[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59039-59040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23231]


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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, 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. 209 and 37 CFR Part 404 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.

Small Interfering RNA Knock-Down of Cannabinoid-1 Receptor (CB1R) for 
the Treatment or Prevention of Type-2 Diabetes

    Description of Technology: Endocannabinoids (EC) are lipid 
signaling molecules that act on the same cannabinoid receptors that 
recognize and mediate the effects of marijuana. Activation of the EC 
receptor CB1R has been shown to play a key role in the development of 
obesity and its metabolic consequences, including insulin resistance 
and type 2 diabetes. Researchers at NIH have now demonstrated in the 
Zucker diabetic fatty (ZDF) rat model of type-2 diabetes that beta-cell 
loss is caused by the CB1R-mediated activation of a macrophage-mediated 
inflammatory response. They have further demonstrated that treatment of 
ZDF rats with a peripheral CB1R antagonist restores normoglycemia and 
preserves beta-cell function and that similar results were seen 
following selective in vivo knockdown of macrophage CB1R by daily 
treatment of ZDF rats with D-glucan-encapsulated CB1R Small interfering 
RNA (siRNA). Therefore, knock-down of CB1R with siRNA may represent a 
new method of treating type-2 diabetes or preventing the progression of 
insulin resistance to overt diabetes.
    Potential Commercial Applications: Treatment of obesity, insulin 
resistance, and diabetes.
    Competitive Advantages: A new means of inhibiting the 
endocannabinoid receptor CB1R.
    Development Stage: In vivo data available (animal).
    Inventors: George Kunos (NIAAA), Tony Jourdan (NIAAA), Michael P. 
Czech (UMass Medical School), Myriam Aouadi (UMass Medical School).
    Intellectual Property: HHS Reference No. E-103-2013/0--US 
Application No. 61/839,239 filed June 25, 2013.
    Licensing Contact: Jaime M. Greene; 301-435-5559; 
[email protected].

Methods for the Treatment of AIDS and Other Retroviral Diseases Using 
Plant-Derived Compounds

    Description of Technology: Human immunodeficiency virus-1 (HIV-1) 
affects 1.4 million patients in the U.S. and over 33 million worldwide. 
While highly active antiretroviral therapy (HAART), the current 
standard of care, is effective in suppressing retroviral activity, cure 
has not been achieved due to the persistence of latently infected T 
cells in treated patients. An agent capable of sensitizing this T cell 
subpopulation concordant with HAART may add significant benefit to 
individuals with retroviral diseases.
    Researchers at the NIH have identified Englerin A and its 
derivatives as potent and specific activators of viral replication in 
infected T cells. Use of these compounds in conjunction with existing 
antiviral therapies has been described for the treatment of AIDS, adult 
T cell leukemia/lymphoma and other retroviral diseases.
    Intellectual property assets available for license include novel 
compositions of Englerin A along with methods of their use in the 
treatment of retroviral diseases.

Potential Commercial Applications

     Novel adjuvant therapy for the treatment of retroviral 
diseases such as AIDS or HTLV-induced leukemia/lymphoma.
     Therapeutic for the management of T lymphocytopenia.

Competitive Advantages

     Englerin A and its derivatives are potent and selective 
activator of protein kinase C theta in immune cells.
     Compounds are anticipated to have fewer off-target 
toxicities relative to currently available PKC activators (e.g., 
interleukins-2 and 7).
     Compounds are optimized for use in combination with 
clinically available antiviral agents.

Development Stage

     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Leonard Neckers, Marston Lineham, Carole Sourbier, Jane 
Trepel, Min-jung Lee, Bradley Scroggins, John Beutler (all of 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].

[[Page 59040]]

    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].
    4. Sourbier C, et al. Englerin A stimulates PKC theta to inhibit 
insulin signaling and to simultaneously activate HSF1: 
pharmacologically induced synthetic lethality. Cancer Cell. 2013 Feb 
11;23(2):228-37. [PMID 23352416].
    Intellectual Property: HHS Reference No. E-201-2012/0--US 
Application No. 61/726,975 filed November 15, 2012.

Related Technologies

     HHS Reference No. E-064-2008--``Englerin A: A Novel Renal 
Cancer Therapeutic Isolated from an African Plant.''
     HHS Reference No. E-042-2012--``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 
derivatives for retroviral therapy. For collaboration opportunities, 
please contact John D. Hewes, Ph.D. at [email protected].

Development of Immune System Tolerance for the Treatment of Autoimmune 
Disease

    Description of Technology: The present invention provides a 
therapeutic method for the treatment of autoimmune or autoinflammatory 
diseases by first breaking down the dysregulated immune system and then 
reprogramming the immune system to restore tolerance to the patient's 
self-antigens by induction of antigen specific regulatory T cells. The 
inventors have shown that only with the combination of apoptosis, 
phagocytes, and antigen can antigen-specific regulatory T cells 
(Treg) cells be optimally generated to develop long-term 
immune tolerance. This strategy for developing immune tolerance can be 
applied to the treatment of autoimmune diseases.
    Potential Commercial Applications: Treatment of autoimmune disease.
    Competitive Advantages: This technology represents a novel means of 
treating autoimmune disease.

Development Stage

     Early-stage.
     In vivo data available (animal).
    Inventors: Wanjun Chen (NIDCR), Shimpei Kassagi, Pin Zhang.
    Intellectual Property: HHS Reference No. E-186-2009/0--US 
Provisional Application No. 61/844,564 filed July 10, 2013.
    Licensing Contact: Jaime M. Greene; 301-435-5559; 
[email protected].

    Dated: September 19, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-23231 Filed 9-24-13; 8:45 am]
BILLING CODE 4140-01-P