[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55497-55498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8082]



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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, HHS.

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.

Epstein-Barr Negative Lymphoma-Derived Cell Lines

    Description of Technology: The National Institutes of Health 
developed multiple lymphoid cell lines that were derived from patients 
with undifferentiated lymphoma of Burkitt's or non-Burkitt's type (now 
known as Burkitt and Burkitt-like lymphoma). Burkitt lymphoma is a 
highly aggressive B-cell lymphoma, which accounts for approximately 
half of all non Hodgkin's lymphomas in children. It also occurs in 
adults, and in some patients with compromised immune systems, e.g., in 
patients infected with HIV. The cell lines have been used to advance 
our understanding of the molecular mechanisms of lymphomagenesis, and 
thus, can be used for the identification of molecular targets for drugs 
or other agents that can be developed for the treatment of lymphomas 
and other tumors.
    The Epstein-Barr virus (EBV) has been implicated in the 
pathogenesis of Burkitt lymphoma, although geographical variations 
occur. Ten out of sixteen cell lines derived at the NIH were found to 
be negative for Epstein-Barr virus (EBV), consistent with the low 
frequency of EBV association in this tumor in the USA. The cell lines 
were screened for chromosomal aberrations and fifteen were found to 
contain reciprocal translocation between chromosome 8 and 14, t(8;14). 
These exchanges involve the chromosomal regions on which the c-myc 
oncogene (8q24.1) and the heavy-chain immunoglobulin genes (14q32) 
reside.
    Applications: (1) Screening tool to identify novel genes unique to 
or overexpressed in Burkitt lymphoma; (2) Screen for compounds that 
kill tumor cells and represent potential therapeutic agents; (3) 
Control in screening for novel genes expressed or overexpressed in EBV 
+ Burkitt lymphoma; (4) Control for therapeutic agents directed against 
EBV genes or genes induced by EBV
    Inventor: Ian Magrath (NCI)
    Publications: 1. IT Magrath, et al., ``Characterization of 
lymphoma-derived cell lines: comparison of cell lines positive and 
negative for Epstein-Barr virus nuclear antigen. I. Physical, 
cytogenetic, and growth characteristics.'' J Natl Cancer Inst. 1980 
March; 64(3):465-476.
    2. IT Magrath, et al., ``Characterization of lymphoma-derived cell 
lines: Comparison of cell lines positive and negative for Epstein-Barr 
virus nuclear antigen. II. Surface markers.'' J Natl Cancer Inst. 1980 
Mar; 64(3):477-483.
    Patent Status: HHS Reference No. E-221-2006/0--Research Tool.
    Licensing Status: Available for licensing under a biological 
material license.
    Licensing Contact: John Stansberry, PhD; 301/435-5236; 
[email protected].

Organic Thiophosphate Antiretroviral Agents

    Description of Technology: The current technology represents a 
potentially safe and effective addition to the antiretroviral drug 
combinations used for treatment of HIV infection. Amifostine, 
phosphonol and functional derivatives thereof are available for 
licensing and commercial development for use as antiretroviral drugs. 
These organic thiophosphate reducing agents inhibit HIV viral growth 
and protein expression in HIV-infected human white blood cells without 
destroying the cells. The compounds described in this technology block 
growth of HIV by a mechanism that is dependent on the level of 
aminothiol reducing agent in the cellular environment. In addition, a 
range of effective doses and methods for oral administration of the 
available organic thiophosphates is provided.
    Applications: (1) Novel therapeutics for the treatment of HIV 
infection; (2) Safe and effective addition to the drug combinations 
currently used to treat HIV/AIDS.
    Market: (1) Nearly 40.3 million people living with HIV worldwide, 
including approximately 2.0 million people in North America and Europe; 
(2) Anti-HIV/AIDS therapeutics experience accelerated market acceptance 
and draw revenues of approximately $240 million to $1 billion.
    Development Status: Preclinical data is available at this time.
    Inventors: Miriam C. Poirier (NCI), Gene M. Shearer (NCI), et al.
    Related Publications: 1. T Kalebic and PS Schein. Organic 
thiophosphate WR-151327 suppresses expression of HIV in chronically 
infected cells. AIDS Res Hum Retroviruses. 1994 Jun; 10(6):727-733.
    2. JL Rossio, MT Esser, K Suryanarayana, DK Schneider, JW Bess Jr, 
GM Vasquez, TA Wiltrout, E Chertova, MK Grimes, Q Sattentau, LO Arthur, 
LE Henderson, JD Lifson. Inactivation of human immunodeficiency virus 
type 1 infectivity with preservation of conformational and functional 
integrity of virion surface proteins. J Virol. 1998 Oct; 72(10):7992-
8001.
    3. CF Perno, R Yarchoan, DA Cooney, NR Hartman, S Gartner, M 
Popovic, Z Hao, TL Gerrard, YA Wilson, DG Johns, et al. Inhibition of 
human immunodeficiency virus (HIV-1/HTLV-IIIba-L) replication in fresh 
and cultured human peripheral blood monocytes/macrophages by 
azidothymidine and related 2',3'-dideoxynucleosides. J Exp Med. 1988 
Sep 1; 168(3):1111-1125.
    4. LS Clark, RJ Albertini, JA Nicklas. The aminothiol WR-1065 
protects T lymphocytes from ionizing radiation-induced deletions of the 
HPRT gene. Cancer Epidemiol Biomarkers Prev. 1997 Dec; 6(12):1033-1037.
    5. NP Nguyen, B Levinson, S Dutta, U Karlsson, KC Kelly, J Dowell, 
A Ludin, S Sallah. Amifostine and curative intent chemoradiation for 
compromised cancer patients. Anticancer Res. 2003 Mar-Apr; 23(2C):1649-
1656.
    Patent Status: U.S. Provisional Application No. 60/792,431 filed 17 
Apr 2006 (HHS Reference No. E-017-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Sally Hu, PhD; 301/435-5606; [email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Cellular Carcinogenesis and Tumor Promotion is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or

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commercialize these organic thiophosphate antiretroviral agents. Please 
contact Betty Tong, PhD at 301/594-4263 or [email protected] for more 
information.

    Dated: September 18, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 06-8082 Filed 9-21-06; 8:45 am]
BILLING CODE 4140-01-P