[Federal Register Volume 68, Number 222 (Tuesday, November 18, 2003)]
[Notices]
[Pages 65077-65078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28788]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is 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 
application 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 application.

Methods of Diagnosis of Colorectal Cancer, Compositions and Methods of 
Screening for Modulators of Colorectal Cancer

    Thomas Ried and Madhvi Upender (NCI).
    U.S. Provisional Application No. 60/340,124 filed 13 Dec 2001 (DHHS 
Reference No. E-206-2003/0-US-01); U.S. Patent Application No. 10/
318,578 filed 12 Dec 2002 (DHHS Reference No. E-206-2003/0-US-02).
    Licensing Contact: Catherine Joyce; (301) 435-5031; 
[email protected].
    Oncogene activation by gene amplification is a major pathogenetic 
mechanism in human cancer. Comparative genomic hybridization and DNA 
microarray expression profiling was used to examine the expression of 
over 2000 genes that were identified as residing on chromosome arms 
that were amplified in metastatic colon cancer cancers i.e. 7p, 8q, 
13q, and 20q. The results indicated that amplified genes that also 
demonstrate increased expression levels are quite rare. However, the 
results also identified 93 genes, which reside on the chromosome arms 
in question, which showed an increased expression level concomitant 
with amplification. Some of these genes could provide targets for 
therapy.
    As a result of the above findings, the inventors contemplate 
methods of diagnosing colon cancer through detection of the increased 
expression of one or more of the identified 93 genes. Aspects of this 
work have been published as follows: Platzer et al., 2002, Silence of 
Chromosomal Amplifications in Colon Cancer, Cancer Research 62:1134-
1138.
    This technology is available for licensing on an exclusive or a 
non-exclusive basis.

Compositions and Methods for Detecting Abnormal Cell Proliferation

    Lance Liotta et al. (NCI).
    U.S. Provisional Application No. 60/466,154 filed 28 Apr 2003 (DHHS 
Reference No. E-253-2002/0-US-01).
    Licensing Contact: Catherine Joyce; (301) 435-5031; 
[email protected].
    The invention relates to the discovery that class 5 semaphorins are 
linked to cancer. A Drosophila model system was used to identify genes 
that functionally alter tumorigenicity or metastasis. Deletion of 
Drosophila lethal giant larvae (l(2)gl) leads to highly invasive and 
widely metastatic tumors on transplantation into adult flies. Random 
homozygous P element insertions were screened for the ability to 
modulate the l(2)gl phenotype. Analysis of metastasis patterns of the 
lines containing P element insertions and lacking wild-type l(2)gl 
expression identified Semaphorin 5c (Sema 5c) as being required for 
tumorigenicity.
    Semaphorin 5c, is a transmembrane protein with a large 
extracellular domain that contains seven thrombospondin type I (Tsp I) 
repeats. The semaphorin 5c gene belongs to the class 5 group of 
semaphorins, which are transmembrane proteins with short cytoplasmic 
(C-terminal) tails and extracellular domains containing seven 
thrombospondin type I repeats, a plexin domain, and a semaphorin domain 
sequences. Class 3 semaphorins, previously linked to cancer, are 
structurally different from class 5, lacking the thrombospondin repeats 
present in the transmembrane class 5 semaphorins.
    The invention is a screening method using Drosophila to (a) screen 
for functional important genes associated with cancer growth, invasion 
and metastasis, and (b) screen for the effects of an anti-cancer 
targeted therapy by administering the therapy to the drosophila host 
bearing the tumor. In addition the invention covers a specific gene 
Semaphorin 5c which is a potential therapeutic target acting in the 
TGFbeta pathway.

[[Page 65078]]

    As part of the invention, the inventors contemplate the following:
    (i) a method of detecting an increased risk for abnormal cellular 
proliferation in a subject via detection of overexpression of the Sema 
5 gene product;
    (ii) methods and compositions for treating abnormal cellular 
proliferation in a subject by administering a molecule that decreases 
or prevents expression of a Sema 5 gene product or a molecule that 
binds to Sema 5 antigen on the surface of the cell and targets the cell 
for destruction.
    This technology is available for licensing on an exclusive or a 
non-exclusive basis.

Novel Antisense Oligonucleotides Targeting Folate Receptor Alpha

    Mona S. Jhaveri, Patrick C. Elwood, Koong-Nah Chung (NCI).
    U.S. Provisional Application No. 60/274,249 filed 09 Mar 2001 (DHHS 
Reference No. E-321-2000/0-US-01).
    Licensing Contact: Catherine Joyce; 301/435-5034; 
[email protected].
    Ovarian cancer is the fifth leading cause of cancer death for women 
in the United States. Drug resistance of ovarian tumors to chemotherapy 
is a common problem resulting in only 20 to 30 percent overall 5-year 
survival rates. Folate is a vitamin that is absolutely necessary for 
cell survival. Some cancer cells, including ovarian carcinomas, have an 
abundance of a folate-binding protein termed the human alpha folate 
receptor (ahFR). It is believed that the elevated levels of ahFR 
contribute to the cells' cancerous state by mediating increased folate 
uptake or by generating positive regulatory growth signals. This 
invention comprises a genetic therapy that diminishes the levels of 
ahFR using antisense oligonucleotides that block the transcription of 
the gene. Studies have shown that this invention significantly 
decreases proliferation of cultured cancer cells and sensitizes these 
cells to treatment with chemotherapeutic drugs. Further development of 
receptor-targeted antisense oligonucleotides and related compounds have 
potential therapeutic value for a range of difficult-to-treat cancers 
including cancers of the ovary, cervix, uterus, and brain.

    Dated: November 10, 2003.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 03-28788 Filed 11-17-03; 8:45 am]
BILLING CODE 4140-01-P