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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 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 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.

Immunogenic Epitopes for Fibroblast Growth Factor-5 (FGF-5) Presented by HLA-A3 and HLA-A2

James Yang et al. (NCI).

DHHS Reference No. E-031-2003/0-US-01 filed 19 Nov 2002.

Licensing Contact: Jonathan Dixon; (301) 435-5559; dixonj@od.nih.gov.

Approximately 30,000 patients are diagnosed with renal cell carcinoma (RCC) each year in the United States, and an estimated 12,000 patients die of this disease. Most patients are diagnosed with advanced local disease or metastatic disease. Current therapies include removal of the kidney (nephrectomy) or high dose immunotherapy with IL-2, which has been able to achieve success in only part (15-20%) of the patient population. Even with a successful nephrectomy, it is likely that patients with advanced local diseases will develop metastases. Therefore, new methods are needed to Start Printed Page 10733improve on IL-2 therapy and expand the curative potential of therapies for patients with RCC.

The present invention discloses peptides for use in immunotherapy of tumors. The peptides, both an HLA-A2 and an HLA-A3 epitope, are derived from the amino acid sequence of an RCC-associated antigen, fibroblast growth factor-5 (FGF-5). Plans are underway to investigate both peptides in clinical trials of peptide vaccination in patients with advanced renal cancer. In addition, FGF-5 also appears to be over-expressed in other common adenocarcinomas such as breast, prostate and bladder cancer and very few antigens suitable for vaccine therapies exist for those cancers.

Modified Oligonucleotides and Methods of Use Thereof

Dr. Seidman et al. (NIA).

DHHS Reference No. E-176-2002/0 filed May 13, 2002.

Licensing Contact: Catherine Joyce; (301) 435-5031; e-mail: joycec@od.nih.gov.

Triple helix forming oligonucleotides (TFOs) that bind chromosomal targets in living cells may be used as tools for genome manipulation, including gene knockout, conversion, or recombination. The instant invention relates to the discovery that TFOs containing a particular pattern of certain ribose substitutions resulted in a knock-out frequency of the hamster HPRT gene that was 300-400 fold above background. Aspects of this work have been published in Puri et al., 2002, Biochemistry 41(24):7716-7724.

The above-mentioned invention is available for licensing on a non-exclusive basis.

Quantitative Assay of the Angiogenic and Antiangiogenic Activity of a Test Molecule

Steven Libutti (NCI).

DHHS Reference No. E-152-2002/0 filed 09 Apr 2002.

Licensing Contact: Matthew Kiser; (301) 435-5236; kiserm@od.nih.gov.

The invention provides a method of measuring the angiogenic or antiangiogenic activity of a test molecule. The method comprises obtaining an embryonated fowl egg, creating a window in the shell of the fowl egg, such that the CAM membrane is exposed, providing to a test region of interest on the CAM a substrate, administering to a vessel located in the CAM a test molecule, administering to a vessel located in the CAM a fluorescent-labeled particle, such that the fluorescent-labeled particle travels through each vessel contained in the test region of interest, removing the substrate and the test region of interest from the fowl egg, capturing a three-dimensional image of the test region of interest, wherein the three-dimensional image comprises a plurality of pixels, such that a fluorescent vascular density (FVD) value can be assigned to the test region of interest, and comparing the FVD value of the test region of interest with the FVD value of a control region of interest that was prepared in the same manner as the test region of interest but without the administration of a test molecule, such that the angiogenic or antiangiogenic activity of the test molecule is measured. A lower FVD value of the test region of interest as compared to the FVD value of the control region of interest is indicative of the test molecule being useful as an inhibitor of angiogenesis. Conversely, a higher FVD value of the test region of interest as compared to the FVD value of the control region of interest is indicative of the test molecule being useful as a stimulator of angiogenesis.

Use of Semenogelin in the Diagnosis, Prognosis, and Treatment of Cancer

David Roberts and Henry Krutzsch (NCI).

DHHS Reference No. E-138-2001/0-US-01 filed 06 Apr 2001 and DHHS Reference No.

E-138-2001/0-PCT-02 filed 03 Apr 2002 (PCT/US02/10535).

Licensing Contact: Matthew Kiser; (301) 435-5236; kiserm@od.nih.gov.

The invention provides a method of diagnosing cancer in a male mammal wherein the cancer is other than prostate cancer. The method comprises: (a) Obtaining a test sample from the male mammal, and (b) assaying the test sample for an increased level of semenogelin, wherein the increased level of semenogelin in the test sample is diagnostic for the cancer. The test sample can be assayed for an increased level of semenogelin in (b) by comparing the level of semenogelin in the test sample to the level of semenogelin in a control sample obtained from one or more cancer-free male mammals of the same species, wherein an increase in the level of semenogelin in the test sample as compared to the control sample obtained is diagnostic for the cancer. Alternatively, the level of semenogelin in the test sample can be compared to an already determined range of semenogelin for cancer-free male mammals of the same species.

In addition, the invention provides a method of diagnosing cancer in a female mammal. The method comprises: (a) Obtaining a test sample from the female mammal, and (b) assaying the test sample for the presence of semenogelin, wherein the presence of semenogelin in the test sample is diagnostic for the cancer.

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Dated: February 24, 2003.

Steven M. Ferguson,

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

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[FR Doc. 03-5211 Filed 3-5-03; 8:45 am]

BILLING CODE 4140-01-P