[Federal Register Volume 70, Number 140 (Friday, July 22, 2005)]
[Notices]
[Pages 42350-42351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14497]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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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; 
[email protected].

    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

[[Page 42351]]

database 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; 
[email protected].

    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.

    Dated: July 15, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-14497 Filed 7-21-05; 8:45 am]
BILLING CODE 4140-01-P