[Federal Register Volume 65, Number 239 (Tuesday, December 12, 2000)]
[Notices]
[Pages 77652-77654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31526]


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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 agencies 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.

A Mouse Model of UV-Inducible Cutaneous Malignant Melanoma

Glenn Merlino et al. (NCI)
DHHS Reference No. E-281-00/0
Licensing Contact: Elaine White; 301/496-7056 ext. 282; e-mail: 
[email protected]

    The current invention embodies a genetically engineered mouse 
harboring a hepatocyte growth factor/scatter factor transgene (``HGF/
SF''). The Met signaling pathway, which has been implicated in the 
development of human melanoma, is chronically

[[Page 77653]]

activated in the HGF/SF mice. Upon exposure to a single neonatal dose 
of erythrogenic UV radiation, the mice develop cutaneous malignant 
melanoma which is consistent with the epidemiology and pathogenesis of 
melanomas observed in humans. The mice, therefore, represent a valuable 
model for studying the development of malignant melanoma in humans, for 
determining the consequences of ultraviolet radiation, and for 
assessing the efficacy of therapeutic agents and vaccines against 
melanoma. While no patent rights are available for this invention, 
breeding pairs of mice are available for licensing via Biological 
Materials License Agreements.

Gamma-Glutamyl Transpeptidase Inhibitors: Novel Chemotherapeutic 
Agents

Robert E. London, Scott A. Gabel (NIEHS)
DHHS Reference No. E-243-00/0 filed 05 Oct 2000
Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: 
[email protected]
    Gamma-glutamyl transpeptidase (GGTP) plays a central role in the 
metabolism of glutathione. It has been shown to be a marker for 
neoplasia and cell transformation, and it is induced by the presence of 
many anti-cancer drugs. Common human epithelial tumors, including, but 
not necessarily limited to, breast, ovarian and prostate tumors are 
GGTP-positive. The invention relates to novel inhibitors of GGTP, and 
their use to treat cancer. In particular, the technology could be used 
to (1) interfere with glutathione metabolism in GGTP-positive cancers 
by perhaps altering the cellular orientation of GGTP; (2) potentiate 
the effects of radiation and chemotherapeutic drugs, in particular, 
cisplatin, on cancer cells by interfering with cysteine recycling and 
glutathione regeneration; and (3) reduce renal toxicity for some 
chemotherapeutic drugs by blocking the metabolism of glutathione-
conjugates into toxic agents, e.g., mercapturic acids. The patent 
application contains composition of matter claims as well as method 
claims.

Protein Kinase A and the Carney Complex

Constantine A. Stratakis, Lawrence S. Kirschner (NICHD)
DHHS Reference No. 259-00/0 filed 25 Aug 2000
Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: 
[email protected]

    The present invention provides compositions and methods useful in 
the diagnosis and prognosis of Carney complex (CNC), as well as methods 
and compositions for the identification of compounds useful in the 
treatment and/or prevention of CNC. CNC is a multiple endocrine 
neoplasia syndrome that affects the adrenal cortex, pituitary gland, 
thyroid gland and gonads. Additionally, compositions and methods are 
provided for the diagnosis and treatment of conditions associated with 
skin pigmentation defects, including but not limited to, freckling, as 
well as endocrine tumors including, but not limited to, adrenal and 
pituitary tumors. Finally, compositions and methods are provided for 
the diagnosis and treatment of various types of cancers associated with 
abnormal protein kinase A activity, and cancers and tumors in which 
protein kinase A regulatory subunit 1A acts as a tumor-suppressor gene. 
These actions are possible due to the identification of specific 
genetic sequences, and the use of this information in assay systems to 
detect, diagnose and treat the aforementioned conditions.

SH2 Domain Binding Inhibitors

Terrence R. Burke, Yang Gao, Johannes Voight (NCI)
DHHS Reference No. E-262-00/0 filed 22 Aug 2000
Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: 
[email protected]

    Signal transduction, the process of relaying extracellular messages 
to the intracellular cytoplasm and the nucleus, is critical to normal 
cellular homeostasis, and protein-tyrosine kinases play a central role 
in this biological function. Examples of this latter class of enzymes 
include the PDGF receptor, the FGF receptor, the HGF receptor, members 
of the EGF receptor family, including the EGF receptor itself and erb-
B2, erb-B3 and erb-B4 kinases; the src kinase family, Fak kinase and 
the Jak kinase family. Protein-tyrosine phosphorylation is known to be 
involved in modulating the activity of a variety of target enzymes and 
in the formation of specific complex networks involved in signal 
transduction via proteins containing specific amino acid sequences, 
called the Src homology 2, or SH2 domain. A malfunction in this 
protein-tyrosine phosphorylation through tyrosine kinase overexpression 
and/or deregulation, can be manifested by various oncogenic and 
hyperproliferative disorders, such as cancer, inflammation, autoimmune 
disease, hyperproliferative skin disorders, e.g., psoriasis and 
allergy/asthma. The disclosed compounds, e.g. peptides, preferably, 
macrocyclic peptides, are SH2 domain inhibitors with enhanced binding 
affinity. The claims of the current application are directed to 
compositions of matter and methods of use which provide for the 
diagnosis, testing and treatment of the aforementioned disease states.

Use and Targeting of CD98 Light-Chain Proteins in Therapies for 
Thyroid Hormone Disorders

Yun-Bo Shi (NICHD)
DHHS Reference No. E-054-00/0 filed 30 Jun 2000
Licensing Contact: Marlene Shinn; 301/496-7056 ext. 285; e-mail: 
[email protected]

    Thyroid hormone disorders are among the most common problems in the 
Western world. These include hypo-and hyper-thyroidism (including 
goiter), as well as obesity and developmental abnormalities caused by 
excess or deficient levels of thyroid hormones during pregnancy.
    The NIH announces the discovery of a protein, which is a member of 
the CD98 light-chain permease family, which acts as a thyroid hormone 
transporter across vertebrate cell membranes. This protein provides a 
missing link in the chain by which thyroid hormones in the blood reach 
the cell nucleus. By utilizing the CDNA of this protein, genomic 
libraries can be screened for sequences capable of being used as 
primers for use in diagnostics. Also, by targeting this protein through 
drug discovery, new treatments for thyroid disorders may be found and 
developed.

Method of Regulating Interleukin-12 (IL-12) Production by 
Administering CCR5 Agonists and Antagonists

Sher et al. (NIAID)
PCT/US00/01019 filed 14 Jan 2000
Licensing Contact: J.P. Kim; 301/496-7056 ext. 264; e-mail: 
[email protected]

    Interleukin-12 (IL-12) is a cytokine produced by the body which is 
necessary for the development of effective cellular immunity against 
many microbial agents. Increasing IL-12 production has been shown to 
both enhance the immune clearance of microbial agents as well as 
augment the protection induced by vaccines. At the same time a number 
of inflammatory diseases are associated with the excess production of 
this cytokine. Therefore, methods are needed to both boost IL-12 
production for the induction of host resistance as well as suppress it 
to treat these immunopathologic disorders.
    The present invention relates to methods for increasing IL-12

[[Page 77654]]

production in a cell by administering CCR5 agonists and methods for 
decreasing IL-12 production in a cell administering CCR5 antagonists. 
The invention also relates to methods for increasing IL-12 production 
by administering CCR5 agonists and to methods for decreasing IL-12 
production in a subject by administering CCR5 antagonists.

    Dated: November 11, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 00-31526 Filed 12-11-00; 8:45 am]
BILLING CODE 4140-01-P