[Federal Register Volume 73, Number 208 (Monday, October 27, 2008)]
[Notices]
[Pages 63716-63718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25566]


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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.

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.

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

[[Page 63717]]

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.
    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, PhD at 301-435-3121 or 
[email protected] 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; 
[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.

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; 
[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

[[Page 63718]]

commercialize methods of increasing epithelial cell growth. Please 
contact John D. Hewes, PhD at 301-435-3121 or [email protected] for 
more information.

    Dated: October 20, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-25566 Filed 10-24-08; 8:45 am]
BILLING CODE 4140-01-P