro-6-methoxy-3H-dibenz-[de,h]isoquinoline-l,3-dione as targeted
anti-tumor agents. The use of targeted toxin conjugates with anti-
cancer antibodies, such as herceptin, is increasing. Based on a
comparison with the structurally complex toxins, such as DM1, available
in the market, these novel toxins are more stable in circulation, thus
making the toxin-conjugates more tumor-selective and less toxic. As
such, these compounds are superior alternatives to the existing toxins.
The invention describes a potent and easy to synthesize toxin that
can be used for generating a variety of prodrugs. These compounds can
be attached to a ligand that recognizes a receptor on cancer cells, or
to a peptide that is cleaved by tumor-specific proteases. The compounds
are topoisomerase inhibitors and are mechanistically different from DM1
that targets tubulin.
The structure of the toxin allows it to be modified with a peptide
linker that is stable, but rapidly cleaved in lysosomes after the
compound is specifically taken up by cancer cells.
Potential Commercial Applications: The compounds can be used for
preparation of a variety of potent anti-cancer agents with low systemic
toxicity.
Competitive Advantages:
Easy to prepare
Structural features make these compounds more stable in
circulation
Toxin conjugates are more tumor-selective and less toxic
Development Status:
In vitro data available
In vivo data available (animal)
Inventors: Nadya Tarasova, et al. (NCI).
Intellectual Property: HHS Reference No. E-160-2006/0--U.S. Patent
No. 8,008,316 issued 30 Aug 2011.
Licensing Contact: Jennifer Wong; 301-465-4633;
[email protected].
Dated: February 29, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-5356 Filed 3-5-12; 8:45 am]
BILLING CODE 4140-01-P