[Federal Register Volume 67, Number 40 (Thursday, February 28, 2002)]
[Notices]
[Page 9306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4831]



[[Page 9306]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 contacting Catherine 
Joyce, Ph.D., J.D., at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3821; telephone: 301/496-7056 ext. 258; fax: 301/402-
0220; e-mail: [email protected]. A signed Confidential Disclosure 
Agreement will be required to receive copies of the patent 
applications.

Methods of Generating Human CD4+ Th1 Cells

    Dr. Daniel H. Fowler et al. (NCI).

[DHHS Reference No. E-335-01/0 filed 31 Aug 2001]

    This technology pertains to the identification of specific culture 
conditions that yield human CD4+ T cells highly enriched for Th1 
cytokine production. Recently, techniques have been developed that 
enable the in vitro expansion of mixed populations of T cells (CD4+ T-
cells and CD8+ T-cells) using magnetic microbeads to which monoclonal 
antibodies to CD3 and CD28 have been attached. This technology is being 
developed commercially as the Xcellerate'' technology by Xcyte 
Therapies, Inc., Seattle, Washington.
    The instant invention is directed to the use of the 3/28 bead-
stimulated expansion of CD4+ cells, under specific culture conditions, 
to yield highly pure populations of Th1 cells. The reported conditions 
permit the production of large numbers of pure Th1 CD4+ cells from 
human CD4+ cells. Autologous populations of pure Th1 CD4+ cells may be 
useful for anti-cancer therapy and/or to enhance the immune response 
against infectious agents.

Methods of Generating Human CD4+ Th2 Cells

    Dr. Daniel H. Fowler et al. (NCI).

[DHHS Reference No. E-114-01/0 filed 02 Jul 2001]

    This technology pertains to the identification of specific culture 
conditions that yield a high purity of Th2 cells. Recently, techniques 
have been developed that enable the in vitro expansion of mixed 
populations of T cells (CD4+ T-cells and CD8+ T-cells) using magnetic 
microbeads to which monoclonal antibodies to CD3 and CD28 have been 
attached. This technology is being developed commercially as the 
Xcellerate'' technology by Xcyte Therapies, Inc., Seattle, Washington.
    The instant invention is directed to the use of the 3/28 bead-
stimulated expansion of CD4+ cells, under specific culture conditions, 
to yield highly pure populations of Th2 cells. The reported conditions 
permit the production of large numbers of pure Th2 CD4+ cells from 
human CD4+ cells. This technology is potentially applicable for the 
treatment of several medical conditions. Particularly, research 
regarding the clinical application of using pure Th2 cells for reducing 
graft-versus-host disease (GVHD) during allogeneic stem cell 
transplantation (used in the treatment of leukemia and lymphoma) has 
proceeded to the stage of Phase I clinical trials.

Transforming Growth Factor-Beta (TGF-Beta) Antagonist Selectively 
Neutralizes ``Pathological'' TGF-Beta

    Drs. Lalage Wakefield and Yu-an Yang (NCI).

[DHHS Reference No. E-059-01/0 filed 21 Jun 2001]

    This technology pertains to the use of a soluble transforming 
growth factor-beta (TGF-beta) antagonist (SR2F) for the suppression of 
metastasis. The SR2F antagonist is composed of the soluble 
extracellular domain of the type II TGF-beta receptor fused to the Fc 
domain of human IgG. In accordance with the invention, it has been 
discovered that overexpression of the SR2F antagonist in transgenic 
mice significantly protects against experimentally induced metastasis 
without inducing the negative effects associated with loss of TGF-beta 
function in the TGF-beta knock out mice. Lifetime exposure to the 
antagonist did not result in any increase in spontaneous or induced 
tumorigenesis, and there was no evidence for significant manifestations 
of autoimmune disease or increase in inflammatory lesions. The 
inventors speculate that this apparent ability of SR2F to discriminate 
between ``physiological'' and ``pathological'' TGF-beta relates to the 
relative accessibility of the two forms of TGF-beta, with only 
pathological TGF-beta being accessible to the antagonist.

    Dated: February 20, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 02-4831 Filed 2-27-02; 8:45 am]
BILLING CODE 4140-01-P