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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.

Peptide and Peptidomimetic Inhibitors of Smoothened Protein as Anti-neoplastic Agents

Description of Technology: Cancer is caused by the improper regulation of certain signaling proteins in the cell. Start Printed Page 75259One of these pathways is the Hedgehog/Patched (HH/PTCH) pathway. Hedgehog is a secreted protein involved in the growth and development of embryonic cells. Patched is the receptor for hedgehog proteins and regulates a membrane protein called Smoothened (SMO). This pathway is activated in many tumor cells, including those in prostate, pancreas, stomach, and small cell cancer.

The technology is directed towards several synthetic peptides (including all-D analogs) corresponding to specific region of the SMO protein. Experiments in vitro demonstrate that they potentially suppress the growth of cancer cells and inhibit the expression of the HH/PTCH pathway genes. These novel SMO inhibitors are much more effective in inhibiting cell growth than currently available cyclopamine and cyclopamine derivatives. These novel peptides and their metabolically more stable analogs have a high potential for cancer therapy. Due to their high hydrophobic properties, these can be easily formulated for specific intratumor delivery or topical creams for skin disorders.

Applications and Modality: (1) A potent, highly soluble cancer therapeutic; (2) Novel compounds that inhibit HH/PTCH pathway genes; (3) Skin permeable compounds that can be formulated into topical creams for skin malignancies treatment and prevention and treatment of psoriasis.

Market: (1) 600,000 deaths from cancer related diseases estimated in 2006; (2) This technology involving therapeutics for the treatment of several cancers has a potential market of several billion U.S. dollars; (3) Psoriasis affects an estimated 2-3 percent of the world's population; (4) Dermatologic diseases affect an estimated 50 million Americans; (5) Skin therapeutic market is worth over $2 billion in annual sales of prescription medications with an estimated yearly growth rate of 5%;

(6) The overall annual cost of psoriasis treatment has been estimated to be from $650 million to $2 billion in the United States.

Development Status: The technology is currently in the pre-clinical stage of development.

Inventors: Nadia Tarasova, Michael Dean, and Lou Hong (NCI).

Related Publication: L Covic et al. Activation and inhibition of G protein-coupled receptors by cell-penetrating membrane-tethered peptides. Proc Natl Acad Sci USA. 2002 Jan 22; 99(2):643-648.

Patent Status: U.S. Provisional Application No. 60/855,422 filed 31 Oct 2006 (HHS Reference No. E-014-2007/0-US-01).

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

Licensing Contact: Jennifer Wong; 301/435-4633; wongje@mail.nih.gov.

Collaborative Research Opportunity: The NCI-Frederick Structural Biophysics Laboratory is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Peptide and Peptidomimetic Inhibitors of Smoothened Protein as Anti-neoplastic Agents. Please contact Betty Tong, Ph.D. at 301-594-4263 for more information.

Extracellular Matrix/Metastasis Modifier Genes as a Method for Characterization and Prevention of Metastatic Tumor

Description of Technology: To a large extent cancer mortality is due to metastatic disease than a primary tumor. Recent evidence suggests that metastatic disease can be an early event and in majority of patients metastasis starts by the time the disease is diagnosed. Thus there is a need for methods of characterizing the early metastatic process for better treatment of cancer.

This invention provides methods of characterizing the metastatic capacity of a tumor as well as inhibiting metastasis of a cancer cell. More specifically, this invention discloses an extracellular matrix (ECM) modifier protein named Anakin, detection of the Anakin protein as a marker for metastatic disease and use of Anakin as potential therapeutic target.

Applications and Modality: (1) Method of diagnosis for early metastasis and therapeutic inhibition of metastasis; (2) Nucleic acid sequence of Anakin protein, an extracellular matrix (ECM) modifier gene; (3) SiRNA sequences that inhibit Anakin expression as therapeutics; (4) Purified antibodies that recognize Anakin protein as a research reagent and in diagnostics related products.

Market: 600,000 deaths from cancer related diseases estimated in 2006.

Development Status: The technology is currently in the pre-clinical stage of development.

Inventors: Kent W. Hunter (NCI) et al.

Patent Status: U.S. Provisional Application No. 60/778,463 filed 31 Mar 2006 (HHS Reference No. E-125-2006/1-US-01).

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

Licensing Contact: Mojdeh Bahar, J.D.; 301/435-2950; baharm@mail.nih.gov.

Collaborative Research Opportunity: The NCI Laboratory of Population Genetics is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of Anakin as a prognostic tool for diagnosing breast cancer outcome. Please contact Betty Tong, Ph.D. at 301-594-4263 for more information.

Novel Treatments for Autoimmune Neuroinflammatory Diseases Including Multiple Sclerosis

Description of Technology: Multiple sclerosis is caused when T cells mistakenly attack myelin, the protective fatty layer surrounding neurons in the brain and spinal cord, to initiate autoimmune responses and inflammation of the central nervous system (CNS). An increase in T cell-endothelial cell interactions and/or increased infiltration of immune cells to the CNS may play a role in the onset and/or progression of this disease.

Researchers at the NIH previously reported that extracellular adherence protein (Eap) produced by Staphylococcus aureus interacts with intercellular adhesion molecule 1 to prevent beta2-integrin-dependent inflammatory cell recruitment. They have now shown that Eap administration to mice with experimental autoimmune encephalomyelitis, a condition thought to be a model for human multiple sclerosis, blocks T cell recruitment to the brains of the EAE affected mice, inhibits the onset of this disease, and reverses paralysis. Eap also reduces delayed-type hypersensitivity in affected mice by inhibiting T cell infiltration and plasma leakage.

Available for licensing are methods for administering an Eap agent in an amount that will treat or prevent autoimmune neuroinflammatory diseases such as multiple sclerosis, decrease the infiltration of immune cells to the central nervous system, and inhibit T cell-endothelial cell interactions.

Applications: (1) Potential non-toxic treatment for autoimmune neuroinflammatory diseases, such as multiple sclerosis; (2) Potential therapy for alleviating symptoms associated with multiple sclerosis such as paralysis.

Market: (1) In the United States, approximately 400,000 people are living with multiple sclerosis, and about 200 people are diagnosed with multiple sclerosis each week; (2) The average annual direct and indirect cost of multiple sclerosis in the United States is $23 billion. Start Printed Page 75260

Development Status: Animal data is available.

Inventors: Triantafyllos Chavakis (NCI) et al.

Publications:

(1) T Chavakis et al. Staphylococcus aureus extracellular adherence protein serves as anti-inflammatory by inhibiting the recruitment of host leukocytes. Nat Med. 2002 Jul;8(7):687-693.

(2) C Xie et al. Suppression of experimental autoimmune encephalomyelitis by extracellular adherence protein of Staphylococcus aureus. J Exp Med. 2006 Apr 17;203(4):985-994.

Patent Status: U.S. Provisional Application No. 60/771,884 filed 10 Feb 2006 (HHS Reference No. E-295-2005/0-US-01).

Availability: Available for exclusive and non-exclusive licensing.

Licensing Contact: Norbert Pontzer, Ph.D., J.D.; 301/435-5502; pontzern@mail.nih.gov.

Collaborative Research Opportunity: The National Cancer Institute Experimental Immunology Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Novel Treatments for Autoimmune Neuroinflammatory Diseases including Multiple Sclerosis. Please contact Betty Tong, Ph.D. at 301-594-4263 for more information.

Gene Cassette for Enhancement of Protein Production

Description of Technology: There is a continuing market need for expression systems that improve recombinant protein production for disease therapeutics or research materials. The present invention describes a “gene cassette” containing the aadA1 (aminoglycoside adenylyltransferase) gene that increases protein expression levels when incorporated into a bacterial or eukaryotic host genome. In bacterial systems, the inventors have shown that this gene cassette induces enhancement of protein production and accumulation. This inducement is not restricted by the nature of the vector, induction system or nature of protein. In particular, this invention has yielded 3-fold upregulation of anti-HIV peptide expression levels in a microbial microbicide (see reference below). This technology offers an effective mechanism for increased product yield that can be utilized for pharmaceutical or biotechnological applications.

Applications: (1) Affordable gene cassette that increases production of recombinant or native proteins with reduced culture volume and faster processing time; (2) Increases efficacy and potency of cell-based therapeutics that overexpress endogenous or heterologous proteins.

Market: (1) Producers of protein, peptide, or cell-based therapeutics who would benefit from enhanced protein expression; (2) Researchers worldwide who utilize expression systems for protein synthesis.

Development Status: System validated in bacterial cells. Development underway for use in eukaryotic expression systems.

Inventors: Shankar Adhya and Sudeshna Kar (NCI).

Publication: S Rao, S Hu, L McHugh, K Lueders, K Henry, Q Zhao, RA Fekete, S Kar, S Adhya, DH Hamer. Toward a live microbial microbicide for HIV: commensal bacteria secreting an HIV fusion inhibitor peptide. Proc Natl Acad Sci U S A. 2005 Aug 23;102(34):11993-8. Epub 2005 Jul 22, doi 10.1073/pnas.0504881102.

Patent Status: U.S. Provisional Application No. 60/571,943 filed 18 May 2004 (HHS Reference No. E-261-2003/0-US-01); PCT Application No. PCT/US2005/17001 filed 17 May 2005, which published as WO 2005/116222 on 08 Dec 2005 (HHS Reference No. E-261-2003/0-PCT-02).

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

Licensing Contact: Tara L. Kirby, Ph.D.; 301/435-4426; tarak@mail.nih.gov.

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Dated: December 6, 2006.

Steven M. Ferguson,

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

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[FR Doc. E6-21301 Filed 12-13-06; 8:45 am]

BILLING CODE 4140-01-P