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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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; clouset@mail.nih.gov.

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; clouset@mail.nih.gov.

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. Start Printed 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; baharm@mail.nih.gov.

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; boodenm@mail.nih.gov.

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-α. 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; kindraj@mail.nih.gov.

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.

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Dated: March 24, 2005.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 05-6638 Filed 4-1-05; 8:45 am]

BILLING CODE 4140-01-P