Notice: Government-Owned Inventions; Availability for Licensing

Federal Register: May 13, 2008 (Volume 73, Number 93)              
                  Page 27541-27542

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, 
MD 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.

Multicolored Fluorescent Cell Lines for High-Throughput Angiogenesis 
and Cytotoxicity Screening

    Description of Technology: Understanding the biological processes 
that underlie cellular organization and communication has become a 
vital element in the discovery of new therapeutics, and in evaluating 
the efficiency of existing therapeutic approaches. One frequently-
studied example of a system in which multiple cell types function 
together and influence each other is angiogenesis, which is 
fundamentally important in tissue development, vascular disease, and 
cancer. The availability of high-throughput, simple assays for the 
study of multiple-cell biological processes, such as angiogenesis, is 
essential for the development of therapeutics and diagnostics for 
disorders governed by these complex processes.
    The inventors have developed a series of immortalized cell lines, 
selected to represent the different cell types found in angiogenesis in 
vivo, that constitutively express different fluorescent proteins. Based 
on these cell lines, the inventors have developed several in vitro 
angiogenesis assays and a software application that can be used to 
investigate the relationships between different cells involved in 
angiogenesis, to develop new combinatorial approaches to boost the 
efficiency of existing therapeutics, and to facilitate the discovery of 
new potential single or combination drugs. These assays have several 
advantages over currently-available kits, such as the capability for 
real-time monitoring of cellular interaction and activity, shortened 
and simplified protocols, and no added detection reagents to disrupt 
assay results. The inventors have also developed a cytotoxicity assay 
using these cells that would be suitable for screening libraries of 
potential new drugs.
    Applications: This technology could potentially be used to develop 
a high-throughput screening assay for angiogenesis or anti-angiogenesis 
drugs, or to screen compounds for cytotoxicity. A diagnostic test based 
on this technology could be used to monitor levels of angiogenic 
factors in the blood, to aid in personalized therapies for cancer and 
other angiogenesis-dependent diseases.
    Development Status: The inventors have already demonstrated proof 
of concept for this technology by developing a high-throughput screen 
for potential angiogenic drugs, and they have also recently developed a 
cytotoxicity assay. They are in the process of identifying further uses 
for this technology, and have also developed a software application for 
analysis of tube formation assays.
    Inventors: Enrique Zudaire and Frank Cuttitta (NCI).
    Patent Status: U.S. Patent Application No. 12/060,752 filed 01 Apr 
2008 (HHS Reference No. E-281-2007/0-US-02)
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Tara L. Kirby, PhD; 301-435-4426; 
tarak@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute 
Angiogenesis Core Facility is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize multicolored fluorescent cell lines 
for high-throughput angiogenesis and cytotoxicity screening. Please 
contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for 
more information.

A Novel Growth Factor and Anti-Apoptotic Agent for Promoting Lung 
Development and Treating Lung Disease

    Description of Technology: This invention discloses the novel use 
of the uteroglobin-related protein 1 (UGRP1), also known as 
secretoglobin family 3A member 2 (SCGB3A2), as a cell proliferative and 
anti-apoptotic agent that can be used to promote lung development and 
treat lung disease. SCGB3A2 is a member of the uteroglobin/Clara cell 
secretory protein or Secretoglobin gene superfamily of secretory 
proteins that is normally expressed in the epithelial cells of the 
trachea, bronchus, and bronchioles, and is known for its anti-
inflammatory activity. NIH scientists have, however, recently 
discovered the surprising growth factor and anti-apoptotic activities 
of SCGB3A2. These activities allow SCGB3A2 to be used to prevent the 
development of neonatal respiratory distress, promote lung development, 
and inhibit the lung damage that results from treatment with certain 
anti-cancer agents such as bleomycin.
    SCGB3A2 administration ex vivo and in vivo was shown to enhance 
cell proliferation and branching morphogenesis. SCGB3A2 was also shown 
to suppress or repair bleomycin induced DNA damage/fibrosis when given 
before, or together with bleomycin treatment in in vitro organ culture, 
and in an in vivo mouse model of pulmonary fibrosis. These cell 
proliferative and morphogenic effects of SCGB3A2 make it an attractive 
candidate for therapeutic use in the treatment of several lung diseases 
that involve tissue injury or inflammation, such as, pulmonary 
fibrosis, interstitial pneumonia, emphysema and cancer. SCGB3A2 therapy 
is also envisioned for use as a lung development agent in premature 
newborn infants born with underdeveloped lungs.
    Applications: Repair of damaged lung tissue; Lung development in 
premature newborn infants.
    Development Status: Ex vivo and in vivo mouse studies conducted.
    Inventors: Shioko Kimura and Reiko Kurotani (NCI).
    Publication: Y Chiba, R Kurotani, T Kusakabe, T Miura, BW Link, M 
Misawa, S Kimura. Uteroglobin-related protein 1 expression suppresses 
allergic airway inflammation in mice. Am J Respir Crit Care Med. 2006 
May 1;173(9):958-964.
    Patent Status: U.S. Provisional Application No. 60/847,747 filed 27 
Sep 2006 (HHS Reference No. E-286-2006/0-US-01); PCT Application No. 
PCT/

[[Page 27542]]

US2007/079771 filed 27 Sep 2007 (HHS Reference No. E-286-2006/2-PCT-
01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jasbir (Jesse) S. Kindra, J.D., M.S.; 301-435-
5170; kindraj@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Metabolism is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize SCGB3A2 as a clinical tool to treat 
and/or prevent lung diseases and/or damage caused by various insults 
including use of the chemotherapeutic agent bleomycin. Lung diseases 
include pulmonary fibrosis, interstitial pneumonia, emphysema and 
cancer. We would like to evaluate the effect of SCGB3A2 on the 
development of emphysema in a smoking model mouse, and as a means to 
attenuate the severity of all aforementioned diseases in larger animals 
such as lamb, goat and monkey. We also would like to evaluate the 
effect of SCGB3A2 on lung maturation using pregnant larger animals. 
Please contact John D. Hewes, PhD at 301-435-3121 or 
hewesj@mail.nih.gov for more information.

    Dated: May 8, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-10682 Filed 5-12-08; 8:45 am]

BILLING CODE 4140-01-P