[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Pages 6706-6707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2394]


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

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 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.

Methods for Prophylaxis and Treatment of HER-2/neu Tumors

John C Morris, Jay A. Berzofsky, Yoshio Sakai, Jong-Myun Park, Masake 
Terabe (all of NCI).
Serial Nos. PCT/US2003/034362 filed 29 Oct 2003 (DHHS Reference No. E-
025-2003/1-PCT-1) and 60/422,395 filed 30 Oct 2002 (DHHS Reference No. 
E-025-2003/0-US-01).
Licensing Contact: Susan S. Rucker; (301) 435-4478; 
[email protected].

    This application relates to methods for cancer prophylaxis and 
treatment. More particularly, the application relates to methods for 
the treatment and prophylaxis of cancers caused by the activity of the 
HER-2/neu/erbB-2 gene employing immunotherapy. Such cancers include 
breast cancers, cancers of the female genital tract and some cancers of 
the gastrointestinal tract.
    The methods claimed involve the use of a HER-2/neu vaccine 
employing recombinant non-replicating adenovirus expressing a HER-2/
neu/erbB-2 gene. In a preferred embodiment the vaccine comprises a 
recombinant non-replicating adenoviral vector encoding a HER-2/neu/
erbB-2 gene that is expressed as a truncated HER-2/neu/erbB-2 protein. 
Antigen presenting cells, such as dendritic cells infected with the 
recombinant adenoviral vector, process and present the truncated HER-2/
neu/erbB-2 protein, thereby stimulating an immune response. Preferred 
HER-2/neu/erbB-2 proteins contain regions of the extracellular domain 
and the transmembrane domain of the intact HER-2/neu/erbB-2 gene 
product and do not contain any tyrosine kinase domains.
    This work has been published in part in Sakai, Y, et al. Cancer 
Research 64(21): 8022 (Nov 1 2004) and as WO 2004/041065 (May 21 2004).

Antibodies and Polypeptides to AAMP-1 for Use in Diagnosis and Therapy 
of AAMP-1-Expressing Cancers

Lance Liotta et al. (NCI).
U.S. Patent No. 6,274,134 issued 14 Aug 2001 (DHHS Reference No. E-084-
1991/1-US-01); Australian Patent No. 684806 issued 23 Apr 1998 (DHHS 
Reference No. E-084-1991/1-AU-05).
Licensing Contact: Thomas Clouse; (301) 435-4076; 
[email protected].

    Angio-associated migratory cell protein (AAMP-1) was first isolated 
from a human melanoma cell line as a motility-associated cell protein. 
AAMP-1 contains two immunoglobin domains,

[[Page 6707]]

six WD40 repeats, and a heparin-binding domain. In vitro, over 
expression of AAMP-1 promotes tumor cell invasion and metastasis as 
well as angiogenesis. AAMP-1 was later found to be over expressed in 
endothelial cells, cytotrophoblasts, and poorly differentiated colon 
adenocarcinoma cells found in lymphatics. In addition, gene expression 
studies have shown that AAMP-1 is over expressed in breast and 
gastrointestinal tumors.
    The issued patents claim proteins, polypeptides, and recombinant 
polyclonal antibodies specific to AAMP-1 and their use in diagnostic 
and therapeutic applications. The antibodies are specific and can 
detect formalin-fixed antigen and SDS-denatured antigen.
    These antibodies can be used for detailed expression studies of 
AAMP-1 in different cancer cell lines. The antibodies could also be 
used to promote cell adhesion to a substrate, promote tissue acceptance 
of prostheses, and promote wound healing. The antibodies could also be 
used to detect AAMP-1 in patient's sera as a useful diagnostic marker 
for multiple carcinomas including high nuclear grade ductal carcinoma 
in situ (Clinical Cancer Research Dec 2002 8:3788-95).

    Dated: January 31, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-2394 Filed 2-7-05; 8:45 am]
BILLING CODE 4140-01-P