[Federal Register Volume 72, Number 184 (Monday, September 24, 2007)]
[Notices]
[Pages 54272-54274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18798]


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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 Transgenic Mouse Expressing Reverse Tetracycline-Controlled 
Transactivator in Melanocytes

    Description of Technology: Available for licensing are transgenic 
mice that allow for specific and inducible expression of proteins in 
melanocytes. Melanocytes are difficult to study because of their 
paucity in mammalian skin, and these mice present a readily available 
source of these cells and model to study melanocyte diseases such as 
melanoma of the skin and eye. The mice can be crossed with transgenic 
mice that harbor the green fluorescent protein (GFP) gene, resulting in 
melanocyte-specific GFP labeling. GFP labeling can aid in imaging and/
or isolation of melanocytes via fluorescence activated cell sorting, 
and it can be used to study melanocytes at both the cellular and 
molecular level.
    Applications: Research tool to study melanocytes and melanocyte 
related diseases such as melanoma of the skin and eye.
    Model to develop and test cosmetic dermatology products such as 
skin tanners.
    Advantages: Research tool to study melanocytes at the cellular and 
molecular level.
    Melanocytes compose a minute fraction of mammalian skin. These mice 
present a significant advantage in labeling, imaging and isolating 
these cells.
    Market: An estimated 59,940 Americans will be diagnosed with skin 
cancer in 2007.
    An estimated 8,110 Americans will die of skin cancer in 2007.
    Intraocular melanoma is a rare disease. For every 100,000 
Americans, there are approximately 17.7 new cases of intraocular 
melanoma.
    Cosmetic dermatology industry is worth billions of dollars.
    Inventors: Glenn T. Merlino, M. Raza Zaidi, et al. (NCI)
    Publication: Planned oral presentation at the Fourth International 
Congress on Melanoma in New York City, November 1-4, 2007. The 
technology is mentioned in the Abstract for this meeting.
    Patent Status: HHS Reference No. E-308-2007/0--Research Tool. 
Patent protection is not being sought for this technology.
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Cancer 
Biology and Genetics of the National Cancer Institute is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
use of transgenic mice that allow for specific and inducible expression 
of proteins in melanocytes. Please contact John D. Hewes, Ph.D. at 301-
435-3121 or [email protected] for more information.

Chimeric Peptide Antigen Library: A Novel Tool for the Development of 
Vaccines Against Variable Pathogens Such as HIV, Tuberculosis, 
Hepatitis C and Malaria

    Description of Technology: Many pathogens of dangerous human 
diseases such as HIV-1, HIV-2, viruses of hepatitis B and C, virus of 
influenza, viruses of dengue fever of types 1-4, pathogens of malaria 
and tuberculosis all possess significant variability.
    Libraries of chimeric peptides, which imitate the genetic 
variability of the variable sections of the pathogenic protein, can 
cause a defensive immune response to the wide spectrum of the pathogen 
diversity. The immunogenic collections of chimeric peptides (libraries 
of variable chimeric peptides) in total reflect the natural and 
potential variability of the sections which determine antigenic 
activity.
    The present invention relates to antigenic peptides, the methods of 
their preparation and their peptide libraries and it can be used for 
preparation of vaccines and medicine diagnostics. More specifically, 
the invention describes that the number of sequences in the library 
(size of library) is equal to the product of the number of possible 
residues in each position of peptide. The size of library can be 
reduced by sequential removal of residues which have the lowest 
frequency until the size will reach the required value.
    Applications: Variable chimeric peptide libraries (VPCLs) can help 
construct effective vaccines capable of treating variable infectious 
agents such as HIV, TB, and Malaria.
    Advantages: VPCLs represent naturally occurring and potential 
variability of antigenically active regions in one vaccine.

[[Page 54273]]

    Such VPCLs can induce production of a wide range of antibodies and 
cytotoxic T-lymphocytes (CTLs) with joint specificity that covers the 
diversity of antigenic variants of the variable infectious agent.
    Benefits: Several million people worldwide are suffering from 
diseases caused by variable pathogens. Variable pathogens important for 
human health include but are not limited to HIV, hepatitis, influenza, 
malaria and tuberculosis. The HIV market is currently $10 billion U.S. 
dollars. Additionally, the HIV market is forecast to grow at a rate of 
10.3% over the next five years.
    Inventors: Amir Maksyutov (VECTOR, Russia) et al.
    Development Status: Method of constructing VPCLs has been 
established.
    Patent Status: PCT Patent Application PCT/RU2003/000421 was filed 
25 Sep, 2003 (HHS Ref. No. E-167-2007/0).
    PCT Publication: Antigenic Peptides.
    Licensing Contact: Sabarni K. Chatterjee at 301-594-4697 or by e-
mail at [email protected]; or Jasbir Kindra at 301-435-5559 or 
by e-mail at [email protected].

Treatment of Primary Tumors and Tumor Metastases With TNF-alpha 
Antagonists

    Description of Technology: The role of TGF-[beta]1 in tumorigenesis 
is well-documented. However, the mechanism behind the induction of TGF-
[beta]1 remains poorly understood. As a result, potential targets for 
the treatment of cancers associated with TGF-[beta]1 have escaped 
detection. This invention uncovers a two-step process of TGF-[beta]1 
induction, thereby providing alternative targets for cancer treatment.
    TGF-[beta]1 induction requires signaling through by IL-13 through 
IL13-R[alpha]2. However, IL13-R[alpha]2 must first be induced, 
requiring signaling by TNF[alpha] and IL4 or IL-13 through IL13-
R[alpha]1. Thus, by blocking TNF[alpha] signaling, one can block the 
expression of TGF-[beta]1. This invention concerns new methods of 
treating cancers associated with TGF-[beta]1 expression involving the 
administration of TNF[alpha] antagonists.
    Applications and Advantages: New cancer treatment for a wide 
variety of cancers, including colon cancer.
    Provides a treatment option for patients who don't respond to 
currently available anti-cancer agents.
    Benefits: This new method may provide a social benefit by improving 
the quality/length of patient life for cancer patients who do not 
respond to currently available treatment methods.
    The cancer therapeutic market is expected to reach $27 billion by 
2009, providing an excellent financial opportunity.
    Inventors: Warren Strober (NIAID) et al.
    U.S. Patent Status: U.S. Provisional Application filed (HHS 
Reference No. E-161-2007/0-US-01)
    Licensing Contact: David A. Lambertson, Ph.D.; Phone: (301) 435-
4632; Fax: (301) 042-0220; E-mail: [email protected]
    Collaborative Research Opportunity: The National Institutes of 
Health, NIAID, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize ``Treatment of Primary Tumors and Tumor 
Metastases with TNF-alpha Antagonists.'' Please contact Dr. Warren 
Strober at [email protected] for more information.

Therapeutic HIV Vaccine and Associated Protocols

    Description of Technology: This technology describes a therapeutic 
HIV DNA vaccine to be administered to individuals who have previously 
experienced or are undergoing antiretroviral therapy (ART). The 
therapeutic DNA vaccine can also be administered in combination with a 
vector encoding an IL-15 and/or IL-15 receptor alpha (IL-15Ra) 
polypeptide. In primate studies, the technology was found to be 
particularly effective when the vaccine composition was administered by 
electroporation and expressed six (6) HIV antigens (including two (2) 
gag polypeptides and two (2) envelope polypeptides) and IL-15 and IL-
15Ra. The antigens are typically modified with a destabilizing 
sequence, a secretory polypeptide and/or a degradation signal. 
Successive administration up to as many as nine resulted in continual 
boost of the immune response against the encoded antigen. A potent 
immunotherapeutic vaccine as described here could be an important 
technology for the fight against HIV/AIDS.
    Applications: Therapeutic HIV DNA vaccines.
    Inventor: Barbara Felber et al. (NCI).
    Patent Status: U.S. Provisional Application filed 12 Jun 2007 (HHS 
Reference No. E-103-2007/0-US-01).
    PCT Application No. PCT/US2007/000774 filed 12 Jan 2007 (HHS 
Reference No. E-254-2005/2-PCT-01).
    PCT Application No. PCT/US2001/45624, filed 1 Nov 2001, and 
National Stage filed in AU, JP, US, CA, and EP (HHS Reference No. E-
308-2000/0).
    U.S. Patent Application No. 11/571,879 filed 9 Jan 2007 (HHS 
Reference No. E-249-2004/1-US-02).
    Development Status: Primate data available
    Licensing Status: Available for licensing
    Licensing Contact: Susan Ano, Ph.D.; 301-435-5515; 
[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 HIV DNA vaccines. Please contact John D. Hewes, Ph.D. at 
301-435-3121 or [email protected] for more information.

Optically Active Radio-Labeled Reverse Transcriptase Inhibitors

    Description of Technology: Researchers at the NIH developed a novel 
and efficient method for preparing F-18 labeled reverse transcriptase 
inhibitors, particularly, F-18 labeled tenofovir analogues for use as 
PET imaging agents to monitor anti-retroviral drug biodistribution in 
anatomic compartments in HIV-1 infected patients. Fluorine-18 is often 
used to prepare radiotracers and radiopharmaceuticals, but its short 
half-life of 109 minutes demands efficient and rapid radiochemical 
syntheses and purification techniques. This technology provides high 
yields of labeled compounds utilizing rapid synthetic methods and HPLC 
purification in both racemic and optically active forms.
    Available for licensing and commercial development are compositions 
of F-18 labeled tenofovir analogues, as well as methods of synthesis 
and methods of use for such labeled compounds.
    Applications: Non-invasive in vivo molecular imaging tracer useful 
for:
    Evaluating the penetration and kinetics of anti-HIV drugs into 
anatomic compartments in vivo, Addressing changes in drug penetration 
in anatomic compartments during prolonged exposure to anti-HIV drugs.
    Market: U.S. sales of diagnostic radiopharmaceuticals reached 1.69 
billion dollars in 2005 and are expected to reach 3.52 billion dollars 
by 2012.
    Development Status: Early stage
    Inventors: Dale O. Kiesewetter (NIBIB), Michele Di Mascio (NIAID), 
Esther Lim (CC)
    Patent Status: U.S. Provisional Application No. 60/914,732 filed 28 
Apr 2007 (HHS Reference No. E-072-2007/0-US-01)
    Licensing Status: Available for licensing.

[[Page 54274]]

    Licensing Contact: Chekesha S. Clingman, Ph.D.; 301/435-5018; 
[email protected]
    Collaborative Research Opportunity: The NIBIB/IR/Positron Emission 
Tomography Radiochemistry Group and the NIAID Biostatistic Research 
Branch are seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize a Fluorine-18 radiolabeled analog of tenofovir. Please 
contact Peter Moy (NIBIB); 301/496-9270; [email protected] for more 
information.

    Dated: September 17, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-18798 Filed 9-21-07; 8:45 am]
BILLING CODE 4140-01-P