2010-1680. 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.

Mouse Macula Densa Cell Line

Description of Invention: This technology provides a clonally derived macula densa cell line (MMDD1 cells) that closely mimics the known molecular expression pattern of native macula densa (MD) cells. MMDD1 cells are developed from SV-40 transgenic mice using fluorescence-activated cell sorting of renal tubular cells labeled with segment-specific fluorescent lectins. The MMDD1 cells of this technology express COX-2, bNOS, NKCC2, and ROMK, but not Tamm-Horsfall protein, and show rapid 86Rb+ uptake that is inhibited by a reduction in NaCl concentration and by bumetanide or furosemide. These MMDD1 cells provide a useful in vitro model for the study of Macula Densa function.

Inventor: Jürgen B. Schnermann (NIDDK).

Publication: T Yang, JM Park, L Arend, Y Huang, R Topaloglu, A Pasumarthy, H Praetorius, K Spring, JP Briggs, J Schnermann. Low chloride stimulation of prostaglandin E2 release and cyclooxygenase-2 expression in a mouse macula densa cell line. J Biol Chem. 2000 Dec 1;275(48):37922-37929. [PubMed: 10982805].

Patent Status: HHS Reference No. E-234-2009/0—Research Tool. Patent protection is not being pursued for this technology.

Licensing Status: Available for licensing under a Biological Materials License Agreement.

Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-5020; [e-mail].

Collaborative Research Opportunity: The National Institute of Diabetes and Digestive and Kidney Diseases Kidney Disease Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the clonally derived macula densa cell line (MMDD1 cells). Please contact Cindy Fuchs at 301-451-3636 for more information.

Novel Analogues of the Natural Product Schweinfurthin With Specificity for Tumors and Other Disease Manifestations Associated With Neurofibromatosis Type 1

Description of Invention: The global anti-cancer market is forecast to reach $40 billion by 2012. There remains a significant unmet need for therapies to treat neurofibromatosis type 1 (“NF1”), a common genetic disease that afflicts 1 in 3500 people, and malignant tumors carrying NF1 mutations, including tumors of the central and peripheral nervous systems.

Researchers at the National Cancer Institute (“NCI”)-Frederick investigating genetic influences on cancer susceptibility of the nervous system have synthesized novel analogues of Schweinfurthin, a natural compound first isolated from the tropical African plant Macaranga schweinfurthii, to which glioma and leukemia cell lines show significant sensitivity. The Schweinfurthin analogues also have inhibitory activity against mouse and human NF1 cancer cell lines. The analogues have a novel mode of action that appears to involve regulation of cytoskeletal reorganization.

These inhibitors are likely to be accepted in the marketplace because their potent, selective activity and unique specificity in mode of action gives them a distinct advantage over the mechanisms of other existing therapies.

Applications:

• Therapies for tumors associated with NF1 (including brain and peripheral nervous system tumors).
• Therapies for leukemia.
• Therapies for NF1 and associated conditions.

Advantages:

• Utilizes proven small-molecule technology.
• Specificity of mode of action may reduce potential side-effects.
• Novel mode of action may limit market competition.

Development Status: Pre-clinical.

Inventors: Karlyne Reilly et al. (NCI).

Relevant Publication: Turbyville et al., “Schweinfurthin A Selectively Inhibits Proliferation and Rho Signaling in Glioma and Neurofibromatosis type 1 Tumor Cells in an NF1-GRD Dependent Manner”, submitted.

Patent Status: U.S. Patent Application No. 61/174,338, filed 30 Apr 2009 (HHS Reference No. E-183-2009/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; [e-mail].

Collaborative Research Opportunity: The Genetic Modifiers of Tumorigenesis Section at the National Cancer Institute-Frederick is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Schweinfurthins for the treatment of Neurofibromatosis type 1. Please contact John D. Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Detection of Autoantibodies for the Diagnosis of Sjogren's Syndrome

Description of Invention: This invention provides a method for diagnosing Sjogren's syndrome in a subject. In tests utilizing blood from human volunteers, this method demonstrated dramatically higher accuracy (76%) in positively diagnosing Sjogren's syndrome than a standard, currently available immunoassay (46%).

Briefly, this invention employs a panel of mammalian-derived proteins and protein fragments that are often antigentic in individuals with Sjogren's syndrome in concert with a luciferase immunoprecipitation system. In contrast, most currently available immunoassays for diagnosis of rheumatological diseases include either antigens from recombinant bacterial expression systems or single antigens from bovine sources. These immunoassays are likely to fail to present the sufficient variety of specific human epitopes that are necessary for high accuracy diagnoses of Sjogren's syndrome.

Applications:

• Diagnosis of Sjogren's syndrome.
• A component of a panel of diagnostic tests for patients with autoimmune disease symptoms.

Advantages: Higher accuracy than currently available diagnostics of Sjogren's syndrome.

Development Status: Early stage. Initial clinical screens have been completed.

Market: According to the Sjogren's Syndrome Foundation, Inc., it takes on average seven years for a positive Sjogren's syndrome diagnosis as symptoms of this syndrome mimic other conditions and diseases. Up to four million individuals in the United States have Sjogren's syndrome, and half of currently diagnosed cases occur in concert with other autoimmune disease (http://www.sjogrens.org/​home/​about-sjogrens-syndrome).

Inventors: Peter D. Burbelo and Michael J. Iadarola (NIDCR).

Related Publications:

1. Burbelo PD, Leahy HP, Issa AT, Groot S, Baraniuk JN, Nikolov NP, Illei GG, Iadarola MJ. Sensitive and robust luminescent profiling of anti-La and other autoantibodies in Sjogren's syndrome. Autoimmunity. 2009 Sep;42(6):515-524. [PubMed: 19657778]

2. Burbelo PD, Ching KH, Issa AT, Loftus CM, Li Y, Satoh M, Reeves WH, Iadarola MJ. Rapid serological detection of autoantibodies associated with Sjögren's syndrome. J Transl Med. 2009 Sep 24;7:83. [PubMed: 19778440]

3. Burbelo PD, Ching KH, Klimavicz CM, Iadarola MJ. Antibody profiling by Luciferase Immunoprecipitation Systems (LIPS). J Vis Exp. 2009 Oct 7;(32); pii: 1549; doi: 10.3791/1549. [PubMed: 19812534]

Patent Status: U.S. Provisional Application No. 61/224,649 filed 10 Jul 2009 (HHS Reference No. E-070-2009/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Norbert Pontzer, J.D., Ph.D.; 301-435-5502; [e-mail].

Collaborative Research Opportunity: The National Institute of Dental and Craniofacial Research, Laboratory of Sensory Biology, Neurobiology and Pain Therapeutics Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact David W. Bradley, Ph.D. at 301-402-0540 or [e-mail] for more information.

Dated: January 21, 2010.

Richard U. Rodriguez,

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