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Notice

Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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: (301) 496-7057; fax: (301) 402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Standardizing Criteria on Cancer Biomarkers as Foundation of a Database: Creating a Common Language (Data Elements) for Cancer Biomarkers Tracking and Utilization for Professionals in Oncology Research

Mahin Khatami (NCI)

HHS Reference No. E-147-2005/0—Research Tool

Licensing Contact: Michelle A. Booden; (301) 451-7337; boodenm@mail.nih.gov.

Cancer biomarkers (CBs) are important biological tools in modern oncology research for diagnosis, prognosis, prevention, therapy and outcome. Biological characters of biomarkers are as diversified as their utilization potentials. Biomarkers may be proteins/peptides, glycoproteins, lipids, glycolipids, antigens/antibodies, cytokines/chemokines, receptors, enzymes, inhibitors, nutrients/metabolites, DNA/RNA mutations, etc. CBs are found in blood/serum, urine, other biological fluids, and/or tissue specimen.

The NCI has identified a common set of data elements or criteria to describe a large number of cancer biomarkers. These data elements may be used as a foundation for a cancer biomarker Start Printed Page 42351database to track a wide range of data on biomarkers. Generic data elements selected by the NCI will be incorporated into a database and a set of elements will be chosen to tailor for specific markers for suitability and utilization.

The database may be further developed and improved by creation of a web accessible interface providing guidance on how to access a marker of choice according to relevant set of data elements from the foundation; e.g., data elements that best define the marker for specific clinical utilization. Addition and identification of suitable markers within the database and tailoring of data elements could be accomplished by recommendation of a review panel of experts for suitability and/or utilization of selected markers. Marker data will be updated by individual investigators or by a database administrator as additional pertinent information becomes available in the literature on specific marker.

A fully enabled database would allow professionals within industry, research and clinical centers to easily access, retrieve and study the state of technology of a specific biomarker at a point of need. Standardization and proper evaluation and packaging of relevant integrated data on cancer biomarkers into a central database should eventually account for characteristics of an individual's state of health that will not only lead to improved detection of cancer, but also to better prevention and treatment of cancer. Access to archived data will direct industry to better assess the need for development of technologies dependent upon knowledge of the markers and may enhance communication among professionals by enabling them to correspond using a common vocabulary of standardized data elements for biomarkers by referring to the data elements that is the foundation of the database.

In order to facilitate the rapid adaptation of the biomarker database, the NCI inventors would be interested in collaborating with qualified commercial entities to develop the technology (software) under terms of a Cooperative Research and Development Agreement (CRADA).

Use of 8-C1-cAMP as Anticancer Drug

Yoon S. Cho-Chung (NCI)

U.S. Patent No. 5,792,752 issued 11 Aug 1998 (HHS Reference No. E-132-1988/0-US-05)

U.S. Patent No. 5,902,794 issued 11 May 1999 (HHS Reference No. E-132-1988/0-US-06)

Licensing Contact: Michelle A. Booden; (301) 451-7337; boodenm@mail.nih.gov.

Site-selective cAMP analogues that preferentially bind and activate PKA-I or PKA-II exhibit specificity not mimicked by parental cAMP. These analogues demonstrate a synergism of binding in appropriate combinations. 8-Cl-cAMP, which belongs to the ISD (isozyme site discriminator) class of site-selective cAMP analogues, activates and down-regulates PKA-I, but not PKA-II, by binding to both site A and B of RI and to site B of RII. 8-Cl-cAMP inhibits growth, in vitro and in vivo, in a broad spectrum of human carcinoma, fibrosarcoma, and leukemia cell lines without causing cytotoxicity. The growth-inhibitory effect of 8-Cl-cAMP correlates with the down-regulation of RI, the up-regulation of RII, and the suppression of c-myc and c-ras oncogene expression.

8-Cl-cAMP is a promising cancer chemotherapeutic agent that in preclinical studies can reverse the transformed phenotype of, and induce apoptotic cell death in, human cancer cells. Results of a Phase I clinical trial suggest that effective plasma levels (determined in preclinical studies) of 8-Cl-cAMP can be maintained below the maximum tolerated dose. More recently, the NCI has initiated and supported ongoing Phase I clinical trials of 8-Cl-cAMP for the treatment of colon cancer and multiple myeloma. The present invention provides compositions and methods for use of cAMP analogs, including 8-Cl-cAMP, as a therapeutic intervention for multiple human diseases.

This technology is available for licensing on an exclusive or a non-exclusive basis.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

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Dated: July 15, 2005.

Steven M. Ferguson,

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

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[FR Doc. 05-14497 Filed 7-21-05; 8:45 am]

BILLING CODE 4140-01-P