[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17097-17098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6638]


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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.

Biomarkers for Tissue Status

Joseph Riss and J. Carl Barrett (NCI).
U.S. Provisional Application No. 60/649,208 filed 01 Feb 2005 (DHHS 
Reference No. E-064-2005/0-US-01).
Licensing Contact: Thomas P. Clouse; (301) 435-4076; 
[email protected].

    Certain biomarkers are differentially expressed in various tissue 
samples, including those of renal cancer and in kidney ischemia/
reperfusion. The technology relates to methods of quickly and 
accurately diagnosing and monitoring progression of cancer and 
ischemically-injured tissue. The technology provides sensitive 
diagnostic and therapeutic methods using identified biomarkers 
associated with RCC, acute renal failure, renal regeneration and repair 
(RRR), organ transplantation and shipment, wound healing, tumors, and 
organ failure. The potential market for diagnostics and therapeutics in 
this area is substantial. For example, Renal Cell Carcinoma (RCC) 
accounts for three (3) percent of all adult male malignancies in the 
United States. Patent protection for this technology is pending.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Methods of Diagnosing and Treating VHL Associated and Sporadic Renal 
Cell Carcinoma, and Other VHL Associated and Sporadic Counterpart 
Tumors Which Co-Express Epo and the Epo Receptor

    Zhengping Zhuang et al. (NINDS).
    U.S. Provisional Application No. 60/611,616 filed 20 Sep 2004 (DHHS 
Reference No. E-274-2004/0-US-01).
    Licensing Contact: Thomas P. Clouse; (301) 435-4076; 
[email protected].
    While von Hippel-Lindau (VHL) gene germline mutations have been 
identified as the cause of tumors in VHL patients, the link between 
gene mutation and tumor development has remained unclear, e.g., it is 
unknown why only selected organs and cell types are affected. The 
inventors have discovered that EPO and EPOR are co-expressed in tumors 
of VHL patients. The co-expression of the EPO and EPO-receptor is also 
related to the tumor growth and progression in sporadic renal tumors 
and tumors in kidney dialysis patients. Since the co-expression of EPO 
and EPOR are not present in most normal adult tissues, ligands that 
bind to EPOR but do not activate the receptor can target specific tumor 
cells with minimal detrimental effect on normal cells.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

[[Page 17098]]

Metastasis Suppressor Gene on Human Chromosome 8 and Its Use in the 
Diagnosis, Prognosis and Treatment of Cancer

    J. Carl Barrett et al. (NCI).
    U.S. Provisional Application No. 60/591,028 filed 26 Jul 2004 (DHHS 
Reference No. E-226-2004/0-US-01).
    Licensing Contact: Mojdeh Bahar; (301) 435-2950; 
[email protected].
    This invention is directed to an isolated or purified ribonucleic 
acid (RNA) molecule comprising a nucleotide sequence encoded by a human 
Tey1 metastasis suppressor gene located at p21-p12 on chromosome 8 or a 
fragment thereof, wherein the isolated or purified RNA molecule 
comprises from about 10 to about 100 nucleotides. The invention also 
provides methods of diagnosis, prognosis, and treatment of cancer, such 
as prostate cancer, using the isolated or purified RNA molecule.

Use of a Promoter of T-Cell Expansion and an Inducer of CD40 
Stimulation in the Treatment or Prevention of a Pathologic State

    William J. Murphy et al. (NCI).
    U.S. Patent Application No. 10/226,959 filed 23 Aug 2002 (DHHS 
Reference No. E-150-2001/1-US-01).
    Licensing Contact: Michelle A. Booden; (301) 451-7337; 
[email protected].
    Originally described as a protein important in humoral immune 
responses, it is now known that CD40 plays a wider role in regulating 
immune function by increasing both costimulatory molecules and antigen 
presentation. CD40 also contributes to the inflammatory process by 
inducing the secretion of various inflammatory cytokines including 
interleukin (IL)-1, IL-6, IL-12, and TNF-[alpha]. CD40 is expressed on 
a variety of cell types including monocytes, dendritic cells, 
endothelial cells, and carcinomas. The expression of CD40 on a variety 
of carcinoma cells including but not limited to those of the bladder, 
kidney, ovary, skin, and breast and the role of CD40 in the promotion 
of immune function makes CD40 an attractive target for immunotherapy.
    Single agent modalities in disease therapy often fail, particularly 
when given for advanced disease. Previous studies have reported that 
CD40 stimulation can result in significant antitumor effects in various 
preclinical models. Additionally, various cytokines such as IL-2 and 
IL-12 have also been shown to have antitumor efficacy in preclinical 
and clinical trials.
    The present invention describes a method for treating or preventing 
a disease state such as cancer by administrating a combination of a 
promoter of T-cell expansion, a cytokine such as IL-2 or IL-12, and an 
inducer of CD40 stimulation. As claimed in the above patent and 
reported in several publications by Murphy et al, the combination of a 
cytokine and a CD40 stimulator can result in synergistic antitumor 
effects in multiple advanced disease models in which neither agent 
alone resulted in protection or efficacy. This preventative or 
therapeutic intervention could be directed toward multiple human 
carcinomas as well as viral, bacterial, or fungal infections and 
allergic reactions.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Nucleotide and Deduced Amino Acid Sequences of a New Tumor Gene, Int6

    Robert Callahan, Antonio Marchetti, Fiamma Buttitta, Gilbert Smith 
(NCI). U.S. Patent 6,255,104 issued 03 Jul 2001 (DHHS Reference No. E-
265-1994/1-US-01), claiming priority to U.S. Patent Application No. 08/
385,998 filed 09 Feb 1995, now abandoned (DHHS Reference No. E-265-
1994/0-US-01) and PCT Application No. PCT/US96/01884 filed 09 Feb 1996, 
which published as WO 96/24672 on 15 Aug 1996 (DHHS Reference No. E-
265-1994/0-PCT-02).
    U.S. Patent 6,342,392 issued 29 Jan 2002 (DHHS Reference No. E-265-
1994/1-US-02).
    U.S. Patent 6,737,251 issued 18 May 2004 (DHHS Reference No. E-265-
1994/1-US-03).
    U.S. Patent Application No. 10/783,415 filed 19 Feb 2004 (DHHS 
Reference No. E-265-1994/1-US-04).
    Licensing Contact: Jesse Kindra; (301) 435-5559; 
[email protected].
    Murine retroviruses have been useful in the identification of 
mammalian genes involved in tumor development. Five loci have been 
previously identified as integration sites for one specific retrovirus, 
mouse mammary tumor virus (MMTV). This work describes a sixth site of 
integration for MMTV, the Int6 gene. The Int6 gene is highly conserved 
among vertebrate species, including humans. This invention embodies a 
series of reagents derived from the nucleic acid and amino acid 
sequences of the Int6 gene and the use of these reagents in diagnostic 
methods, immunotherapy, gene therapy, and as vaccines.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: March 24, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-6638 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-P