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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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, HuS@mail.nih.gov.

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 hewesj@mail.nih.gov 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. Start Printed 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; soukasp@mail.nih.gov.

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 hewesj@mail.nih.gov 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; soukasp@mail.nih.gov.

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 hewesj@mail.nih.gov for more information.

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Dated: May 15, 2008.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E8-11698 Filed 5-23-08; 8:45 am]

BILLING CODE 4140-01-P