E8-10682. Government-Owned Inventions; Availability for Licensing

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: [phone]; fax: [phone]. 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; [e-mail].

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 [e-mail] 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/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; [e-mail].

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 [e-mail] 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.