E7-11830. Government-Owned Inventions; Availability for Licensing

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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Methods for Prevention and Treatment of Polyomavirus Infection or Reactivation

Description of Technology: Available for licensing and commercial development are methods of using two MAP kinase kinase (MEK) inhibitors, PD98059 and U0126, in the prevention and treatment of polyomavirus infection. Decrease in viral protein expression upon treatment with the MEK inhibitors has been demonstrated for two polyomavirus species, JC virus (JCV) and BK virus (BKV). It is believed that these MEK inhibitors may also be effective against other polyomavirus species in which TGF-β expression is elevated.

JCV is responsible for the demyelination of the central nervous system which is observed in cases of progressive multifocal leukoencephalopathy (PML). PML is most frequently seen in patients with HIV/AIDS, but is also a contributing factor in fatalities in patients with leukemia, lymphoma, and connective tissue diseases, in addition to individuals receiving immunosuppressive therapy for autoimmune disorders or prevention of transplant rejection.

BKV is associated with deadly clinical syndromes such as viruria and viremia, utreteral ulceration and stenosis, and hemorrhagic cystitis. BKV also causes polyomavirus-associated nephrophathy in 1-10% of all renal transplant recipients.

Currently, no effective antiviral agents are available to treat these opportunistic infections. In all observed cases, activation of either JCV and BKV in immunosuppressed patients has resulted in fatality.

Applications: Treatment and prevention of polyomavirus infection in immunocompromised patients.

Development Status: In vitro data is currently available and inventors are actively developing the technology.

Inventors: Veersamy Ravichandran and Eugene Major (NINDS).

Publication: V Ravichandran, PN Jensen, EO Major. MEK1/2 inhibitors block basal and TGF-β1 stimulated JC virus multiplication. J Virol. 2007 Apr 4; Epub ahead of print, doi:10.1128/JVI.02658-06.

Patent Status: U.S. Provisional Application No. 60/908,950 filed 29 Mar 2007 (HHS Reference No. E-101-2007/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301/435-4507; [e-mail].

Collaborative Research Opportunity: The National Institute of Neurological Disorders and Stroke is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize treatment and prevention of polyomavirus infections in immunocompromised patients. Please contact Melissa Maderia, Ph.D. at [e-mail] for more information.

Monoclonal Antibodies That Bind or Neutralize Hepatitis B Virus

Description of Technology: Hepatitis B virus (HBV) chronically infects over 300 million people worldwide. Many of them will die of chronic hepatitis or hepatocellular carcinoma. The present technology relates to the isolation and characterization of a novel neutralizing chimpanzee monoclonal antibody to HBV. The antibody was identified through a combinatorial antibody library constructed from bone marrow cells of a chimpanzee experimentally infected with HBV. The selected monoclonal antibody has been shown to react equally well with wild-type HBV and the most common neutralization escape mutant variants. Therefore, this monoclonal antibody with high affinity and broad reactivity may have distinct advantages over other approaches to immunoprophylaxis and immunotherapy of chronic HBV infection, as most of the monoclonal antibodies currently in use are not sufficiently and broadly reactive to prevent the emergence of neutralization escape mutants of HBV. This technology describes such antibodies, fragments of such antibodies retaining hepatitis B virus-binding ability, fully human or humanized antibodies retaining hepatitis B virus-binding ability, and pharmaceutical compositions including such antibodies. This invention further describes isolated nucleic acids encoding the antibodies and host cells transformed with nucleic acids. In addition, this invention provides methods of employing these antibodies and nucleic acids in the in vitro and in vivo diagnosis, prevention and therapy of HBV diseases.

Inventors: Suzanne U. Emerson (NIAID), Robert H. Purcell (NIAID), et al.

Patent Status: U.S. Provisional Application No. 60/644,309 filed 14 Jan 2005 (HHS Reference No. E-144-2004/0-US-01); PCT Application No. PCT/US2006/001336 filed 13 Jan 2006, which published as WO 2006/076640 on 20 Jul 2006 (HHS Reference No. E-144-2004/0-PCT-02)

Licensing Contact: Chekesha S. Clingman, Ph.D.; 301/435-5018; [e-mail].

Endotracheal Tube Using Unique Leak Hole To Lower Dead Space

Description of Technology: Through injury or diseases, human or animal lungs may become too weak to sustain a sufficient flow of oxygen to the body and to remove adequate amounts of expired carbon dioxide. The present invention is a tracheal tube ventilation apparatus which efficiently rids patients of expired gases and promotes healthier breathing. This is accomplished by creating one or more leak holes in the wall of the endotracheal tube above the larynx, such as in the back of the mouth (i.e., oropharynx), so that expired gases can leak out of the endotracheal tube. The described apparatus is a two stage tube where the first stage has a smaller diameter such that it fits within the confined area of the lower trachea and the second stage has a larger diameter, which fits properly within the larger diameter of the patient's pharynx. The endotracheal tube is preferably wire reinforced and ultra-thin walled so as to reduce airway resistance. The invention substantially reduces endotracheal dead space and is expected to benefit those patients with both early and late stage acute respiratory failure, and reduce or obviate the need for mechanical pulmonary ventilation in many patients.

Applications: Tracheal tube ventilation; Efficiently rid patient of expired gases and thereby promote healthier breathing.

Development Status: System is well developed and operational.

Inventor: Theodor Kolobow (NHLBI).

Patent Status: U.S. Patent No. 7,107,991 issued 19 Sep 2006 (HHS Reference No. E-269-2001/0-US-01); PCT Application No. PCT/US02/29319 filed 16 Sep 2002 (HHS Reference No. E-269-2001/0-PCT-02); Canadian National Stage Filing, Application No. 2463538, filed 16 Sep 2002 (HHS Reference No. E-269-2001/0-CA-03); European National Stage Filing, Application No. 02773398.9, filed 28 Mar 2004 (HHS Reference No. E-269-2001/0-EP-04).

Licensing Status: Available for non-exclusive or exclusive licensing.

Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019; [e-mail].

Collaborative Research Opportunity: The NHLBI/Pulmonary Critical Care Medicine Branch (PCCMB) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize innovative endotracheal tube technology. Please contact Marianne Lynch at 301-594-4094 or [e-mail] for more information.

Increased Protein Expression Vector for Vaccine Applications

Description of Technology: An expression vector with a unique promoter that results in higher level of protein expression than vectors currently in use is available for licensing from the NIH. The elevated levels of expression are achieved through use of a specific promoter, known as CMV/R, in which the Human T-Lymphotrophic Virus (HTLV-1) Long Terminal Repeat (LTR) R-U5 region is substituted for a portion of the intron downstream of the CMV immediate early region 1 enhancer (Barouch et al., 2005). Sequences of 95% or better homology to CMV/R can be used as well. CMV/R vectors are currently being used in a number of clinical trials, including vaccines against West Nile Virus, Ebola virus, and HIV and achieving promising results. The related HIV vaccine technology is available for licensing, as is the Ebola DNA vaccine technology (non-exclusive licensing only). The CMV/R vector can be used for any DNA vaccine or for the production of recombinant proteins in high yields.

Applications: Vector for DNA vaccines; High yield expression of recombinant proteins.

Inventors: Gary Nabel and Zhi-yong Yang (NIAID).

Patent Status: U.S. Patent No. 7,094,598 issued 22 Aug 2006 [HHS Reference No. E-241-2001/1-US-01 (CMV/R)], applications pending in EP, JP, CA, and AU; U.S. Patent Application No. 10/491,121 filed 23 Aug 2004 [HHS Reference No. E-241-2001/0-US-07 (Ebola DNA vaccine)], applications pending in EP, JP, CA, and AU; U.S. Patent Application No. 11/632,522 filed 16 Jan 2007 [HHS Reference No. E-267-2004/1-US-08 (HIV DNA vaccine)].

Licensing Status: Available for non-exclusive licensing.

Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; [e-mail].

Dated: June 11, 2007.

Steven M. Ferguson,

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