[Federal Register Volume 73, Number 160 (Monday, August 18, 2008)]
[Notices]
[Pages 48216-48218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18983]


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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/

[[Page 48217]]

496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement 
will be required to receive copies of the patent applications.

Broadly Neutralizing Anti-HIV Monoclonal Antibody That Targets a New 
Epitope on gp41

    Description of Technology: Blocking entry of HIV into cells and 
vaccine development against HIV are the prime targets of HIV therapy 
and prevention, respectively. Current invention describes a monoclonal 
Fab anti-HIV antibody isolated through panning against the chimeric 
construct NCCG-gp41 by Antibodies-by-Design (Morphosys). One 
of the antibodies has broadly neutralization ability against several 
HIV subtypes in an envelope-pseudotyped-virus neutralization assay. 
This antibody was also shown to have synergistic effect with a gp41-
derived peptide discovered in this laboratory in inhibiting HIV-1 
fusion.
    Applications: Research tool or screening for HIV vaccine.
    Advantages: Can be potentially used as a therapeutic agent to block 
HIV-1 entry into cells.
    Development Status: In vitro data available.
    Market: For the development of drugs against HIV.
    Inventors: G. Marius Clore et al. (NIDDK).
    Publications:
    1. E Gustchina et al. A monoclonal Fab derived from a human 
nonimmune phage library reveals a new epitope on gp41 and neutralizes 
diverse human immunodeficiency virus type 1 strains. J Virol. 2007 
Dec;81(23):12946-12953.
    2. E Gustchina et al. Sequestering the pre-hairpin intermediate of 
gp41 by peptide N36\Mut(e,g)\ potentiates the human immunodeficiency 
virus type 1 neutralizing activity of monoclonal antibodies against the 
N-terminal helical repeat of gp41. J. Virol. in press (2008).
    Patent Status: HHS Reference No. E-229-2008/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: This invention is available for non-exclusive 
licensing as a research tool.
    Licensing Contact: Sally Hu, Ph.D.; 301-435-5606; [email protected].
    Collaborative Research Opportunity: The NIH, Laboratory of Chemical 
Physics is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize this monoclonal Fab. Please contact Dr. G.M. Clore at 
301-496 0782 and/or e-mail at [email protected] for more 
information.

Polyamine Compounds That Bind Tar RNA of HIV and Methods of Treating 
Viral Disorders

    Description of Technology: Current HIV treatment involves applying 
cocktail of drugs targeting either virus entry or one of three viral 
enzymes. Because patients eventually develop resistance to the 
cocktail, a new class of drugs is urgently needed. Current invention 
describes a new class of polyamine compounds that specifically bind to 
HIV RNA at micromolar range to prevent binding of viral RNA to viral 
proteins and therefore blocking viral replication. This differs with 
the mechanisms of current HIV drugs in the market and therefore offers 
new strategy in HIV treatment and prevention. Furthermore, this class 
of compound may aid future development of drugs targeting RNA.
    Applications: Treatment and prevention of HIV infection.
    Advantages: Novel strategy for HIV treatment and prevention; 
Specific binding to HIV RNA and strong activity.
    Development Status: In vitro data available.
    Market: HIV therapeutics and preventatives.
    Inventors: Daniel Appella et al. (NIDDK).
    Publications: Manuscripts in preparation.
    Patent Status: U.S. Provisional Application No. 61/123,076 filed 04 
Apr 2008 (HHS Reference No. E-159-2008/0-US-01).
    Licensing Status: This invention is available for exclusive or non-
exclusive licensing.
    Licensing Contact: Sally Hu, Ph.D.; 301-435-5606; [email protected].
    Collaborative Research Opportunity: The NIDDK, Laboratory of 
Bioorganic Chemistry, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize the application of TAR-binding polyamines 
for the treatment of HIV infections. Please contact Daniel Appella at 
301-451-1052 or [email protected] for more information.

Monoclonal Antibodies to HIV-1 Vpr

    Description of Technology: Available for licensing are monoclonal 
antibodies against HIV-1 viral protein R (Vpr) and the respective 
hybridoma cell lines expressing the same. The antibodies provide a 
means for detecting HIV-1 Vpr. Currently, the mechanism of HIV 
pathogenesis believed to involve viral replication inside immune cells 
and other cells. At present, there are no clinical assays for detecting 
HIV-1 Vpr. Vpr circulates at detectable levels in the blood and is 
likely derived from degraded virions or released from infected cells. 
Vpr facilitates viral replication and disrupt normal cell function. 
Thus measurement of Vpr levels in blood, extracellular fluid, and 
tissue may be of benefit in understanding the pathogenesis of HIV-1 
infection and its myriad complications.
    The hybridoma cell lines (9F12 and 10F2) were selected from a group 
of hybridoma cell lines. These antibodies can be used for detection, 
including immunoasssays (ELISA) and immunoaffinity-capillary 
electrophoresis. The amount of detected HIV-1 Vpr is compared to a 
standardized control sample for determining the progress of disease or 
the presence of known complications like neuropathy, dementia, 
metabolic syndrome, or nephropathy.
    Inventors: Jeffrey Kopp (NIDDK), Terence Philips (NBIB), Schubert 
Ulrich (NIAID), John Yewell (NIAID).
    Patent Status: U.S. Patent Application No. 11/630,880 filed 27 Jun 
2005 (HHS Reference No. E-141-2003/0-US-03).
    Licensing Status: Available for licensing.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].

Anti-Pax 2 Antibody

    Description of Technology: Available for licensing and 
commercialization are anti-Pax 2 polyclonal antibodies that can be used 
for the detection of Pax-2 protein expression in a variety of kidney 
and neuronal tissues. Pax-2 protein, a transcription factor active 
during early kidney development, is expressed at high levels in almost 
all renal proliferative diseases such as renal cancer, polycystic 
kidney disease and acute renal failure.
    The Pax-2 protein has also been linked to Wilms' tumor, a cancerous 
kidney tumor accounting for ~6% of childhood cancers, and for which 
~500 new cases are diagnosed each year in the U.S. Wilms' tumors are 
hard to diagnose in the early stage because they can grow quite large 
without causing any pain. While abdominal ultrasound may be used for 
detection, it is not a practical screening test for otherwise healthy 
children. There are no blood tests or other tests for screening for 
Wilms' tumors which, if diagnosed sufficiently early, may be treated 
with surgery, chemotherapy, and/or radiation therapy.

[[Page 48218]]

    Potential applications of this technology may also include 
detection of Pax-2 protein in urine for both chronic and acute renal 
disease.
    Applications: Diagnostics for renal diseases; Research tools for 
evaluating disease processes of the kidney and other tissues through 
Pax-2 protein expression in the relevant tissues.
    Development Status: Ready for commercialization.
    Patent Status: HHS Reference No. B-039-1996/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Inventor: Gregory Dressler (NICHD).
    Relevant Publications:
    1. GR Dressler. Another niche for Notch. Kidney Int. 2008 
Jun;73(11):1207-1209.
    2. SR Patel et al. The BRCT-domain containing protein PTIP links 
PAX2 to a histone H3, lysine 4 methyltransferase complex. Dev Cell. 
2007 Oct;13(4):580-592.
    3. GR Dressler. The cellular basis of kidney development. Annu Rev 
Cell Dev Biol. 2006;22:509-529.
    4. GB Silberstein et al. Expression of the PAX2 oncogene in human 
breast cancer and its role in progesterone-dependent mammary growth. 
Oncogene. 2002 Feb7;21(7):1009-1016.
    5. GR Dressler and AS Woolf. Pax2 in development and renal disease. 
Int J Dev Biol. 1999;43(5):463-468 (Review).
    6. GR Dressler. Pax-2, kidney development, and oncogenesis. Med 
Pediatr Oncol. 1996 Nov;27(5):440-444.
    7. GR Dressler and EC Douglass. Pax-2 is a DNA-binding protein 
expressed in embryonic kidney and Wilms tumor. Proc Natl Acad Sci USA. 
1992 Feb 15;89(4):1179-1183.
    Licensing Status: Available for non-exclusive licensing as 
biological materials (internal use or commercial use).
    Licensing Contact: RC Tang, JD, LLM; 301-435-5031; 
[email protected].

    Dated: August 7, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-18983 Filed 8-19-08; 8:45 am]
BILLING CODE 4140-01-P