[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Notices]
[Pages 9660-9661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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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; 
[email protected].
    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; 
[email protected].
    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; 
[email protected].
    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

[[Page 9661]]

have 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.

    Dated: February 17, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-3832 Filed 2-25-05; 8:45 am]
BILLING CODE 4140-01-P