01-8087. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Analogs of Thalidomide as Potential Angiogenesis Inhibitors

William Figg et. al. (NCI)

DHHS Reference No. E-282-00/0; filed 27 Feb 2001

Licensing Contact: Matthew Kiser; 301/496-7735 ext. 224; e-mail: [e-mail]

The present invention relates to anti-angiogenesis compositions and methods of using the same. In particular, thalidomide analogs that actively inhibit angiogenesis in humans and animals are claimed. The present methods provide for the inhibition of unwanted angiogenesis through the administration of a composition comprising an effective amount of an “active” thalidomide analog.

Angiogenesis is the formation of new blood vessels from pre-existing vessels, and it is a prominent feature in solid tumor formation and metastasis. For example, angiogenesis seems to play an important role in tumors such as prostate cancer, breast cancer, CNS glioma, and renal cancer, to name a few. Prevention of angiogenesis could halt the growth of these types of tumors and help prevent the resultant damage due to the presence of these tumors.

Recent studies have promoted thalidomide as a potential inhibitor of angiogenesis. The anti-angiogenic activity initially attributed to thalidomide is actually the resulting effects of compounds that are only present following metabolic activation, i.e. “active” thalidomide metabolites. Accordingly, there is a need for the isolation, identification and characterization of these thalidomide metabolites that exhibit superior anti-angiogenic properties. Furthermore, there is a need for purified thalidomide analogs that can mimic the effects of these metabolites.

A number of thalidomide metabolites having superior anti-angiogenic properties have now been isolated and identified. In addition, thalidomide analogs that mimic the effects of the “active” thalidomide (metabolites and variations of such thalidomide analogs) have been synthesized and evaluated. Such thalidomide analog compounds show enhanced potency in the inhibition of angiogenesis without the undesirable effects of administration of thalidomide.

Detection and Quantification of Cripto-1 in Human Milk Using ELISA

Caterina Bianco, David S. Salomon (NCI)

DHHS Reference No. E-290-00/0 filed 26 Jan 2001

Licensing Contact: Matthew Kiser; 301/496-7735 ext. 224; e-mail: [e-mail]

Cripto-1 (CR1) is a member of the epidermal growth factor (EGF)-related families of peptides and is involved in the development and progression of various human carcinomas. In particular, CR1 overexpression has been detected in 50-90% of carcinomas of the colon, pancreas, stomach, gallbladder, breast, lung, endometrium and cervix. Current methodologies of cancer detection, e.g. immunohistochemistry, can be time consuming, inconvenient and oftentimes, inaccurate, and therefore, a need exists for more efficient, reliable and less time consuming methods of detection. The invention relates to such a method of detection. The inventors disclose methods for the detection and quantification of CR1 in human milk, using an ELISA-based protocol. Thus, this test could be used to more effectively detect and perhaps stage cancers. Additionally, should particular tumor cells, e.g. breast tumor cells, express a sufficiently high level of CR1, it may be possible to use the disclosed assay to detect and measure CR1 in human serum and/or plasma. Claims to these routes of detection are also present in the patent application. As such, a novel, efficient and useful in vitro diagnostic and prognostic test is now available to suitable commercial partners.

Dated: March 23, 2001.

Jack Spiegel,

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