[Federal Register Volume 68, Number 44 (Thursday, March 6, 2003)]
[Notices]
[Pages 10732-10733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5211]


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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 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; [email protected].

    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

[[Page 10733]]

improve 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: 
[email protected].

    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; [email protected].

    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; [email protected].

    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.

    Dated: February 24, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology, Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 03-5211 Filed 3-5-03; 8:45 am]
BILLING CODE 4140-01-P