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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.

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.

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 Start Printed Page 63717progressive 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.

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, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.

Use of Suppressive Oligonucleotides to Treat Uveitis

Description of Technology: Uveitis is a major cause of visual loss in industrialized nations. Uveitis refers to an intraocular inflammation of the uveal tract, namely, the iris, choroids, and ciliary body. Uveitis is responsible for about ten percent (10 %) of the legal blindness in the United States. Complications associated with uveitis include posterior synechia, cataracts, glaucoma and retinal edema.

Suppressive CpG oligodeoxynucleotides (ODNs) are ODNs capable of reducing an immune response, such as inflammation. Suppressive ODNs are DNA molecules of at least eight nucleotides in length, where the ODN forms a G-tetrad, and has a circular dichroism value greater than 2.9. In a suppressive ODN, the number of guanosines is at least two.

This application claims compositions and methods for the treatment of uveitis. Specifically, the application claims use of suppressive CpG ODNs to treat uveitis. The compositions and methods of the application can be used for the treatment of anterior, posterior and diffuse uveitis.

Application: Vaccine adjuvants, production of vaccines, immunotherapeutics.

Developmental Status: Preclinical studies have been performed; oligonucleotides have been synthesized.

Inventors: Dennis Klinman (FDA/CBER; NCI), Igal Gery (NEI), Chiaki Fujimoto (NEI).

Patent Status: U.S. Provisional Application No. 60/569,276 filed 06 May 2004 (HHS Reference No. E-152-2004/0-US-01); PCT Application No. PCT/US2005/015761 filed 05 May 2005, which published as WO 2005/11539 on 09 Dec 2006 (HHS Reference No. E-152-2004/0-PCT-02); U.S. Patent Application No. 11/579,518 filed 03 Nov 2006 (HHS Reference Number E-152-2004/0-US-03); International filings in Australia, Canada, China, Europe, India, Japan, Mexico.

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.

Use of CpG Oligodeoxynucleotides To Induce Epithelial Cell Growth

Description of Invention: Wound repair is the result of complex interactions and biologic processes. Three phases have been described in normal wound healing: Acute inflammatory phase, extracellular matrix and collagen synthesis, and remodeling. The process involves the interaction of keratinocytes, fibroblasts and inflammatory cells at the wound site. The sequence of the healing process is initiated during an acute inflammatory phase with the deposition of provisional tissue. This is followed by re-epithelialization, collagen synthesis and deposition, fibroblast proliferation, and neovascularization, all of which ultimately define the remodeling phase. These events are influenced by growth factors and cytokines secreted by inflammatory cells or by the cells localized at the edges of the wound.

Tissue regeneration is believed to be controlled by specific peptide factors which regulate the migration and proliferation of cells involved in the repair process. Thus, it has been proposed that growth factors will be useful therapeutics in the treatment of wounds, burns and other skin disorders. However, there still remains a need for additional methods to accelerate wound healing and tissue repair.

This application claims methods of increasing epithelial cell growth. The methods include administering a therapeutically effective amount of a CpG oligodeoxynucleotide (ODN) to induce epithelial cell division. Also claimed are methods of inducing wound healing. The method includes treating the wound with a CpG oligonucleotide, thereby inducing wound healing. The wound can be any type of wound, including trauma or surgical wounds. The CpG ODN can be applied systemically or locally.

Application: Induction of wound healing through use of CpG oligodeoxynucleotides.

Developmental Status: CpG oligonucleotides have been synthesized and preclinical studies have been performed.

Inventors: Dennis Klinman and Takahashi Sato (NCI).

Patent Status: U.S. Provisional Application No. 60/970,145 filed 05 Sep 2007 (HHS Reference No. E-242-2007/0-US-01).

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 Start Printed Page 63718commercialize methods of increasing epithelial cell growth. Please contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.

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Dated: October 20, 2008.

Richard U. Rodriguez,

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

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[FR Doc. E8-25566 Filed 10-24-08; 8:45 am]

BILLING CODE 4140-01-P