[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Pages 56658-56660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22497]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
FOR FURTHER INFORMATION CONTACT: 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.
Image Analysis Software for Quantitative Evaluation of Striation
Patterns and Their Defects in Skeletal Muscles
Description of Technology: Available for licensing is software
written in MatLab for evaluating striation patters in images of
skeletal muscle fibers for better sensitivity in the quantitation of
skeletal muscle disorders. Skeletal muscles have a regular, periodic
organization (the periodicity of the sarcomeres), which is not only
structural but also functional. Muscle pathologies create disorder in
the normally periodic myofibrils. Objective grading of muscle
morphology is necessary to assess muscle health, compare biopsies, and
evaluate treatments and the evolution of disease.
Potential Commercial Applications: Drug development for muscular
disorders.
Competitive Advantages: Automated analysis of sarcomere dysplasia
for objective grading of muscle morphology.
Development Stage: Prototype.
Inventors: Wenhua Liu and Evelyn Ralston (NIAMS).
Publications:
1. Plotnikov SV, et al. Measurement of muscle disease by
quantitative second-harmonic generation imaging. J Biomed Opt. 2008
Jul-Aug;13(4):044018. [PMID 19021346].
2. Friedrich O, et al. Microarchitecture is severely compromised but
motor protein function is preserved in dystrophic mdx skeletal
muscle. Biophys J. 2010 Feb 17;98(4):606-16. [PMID 20159157].
3. Llewellyn ME, et al. Minimally invasive high-speed imaging of
sarcomere contractile dynamics in mice and humans. Nature 2008 Aug
7;454(7205):784-8. [PMID 18600262].
Intellectual Property: HHS Reference No. E-264-2012/0--Software
Research Tool. Patent protection is not being pursued for this
technology.
Licensing Contact: Michael Shmilovich; 301-435-5019;
[email protected].
Collaborative Research Opportunity: The Light Imaging Section of
NIAMS, NIH, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize software for image analysis of cells and
tissues and skeletal muscle. For collaboration opportunities, please
contact Wenhua Liu at [email protected] or 301-451-4815.
Capillary Viscometer for Measuring Viscosity of Macromolecular
Solutions of Biological Relevance
Description of Technology: A capillary-based device and system for
measuring the rheological properties of solutions of synthetic and
biological polymers. The device automatically serially dilutes and
varies the flow rate of a sample, permitting measurement of solution
viscosity across wide ranges of concentration and shear rate without
changing samples. The device can rapidly and accurately assay solute
stability, solute-solvent and solute-solute interactions in solutions
of proteins and other macromolecules of biotechnological and
pharmaceutical interest, as well as solution injectability.
Potential Commercial Applications: Rapid characterization of
composition-dependent rheological properties of candidate
biopharmaceuticals and industrial polymers.
Competitive Advantages:
Automatic variation of solute concentration
Automatic variation of shear rate
Direct measurement of solution injectability
Development Stage:
Prototype
In vitro data available
Inventors: Allen Minton and Asaf Grupi (NIDDK).
Intellectual Property: HHS Reference No. E-231-2012/0--US
Provisional Application No. 61/691,209 filed 20 Aug 2012.
Licensing Contact: Michael Shmilovich; 301-435-5019;
[email protected].
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize automated
capillary viscometer. For collaboration opportunities, please contact
Allen P. Minton at [email protected] or Asaf Grupi at
[email protected].
Use of Erythropoietin and Derivatives for Treatment of Hypertension
Description of Technology: Erythropoietin (EPO), a natural hormone
produced by kidneys is associated with stimulation of red blood cell
production. Recombinant human erythropoietin (rhEPO) is currently used
for treatment of anemia and has powerful cardioprotective properties.
Hypertension remains a major health problem and a serious risk factor
for stroke and chronic heart failure. Researchers at the NIH have
discovered that administering a therapeutically effective dose of rhEPO
or an EPO derivative including carbamylated erythropoietin (CEPO) and
Helix B surface peptide (HBSP), have an acutely reducing both systolic
and diastolic blood pressure, via Nitric Oxide (NO) signaling. Long-
term administration of derivative of EPO, HBSP, prevents elevation of
arterial blood pressure in an animal model of hypertension. Unlike
long-term treatment with rhEPO, administration of EPO derivatives, such
as HBSP, does not stimulate excessive red cell production and will be
useful in the development of anti-hypertensive drugs.
Potential Commercial Applications: Therapeutics for treatment of
hypertension.
Competitive Advantages:
Administration of EPO and derivatives does not stimulate
excessive red blood cell production
This technology utilizes activation of natural
vasodilation mechanisms
[[Page 56659]]
rhEPO and EPO derivatives provide tissue-protective
properties, which none of existing antihypertensive drugs does
Development Stage:
Early-stage
Pre-clinical
In vitro data available
Inventors: Mark Talan, Ismayil Ahmet, Edward Lakatta (all of NIA).
Publication: Ahmet I, et al. Acute hemodynamic effects of
erythropoietin do not mediate its cardioprotective properties. Biolog
Open 2012, in press.
Intellectual Property:
HHS Reference No. E-158-2012/0--U.S. Provisional
Application No. 61/636,547 filed 20 Apr 2012
HHS Reference No. E-158-2012/1--U.S. Provisional
Application No. 61/638,328 filed 25 Apr 2012
HHS Reference No. E-158-2012/2--U.S. Provisional
Application No. 61/656,698 filed 07 Jun 2012
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
[email protected].
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
new anti-hypertensive drug based of non-erythropoietic derivatives of
erythropoietin that combines vasodilative and tissue protective
properties. For collaboration opportunities, please contact Vio Conley,
M.S. at [email protected].
High-Affinity Mouse Monoclonal Antibodies to Glypican-3 (GPC3) for
Treatment of Cancer
Description of Technology: Liver cancer is the fifth most common
cancer in the world, with hepatocellular cancer (HCC) representing the
preponderance of these liver cancers. As with many cancers, positive
prognosis for a patient diagnosed with HCC correlates with the early
detection of the disease. Unfortunately, HCC is usually detected at a
late stage in its development, leading to poor prognosis for most
patients. As a result, there is great interest and value in developing
new agents which can detect the presence of HCC in a patient at an
early stage.
Glypican-3 (GPC3) is a cell surface heparan sulfate glycoprotein
that is expressed on the vast majority of HCC cells. The correlation
between GPC3 expression and HCC makes GPC3 an attractive candidate for
studying the disease progression and treatment of HCC. The presence,
progression and treatment of this disease can potentially be monitored
by tracking the level of expression of GPC3 on cells. This can be
accomplished using monoclonal antibodies which recognize only GPC3,
particularly the cell surface domain of the protein. This invention
concerns the generation of several monoclonal antibodies that are
specific for the cell surface domain of GPC3 (YP6, YP7, YP8, YP9 and
YP9.1), and which can be used either as therapeutic candidates for
treating GPC3-related diseases or as research reagents for studying the
role of GPC3 in HCC.
Potential Commercial Applications: Monoclonal antibodies for use as
therapeutics, including:
Treatment of HCC as a stand-alone antibody
Treatment of HCC as an antibody-drug conjugate, such as an
immunotoxin Antibodies for use as research materials, including:
Detection of cells that express GPC3 for monitoring HCC
disease progression and treatment
Immunostaining for tumor imaging
ELISA and immunohistochemistry applications
Any other antibody-related research use, including
immunoprecipitation, western blot analysis, etc.
Competitive Advantages:
Higher binding affinity (subnanomolar levels) than
commercially available GPC3 antibodies such as 1G12
Increased binding activity potentially improves
therapeutic value through improved specificity and lower effective drug
concentrations
Recognition of cells with low levels of GPC3 expression
Able to bind to wild-type GPC3 (conjugated to heparan
sulfate) better than the GPC3 core protein (lacking heparan sulfate)
Development Stage:
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Mitchell Ho et al. (NCI).
Publications:
1. Ho M, Kim H. Glypican-3: A new target for cancer immunotherapy.
Eur J Cancer. 2011 Feb;47(3):333-8. [PMID 21112773].
2. Ho M. Advances in liver cancer antibody therapies: A focus on
glypican-3 and mesothelin. BioDrugs. 2011 Oct 1;25(5):275-84. [PMID
21942912].
3. Phung Y, et al. High-affinity monoclonal antibodies to cell
surface tumor antigen glypican-3 generated through a combination of
peptide immunization and flow cytometry screening. MAbs. 2012 Sep
1;4(5):592-9. [PMID: 22820551].
Intellectual Property: HHS Reference No. E-136-2012/0--U.S.
Provisional Application No. 61/654,232 filed 01 Jun 2012.
Related Technology: HHS Reference No. E-130-2011/0--U.S.
Provisional Application No. 61/477,020 filed 19 Apr 2011; PCT
Application No. PCT/US2012/034186 filed 19 Apr 2012.
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
[email protected].
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
liver cancer therapy and diagnostics, humanization, antibody drug/toxin
conjugates. For collaboration opportunities, please contact John Hewes,
Ph.D. at [email protected].
New Targeted Therapy for Acute Myeloid Leukemia and Acute Lymphoblastic
Leukemia
Description of Technology: The invention describes the use of
benzodiazepine compounds for the treatment of acute myeloid leukemia
(AML) and acute lymphoblastic leukemia (ALL). Specifically, the
compounds can be used to treat core binding factor (CBF) leukemias,
which are a subgroup of leukemia associated with the generation of
fusion genes, arising from the binding between the transcription
factors: Core binding factor-beta (CBF?) and runt-related transcription
factor 1 (RUNX1). The compounds described in this invention have been
found to inhibit the binding of CBF[beta] and RUNX1, resulting in
selectively killing leukemia cells in culture and suppressing leukemia
in a mouse model.
In addition, the binding of runt-related transcription factors from
the RUNX family have been implicated in the development of other
diseases, including (but not limited to): Platelet disorders, solid
tumours (e.g., lymphoma, breast cancer, osteosarcoma) and bone diseases
(e.g., osteoporosis, cleidocranial dysplasia and intervertebral disk
degeneration). Thus, the use of these compounds may represent new
targeted therapies for AML and ALL as well as other RUNX-related
disorders.
Potential Commercial Applications:
Targeted drug therapies for AML and ALL.
Combination chemotherapies for AML and ALL.
Therapies for other RUNX related disorders, including
platelet disorders, solid tumours (e.g., lymphoma, breast cancer,
osteosarcoma) and bone diseases
[[Page 56660]]
(e.g., osteoporosis, cleidocranial dysplasia and intervertebral disk
degeneration).
Competitive Advantages:
Proof of concept demonstrated in a mouse model.
Compounds have been previously tested in clinical studies
for anti-HIV drugs.
Development Stage:
Early-stage.
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: Pu Paul Liu (NHGRI), Wei Zheng (NCATS), Juan J. Marugan
(NCATS), Noel T. Southall (NCATS), Lea Cunningham (NCI).
Publication: Cunningham L, et al. Identification of benzodiazepine
Ro5-3335 as an inhibitor of CBF leukemia through quantitative high
throughput screen against RUNX1-CBF[beta] interaction. Proc Natl Acad
Sci USA. 2012 Sep 4;109(36):14592-7. [PMID 22912405].
Intellectual Property: HHS Reference No. E-060-2011/0--
U.S. Provisional Application No. 61/453,863 filed 17 Mar
2011
PCT Application No. PCT/US2012/029169 filed 15 Mar 2012
Licensing Contact: Sabarni K. Chatterjee, Ph.D.; 301-435-5587;
[email protected].
Collaborative Research Opportunity: The National Human Genome
Research Institute (NHGRI), Oncogenesis and Development Section, is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
benzodiazepine compounds described above to treat CBF leukemia, AML,
ALL, and/or other RUNX-related disorders. Please contact Claire T.
Driscoll, Director of NHGRI Technology Transfer Office
([email protected]; 301-594-2235) for more information.
Novel Methods for Using Biomarkers To Monitor Glucose Levels and Screen
for Diabetes Risk
Description of Technology: A primary goal of diabetes therapy is to
improve control of blood glucose levels (known as glycemic control) in
patients. Prospective studies of both Type 1 and Type 2 diabetes
indicate that careful glycemic control significantly reduces the risk
of microvascular, neurological, and cardiovascular complications of
diabetes. The current method of monitoring glycemic control involves
measuring levels of the intracellular hemoglobin (HbA1C). However,
levels of HbA1C reflect glycemic control over a timeframe of several
months and are susceptible to a variety of perturbing factors such as
hematologic disorders, kidney disease, aspirin or penicillin use, or
alcohol intake.
This technology describes a family of novel glycated peptide and
protein biomarkers for glycemic control, as well as a method to monitor
glycemic control in diabetic patients. In contrast to intracellular
HbA1C, this technology detects glycated plasma proteins, which may
reflect changes in glycemic control more rapidly and with more
sensitivity. A diagnostic test developed using this technology could be
envisioned to supplement or replace current HbA1C-based glycemic
monitoring and screen individuals for risk of diabetes.
Potential Commercial Applications:
Diagnostic test to measure glycemic control in diabetic
patients
Diagnostic test to screen patients for risk of developing
diabetes
Competitive Advantages:
Detects plasma proteins rather than intracellular markers
May provide more rapid and sensitive detection than
currently used methods
Development Stage:
Early-stage
In vitro data available
Inventor: Perry J. Blackshear (NIEHS).
Intellectual Property: HHS Reference No. E-057-2005/0--
PCT Application No. PCT/US2007/063385 filed 06 Mar 2007
U.S. Application No. 12/281,909 filed 27 Oct 2008
Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426;
[email protected].
A Novel Glucocorticoid Receptor Cofactor for Use as an Adjunct to
Steroid-Based Therapies
Description of Technology: Methods of using STAMP (SRC-1 and TIF-2
Associated Modulatory Protein) polypeptides for modulating steroid or
nuclear receptor activity, alone or in combination with a steroid or
nuclear receptor modulator. The novel protein, STAMP, modulates the
trans-activation properties of glucocorticoid receptors and other
steroid receptors. STAMP may be useful as a steroid-sparing agent for
decreasing the severity of unwanted side-effects during steroid
treatment, particularly in long-term treatment for chronic disease.
Steroid hormones such as androgens and glucocorticoids are used in
the treatment of many diseases. They act to regulate many physiological
responses by binding to steroid receptors. However, because steroid
receptors are expressed in many tissues, efforts to therapeutically
modify the effects of steroid hormones on a specific tissue or on a
specific receptor of the steroid receptor family often cause
undesirable effects in other tissues or on other receptors.
Potential Commercial Applications: Adjunct to steroid-based
therapies for diseases such as arthritis, asthma, inflammatory and
autoimmune diseases.
Competitive Advantages:
Reduce the severity of unwanted side-effects from
conventional steroid hormone therapies.
Particularly beneficial for long-term therapies.
Development Stage:
Early-stage
In vitro data available
Inventors: S. Stoney Simons and Yuanzheng He (NIDDK).
Publications:
1. He Y, et al. STAMP alters the growth of transformed and ovarian
cancer cells. BMC Cancer. 2010 Apr 7;10:128. [PMID 20374646]
2. He Y, Simons SS Jr. STAMP, a novel predicted factor assisting
TIF2 actions in glucocorticoid receptor-mediated induction and
repression. [PMID 17116691]
3. He Y, et al. Modulation of induction properties of glucocorticoid
receptor-agonist and -antagonist complexes by coactivators involves
binding to receptors but is independent of ability of coactivators
to augment transactivation. [PMID 12376547]
Intellectual Property: HHS Reference No. E-056-2004/0--U.S. Patent
No. 7,867,500 issued 11 Jan 2011.
Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426;
[email protected].
Dated: September 7, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-22497 Filed 9-12-12; 8:45 am]
BILLING CODE 4140-01-P