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Government-Owned Inventions; Availability for Licensing

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National Institutes of Health, Public Health Service, DHHS.




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.


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.

Compositions and Methods for the Treatment of Immune-Related Disease

F. Xavier Valencia and Peter E. Lipsky (NIAMS), U.S. Provisional Application filed 07 Jan 2005 (DHHS Reference No. E-355-2004/0-US-01).

Licensing Contact: Fatima Sayyid; 301/435-4521;

The ability of the immune system to discriminate between self and non-self is controlled by central and peripheral tolerance mechanisms. One of the most important ways the immune system controls the outcome of such a response is through naturally occurring CD4+CD25+ regulatory T cells.

The present invention relates to compositions and methods for treating immune related disease, a method for determining the presence of or predisposition to an immune related disease, and a pharmaceutical composition for treating an immune related disease in a mammal.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Expression Tags for High Yield Soluble Expression of Recombinant Proteins

Deb K. Chatterjee and Dominic Esposito (NCI), U.S. Provisional Application No. 60/564,982 filed 26 Apr 2004 (DHHS Reference No. E-103-2004/0-US-01).

Licensing Contact: Susan Carson, 301-435-5020;

Production of large quantities of soluble and correctly folded proteins is essential for a variety of applications ranging from functional analysis and structure determination to clinical trials. E. coli is a widely used expression system that offers the advantages of ease of handling, cost-effectiveness and the ability to produce proteins in high yield. However, the enhanced production obtainable with E. coli expression systems is frequently accompanied by problems of protein insolubility, production host non-viability and aberrant protein folding. Many strategies have been proposed to address these problems, in particular the use of fusion vectors that mediate the expression of a target gene linked to a peptide signal sequence or to a “chaperone” or “carrier” protein that is capable of “escorting” the fusion protein out of the cytoplasm and into the periplasmic space. However, there remains a need for methods that provide soluble proteins that are correctly folded and in functional form without unacceptably diminishing the yield of recovered protein or requiring complex host strains.

NIH researchers have developed a fusion polynucleotide in which a polynucleotide encoding a desired target protein is linked to one or more chaperone protein domains (Skp and DsbC) with or without the signal sequence. This permits the expressed proteins to be transported to the periplasm or to be retained in the cytoplasm respectively and these vectors were used to successfully express significant amounts of such difficult to express proteins as Hif1a, Folliculin (fol), a Folliculin domain (FD), Wnt5a, Endostatin, YopD, IL13 and IFN-Hybrid3. These fusion vectors are available for licensing and are useful tools for the expression of commercially viable amounts of functional proteins of therapeutic and scientific interest.

In addition to licensing, the technology is available for further development through collaborative research with the inventors via a Cooperative Research and Development Agreement (CRADA).

Novel Potent Monoamine Oxidase Inhibitors

Kenneth L. Kirk et al. (NIDDK), U.S. Provisional Application No. 60/484,710 filed 03 Jul 2003 (DHHS Reference No. E-226-2003/0-US-01); PCT Application No. PCT/US04/21505 filed 01 Jul 2004 (DHHS Reference No. E-226-2003/0-PCT-02).

Licensing Contact: Norbert Pontzer; 301/435-5502;

Copper- (EC, and flavin-containing amine oxidases (EC, make up two general classes of the widely distributed monoamine oxidases. Reversible and irreversible inhibitors of the flavin monoamine oxidases have been developed and investigated for treatment of diseases of the CNS such as depression, Parkinson's disease and Alzheimer's disease. These researchers have developed several new arylethyl and benzyl amine derivatives that incorporate both the key cyclopropane ring and fluorine substitution at strategic positions. The combined effects of this substitution pattern have led to new inhibitors of greatly increased potency and selectivity for all classes of monoamine oxidases. Their potent copper amine oxidase inhibitors are the best reversible inhibitors known and could provide vascular protection in advanced diabetics. Further information on these compounds can be found in Yoshida et al., J. Med. Chem. (25 Mar 2004) 47 (7): 1796-1806, 2004, and Yoshida et al., Start Printed Page 9660Bioorg. Med. Chem. (15 May 2004) 12 (10): 2645-2652.

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Dated: February 17, 2005.

Steven M. Ferguson,

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

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[FR Doc. 05-3830 Filed 2-25-05; 8:45 am]