[Federal Register Volume 73, Number 102 (Tuesday, May 27, 2008)]
[Notices]
[Pages 30408-30409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11698]


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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.

C4'-Substituted-2-Deoxyadenosine Analogs and Methods of Treating HIV

    Description of Technology: The invention describes a new use for 
C4'-methyl-2-deoxyadenosine, a nucleoside analog that has significant 
activity against HIV-1 and most strains of HIV previously shown to be 
resistant to other reverse transcriptase nucleoside inhibitor 
treatments. In vitro experimental results show substantial anti-HIV 
activity (blocked infectivity) with no observable cytotoxicity in cell 
culture. Mechanistic studies indicate that this compound blocks DNA 
synthesis by reverse transcriptase.
    Applications: Treatment and prevention of HIV infection.
    Advantages: Nucleoside analog against HIV-1 reverse transcriptase 
with no observable cytotoxicity in cell culture.
    Potential new treatment for HIV-1 infections including infections 
by strains of HIV-1 that are resistant to nucleoside reverse 
transcriptase inhibitors.
    Development Status: In vitro data can be provided upon request.
    Market: Therapeutic for the treatment and/or prevention of HIV 
infection.
    Inventors: Bao-Han Christie Vu, Stephen H. Hughes, Maqbool 
Siddiqui, and Victor E. Marquez (NCI).
    Publication: Meeting Abstract: 8th Annual Symposium for Antiviral 
Resistance in Richmond, VA, November 11-14, 2007 (Can be provided upon 
request).
    Patent Status: U.S. Provisional Application No. 61/002,711 filed 09 
Nov 2007 (HHS Reference No. E-012-2008/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Sally Hu, Ph.D.; 301-435-5606, [email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
HIV Drug Resistance Program is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize C4'-methyl- and C4'-ethyl-
substituted-2-deoxyadenosine analogs. Please contact John D. Hewes, PhD 
at 301-435-3121 or [email protected] for more information.

Method of Treating Infectious and Inflammatory Lung Disease With 
Suppressive Oligonucleotides

    Description of Technology: Lung disease is the number three killer 
in America, responsible for one in seven deaths, and lung disease and 
other breathing problems are the number one killer of babies younger 
than one year old. Today, more than thirty (30) million Americans are 
living with chronic inflammatory lung diseases such as emphysema and 
chronic bronchitis. In addition, approximately one hundred and fifty 
thousand (150,000) Americans are affected by acute respiratory distress 
syndrome (ARDS) each year.
    Many lung diseases are associated with lung inflammation. For 
example, ARDS involves the rapid onset of progressive malfunction of 
the lungs, and is usually associated with the malfunction of other 
organs due to the inability to take up oxygen. The condition is 
associated with extensive lung inflammation and small blood vessel 
injury in all affected organs. ARDS is commonly precipitated by trauma, 
sepsis (systemic infection), diffuse pneumonia, and shock. It also may 
be associated with extensive surgery, and certain blood abnormalities. 
In many cases of ARDS and other inflammatory lung diseases, the 
inflammatory response that accompanies the underlying disease state is 
much more dangerous than the underlying infection or trauma.

[[Page 30409]]

    This application claims use of suppressive oligonucleotides to 
suppress lung inflammation. More specifically, the application claims 
use of suppressive oligonucleotides for the treatment, prevention, or 
inhibition of pneumonia, ARDS, and chronic bronchitis.
    Applications: Vaccine adjuvants, production of vaccines, 
immunotherapeutics.
    Development Status: Preclinical studies have been performed; 
oligonucleotides have been synthesized.
    Inventors: Dennis Klinman (FDA/CBER; NCI) and Hiroshi Yamada (CBER/
FDA).
    Patent Status: U.S. Provisional Application No. 60/417,263 filed 08 
Oct 2002 (HHS Reference Number E-183-2002/0-US-01); U.S. Patent 
Application No. 10/682,130 filed 07 Oct 2003 (HHS Reference Number E-
183-2002/0-US-02).
    Licensing Status: Available for exclusive or nonexclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Experimental Immunology, Immune Modulation Group, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this technology. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

Method of Treating and Preventing Infections in Immunocompromised 
Subjects With Immunostimulatory CpG Oligonucleotides

    Description of Technology: Primary disorders of the immune system 
can be divided into four categories, (1) disorders of the humoral 
immunity, (2) disorders of cellular immunity, (3) disorders of 
phagocytes, and (4) disorders of complement. In addition, there are 
many causes of secondary immunodeficiency such as treatment with 
immunosuppressive or chemotherapeutic agents, protein-losing 
enteropathy, and infection with a human immunodeficiency virus (HIV). 
Generally, immunocompromised patients are unable to mount an immune 
response to a vaccine or an infection in the same manner as non-
immunocompromised individuals.
    Opportunistic infections to which individuals infected with HIV are 
susceptible include bacterial infections such as salmonellosis, 
syphilis and neurosyphilis, tuberculosis (TB), a typical mycobacterial 
infection, and bacillary angiomatosis (cat scratch disease), fungal 
infections such as aspergillosis, candidiasis (thrush, yeast 
infection), coccidioidomycosis, cryptococcal meningitis, and 
histoplasmosis, protozoal infections such as cryptosporidiosis, 
isosporiasis, microsporidiosis, Pneumocystis Carinii pneumonia (PCP), 
and toxoplasmosis, viral infections such as Cytomegalovirus (CMV), 
hepatitis, herpes simplex (HSV, genital herpes), herpes zoster (HZV, 
shingles), human papilloma virus (HPV, genital warts, cervical cancer), 
Molluscum Contagiosum, oral hairy leukoplakia (OHL), and progressive 
multifocal leukoencephalopathy (PML), and neoplasms such as Kaposi's 
sarcoma, systemic non-Hodgkin's lymphoma (NHL), and primary CNS 
lymphoma, among others. These opportunistic infections remain 
principally responsible for the morbidity and mortality associated with 
HIV disease.
    This application claims use of immunostimulatory D-type CpG 
oligonucleotides for the treatment of immunocompromised individuals. 
More specifically, the application claims use of immunostimulatory D-
type CpG oligonucleotides for the treatment of individuals infected 
with HIV.
    Application: Vaccine adjuvants, production of vaccines, 
immunotherapeutics.
    Development Status: Preclinical studies have been performed; 
oligonucleotides have been synthesized.
    Inventors: Dennis Klinman (FDA/CBER; NCI) and Daniela Verthelyi 
(FDA/CBER).
    Patent Status: U.S. Provisional Application No. 60/411,944 filed 18 
Sep 2002 (HHS Reference No. E-153-2002/0-US-01); U.S. Patent 
Application No. 10/666,022 filed 17 Sep 2003 (HHS Reference No. E-153-
2002/0-US-03).
    Licensing Status: Available for exclusive or nonexclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Experimental Immunology, Immune Modulation Group, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this technology. Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

    Dated: May 15, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-11698 Filed 5-23-08; 8:45 am]
BILLING CODE 4140-01-P