[Federal Register Volume 70, Number 46 (Thursday, March 10, 2005)]
[Notices]
[Pages 11995-11997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4675]


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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.

Dimer Inhibitory Peptides of CXCR4 as a Possible Novel Therapy for 
Cancer

Jinhai Wang and Michael Norcross (FDA),
DHHS Reference No. E-037-2005/0--Research Tool,
Licensing Contact: John Stansberry; (301) 435-5236; 
[email protected].

    This invention may control or inhibit cancer metastases by 
targeting

[[Page 11996]]

chemokine receptor dimer formation. Specifically, this invention 
relates to a synthetic peptide of the transmembrane region 4 (TM4) of 
the Chemokine receptor (CXCR4). TM4 inhibits CXCR4 dimerization and 
tumor cell migration. CXCR4 is highly expressed in human breast cancer 
cells, prostate cancer, and pancreatic cancer. CXCR4 is involved in 
breast cancer metastasis and tumor migration. Immunotherapies or 
vaccinations based on blocking chemokine receptor dimerization with TM4 
could be a useful treatment against proliferative diseases and cancer.

Carbohydrate-Encapsulated Gold Nanoparticles as Novel Anti-metastatic 
Agents

Drs. Joseph Barchi (NCI), Sergei Svarovsky (NCI) et al.,
DHHS Reference No. E-001-2005/0-PCT-01,
Licensing Contact: John Stansberry; (301) 435-5236; 
[email protected].

    The invention relates to the development of a new synthesis for the 
tumor-associated, cell-surface carbohydrate moiety, known as the 
Thomsen-Friedenrich T antigen. The inventors prepared a novel, 
multivalent presentation platform by linking this disaccharide antigen 
to the surface of gold nanoparticles and describe the application of 
the multivalent system as an anti-adhesive tool to inhibit metastasis. 
The glyconanoparticles principle described here has the potential to 
integrate all the current knowledge and applications on processes that 
involve carbohydrate molecules (inflammation, viral, bacterial, and 
toxin infection, etc.). Administration of these nanoparticles into mice 
bearing breast tumors was shown to inhibit lung metastases in this 
model. This technology establishes the `` proof of principle'' for 
possible biological applications of glyconanoparticles.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

Methods for the Selection of Subjects for Multiple Sclerosis Therapy

Roland Martin et al. (NINDS),
International Application No. PCT/US04/10584 filed 05 Apr 2004 (DHHS 
Reference No. E-005-2004/0-PCT-01),
Licensing Contact: Thomas Clouse; (301) 435-4076; 
[email protected].

    Multiple Sclerosis (MS) is a life-long chronic autoimmune disease 
diagnosed primarily in young adults who have a virtually normal life 
expectancy. Estimates place the annual costs of MS in the United States 
in excess of $2.5 billion. There are approximately 250,000 to 400,000 
persons in the United States with MS, and approximately 2.5 million 
persons worldwide suffer from MS. A variety of therapies are used to 
treat MS, but there is no single therapy that can be used to treat all 
patients. Furthermore, therapies that are currently approved for MS are 
only moderately effective, and in some patients they have no effect at 
all. The invention provides a method to determine if a patient with MS 
will respond to a therapeutic protocol by analyzing the expression of 
genes expressed by the immune system. For example, a single gene can be 
assessed, or an expression profile of a patient can be created using an 
array comprising gene sequences and analyzed to determine if the 
patient will respond to one or more therapeutic protocols. A cDNA probe 
constructed from mRNA of lymphocytes isolated from a patient can 
hybridize with a microarray, and the extent of hybridization of the 
probes to each gene on the microarray can be determined. The microarray 
can include nucleic acid sequences encoding, for example, IL-8, Bcl-2-
interacting protein, dihydrofolate reductase, gyanylate-binding protein 
1, interferon-induced 17 kDa protein, 2'5' OAS, plakoglobin, interferon 
inducible proteinkinase, and STAT-1, among others.

Methods for Identifying, Diagnosing, and Predicting Survival of 
Lymphomas

Louis M. Staudt et al. (NCI),
PCT Application No. PCT/US2004/029041 filed 03 Sep 2004 (DHHS Reference 
No. E-234-2003/1-PCT-01) and U.S. Non-Provisional Patent Application 
10/934,930 filed on 03 Sep 2004 (DHHS Reference No. E-108-2004/0-US-
01),
Licensing Contact: Jeff Walenta; (301) 435-4633; [email protected].

    Human lymphomas and leukemias are a diverse set of cancers. Many of 
these cancers, while expressing a similar phenotype between different 
individuals, have a diverse underlying genetic basis for the disease. 
This diverse genetic basis has implications on the effective treatment 
of the various phenotypes of lymphoma. For example, a drug that was 
effective against one individual's phenotype of lymphoma will not be 
effective against a similar lymphoma in another individual. An 
invention that helps clinicians classify a lymphoproliferative disorder 
would provide the basis for a ``pharmacogenomic'' method for treating 
such cancers.
    The present invention discloses a novel microarray for obtaining 
gene expression profile data to be used in identifying lymphoma types 
and predicting survival in a lymphoma patient. The present invention 
further discloses a variety of methods for analyzing gene expression 
data obtained from a lymphoma sample, and specific algorithms for 
predicting survival and clinical outcome in a subject suffering from a 
lymphoma. The gene expression profile data set was established using a 
human genome gene chip set measuring the expression of over 27,000 
genes in more than 500 lymphoproliferative tumor samples collected from 
patients at numerous healthcare institutions worldwide.
    This invention could be developed into a useful pharmacogenomic, 
diagnostic product. The number of genes required for an accurate 
prognosis is reduced almost ten-fold from the human genome gene chip, 
allowing for lower density microarray technology and alternative gene 
expression measuring platforms. The choice of the gene set in this 
invention is optimized to provide an all in one method for the 
diagnosis of all lymphomas.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

HGC-1, a Gene Encoding a Member of the Olfactomedin-Related Protein 
Family

Griffin P. Rodgers, Wen-Li Liu, Jiachang Zhang (NIDDK),
U.S. Provisional Patent Application 60/338,759 filed 07 Dec 2001 (DHHS 
Reference No. E-166-2001/0-US-01); PCT Application No. PCT/US02/39148 
filed 09 Dec 2002, which published as WO 03/050293 on 19 Jun 2003 (DHHS 
Reference No. E-166-2001/0-PCT-02),
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    The current technology embodies a newly identified gene, Human 
Granulocyte Colony-Stimulating Factor-Stimulated-Clone-1 (hGC-1) that 
has been cloned and characterized, and its protein sequence has been 
deduced. The gene is expressed in the bone marrow, prostate, small 
intestine, colon, and stomach, and has been mapped to chromosome 13 in 
a region that contains a tumor suppressor gene cluster. The gene is 
found to be selectively present

[[Page 11997]]

in normal human myeloid lineage cells and is believed to play a role in 
allowing lymphocytes to differentiate properly. It is believed that the 
gene may play a role in human prostate cancer, multiple myeloma, B-cell 
chronic lymphocytic leukemia and other types of cancer and can be used 
diagnostically as well as in therapeutic screening activities.

Tyrosyl-DNA Phosphodiesterases (TDP) and Related Polypeptides, Nucleic 
Acids, Vectors, TDP-Producing Host Cell, Antibodies and Methods of Use

Jeffrey J. Pouliot and Howard A. Nash (NIMH),
U.S. Patent Application No. 10/110,176 filed 05 Apr 2002 (DHHS 
Reference No. E-281-1999/0-US-03), claiming priority to U.S. 
Provisional Application No. 60/157,690 filed 05 Oct 1999 (DHHS 
Reference No. E-281-1999/0-US-01),
Licensing Contact: John Stansberry; (301) 451-7337; 
[email protected].

    Topisomerases are cellular enzymes that are vital for replication 
of the genome. However, if topisomerase and DNA form covalent complexes 
that prevent the resealing of DNA, this may lead to cell death. 
Essentially, this invention consists of a new isolated and cloned 
enzyme, tyrosyl-DNA phospodiesterase (TDP1) that is capable of 
hydrolyzing the covalent complexes between topisomerase and DNA, 
allowing the DNA to reseal. The mechanism that defines topiosomerases 
is their capacity to break DNA and, after an interval in which 
topological changes may occur, to reseal the break without the 
intervention of a high-energy cofactor. The breakage of the DNA is 
accompanied by the formation of a covalent bond between topisomerase 
and DNA to create an intermediate that is resolved during the resealing 
step. However, if the resealing step fails, the covalent intermediates 
between topoisomerase I and DNA can form complexes that lead to cell 
death. The failure of the resealing is increased by some chemotherapies 
such as camptothecin. Thus, this technology has many potential 
commercial uses including: a method for screening camptothecin 
analogues or other compounds for their resistance to repair by this 
enzyme or to prescreen patients for their sensitivity to topoisomerase 
inhibitors, which could identify patients most likely to respond to 
camptothecin therapy. Further, this invention provides for a vector 
comprising of the nucleic acid molecule for TDP1 as well as the method 
of altering the level of TDP1 in a cell, a tissue, an organ or an 
organism. Finally, this invention consists of a method for identifying 
a compound that stabilizes a covalent bond complex that forms between 
DNA and topoisomerase I, wherein the covalent bond cannot be cleaved.

Chromatin Insulator Protecting Expressed Genes of Interest for Human 
Gene Therapy or Other Mammalian Transgenic Systems

Drs. Jay H. Chung and Gary Felsenfeld (NIDDK),
U.S. Patent 5,610,053 issued 11 Mar 1997 (DHHS Reference No. E-206-
1992/1-US-01), Licensing Contact: John Stansberry; (301) 435-5236; 
[email protected].

    The technology provides the isolation of a functional DNA sequence 
comprising a chromatin insulating element from a vertebrate system and 
provides the first employment of the pure insulator element as a 
functional insulator in mammalian cells. The technology further relates 
to a method for insulating the expression of a gene from the activity 
of cis-acting regulatory sequences in eukaryotic chromatin.
    This technology could be of major importance in providing a 
mechanism and a tool to restrict the action of cis-acting regulatory 
elements on genes whose activities or encoded products are needed or 
desired to be expressed in mammalian transgenic systems. This 
technology provides the first pure insulator element to function solely 
as an insulator element in human cells. Accordingly, this technology 
could have tremendous practical implications for transgenic technology 
and human gene therapies, either in vitro or in vivo.
    The technology further provides a method and constructs for 
insulating the expression of a gene or genes in transgenic animals such 
that the transfected genes will be protected and stably expressed in 
the tissues of the transgenic animal or its offspring. For example, 
even if the DNA of the construct integrates into areas of silent 
chromatin in the genomic DNA of the host animal, the gene will continue 
to be expressed. The invention could provide a means of improving the 
stable integration and expression of any transgenic construct of 
interest, with efficiencies higher than are achieved presently. Use of 
this invention may represent a large potential savings for licensee's 
constructing transgenic cell lines or animals.

    Dated: March 2, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-4675 Filed 3-9-05; 8:45 am]
BILLING CODE 4140-01-P