E8-31238. 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, Maryland 20852-3804; telephone: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Novel Inhibitor of NF-kappa B Pathway

Description of Technology: Many tumors and blood cell cancers show overactivation of the NF-kappa B signal transduction pathway. This overactivation is associated with cancer forming in the colon, liver and other epithelial sites. In addition, there is evidence that overactivation leads to tumor formation and metastasis. However, this pathway is key for normal immunity, so any inhibition of NF-kappa B overactivation must avoid diminishing the body's ability to fight infection.

This invention claims a compound that inhibits NF-kappa B activation without affecting other transcription factors such as AP-1 and SRE binding proteins. It appears to function by blocking IKK beta and is effective at low micromolar concentrations without affecting cell proliferation or cell survival. At this low concentration, NF-kappa B is reduced to basal levels so this novel compound has prospects for preventing or treating cancer without being detrimental to immunity. In addition, because NF-kappa B overactivation contributes to a variety of inflammatory disorders including colitis, diabetes, prostatitis, and pancreatitis this compound has therapeutic applications beyond cancer.

Applications:

• Therapeutic for the chemoprevention or treatment of cancers associated with the overactivation of NF-kappa B signaling pathway.
• Therapeutic for the treatment of inflammatory disorders related to NF-kappa B overactivation.
• Reagent for the diagnosis of conditions related to overexpression of NF-kappa B.

Advantages:

• Highly specific inhibitor that allows targeting NF-kappa B without inhibiting other transcription factors.
• Effective at preventing carcinogenesis without affecting normal cell proliferation and survival.
• Therapeutic for treatment of cancer that will not compromise the immune system.

Development Status: Early stage.

Market: Cancer is the second leading cause of death in the U.S. and it is estimated that 1.4 million Americans develop cancer in a year.

Inventors: Curtis J. Henrich et al. (NCI).

Publications: None related to invention have been published.

Patent Status: U.S. Provisional Application No. 61/098,977 filed 22 Sep 2008 (HHS Reference No. E-295-2008/0-US-01).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Sabarni K. Chatterjee, Ph.D.; 301-435-5587; [e-mail].

Collaborative Research Opportunity: The National Cancer Institute (SAIC-Frederick) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize around development of analogs and/or further investigations of mechanism of action of the compound. Please contact John D. Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Method for Predicting and Detecting Tumor Metastasis

Description of Technology: Detecting cancer prior to metastasis greatly increases the efficacy of treatment and the chances of patient survival. Although numerous biomarkers have been reported to identify aggressive tumor types and predict prognosis, each biomarker is specific for a particular type of cancer, and no universal marker that can predict metastasis in a number of cancers have been identified. In addition, due to a lack of reliability, several markers are typically required to determine the prognosis and course of therapy.

The inventors discovered a novel CPE splice variant designated CPE-△N and found its expression levels increase according to the presence of cancer and metastasis wherein this variant is upregulated in tumors and further increased in metastatic cancer. This data has been demonstrated both in vitro and in vivo experiments and in liver, breast, prostate, colon, and head and neck cancers. Metastatic liver cells treated with CPE-△N siRNA reversed the cells from being metastatic and arrested cells from further metastasis. Thus, this novel CPE isoform is a biomarker for predicting metastasis and its inhibitors have an enormous potential to increase patient survival.

Applications:

• Method to prognose multiple types of cancer and determine likelihood of metastasis.
• Method to prevent and treat cancer with CPE inhibitors.
• Method to determine the stage of cancer development.
• CPE-△N pharmaceutical compositions.

Development Status: The technology is currently in the pre-clinical stage of development.

Market:

• Global cancer market is worth more than eight percent of total global pharmaceutical sales.
• Cancer industry is predicted to expand to $85.3 billion by 2010.

Inventors: Y. Peng Loh et al. (NICHD).

Patent Status: U.S. Provisional Application No. 61/080,508 filed 14 Jul 2008 (HHS Reference No. E-234-2008/0-US-01).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Jennifer Wong; 301-435-4633; [e-mail].

Collaborative Research Opportunity: The National Institute of Child Health and Human Development, Laboratory of Development Neurobiology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Method for Predicting and Detecting Tumor Metastasis. Please contact John D. Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Dated: December 23, 2008.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.