[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Notices]
[Pages 94-96]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28684]


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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.

Use of Anti-Parafibromin Antibodies to Diagnose Hyperparathyroidism-Jaw 
Tumor Syndrome (HPT-JT) and Parathyroid Cancer

William Simonds, Jian-hua Zhang, and Geoffrey Woodard (NIDDK) U.S. 
Provisional Application No. 60/531,875 filed 22 Dec 2003 (DHHS 
Reference No. E-032-2004/0-US-01)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    This technology relates to methods of diagnosing cancer using 
antibodies that specifically bind to parafibromin. Parafibromin appears 
to be a tumor suppressor. Mutations in the coding sequence, 
specifically truncations or deletions, might be indicative of cancer or 
increased susceptibility to cancer. Antibodies targeting this tumor 
suppressor protein might have utility as a cancer diagnostic or 
prognostic, either alone, or as part of a kit.
    This technology is described, in part, in GE Woodard et al., 
``Parafibromin, product of the hyperparathyroidism-jaw tumor syndrome 
gene HRPT2, regulates cyclin D1/PRAD1 expression.'' Oncogene 2004 Dec 
06 (e-pub ahead of print).

Eosinophil-Derived Neurotoxin, an Antimicrobial Protein with 
Ribonuclease Activity, is an Immunostimulant

De Yang et al. (NCI)
U.S. Patent Application No. 10/834,733 filed 29 Apr 2004 (DHHS 
Reference No. E-191-2003/1-US-01)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    Eosinophil-derived neurotoxin (EDN) has in vitro anti-viral 
activity that is dependent on its ribonuclease activity. This invention 
discloses that EDN is a selective chemoattractant and activator of 
dendritic cells, resulting in dendritic cell migration, maturation, and 
a production of a wide variety of cytokines. Based on these potent 
chemotactic and activating effects on dendritic cells, EDN might be 
useful as a clinical immunoadjuvant for the promotion of immune 
responses to specific antigens of tumors or pathogenic organisms.

Genes Expressed in Prostate Cancer and Methods of Use

Ira Pastan, Tapan Bera, and Byungkook Lee (NCI)
U.S. Provisional Patent Application No. 60/461,399 filed 08 Apr 2003 
(DHHS Reference No. E-148-2003/0-US-01)
PCT Application No. PCT/US04/10588 filed 05 Apr 2004, which published 
as WO 2004/092213 on 28 Oct 2004

[[Page 95]]

(DHHS Reference No. E-148-2003/0-PCT-02)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    This invention is a novel gene, called New Gene Expressed in 
Prostate (NGEP). This gene appears to be expressed only in prostate. 
This gene has two known splice variants of significantly different 
size. The shorter splice variant encodes a cytoplasmic protein, while 
the longer splice variant encodes a plasma membrane protein.
    This patent application contains claims to the polypeptide, NGEP, 
nucleotides encoding NGEP, antibodies that bind NGEP polypeptides, and 
methods of using these polypeptides, polynucleotides, and antibodies.
    The presence of the protein on the cell surface and the selective 
expression in prostate and prostate cancer make this a potential target 
for prostate cancer diagnostics and therapeutics. Potential 
therapeutics could be gene-based, vaccines, antibodies, or 
immunoconjugates. Further information can be obtained by viewing a 
recent publication by the inventors (PNAS v. 104 no. 9, p. 3050-3064, 
March 2, 2004).

Immunogenic Peptides for the Treatment of Prostate and Breast Cancer

Jay Berzofsky, Sang-kon Oh, and Ira Pastan (NCI)
U.S. Provisional Patent Application 60/476,467 filed 05 Jun 2003 (DHHS 
Reference No. E-116-2003/0-US-01)
PCT Application No. PCT/US04/17574 filed 02 Jun 2004 (DHHS Reference 
No. E-116-2003/0-PCT-02)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    This invention relates to antigenic sequences of the T cell 
receptor gamma alternate reading frame protein (TARP). TARP is 
expressed in breast cancer cells and prostate cancer cells. The patent 
application discloses immunogenic TARP polypeptides that generate an 
immune response to breast or prostate cancer cells that express TARP. 
These include sequences modified to make them more immunogenic. The 
application also discloses specific TARP nucleic acid sequences and 
host cells transfected with these nucleic acids. This invention may be 
useful as a therapeutic to treat breast or prostate cancer.

Detection of Antigen-Specific T Cells and Novel T Cell Epitopes by 
Acquisition of Peptide/HLA-GFP Complexes

Steven Jacobson, Utano Tomaru, and Yoshihisa Yamano (NINDS)
PCT Application No. PCT/US04/08960 filed 24 Mar 2004, which published 
as WO 2004/084838 on 07 Oct 2004 (DHHS Reference No. E-084-2003/2-PCT-
01)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    This invention relates to a method for identifying specific T cell 
epitopes and antigen-specific T cells through labeling with an HLA-GFP 
complex expressed on an antigen-presenting cell. The T cells acquired 
the peptide-HLA-GFP complex through T cell mediated endocytosis upon 
specific antigen stimulation. This basic method can be used for several 
purposes. First, it can be used to generate a T-cell immune response 
through the attachment of a reporter peptide to the antigen-presenting 
cell. It can also be used as a way to assay a population of cells to 
determine whether any T cells specific for a particular antigen are 
present. This might be useful in applications related to autoimmunity, 
infectious disease, or cancer. Third, it can be used as a therapeutic 
to eliminate antigen-specific T cells associated with disease, if 
coupled to a toxic moiety.

Use of Cripto-1 as a Biomarker for Neurodegenerative Disease and Method 
of Inhibiting Progression Thereof

David S. Salomon (NCI), Berman Nancy (EM), Edward B. Stephens (EM)
U.S. Provisional Application No. 60/508,750 filed 03 Oct 2003 (DHHS 
Reference No. E-075-2003/0-US-01)
PCT Application No. PCT/US04/32649 filed 01 Oct 2004 (DHHS Reference 
No. E-075-2003/0-PCT-02)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    Cripto-1 is a gene that is currently thought to play an important 
role in several cancers, and is being developed in clinical trials as a 
cancer therapeutic.
    The current invention relates to another use of Cripto-1 as a 
biomarker and possible therapeutic target for a variety of 
neurodegenerative diseases, including NeuroAids, Alzheimer's disease, 
MS, ALS, Parkinson's disease and encephalitis. Cripto-1 appears to be 
overexpressed by 20-fold or more in NeuroAids and as such may be 
enhanced in other inflammatory neurological diseases, and thus assist 
in the early detection of neurological changes associated with these 
diseases, as well as a possible therapeutic target for slowing 
progression.

Protein Kinase C Inhibitor, Related Composition, and Method of Use

Shaomeng Wang, Peter Blumberg (NCI), Nancy Lewin (NCI)
U.S. Provisional Patent Application No. 60/451,214 filed 28 Feb 2003 
(DHHS Reference No. E-073-2003/0-US-01)
PCT Application No. PCT/US04/05855 filed 26 Feb 2004, which published 
as WO 2004/078118 on 16 Sep 2004 (DHHS Reference No. E-073-2003/0-PCT-
02)
Licensing Contact:Brenda Hefti; (301) 435-4632; [email protected].
    Protein kinase C is a critical component in cellular signaling, 
involved in cellular growth, differentiation, and apoptosis. It has 
been identified as a promising therapeutic target for cancer, diabetic 
retinopathy, and Alzheimer's disease, among other indications. This 
invention relates to lead compounds that can inhibit protein kinase C 
isoforms through disruption of their C1 domains. The inventors also 
found that these compounds possess isoform selectivity, an important 
feature for therapeutic specificity. Finally, although the disclosed 
compounds are previously known molecules, novel structures are 
described in the invention that have further improved specificity.

Recombinant Immunotoxin and Use in Treating Tumors

Ira Pastan (NCI), Masanori Onda (NCI), Nai-Kong Cheung (EM)
PCT Application No. PCT/US03/38227 filed 01 Dec 2003, which published 
as WO 2004/050849 on 17 Jun 2004 (DHHS Reference No. E-051-2003/0-PCT-
02)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    The current invention relates to the 8H9 monoclonal antibody (MAb), 
which is highly reactive with a cell surface glycoprotein expressed on 
human breast cancers, childhood sarcomas, and neuroblastomas but is not 
reactive with the cell surface of normal human tissues. This specific 
reactivity suggests that this antibody could be useful as a diagnostic, 
or as a therapeutic molecule to treat breast cancer, osteosarcoma, and 
neuroblastoma. The PCT application claims the 8H9 protein, 8H9 
antibodies, 8H9 immunotoxins, pharmaceutical compositions, and methods 
of use.
    More information can be found in a recent publication: M. Onda et 
al., ``In vitro and in vivo cytotoxic activities of recombinant 
immunotoxin 8H9(Fv)-PE38 against breast cancer, osteosarcoma, and 
neuroblastoma,'' Cancer Res. 2004 Feb 15;64(4):1419-1424.

[[Page 96]]

Activation of Recombinant Diphtheria Toxin Fusion Proteins by Specific 
Proteases Highly Expressed on the Surface of Tumor Cells

Stephen Leppla, Shi-Hui Liu, Manuel Osorio, and Jennifer Avallone 
(NIDCR)
U.S. Provisional Application No. 60/468,577 filed 06 May 2003 (DHHS 
Reference No. E-331-2002/0-US-01)
PCT Application No. PCT/US04/01430 filed 06 May 2004 (DHHS Reference 
No. E-331-2002/0-PCT-02)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    This invention relates to diphtheria toxin fusion proteins 
comprising a diphtheria toxin (DT) cell-killing component and a cell-
binding component such as granulocyte macrophage colony-stimulating 
factor (GM-CSF), interleukin 2 (IL-2), or epidermal growth factor 
(EGF). Receptors for the latter three materials are present on many 
types of cancer cells; therefore, these fusion proteins bind 
preferentially to these cancer cells. A key feature is that these 
toxins are altered so as to require activation by a cell-surface 
protease that is overexpressed on many types of cancers. Examples of 
such proteases include matrix metalloproteinases and urokinase 
plasminogen activator. Consequently, these novel cytotoxins kill tumors 
expressing receptors for either GM-CSF, IL-2, or EGF along with the 
cell-surface protease. Because killing requires the presence of both a 
receptor and a cancer-cell enriched protease, and few normal tissues 
contain both, there is less toxicity to normal cells. Thus, a larger 
amount of the agent may be used for cancer therapy without inducing 
side effects. In other words, these cytotoxins have a higher 
therapeutic index than toxins that are targeted to cells using a single 
strategy.

BASE, a New Cancer Gene, and Uses Thereof

Ira Pastan, Kristi Egland, James Vincent, Byungkook Lee, and Robert 
Strausberg (NCI)
PCT Application No. PCT/US03/39476 filed 10 Dec 2003 (DHHS Reference 
No. E-321-2002/0-PCT-02)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected]
    The present invention identifies a new gene expressed in breast 
cancers. The gene undergoes alternative splicing, and is expressed as 
one of two polypeptides. Both splice variants appear to be secreted 
proteins, and therefore good potential therapeutic targets. The patent 
application claims BASE polypeptides, nucleic acids, gene therapy and 
vaccine uses, and antibodies. This novel gene target might be useful as 
a breast cancer marker for diagnostics, or as a target for breast 
cancer therapeutics.

Applications for the HMGN1 Pathway

Michael Bustin (NCI)
U.S. Provisional Patent Application No. 60/455,728 filed 17 Mar 2003 
(DHHS Reference No. E-208-2002/0-US-01)
PCT Application No. PCT/US04/08060 filed 17 Mar 2004, which published 
as WO 2004/083398 on 30 Sep 2004 (DHHS Reference No. E-208-2002/0-PCT-
02)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected]

    HMGN1 is a protein that binds to nucleosomes, changes chromatin 
structure and affects transcription, and the expression of this protein 
changes during differentiation. Mice lacking this protein have 
increased growth capacity of several skin components, including 
epidermis, epidermal appendages, and dermis. Conceivably, this change 
could be related to an alteration of stem cell differentiation or to 
cell cycling events. The current invention relates to interference with 
this pathway, which might lead to increased stem cell differentiation 
and increased hair cycling and growth in humans as well. This invention 
might be useful to increase hair growth, enhance wound healing for 
epidermal and dermal wounds, and enhance stem cell populations for 
tissue regeneration, gene targeting, or gene therapeutic indications.

    Dated: December 20, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-28684 Filed 12-30-04; 8:45 am]
BILLING CODE 4140-01-P