[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]


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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.

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