[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34392-34393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14038]


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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: 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.

Treatment of Viral Infection by Blocking Interleukin-21

    Description of Technology: Blocking interleukin (IL-21) may be an 
effective method to treat or prevent various viral infections. In the 
course of an immune response to a virus, IL-21, produced primarily by 
CD4+ T cells, can inhibit or stimulate (regulate), immune 
cell function (B cells, T cells, natural killer cells, dendritic 
cells). IL-21 regulation may be either protective or pathological; 
autoimmune disease pathology has been associated with IL-21 promoted 
inflammation (in: Type 1 diabetes, lupus, and multiple sclerosis). This 
technology describes methods of blocking IL-21 that may reduce damaging 
inflammatory responses during certain viral infections. Specifically, 
the absence of IL-21 during respiratory viral infection such as 
pneumonia virus infection actually prevents some of the pathogenic 
effects that may be promoted by IL-21. Methods for controlling IL-21 
signaling may be used to treat to prevent many pathological effects of 
pneumonia viruses, and other viral infections.
    Potential Commercial Applications: Prevention and treatment of many 
pathological effects of viral infections, including pneumonia.
    Competitive Advantages: New method for treating viral infection 
pathology.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vivo data available (animal).
    Inventors: Warren J. Leonard and Rosanne Spolski (NHLBI).
    Publication: Spolski R, et al. IL-21 promotes the pathologic immune 
response to pneumovirus infection. J Immunol. 2012 Feb 15;188(4):1924-
32. [PMID 22238461].
    Intellectual Property: HHS Reference No. E-017-2012/0--U.S. 
Provisional Application No. 61/579,801 filed 23 Dec 2011.
    Licensing Contact: Tedd Fenn; 301-435-5031; Tedd.Fenn.nih.gov.
    Collaborative Research Opportunity: The NHLBI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize treatment of 
viral infection by blocking Interleukin-21 (E-017-2012). For 
collaboration opportunities, please contact Vincent Kolesnitchenko, 
Ph.D. at [email protected].

[[Page 34393]]

Transgenic ZP2 Mouse Model Produces Eggs That Bind to Human Sperm 
Protein

    Description of Technology: Fertilizing sperm bind to an 
extracellular coat surrounding mammalian eggs called zona pellucida. 
Depending on the species, the zona pellucida is composed of ZP1, ZP2, 
ZP3, and/or ZP4 proteins. Recent studies show that sperm successfully 
adhere to the zona pellucida surface when ZP2 is intact. In contrast, 
when ZP2 has been proteolytically cleaved, sperm binding is disrupted.
    To further study the effect of ZP2 cleavage in sperm-egg 
recognition, researchers at NIDDK have developed a transgenic mouse 
expressing human ZP2. Prior attempts using ZP2 knockout mice were 
unsuccessful because the produced eggs were not fertile in vivo. 
Transgenic ZP2 mice produced humanized zonae pellucida, and produced 
fertile eggs to which human sperm successfully and specifically bound. 
This mouse model contradicts previous notions that production of human 
transgenic ZP2 would adversely change the specificity of sperm binding.
    Potential Commercial Applications:
     Transgenic eggs can be used in diagnostic functional 
assays to assess human sperm viability for reproductive technologies.
     Diagnostic assay can be extended to determine presence of 
male infertility in a variety of mammals, including pets, farm 
livestock, and zoological mammals.
    Competitive Advantages:
     This ZP2 mice model produces eggs containing transgenic 
mammalian zona pellucida, which can successfully and specifically be 
fertilized with the corresponding mammalian sperm.
     Use in human infertility studies spares the use of a human 
egg for binding studies.
    Development Stage:
     Prototype.
     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Tracy L. Rankin, Jenell S. Coleman, Olga Epifano, Tanya 
Hoodbhoy, Scott Turner, Jurrien Dean (all of NIDDK).
    Publications:

1. Rankin TL, et al. Fertility and taxon-specific sperm binding persist 
after replacement of mouse sperm receptors with human homologs. Dev 
Cell. 2003 Jul;5(1):33-43. [PMID 12852850].
2. Gahlay G, et al. Gamete recognition in mice depends on the cleavage 
status of an egg's zona pellucida protein. Science. 2010 Jul 
9;329(5988):216-9. [PMID 20616279].

    Intellectual Property: HHS Reference No. E-288-2011/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Related Technology: HHS Reference No. E-162-2011/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; [email protected].

Englerin A: A Novel Renal Cancer Therapeutic Isolated From an African 
Plant

    Description of Technology: Renal cell cancer of the kidney accounts 
for 13 thousand deaths per year, largely due to the ineffective 
treatment methods available. The current standard of care is limited to 
surgical resection of the diseased tissue and to date chemotherapy/
radiation intervention has been of limited effectiveness.
    Researchers at the NIH have isolated a series of novel natural 
compounds from the African plant Phyllanthus engleri that display 
potent anti-cancer properties, particularly in renal cancer cell lines. 
Englerin A displays renal cancer cell line growth inhibition in vitro 
and efficacy against renal and prostate cancer cell lines in vivo. The 
compound can be efficiently extracted from the plant, and recent work 
has described methods for the synthesis of Englerin A and novel 
analogs.
    Further preclinical studies have yielded an optimized formulation 
for parenteral drug administration, the establishment of a method for 
measuring bioavailability, and modeling studies suggestive that 
Englerin A should be orally bioavailable.
    Potential Commercial Applications: The new chemical entities can be 
potential cancer therapeutics, especially for renal cancer.
    Competitive Advantages:
     Isolated compounds are specifically toxic to renal cancer 
cells, a disease with limited current chemotherapeutic options.
     Compounds are effective in vivo and have potential 
applications to other disease states.
     There is reasonable yield and recovery of the compounds 
from the natural product extracts.
     Recent work has identified efficient routes for synthesis 
of Englerin A.
    Development Status:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: John A. Beutler et al. (NCI).
    Publications:

1. Ratnayake R, et al. Englerin A, a selective inhibitor of renal 
cancer cell growth, from Phyllanthus engleri. Org Lett. 2009 Jan 
1;11(1):57-60. [PMID 19061394].
2. Li Z, et al. A brief synthesis of (-)-englerin A. J Am Chem Soc. 
2011 May 4;133(17):6553-6. [PMID 21476574].
3. Akee R, et al. Chlorinated englerins with selective inhibition of 
renal cancer cell growth. J Nat Prod. 2012 Mar 23;75(3):459-63. [PMID 
22280462].

    Intellectual Property: HHS Reference No. E-064-2008/2--U.S. Patent 
Application No. 12/811,245 filed 29 Jul 2010.
    Related Technology: HHS Reference No. E-042-2012/0--U.S. 
Provisional Application No. 61/584,526 filed 09 Jan 2012, ``Use of 
Englerin A for the Treatment of Diabetes, Obesity and Other Diseases.''
    Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Molecular Targets Development Program is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize epoxy-guaiane 
cancer inhibitors. Please contact John D. Hewes, Ph.D. at 301-435-3121 
or [email protected] for more information.

    Dated: June 5, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-14038 Filed 6-8-12; 8:45 am]
BILLING CODE 4140-01-P