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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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.

Mouse Lactoferrin Antibody

Christina T. Teng (NIEHS), DHHS Reference No. E-158-2004/0—Research Tool. Licensing Contact: Marlene Shinn-Astor; 301/435-4426; shinnm@mail.nih.gov.

Lactoferrin, an iron-binding glycoprotein, kills bacteria and modulates inflammatory and immune responses. It is expressed in mucosa membrane and is present in saliva, tears, vaginal secretion and neutrophils. It modulates immune and inflammatory response by down-regulating several cytokines. Therefore, lactoferrin is an important protein in first line of defense and protecting health. Changes in lactoferrin expression could also be used as a marker of gene activation, especially estrogen-induced gene activity in the uterus.

The inventors have uniquely purified a novel 70 kDa estrogen-stimulated glycoprotein, lactoferrin, from mouse uterine luminal fluid. CM-Affi-Gel Blue column chromatography provided a simple one step separation of lactoferrin from the other luminal and serum proteins. Furthermore, a polyclonal antibody was created in rabbit, which has been utilized for immunostaining, Western blot, and elisa assays on human, mouse, rat, and hamster tissues. The cDNA to both human and mouse were cloned. Probes designed to detect the methylation status or polymorphisms of the human lactoferrin gene are available and can be used as diagnostic tool in cancer study.

The inventor has available polyclonal antibodies for both human and mouse, as well as purified mouse lactoferrin protein.

References: (1) Teng, CT et al. 1986. Purification and properties of an oestrogen-stimulated mouse uterine glycoprotein (approx. 70 kDa). Biochemical Journal. 240:413-422. (2) Teng, et al. 2002. Differential expression and estrogen response of lactoferrin gene in the female reproductive tract of mouse, rat, and hamster. Biology of Reproduction. 67:1439-1449.

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

Antibody to Estrogen Related Receptor Alpha

Christina T. Teng (NIEHS), DHHS Reference No. E-157-2004/0—Research Tool.

Licensing Contact: Marlene Shinn-Astor; 301/435-4426; shinnm@mail.nih.gov.

Estrogen related receptor alpha (ERRalpha) is a family member of the steroid/thyroid nuclear receptor superfamily. Estrogen related receptors are thought to regulate similar target genes in the absence of known ligands. For example, the inventors previously cloned the human estrogen receptor-related orphan receptor alpha1 cDNA and demonstrated that it enhances estrogen responsiveness of the lactoferrin gene promoter in transfected human endometrial carcinoma cells.

The inventors have produced a peptide and fusion protein rabbit polyclonal antibody against ERRalpha1-C terminal (anti-ERRalpha-CT), which has been utilized for immunostaining, Chromatin immunoprecipitation (ChIP), immunoprecipitation/immunoblottin (IP/IB) and Western blot. This antibody targets the C-terminus of the protein which is a conserved region in human and mouse. The antibody will be a valuable tool to study the expression and function of the protein in rodent models, whereas the human antibody is already commercially available. The inventors also have available mouse cDNA for ERRalpha1 which can be used to detect mRNA.

Reference: Shigeta, H, et al. 1997. The mouse estrogen receptor-related orphan receptor alpha1: molecular cloning and estrogen responsiveness. Journal of Molecular Endocrinology. 19:299-309.

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

A Novel, Preservative-Free Steroid Formulation for Use as an Anti-Inflammatory

Michael R. Robinson (NEI), George Grimes (CC), Luisa Gravlin (CC), Gopal Potti (CC), Peng Yuan (CC) and Karl Csaky (NEI), U.S. Provisional Patent Application No. 60/628,741 filed 17 Nov 2004 (DHHS Reference No. E-094-2003/0-US-01).

Licensing Contact: Susan Carson; 301/435-5020; carsonsu@mail.nih.gov.

Corticosteroids, such as dexamethasone, methylprednisolone and triamcinolone acetonide (TAC), have been used for many years in the treatment of inflammation and in relieving pain caused by inflammation (for example chronic back and joint pain). Intraocular inflammation is also treated with steroids; however, there are no commercial corticosteroid preparations approved by the FDA for use in the eye and off-label use of current commercial formulations can be accompanied by toxic side effects, which can lead to vision loss. Inflammation is present in eye diseases including uveitis, diabetic retinopathy, venous occlusive disease and age-related macular degeneration, which are estimated to affect more than 200,000 patients in the U.S. alone. This number is likely to increase as the population ages, and there remains a need for a cost-effective, safe, efficient steroid formulation for treating these conditions.

NIH researchers at the National Eye Institute and the Clinical Center have devised a novel preservative-free formulation of the generic steroid TAC with an improved safety profile that permits intravitreal injection. The invention is a pharmaceutical composition free of preservatives and dispersion agents (TAC-PF) that are thought to be responsible for certain toxic side effects. Pre-clinical ocular toxicology and pharmacokinetic studies Start Printed Page 9661have been performed using a commercial formulation (KenalogTM) as a comparator with the invention. No ocular toxicity was seen with TAC-PF. The inventors have an IND in place and have positive results in the treatment of diabetic macular edema with a single dose of TAC-PF. The targeted indications for the present novel TAC formulation include diabetic retinopathy and macular edema, uveitis and age-related macular degeneration. Additionally, this formulation, which benefits from an improved safety profile, could possibly be used in other indications where steroid injections are used to control inflammation.

This formulation is available for licensing and claims are directed to a pharmaceutical composition free of classical preservatives and comprising a glucocorticoid or angiostatic steroid. Claims are also directed to methods of making and treating a variety of ocular conditions and other inflammatory conditions including pain by a variety of routes of administration, including intravitreally, intrathecally, etc.

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

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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. 05-3832 Filed 2-25-05; 8:45 am]

BILLING CODE 4140-01-P