[Federal Register Volume 71, Number 218 (Monday, November 13, 2006)]
[Notices]
[Pages 66176-66177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19050]


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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.

A Simian Immunodeficiency Virus Expressing HIV-1 Reverse Transcriptase 
for the Study of Antiviral Drug Resistance in Macaques

    Description of Technology: Antiviral drug-resistance is the primary 
source for the decreased efficacy of currently available human 
immunodeficiency virus-1 (HIV-1) therapies. The available material 
provides a model system in which to test new antiviral treatment 
efficacy as well as the development of multi-drug-resistance to HIV-1 
reverse transcriptase inhibitors, which is a widespread obstacle of 
existing antiretroviral therapies. This invention describes a simian 
immunodeficiency virus (SIV) that expresses HIV-1 reverse 
transcriptase. The available virus infects and replicates in macaques 
and has demonstrated use in the study of drug-resistance in an animal 
model. This technology represents an advantage over traditional SIVs, 
which are not susceptible to FDA-approved antiretroviral drugs and as a 
result cannot be used to study HIV drug-resistance in animals. Thus, 
the current research tool provides a novel resource for advancing the 
study of drug-resistance to antiretroviral therapy and has the 
potential to contribute to the development of innovative therapeutic 
agents that are successful against drug-resistant HIV strains.
    Application: Research and development of novel therapeutics for the 
treatment of drug-resistant HIV.
    Development Status: Biological Material is sufficient for use as a 
research tool.
    Inventors: Vineet N. KewalRamani and Zandrea Ambrose (NCI).
    Related Publication: Z Ambrose, V Boltz, S Palmer, JM Coffin, SH 
Hughes, VN KewalRamani. In vitro characterization of a simian 
immunodeficiency virus-human immunodeficiency virus (HIV) chimera 
expressing HIV type 1 reverse transcriptase to study antiviral 
resistance in pigtail macaques. J Virol. 2004 Dec;78(24):13553-13561.
    Patent Status: HHS Reference No. E-315-2006/0--Biological Material.
    Licensing Status: Available for non-exclusive licensing under a 
Biological Materials License Agreement.
    Licensing Contact: Sally Hu, PhD; 301/435-5606; [email protected].
    Collaborative Research Opportunity: The National Cancer Institute's 
HIV Drug Resistance Program is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize animal models in which to evaluate 
anti-HIV-1 therapy. Please contact Betty Tong, PhD at 301-594-4263 or 
[email protected] for more information.

Anti-H5N1 Influenza Activity of the Antiviral Protein Cyanovirin

    Description of Technology: Influenza A viral subtype H5N1 causes 
avian influenza and is currently the subject of increasing 
international attention. Usually, avian influenza infection is limited 
to birds and pigs; however H5N1 has the unique capacity to bring about 
severe illness and death in humans. H5N1 is highly contagious, fast 
spreading and rapidly evolving and therefore has the potential to cause 
a worldwide health epidemic.
    The available technology embodies methods of using a cyanovirin-N 
(CV-N) peptide, protein, or nucleic acid in the prevention and/or 
treatment of infection. Methods, which utilize CV-N in the treatment of 
certain influenza strains, have previously been demonstrated. However, 
the novel use of CV-N to treat the H5N1 strain is

[[Page 66177]]

unique and development of prophylactics and/or therapeutics against the 
virus represents a significant contribution to agriculture and public 
health sectors throughout the world.
    Application: Novel therapeutics for the treatment and prevention of 
avian influenza.
    Development Status: In vitro and early-stage animal studies have 
been performed.
    Inventors: Barry R. O'Keefe and James B. McMahon (NCI).
    Patent Status: U.S. Provisional Application No. 60/838,712 filed 18 
Aug 2006 (HHS Reference No. E-198-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Sally Hu, PhD; 301/435-5606; [email protected].
    Collaborative Research Opportunity: The NCI Molecular Targets 
Development Program is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize cyanovirin-N for use against H5N1 influenza. 
Please contact Betty Tong, PhD at 301-594-4263 or [email protected] 
for more information.

Methods for Treating Drug-Resistant HIV-1 Infection

    Description of Technology: Drug-resistance is a critical factor 
contributing to the loss of clinical benefit of currently available 
human immunodeficiency virus-1 (HIV-1) therapies. Accordingly, 
combination therapies have evolved to address the rapidly evolving 
virus. However, there has been great concern regarding the growing 
resistance of HIV-1 strains to current therapies as multi-drug 
resistance to protease inhibitors is becoming more common. The current 
technology embodies a breakthrough against this immense obstacle of 
existing HIV-1 treatments.
    Compositions and methods of inhibiting the protease of multi-drug 
resistant retroviruses such as HIV-1 are available for non-exclusive 
licensing and commercial development. The antiviral activity of the 
compound described by the current invention has been established 
against multi-protease inhibitor-resistant HIV-1 variants and 
demonstrated effective in patients with widespread resistance to 
currently available protease inhibitors. In addition, commercial 
development of this composition has resulted in the production of a 
novel drug that has recently been granted accelerated approval by the 
U.S. Food and Drug Administration (FDA) for the treatment of HIV-1 in 
patients who are non-responsive to existing antiretroviral therapies.
    The available composition retains the unique ability to inhibit 
drug resistant mutants due to its distinctive points of interaction 
with the enzyme: the agent tightly binds to the part of the protease 
substrate binding site, which the virus cannot easily change. Other 
``conventional'' protease inhibitors bind to other parts of the 
protease substrate binding site, which the virus can relatively easily 
change, rendering these drugs ineffective after repeated use. 
Therefore, the current technology represents a highly effective method 
of targeting drug resistant HIV-1 strains.
    Applications: (1) Novel therapeutics for the treatment of drug-
resistant HIV; (2) Safe and effective methods for administration of 
anti-HIV/AIDS drugs.
    Development Status: Clinical trials have been performed with 
PrezistaTM (darunavir), a drug resulting from development of 
the present technology, which has received accelerated approval from 
the FDA.
    Inventors: John W. Erickson (SAIC/NCI), Sergei V. Gulnik (SAIC/
NCI), Hiroaki C. Mitsuya (NCI), and Arun K. Ghosh.
    Related Publications:
    1. K Yoshimura, R Kato, MF Kavlick, A Nguyen, V Maroun, K Maeda, KA 
Hussain, AK Ghosh, SV Gulnik, JW Erickson, H Mitsuya. A potent human 
immunodeficiency virus type 1 protease Inhibitor, UIC-94003 (TMC 126), 
and selection of a novel (A28S) mutation in the protease active site. J 
Virol. 2002 Feb;76(3):1349-1358.
    2. Y Koh, K Maeda, H Ogata, G Bilcer, T Devasamudram, JF Kincaid, P 
Boross, Y-F Wang, Y Tie, P Volarath, L Gaddis, JM Louis, RW Harrison, 
IT Weber, AK Ghosh, H Mitsuya. Novel bis tetrahydrofuranyl-urethane-
containing nonpeptidic protease inhibitor (PI) UIC-94017 (TMC114) 
potent against multi-PI-resistant human immunodeficiency virus in 
vitro. Antimicrob Agents Chemother. 2003 Oct;47(10):3123-3129.
    3. AK Ghosh, PR Sridhar, S Leshchenko, AK Hussain, J Li, AY 
Kovalevsky, DE Walters, JE Wedekind, V Grum-Tokars, D Das, H Mitsuya. 
Structure-based design of novel HIV-1 protease inhibitors to combat 
drug resistance. J Med Chem. 2006 Aug 24; 49(17):5252-5261.
    4. AK Ghosh, P Ramu Sridhar, N Kumaragurubaran, Y Koh, IT Weber, H 
Mitsuya. Bis-tetrahydrofuran: a privileged ligand for darunavir and a 
new generation of HIV protease inhibitors that combat drug resistance. 
ChemMedChem. 2006 Sep;1(9):939-950.
    Patent Status: U.S. Patent Application No. 09/720,276 filed 07 Mar 
2001 (HHS Reference No. E-200-1998/0-US-02); European Patent 
Application No. 99931861.1 filed 23 Jun 1999 (HHS Reference No. E-200-
1998/0-EP 08).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Sally Hu, PhD; 301/435-5606; [email protected].

    Dated: November 3, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E6-19050 Filed 11-9-06; 8:45 am]
BILLING CODE 4140-01-P