Government-Owned Inventions; Availability for Licensing, 18561-18564 [2011-7925]
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Emcdonald on DSK2BSOYB1PROD with NOTICES
compliance with the Hill-Burton
uncompensated services assurance and
administers construction grant programs
under section 1610(b) of the Public
Health Service Act, under the Health
Care and Other Facilities (HCOF)
program, and under the Patient
Protection and Affordable Care Act,
Public Law 111–148. Specifically, the
Division: (1) Administers the process for
awarding new construction and
equipment grants, under section
1610(b), the HCOF, and the PPACA
programs, including ensuring the
delivery of comprehensive architectural
and engineering services and ensuring
compliance with historic preservation
and other laws and regulations related
to construction projects, maintains a
computerized database of key project
information, and provides technical
assistance in application preparation to
potential grantees under Division grant
programs; (2) monitors grant projects
during construction to assure
compliance with the terms of the award,
reviews requests for changes in scope to
grant projects, and obtains information
needed to close out completed grant
projects; (3) establishes, develops,
monitors, and enforces the
implementation of Hill-Burton
regulations, policies, procedures, and
guidelines for use by staff and health
care facilities; (4) maintains a system for
receipt, analysis and disposition of
audit appeals by Hill-Burton obligated
facilities and for receiving and
responding to patient complaints; (5)
manages the recovery or waiver of
recovery of Federal grant funds process
for Titles VI and XVI; (6) manages the
national Hill-Burton Hotline to ensure
that consumers receive timely and
accurate information on the program;
and (7) provides architectural and
engineering services to other Agencies
such as the Administration for Children
and Families and the Food and Drug
Administration.
Division of Vaccine Injury
Compensation (RR4)
This Division of Vaccine Injury
Compensation (DVIC) administers all
statutory authorities related to the
operation of the National Vaccine Injury
Compensation Program (VICP) by the:
(1) Evaluation of petitions for
compensation filed under the VICP
through medical review and assessment
of compensability for all complete
claims; (2) processing of awards for
compensation made under the VICP; (3)
promulgation of regulations to revise the
Vaccine Injury Table; (4) provision of
professional and administrative support
to the Advisory Commission on
Childhood Vaccines (ACCV); (5)
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development and maintenance of all
automated information systems
necessary for program implementation;
(6) provision and dissemination of
program information; and (7)
contributes to the understanding of
vaccine-related adverse events through
the analysis of VICP claims. The VICP
maintains a working relationship with
other relevant Federal and private sector
partners in its administration and
operation.
Office of Pharmacy Affairs (RR7)
The Office of Pharmacy Affairs (OPA)
promotes access to clinical and cost
effective pharmacy services to enable
participating entities to stretch scarce
Federal resources in order to serve more
patients, expand their services or offer
additional services. Specifically the
office: (1) Manages the 340B
involvement of pharmaceutical
manufacturers that participate in the
Medicaid program, through
Pharmaceutical Pricing Agreements; (2)
maintains a publicly accessible database
of participating covered entities, sites,
and contract pharmacies; (3) publishes
guidelines/regulations to assist in the
understanding and participation in the
340B Program; (4) maintains a Prime
Vendor Program to increase the value of
the 340B Program; (5) maintains the
Pharmacy Services Support Center to
assist OPA and the diverse Program
stakeholders to understand and make
best use of the 340B Program; (6) fosters
mutually productive relationships with
Federal and private sector partners; (7)
provides a national platform for the
coordination and development of
leading practices for pharmacy services;
(8) promotes comprehensive and
efficient pharmacy management
application and systems use to ensure
safe and effective medication use; and
(9) manages quality improvement
activities such as the Patient Safety and
Clinical Pharmacy Services
Collaborative.
Section RR–30, Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is upon date of
signature.
Dated: March 28, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011–7781 Filed 4–1–11; 8:45 am]
BILLING CODE 4165–15–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
New Molecules for HIV Therapeutics:
Fab, scFv, and Related Binding
Molecules Specific for HIV–1 Rev
Description of Invention: The
invention offered for licensing and
commercial development is in the field
of HIV therapeutics. More specifically,
the invention relates to methods and
compositions for treating and/or
inhibiting HIV infection or any other
lentivirus. The invention describes the
identification, though phage display, of
a chimeric rabbit/human anti-Rev Fab
(SJS–R1) that can inhibit polymerization
of the HIV Rev protein and thus inhibit
its normal function in virus replication.
The Fab binds with very high affinity to
a conformational epitope in the Nterminal half of HIV–1 Rev. The
corresponding single chain antibody
(scFv) was also prepared and
characterized. Methods of making and
using SJS–R1 Fab and SJS–R1 scFv, and
antibodies and antibody fragments that
share at least one CDR with SJS–R1 Fab,
are provided. Specific described
methods include methods of preventing
or reversing polymerization of HIV Rev,
methods of reducing infectivity of
replication of a lentivirus, inhibiting
Rev function in a cell infected with a
lentivirus, and methods of treating a
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Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices
disease or symptom associated with Rev
expression in an animal.
Applications: HIV therapeutics.
Advantages
• The invention utilizes a novel target
and thus can be effective in conjunction
with other HIV drugs.
• The chimeric structure of the Fab
makes it possible to produce it in rabbit
in high yields while being readily
applicable for human treatment.
Development Status: The therapeutic
molecules have been produced and their
strong affinity to Rev and its inhibitory
effect on HIV proliferation was
demonstrated.
Inventors: Stephen J. Stahl (NIAMS) et
al.
Patent Status: U.S. Provisional
Application No. 61/439,307 filed
February 3, 2011 (HHS Reference No. E–
064–2011/0–US–01), entitled
‘‘Generation and Use of Fab, scFv, and
Related Binding Molecules Specific for
HIV–1 Rev.’’
Related Publications
1. Stahl SJ, Watts NR, Rader C,
DiMattia MA, Mage RG, Palmer I,
Kaufman JD, Grimes JM, Stuart DI,
Steven AC, Wingfield PT. Generation
and characterization of a chimeric
rabbit/human Fab for co-crystallization
of HIV–1 Rev. J Mol Biol. 2010 Apr
2;397(3):697–708. [PubMed: 20138059]
2. DiMattia MA, Watts NR, Stahl SJ,
Rader C, Wingfield PT, Stuart DI, Steven
AC, Grimes JM. Implications of the
HIV–1 Rev dimer structure at 3.2 A
resolution for binding to the Rev
response element. Proc Natl Acad Sci U
S A. 2010 Mar 30;107(13):5810–5814.
[PubMed: 20231488]
Licensing Status: Available for
licensing and commercial development.
Emcdonald on DSK2BSOYB1PROD with NOTICES
Licensing Contacts
• Uri Reichman, PhD, MBA; 301–
435–4616; UR7a@nih.gov.
• John Stansberry, PhD; 301–435–
5236; js852e@nih.gov.
Collaborative Research Opportunity:
The National Institute of Arthritis and
Musculoskeletal and Skin Diseases,
Protein Expression Laboratory is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize the technology. Please
contact Cecilia Pazman, PhD at 301–
402–5579 for more information.
Modulation of Leucine-Rich Repeats
and Calponin Homology DomainContaining Protein 4 (Lrch4) Activity
for Therapeutic Applications
Description of Invention: NIH
Inventors have recently discovered a
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novel Leucine-rich repeat and calponin
homology domain-containing protein 4
(Lrch4) in a proteomic screen of the
plasma membrane of lipopolysaccharide
(LPS)-exposed macrophages. Expression
data by RT–PCR revealed that all Lrch
family members (1–4) are expressed in
macrophages, but only Lrch4 was
recruited into lipid rafts (signaling
microdomains of the plasma membrane)
by LPS. Lrch4 is the most highly
expressed Lrch family member in mouse
tissues. It is a predicted single-spanning
transmembrane protein that is encoded
by the Lrch4 gene in humans. The Lrch4
ectodomain is predicted to have a series
of leucine-rich repeats, the motifs by
which Toll like Receptors (TLR) are
thought to bind microbial ligands. The
human form of Lrch4 is 83% identical
to murine Lrch4 and is predicted to
have 680 amino acids and a molecular
weight of 73 kDa.
NIH inventors have shown that Lrch4
is expressed on the plasma membrane of
macrophages. They have determined
that Lrch4 regulates pro-inflammatory
signals (NF-kB activation, cytokine
induction) emanating from all TLRs
tested, and also regulates ligandindependent signals from MyD88.
Further, LPS-induced p38, JNK, and
NFkB activation are attenuated
following Lrch4 knockdown, indicating
that Lrch4 regulates upstream LPS
signaling events. LPS-induced
expression of the NF-kB-dependent
cytokine TNFa was attenuated
following Lrch4 knockdown at the level
of both transcript and protein. Based on
these and other findings, the inventors
of this technology propose that Lrch4
may be a novel component of TLR
receptor complexes and that modulation
of Lrch4 activity might open up new
opportunities for developing novel
therapeutics for inflammatory diseases.
Applications: Identification and
development of modulators of Lrch4
activity to treat inflammatory disorders,
cancer, and sepsis.
Development Status: Early-stage.
Inventors: Michael B. Fessler, et al.
(NIEHS).
Related Publication: Dhungana S et al.
Quantitative proteomics analysis of
macrophage rafts reveals
compartmentalized activation of the
proteasome and of proteasome-mediated
ERK activation in response to
lipopolysaccharide. Mol Cell Proteomics
2009 Jan; 8(1):201–213. [PubMed:
18815123]
Patent Status: U.S. Provisional
Application No. 61/433,491 filed 17
January 2011 (HHS Reference No. E–
012–2011/0–US–01).
Licensing Status: Available for
licensing.
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Licensing Contact: Suryanarayana
Vepa, PhD, J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Environmental
Health Sciences (NIEHS) Laboratory of
Respiratory Biology is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize Lrch4. Please contact Dr.
Elizabeth M. Denholm at
denholme@niehs.nih.gov for more
information.
Superparamagnetic Nanocomplexes
and Their Use as Contrast Agents in
MRI
Description of Invention: The
invention offered for licensing and
commercial development relates to the
fields of cell therapy and tracking of
such therapy by magnetic resonance
imaging. More specifically the
technology describes novel
superparamagnetic magnetic resonance
contrast agents, methods of making the
agents, and methods of labeling cells
with the contrast agents and imaging the
labeled cells using magnetic resonance.
The self assembled agents are
composed of three (3) components:
Superparamagnetic iron oxide
nanoparticle (e.g. F3O4), associated
with a carbohydrate coating (e.g., a
polycation (e.g., Protamine Sulfate); and
a polycation (e.g.,
glycosaminoglycan:Heparin). Selfassembling superparamagnetic
nanocomplexes made from simple
commercially available chemicals such
as Heparin sulfate (H), Protamine sulfate
(P), and Ferumoxytol nanocomplexes
(HPF nanocomplexes) can effectively
label stem cells, immune cells, tumor
cells, or any other therapeutically
engineered cells for cellular MRI.
Biological cells can be labeled with the
nanocomplexes by contacting cells
under conditions sufficient to produce
the nanocomplexes, or by contacting the
cells with pre-assembled
nanocomplexes. The labeled biological
cells can be transplanted into an
individual, imaged by MRI and the
migration pattern and/or cellular
distribution pattern of the labeled
biological cells in the subject can then
be detected. This technique will readily
facilitate the tracking of the therapeutic
cells, and thus render cell-based therapy
and/or tissue repair more precise,
accurate and effective.
Applications
Clinical—
• Cell-based therapy (e.g. stem cells,
or immune cells therapy, genetic
engineered cells); monitoring and
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Licensing Status: Available for
licensing and commercial development.
detecting cell trafficking and
distribution.
• Diagnostics.
Research—
• Cell-based therapy.
• Tissue regeneration.
Licensing Contacts
Advantages
• Avoid radioactive labeling.
• More efficient cell incorporation
than the use of noncomplexed
paramagnetic or superparamagnetic
particles.
• Non toxic.
• Easily prepared from three (3)
commercially available FDA approved
drugs off label. No synthesis is required
(self assembled).
• No FDA approved MRI contrast
agent containing paramagnetic or
superparamagnetic iron oxide
nanoparticles.
Development Status
• The labeling complex has been
repeatedly prepared. May require some
further optimization for specific cell
products and scale up.
• Incorporation into mammal cells
has been demonstrated.
Market: The total U.S. market for
imaging reagents was $2.8 billion in
2003 and is expected to grow to $4.5
billion by 2010 at an average annual
growth rate of 6.9%. Sales of MRI
reagents for cardiovascular applications
were $770 million in 2003 and are
expected to rise at an average annual
growth rate of 7.0%. Reagents used in
oncology and gastrointestinal tract are
rising at average annual growth rates of
7.0% and 5.1%, respectively. The
subject technology maybe readily
applied in both diagnostics and
therapeutic fields. A commercial
development of the subject technology
may therefore be attractive for
commercial organizations.
Inventors: Joseph A. Frank et al. (CC).
Patent Status: U.S. Provisional
Application No. 61/439,106 filed
February 3, 2011 (HHS Reference No. E–
285–2010/0–US–01), entitled
‘‘Superparamagnetic Nanocomplexes,
Articles, and Methods of Use Thereof’’.
Emcdonald on DSK2BSOYB1PROD with NOTICES
Relevant Publications
1. Frank JA, Anderson SA, Kalsih H,
Lewis BK, Yocum GT, Arbab AS.
Methods for magnetically labeling stem
and other cells for detection by in vivo
magnetic resonance imaging.
Cytotherapy. 2004; 6(6):621–625.
[PubMed: 15773025]
2. Arbab AS, Liu W, Frank JA.
Cellular magnetic resonance imaging:
current status and future prospects.
Expert Rev Med Devices. 2006
Jul;3(4):427–439. [PubMed: 16866640]
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• Uri Reichman, PhD, MBA; 301–
435–4616; UR7a@nih.gov.
• John Stansberry, PhD; 301–435–
5236; js852e@nih.gov.
Collaborative Research Opportunity:
The Clinical Center, Frank Laboratory,
Radiology and Imaging Sciences, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
technology. Please contact Joseph A.
Frank MS MD at 301–402–4314 or
jafrank@helix.nih.gov for more
information.
Methods of Treating Age-Related
Macular Degeneration
Description of Invention: Available for
licensing is a novel method of treating
age related macular degeneration
(AMD). AMD is the leading cause of
irreversible blindness in elderly
populations worldwide. Inflammation,
among other factors, has been suggested
to play an important role in AMD
pathogenesis. Recent studies have
demonstrated a link between the
complement system, inflammation, and
AMD pathogenesis. Notably, researchers
at NEI have shown that certain members
of the C5a pathway are increased in
AMD patients, and in vitro experiments
demonstrated that those same pathway
members cause a decrease in retinal
pigment epithelium (RPE) viability, a
hallmark of AMD. Blocking the C5a
pathway presents a promising approach
to prevent and treat AMD.
Application: Prevention and/or
treatment of Age-related Macular
Degeneration.
Development Status: In vivo mouse
studies are in progress to test the
effectiveness of the treatment.
Market: Age-related macular
degeneration is a leading cause of
severe, irreversible vision impairment in
developed countries (https://
geteyesmart.org/eyesmart/diseases/
amd.cfm). It is estimated that 1.8
million Americans 40 years and older
are affected by AMD and an additional
7.3 million with large drusen (yellow or
white deposits under the retina) are at
substantial risk of developing AMD. The
number of people with AMD is
estimated to reach 2.95 million in 2020.
AMD is the leading cause of permanent
impairment of reading and fine or closeup vision among people aged 65 years
and older (https://www.cdc.gov/
visionhealth/basic_information/
eye_disorders.htm).
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Inventors: Robert B. Nussenblatt et al.
(NEI).
Patent Status: U.S. Provisional
Application No. 61/429,580 filed 04 Jan
2011 (HHS Reference No. E–099–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jaime M. Greene,
M.S.; 301–435–5559;
greenejaime@mail.nih.gov.
Methods for Inhibiting
Proinflammatory Cytokine Expression
Using Ghrelin
Description of Invention: Ghrelin, an
endogenous ligand for growth hormone
secretagogue receptors (GHS–R), is
primarily produced by the stomach but
also by many other organs systems in
the body (including the immune system)
serves as a potent circulating orexigen
controlling energy expenditure,
adiposity and GH secretion. We have
discovered that ghrelin exerts antiinflammatory effects via inhibiting the
secretion of both acute and chronic
cytokines including IL–1, IL–6, TNFalpha, IFN-gamma, IL–12 p40, Il–17,
various chemokines and CSFs in vitro in
human and murine cells as well as in
vivo in murine models of sepsis,
inflammation and aging. We also found
that ghrelin directly controls human
growth hormone and insulin growth
factor expression by human immune
cells.
Applications: This invention is useful
for treatment of various inflammatory
disorders including inflammatory bowel
disease, Crohn’s disease, rheumatoid
arthritis, multiple sclerosis,
atherosclerosis, endotoxemia and graftversus-host disease.
Inventors: Vishwa D. Dixit and Dennis
D. Taub (NIA).
Relevant Publications
1. Dixit VD, Schaffer EM, Pyle RS,
Collins GD, Sakthivel SK, Palaniappan
R, Lillard JW Jr, Taub DD. Ghrelin
inhibits leptin- and activation-induced
proinflammatory cytokine expression by
human monocytes and T cells. J Clin
Invest. 2004 Jul; 114(1):57–66. [PubMed:
15232612] Note: Article highlighted in
this issue of JCI. This was also the
subject of a Science SAGE KE News
Focus article—M Leslie. Opposites
Detract. Sci Aging Knowl Environ. 2004
Jul 14; 28:nf65 [doi: 10.1126/
sageke.2004.28.nf65].
2. Dixit VD, Weeraratna AT, Yang H,
Bertak D, Cooper-Jenkins A, Riggins GJ,
Eberhart CG, Taub DD. Ghrelin and the
growth hormone secretagogue receptor
constitute a novel autocrine pathway in
astrocytoma motility. J Biol Chem. 2006
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Licensing Contact: Sally H. Hu, PhD,
M.B.A.; 301–435–5606;
hus@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute on Aging is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
Methods of Inhibiting Proinflammatory
Cytokine Expression Using Ghrelin.
Please contact Nikki Guyton at 301–
435–3101 or guytonn@mail.nih.gov for
more information.
Relevant Reviews
Emcdonald on DSK2BSOYB1PROD with NOTICES
Jun 16; 281(24):16681–16690. [PubMed:
16527811]
3. Dixit VD, Yang H, Sun Y,
Weeraratna AT, Smith RG, Taub DD.
Ghrelin promotes thymopoiesis during
aging. J Clin Invest. 2007 Oct;
117(10):2778–2790. [PubMed:
17823656] Note: Article highlighted in
this issue of JCI.
4. Yang H, Dixit VD, Patel K,
Vandanmagsar B, Collins G, Sun Y,
Smith RG, Taub DD. Reduction in
hypophyseal growth hormone and
prolactin expression due to deficiency
in ghrelin receptor signaling is
associated with Pit-1 suppression:
relevance to the immune system. Blood
Behav Immun. 2008 Nov; 22(8):1138–
1145. [PubMed: 18602461]
5. Dixit VD, Yang H, Cooper-Jenkins
A, Giri BB, Patel K, Taub DD. Reduction
of T cell-derived ghrelin enhances
proinflammatory cytokine expression:
implications for age-associated increases
in inflammation. Blood. 2009 May 21;
113(21):5202–5205. [PubMed:
19324904]
Government-Owned Inventions;
Availability for Licensing
6. Dixit V and Taub DD. Ghrelin and
immunity: a young player in an old
field. Exp. Gerontol. 2005 Nov;
40(11):900–910. [PubMed: 16233968]
7. Taub DD. Novel connections
between the neuroendocrine and
immune systems: the ghrelin
immunoregulatory network. Vitam
Horm. 2008; 77:325–346. [PubMed:
17983863]
8. Taub DD. Neuroendocrine
interactions in the immune system. Cell
Immunol. 2008 Mar–Apr; 252(1–2):1–6.
[PubMed: 18619587] Note: Image from
article used on the cover of this issue.
9. Redelman D, Welniak LA, Taub D,
Murphy WJ. Neuroendocrine hormones
such as growth hormone (GH) and
prolactin (PRL) are integral members of
the immunological cytokine network.
Cell Immunol. 2008 Mar–Apr; 252(1–
2):111–121. [PubMed: 18313040]
10. Patel K and Taub DD. Role of
neuropeptides, hormones, and growth
factors in regulating thymopoiesis in
middle to old age. F1000 Biol Rep. 2009
May 28; 1. pii: 42. [PubMed: 20948643]
11. Taub DD, Murphy WJ, Longo DL.
Rejuvenation of the aging thymus:
growth hormone-mediated and ghrelinmediated signaling pathways. Curr Opin
Pharmacol. 2010 Aug; 10(4):408–424.
[PubMed: 20595009]
Patent Status: U.S. Patent Application
No. 11/596,310 filed 06 Jun 2008 (HHS
Reference No. E–016–2004/0–US–07)
and related international applications.
Licensing Status: Available for
licensing.
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Dated: March 29, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–7925 Filed 4–1–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
Diagnostic and Prognostic Serum
Biomarkers for Cancer Patients Treated
With Cancer Vaccines
Description of Technology: Although
antibodies are a critical element of the
immune response, the role of antibody
responses in cancer vaccines is still
unknown. Carbohydrate antigens, which
are directly or indirectly involved in
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most types of cancer vaccines, are a
class of antigens that has been largely
understudied but play a significant role
in the immune response of cancer
vaccines.
This invention involves the
identification of serum biomarkers for
cancer that target carbohydrate antigens.
The biomarkers are specific subpopulations of serum antibodies present
in the serum of patients that bind to
various glycan and/or glycoprotein
antigens, such as the Forssman antigen.
The biomarkers are useful for (a)
predicting a patient’s immune responses
to a cancer vaccine, (b) measuring the
efficacy of a cancer vaccine, and (c)
determining the prognosis and longterm survival of cancer patients.
Applications:
• Diagnostic and prognostic test to
monitor the progression and long-term
survival of cancer patients.
• Predictive indicator of cancer
patients’ immune response to a cancer
vaccine.
• Indicator to monitor the efficacy of
a cancer vaccine.
Advantages: The technology is backed
by clinical data.
Development Status: Preliminary
clinical data; validation studies are
ongoing (confirmed findings in two
independent patient groups).
Market: Cancer Vaccines are emerging
as the forefront treatment regimens for
several cancers. Provenge® was recently
approved by the FDA for the treatment
of prostate cancer. There are several
other cancer vaccines in clinical trials.
This technology can be developed
into a pioneering test, as no such test to
monitor prognosis and efficacy of cancer
vaccines currently exists in the market.
Inventors: Jeff Gildersleeve, et al.
(NCI).
Publications: No publications directly
related to this technology.
Patent Status:
• U.S. Provisional Application No.
61/371,537 filed August 6, 2010 (HHS
Reference No. E–234–2010/0–US–01).
• U.S. Provisional Application No.
61/443,955 filed February 17, 2011
(HHS Reference No. E–234–2010/1–US–
01).
Licensing Status: Available for
licensing.
Licensing Contact: Sabarni Chatterjee,
M.B.A., PhD; 301–435–5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Chemical Biology Laboratory, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize anti-glycan serum
antibodies as biomarkers for cancer or
E:\FR\FM\04APN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18561-18564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7925]
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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 Molecules for HIV Therapeutics: Fab, scFv, and Related Binding
Molecules Specific for HIV-1 Rev
Description of Invention: The invention offered for licensing and
commercial development is in the field of HIV therapeutics. More
specifically, the invention relates to methods and compositions for
treating and/or inhibiting HIV infection or any other lentivirus. The
invention describes the identification, though phage display, of a
chimeric rabbit/human anti-Rev Fab (SJS-R1) that can inhibit
polymerization of the HIV Rev protein and thus inhibit its normal
function in virus replication. The Fab binds with very high affinity to
a conformational epitope in the N-terminal half of HIV-1 Rev. The
corresponding single chain antibody (scFv) was also prepared and
characterized. Methods of making and using SJS-R1 Fab and SJS-R1 scFv,
and antibodies and antibody fragments that share at least one CDR with
SJS-R1 Fab, are provided. Specific described methods include methods of
preventing or reversing polymerization of HIV Rev, methods of reducing
infectivity of replication of a lentivirus, inhibiting Rev function in
a cell infected with a lentivirus, and methods of treating a
[[Page 18562]]
disease or symptom associated with Rev expression in an animal.
Applications: HIV therapeutics.
Advantages
The invention utilizes a novel target and thus can be
effective in conjunction with other HIV drugs.
The chimeric structure of the Fab makes it possible to
produce it in rabbit in high yields while being readily applicable for
human treatment.
Development Status: The therapeutic molecules have been produced
and their strong affinity to Rev and its inhibitory effect on HIV
proliferation was demonstrated.
Inventors: Stephen J. Stahl (NIAMS) et al.
Patent Status: U.S. Provisional Application No. 61/439,307 filed
February 3, 2011 (HHS Reference No. E-064-2011/0-US-01), entitled
``Generation and Use of Fab, scFv, and Related Binding Molecules
Specific for HIV-1 Rev.''
Related Publications
1. Stahl SJ, Watts NR, Rader C, DiMattia MA, Mage RG, Palmer I,
Kaufman JD, Grimes JM, Stuart DI, Steven AC, Wingfield PT. Generation
and characterization of a chimeric rabbit/human Fab for co-
crystallization of HIV-1 Rev. J Mol Biol. 2010 Apr 2;397(3):697-708.
[PubMed: 20138059]
2. DiMattia MA, Watts NR, Stahl SJ, Rader C, Wingfield PT, Stuart
DI, Steven AC, Grimes JM. Implications of the HIV-1 Rev dimer structure
at 3.2 A resolution for binding to the Rev response element. Proc Natl
Acad Sci U S A. 2010 Mar 30;107(13):5810-5814. [PubMed: 20231488]
Licensing Status: Available for licensing and commercial
development.
Licensing Contacts
Uri Reichman, PhD, MBA; 301-435-4616; UR7a@nih.gov.
John Stansberry, PhD; 301-435-5236; js852e@nih.gov.
Collaborative Research Opportunity: The National Institute of
Arthritis and Musculoskeletal and Skin Diseases, Protein Expression
Laboratory is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize the technology. Please contact Cecilia Pazman, PhD at
301-402-5579 for more information.
Modulation of Leucine-Rich Repeats and Calponin Homology Domain-
Containing Protein 4 (Lrch4) Activity for Therapeutic Applications
Description of Invention: NIH Inventors have recently discovered a
novel Leucine-rich repeat and calponin homology domain-containing
protein 4 (Lrch4) in a proteomic screen of the plasma membrane of
lipopolysaccharide (LPS)-exposed macrophages. Expression data by RT-PCR
revealed that all Lrch family members (1-4) are expressed in
macrophages, but only Lrch4 was recruited into lipid rafts (signaling
microdomains of the plasma membrane) by LPS. Lrch4 is the most highly
expressed Lrch family member in mouse tissues. It is a predicted
single-spanning transmembrane protein that is encoded by the Lrch4 gene
in humans. The Lrch4 ectodomain is predicted to have a series of
leucine-rich repeats, the motifs by which Toll like Receptors (TLR) are
thought to bind microbial ligands. The human form of Lrch4 is 83%
identical to murine Lrch4 and is predicted to have 680 amino acids and
a molecular weight of 73 kDa.
NIH inventors have shown that Lrch4 is expressed on the plasma
membrane of macrophages. They have determined that Lrch4 regulates pro-
inflammatory signals (NF-[kappa]B activation, cytokine induction)
emanating from all TLRs tested, and also regulates ligand-independent
signals from MyD88. Further, LPS-induced p38, JNK, and NF[kappa]B
activation are attenuated following Lrch4 knockdown, indicating that
Lrch4 regulates upstream LPS signaling events. LPS-induced expression
of the NF-[kappa]B-dependent cytokine TNF[alpha] was attenuated
following Lrch4 knockdown at the level of both transcript and protein.
Based on these and other findings, the inventors of this technology
propose that Lrch4 may be a novel component of TLR receptor complexes
and that modulation of Lrch4 activity might open up new opportunities
for developing novel therapeutics for inflammatory diseases.
Applications: Identification and development of modulators of Lrch4
activity to treat inflammatory disorders, cancer, and sepsis.
Development Status: Early-stage.
Inventors: Michael B. Fessler, et al. (NIEHS).
Related Publication: Dhungana S et al. Quantitative proteomics
analysis of macrophage rafts reveals compartmentalized activation of
the proteasome and of proteasome-mediated ERK activation in response to
lipopolysaccharide. Mol Cell Proteomics 2009 Jan; 8(1):201-213.
[PubMed: 18815123]
Patent Status: U.S. Provisional Application No. 61/433,491 filed 17
January 2011 (HHS Reference No. E-012-2011/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Suryanarayana Vepa, PhD, J.D.; 301-435-5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Environmental Health Sciences (NIEHS) Laboratory of Respiratory Biology
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize Lrch4. Please contact Dr. Elizabeth M. Denholm at
denholme@niehs.nih.gov for more information.
Superparamagnetic Nanocomplexes and Their Use as Contrast Agents in MRI
Description of Invention: The invention offered for licensing and
commercial development relates to the fields of cell therapy and
tracking of such therapy by magnetic resonance imaging. More
specifically the technology describes novel superparamagnetic magnetic
resonance contrast agents, methods of making the agents, and methods of
labeling cells with the contrast agents and imaging the labeled cells
using magnetic resonance.
The self assembled agents are composed of three (3) components:
Superparamagnetic iron oxide nanoparticle (e.g. F3O4), associated with
a carbohydrate coating (e.g., a polycation (e.g., Protamine Sulfate);
and a polycation (e.g., glycosaminoglycan:Heparin). Self-assembling
superparamagnetic nanocomplexes made from simple commercially available
chemicals such as Heparin sulfate (H), Protamine sulfate (P), and
Ferumoxytol nanocomplexes (HPF nanocomplexes) can effectively label
stem cells, immune cells, tumor cells, or any other therapeutically
engineered cells for cellular MRI. Biological cells can be labeled with
the nanocomplexes by contacting cells under conditions sufficient to
produce the nanocomplexes, or by contacting the cells with pre-
assembled nanocomplexes. The labeled biological cells can be
transplanted into an individual, imaged by MRI and the migration
pattern and/or cellular distribution pattern of the labeled biological
cells in the subject can then be detected. This technique will readily
facilitate the tracking of the therapeutic cells, and thus render cell-
based therapy and/or tissue repair more precise, accurate and
effective.
Applications
Clinical--
Cell-based therapy (e.g. stem cells, or immune cells
therapy, genetic engineered cells); monitoring and
[[Page 18563]]
detecting cell trafficking and distribution.
Diagnostics.
Research--
Cell-based therapy.
Tissue regeneration.
Advantages
Avoid radioactive labeling.
More efficient cell incorporation than the use of
noncomplexed paramagnetic or superparamagnetic particles.
Non toxic.
Easily prepared from three (3) commercially available FDA
approved drugs off label. No synthesis is required (self assembled).
No FDA approved MRI contrast agent containing paramagnetic
or superparamagnetic iron oxide nanoparticles.
Development Status
The labeling complex has been repeatedly prepared. May
require some further optimization for specific cell products and scale
up.
Incorporation into mammal cells has been demonstrated.
Market: The total U.S. market for imaging reagents was $2.8 billion
in 2003 and is expected to grow to $4.5 billion by 2010 at an average
annual growth rate of 6.9%. Sales of MRI reagents for cardiovascular
applications were $770 million in 2003 and are expected to rise at an
average annual growth rate of 7.0%. Reagents used in oncology and
gastrointestinal tract are rising at average annual growth rates of
7.0% and 5.1%, respectively. The subject technology maybe readily
applied in both diagnostics and therapeutic fields. A commercial
development of the subject technology may therefore be attractive for
commercial organizations.
Inventors: Joseph A. Frank et al. (CC).
Patent Status: U.S. Provisional Application No. 61/439,106 filed
February 3, 2011 (HHS Reference No. E-285-2010/0-US-01), entitled
``Superparamagnetic Nanocomplexes, Articles, and Methods of Use
Thereof''.
Relevant Publications
1. Frank JA, Anderson SA, Kalsih H, Lewis BK, Yocum GT, Arbab AS.
Methods for magnetically labeling stem and other cells for detection by
in vivo magnetic resonance imaging. Cytotherapy. 2004; 6(6):621-625.
[PubMed: 15773025]
2. Arbab AS, Liu W, Frank JA. Cellular magnetic resonance imaging:
current status and future prospects. Expert Rev Med Devices. 2006
Jul;3(4):427-439. [PubMed: 16866640]
Licensing Status: Available for licensing and commercial
development.
Licensing Contacts
Uri Reichman, PhD, MBA; 301-435-4616; UR7a@nih.gov.
John Stansberry, PhD; 301-435-5236; js852e@nih.gov.
Collaborative Research Opportunity: The Clinical Center, Frank
Laboratory, Radiology and Imaging Sciences, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact Joseph A. Frank MS MD at 301-402-4314 or
jafrank@helix.nih.gov for more information.
Methods of Treating Age-Related Macular Degeneration
Description of Invention: Available for licensing is a novel method
of treating age related macular degeneration (AMD). AMD is the leading
cause of irreversible blindness in elderly populations worldwide.
Inflammation, among other factors, has been suggested to play an
important role in AMD pathogenesis. Recent studies have demonstrated a
link between the complement system, inflammation, and AMD pathogenesis.
Notably, researchers at NEI have shown that certain members of the C5a
pathway are increased in AMD patients, and in vitro experiments
demonstrated that those same pathway members cause a decrease in
retinal pigment epithelium (RPE) viability, a hallmark of AMD. Blocking
the C5a pathway presents a promising approach to prevent and treat AMD.
Application: Prevention and/or treatment of Age-related Macular
Degeneration.
Development Status: In vivo mouse studies are in progress to test
the effectiveness of the treatment.
Market: Age-related macular degeneration is a leading cause of
severe, irreversible vision impairment in developed countries (https://geteyesmart.org/eyesmart/diseases/amd.cfm). It is estimated that 1.8
million Americans 40 years and older are affected by AMD and an
additional 7.3 million with large drusen (yellow or white deposits
under the retina) are at substantial risk of developing AMD. The number
of people with AMD is estimated to reach 2.95 million in 2020. AMD is
the leading cause of permanent impairment of reading and fine or close-
up vision among people aged 65 years and older (https://www.cdc.gov/visionhealth/basic_information/eye_disorders.htm).
Inventors: Robert B. Nussenblatt et al. (NEI).
Patent Status: U.S. Provisional Application No. 61/429,580 filed 04
Jan 2011 (HHS Reference No. E-099-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
greenejaime@mail.nih.gov.
Methods for Inhibiting Proinflammatory Cytokine Expression Using
Ghrelin
Description of Invention: Ghrelin, an endogenous ligand for growth
hormone secretagogue receptors (GHS-R), is primarily produced by the
stomach but also by many other organs systems in the body (including
the immune system) serves as a potent circulating orexigen controlling
energy expenditure, adiposity and GH secretion. We have discovered that
ghrelin exerts anti-inflammatory effects via inhibiting the secretion
of both acute and chronic cytokines including IL-1, IL-6, TNF-alpha,
IFN-gamma, IL-12 p40, Il-17, various chemokines and CSFs in vitro in
human and murine cells as well as in vivo in murine models of sepsis,
inflammation and aging. We also found that ghrelin directly controls
human growth hormone and insulin growth factor expression by human
immune cells.
Applications: This invention is useful for treatment of various
inflammatory disorders including inflammatory bowel disease, Crohn's
disease, rheumatoid arthritis, multiple sclerosis, atherosclerosis,
endotoxemia and graft-versus-host disease.
Inventors: Vishwa D. Dixit and Dennis D. Taub (NIA).
Relevant Publications
1. Dixit VD, Schaffer EM, Pyle RS, Collins GD, Sakthivel SK,
Palaniappan R, Lillard JW Jr, Taub DD. Ghrelin inhibits leptin- and
activation-induced proinflammatory cytokine expression by human
monocytes and T cells. J Clin Invest. 2004 Jul; 114(1):57-66. [PubMed:
15232612] Note: Article highlighted in this issue of JCI. This was also
the subject of a Science SAGE KE News Focus article--M Leslie.
Opposites Detract. Sci Aging Knowl Environ. 2004 Jul 14; 28:nf65 [doi:
10.1126/sageke.2004.28.nf65].
2. Dixit VD, Weeraratna AT, Yang H, Bertak D, Cooper-Jenkins A,
Riggins GJ, Eberhart CG, Taub DD. Ghrelin and the growth hormone
secretagogue receptor constitute a novel autocrine pathway in
astrocytoma motility. J Biol Chem. 2006
[[Page 18564]]
Jun 16; 281(24):16681-16690. [PubMed: 16527811]
3. Dixit VD, Yang H, Sun Y, Weeraratna AT, Smith RG, Taub DD.
Ghrelin promotes thymopoiesis during aging. J Clin Invest. 2007 Oct;
117(10):2778-2790. [PubMed: 17823656] Note: Article highlighted in this
issue of JCI.
4. Yang H, Dixit VD, Patel K, Vandanmagsar B, Collins G, Sun Y,
Smith RG, Taub DD. Reduction in hypophyseal growth hormone and
prolactin expression due to deficiency in ghrelin receptor signaling is
associated with Pit-1 suppression: relevance to the immune system.
Blood Behav Immun. 2008 Nov; 22(8):1138-1145. [PubMed: 18602461]
5. Dixit VD, Yang H, Cooper-Jenkins A, Giri BB, Patel K, Taub DD.
Reduction of T cell-derived ghrelin enhances proinflammatory cytokine
expression: implications for age-associated increases in inflammation.
Blood. 2009 May 21; 113(21):5202-5205. [PubMed: 19324904]
Relevant Reviews
6. Dixit V and Taub DD. Ghrelin and immunity: a young player in an
old field. Exp. Gerontol. 2005 Nov; 40(11):900-910. [PubMed: 16233968]
7. Taub DD. Novel connections between the neuroendocrine and immune
systems: the ghrelin immunoregulatory network. Vitam Horm. 2008;
77:325-346. [PubMed: 17983863]
8. Taub DD. Neuroendocrine interactions in the immune system. Cell
Immunol. 2008 Mar-Apr; 252(1-2):1-6. [PubMed: 18619587] Note: Image
from article used on the cover of this issue.
9. Redelman D, Welniak LA, Taub D, Murphy WJ. Neuroendocrine
hormones such as growth hormone (GH) and prolactin (PRL) are integral
members of the immunological cytokine network. Cell Immunol. 2008 Mar-
Apr; 252(1-2):111-121. [PubMed: 18313040]
10. Patel K and Taub DD. Role of neuropeptides, hormones, and
growth factors in regulating thymopoiesis in middle to old age. F1000
Biol Rep. 2009 May 28; 1. pii: 42. [PubMed: 20948643]
11. Taub DD, Murphy WJ, Longo DL. Rejuvenation of the aging thymus:
growth hormone-mediated and ghrelin-mediated signaling pathways. Curr
Opin Pharmacol. 2010 Aug; 10(4):408-424. [PubMed: 20595009]
Patent Status: U.S. Patent Application No. 11/596,310 filed 06 Jun
2008 (HHS Reference No. E-016-2004/0-US-07) and related international
applications.
Licensing Status: Available for licensing.
Licensing Contact: Sally H. Hu, PhD, M.B.A.; 301-435-5606;
hus@mail.nih.gov.
Collaborative Research Opportunity: The National Institute on Aging
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize Methods of Inhibiting Proinflammatory Cytokine Expression
Using Ghrelin. Please contact Nikki Guyton at 301-435-3101 or
guytonn@mail.nih.gov for more information.
Dated: March 29, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-7925 Filed 4-1-11; 8:45 am]
BILLING CODE 4140-01-P
