[Federal Register Volume 69, Number 209 (Friday, October 29, 2004)]
[Notices]
[Pages 63160-63161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24166]


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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 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.

Mouse Monoclonal Antibody (4G11) Against Insulin-Like Growth Factor I 
Receptor

Peter Nissley, Peta-Gay Jackson-Booth, Cheryl Terry, Brett Lackey, 
Martyna Lopaczynska (NCI)
DHHS Reference No. E-342-2004/0-US-01
Licensing Contact: John Stansberry; (301) 435-5236; 
[email protected].

    The insulin-like growth factor I receptor (IGF-IR) is emerging as a 
molecular target for cancer treatment. Prospective studies in humans 
provide evidence for a relationship between circulating levels of both 
IGF-I and IGF binding protein 3 (IGFBP-3) and the risk for the 
development of cancers of the prostate, breast, lung, and colon. Many 
human cancers express or over-express components of the IGF signaling 
pathway, in particular IGF-II and the IGF-I receptor. This technology 
describes a mouse monoclonal antibody that binds the insulin-like 
growth factor I receptor. The IGF-IR monoclonal antibody 4G11 blocks 
binding of IGF-I to its receptor and promotes down regulation of the 
receptor in MCF-7 breast cancer cells, MG-63 osteosarcoma cells and a 
panel of colon cancer cells. Additionally, 4G11 stimulated down-
regulation of the IGF-I receptors in MCF-7 cells results in inhibition 
of Akt and MAPK activation by IGF-I. This monoclonal antibody has 
utility as a laboratory reagent for immunoprecipitations, and as an 
inhibitor of the IGF-I signaling pathway. A humanized form of 
monoclonal antibody 4G11 would potentially have utility as a 
therapeutic to treat a variety of cancers in which IGF-IR signaling has 
been shown to be important. This research is partially described in 
Horm Metab Res 2003; 35: 850-856.

Beta-Glucuronidase Cleavable Prodrugs of O6-Alkylguanine-DNA 
Alkyltransferase Inactivators

Robert C. Moschel et al. (NCI)
U.S. Provisional Application filed 08 Sep 2004 (DHHS Reference No. E-
307-2004/0-US-01)
Licensing Contact: George Pipia; (301) 435-5560; [email protected].

    The present invention relates to prodrugs of inactivators of O6-
alkylguanine-DNA alkyltransferase. The prodrugs are cleaved by the 
beta-glucuronidase enzyme found in tumor cells or co-administered to 
the patient, and the drugs are targeted for use in cancer treatment in 
combination with antineoplastic alkylating agent such as 1,3-bis(2-
chloroethyl)-1-nitrosouria or temozolomide.

Transcytosis of Adeno-Associated Viruses

John A. Chiorini and Giovanni Di Pasquale (NIDCR)
U.S. Provisional Application filed 08 Sep 2004 (DHHS Reference No. E-
298-2004/0-US-01)
Licensing Contact: Jesse Kindra; (301) 435-5559; [email protected].

    The invention relates to a method for delivering nucleic acids to a 
variety of cells including those of the gut, kidney, lung and central 
nervous system. The underlying cells of such organs are covered by a 
barrier of endothelial or epithelial cells which can limit the transfer 
of nucleic acids, or other potentially therapeutic agents, to the 
underlying target cells. To overcome this limitation, the method 
employs certain members of the parvovirus family to transcytose the 
barrier cells. During transcytosis, the virus passes through these 
barrier cells and can infect cells of the underlying layer. Therefore, 
this method could facilitate the transfer of nucleic acids to cells 
that currently available viral vectors are unable to reach.
    The method could be applied to the treatment of neurodegenerative 
diseases such as Parkinson's, Alzheimer's, Huntington's, lysosomal 
storage diseases, the dominant spinal cerebellar ataxias, and Krabbe's 
disease without the need for stereotactic injection. The method could 
potentially also be used in the treatment of genetic muscle disorders 
such as muscular dystrophy. Several of the viruses described in the 
invention are serologically distinct and could be used in patients who 
have developed an immune response to other vectors.

Multimeric Protein Toxins to Target Cells Having Multiple Identifying 
Characteristics

Stephen Leppla (NIAID), Shi-hui Liu (NIAID), and Thomas Bugge (NIDCR)
U.S. Provisional Application No. 60/543,417 filed 09 Feb 2004 (DHHS 
Reference No. E-059-2004/0-US-01)
Licensing Contact: Brenda Hefti; (301) 435-4632; [email protected].

    This technology relates to multimeric bacterial protein toxins 
which can be used to specifically target cells. Specifically, this is a 
modified recombinant anthrax toxin protective antigen (PrAg) that has 
been modified in several ways. First, the PrAg can be activated both by 
a metalloproteinase (MMP) and by urokinase plasminogen activator (uPA). 
Second, the native PrAg

[[Page 63161]]

lethal factor (LF) binding site has been modified so that only a 
modified PrAg comprising two different monomers can bind anthrax LF. 
When administered with an effector component, the recombinant anthrax 
toxins are toxic only to cells expressing both a MMP and uPA on their 
surface. This technology is therefore useful for selective methods of 
treating cancers, because many cancer cells express multiple cell-
surface proteases.

Novel Human Cancer Antigen, NY ESO-1/CAG-3, and Gene Encoding Same

Rong-fu Wang (EM), Steven A. Rosenberg (NCI)
U.S. Provisional Application No. 60/061,428 filed 08 Oct 1997 (DHHS 
Reference No. E-265-1997/0-US-01); PCT Application No. PCT/US98/19609 
filed 21 Sep 1998, which published as WO 99/18206 on 15 Apr 1999 (DHHS 
Reference No. E-265-1997/0-PCT-02); U.S. Patent Application No. 09/
529,206 filed 21 Sep 1998 (DHHS Reference No. E-265-1997/0-US-04)
Licensing Contact: Jesse Kindra; (301) 435-5559; [email protected].

    The current invention embodies the identification, isolation and 
cloning of a gene encoding a novel tumor antigen, NY ESO-1/CAG-3, as 
well as cancer peptides thereof and antigenic cancer epitopes contained 
within the cancer peptides. This novel antigen is recognized by 
cytotoxic T lymphocyte clones derived from the TIL586 (tumor 
infiltrating lymphocyte) cell line in an HLA restricted manner.
    The inventors believe that cancer peptides which are encoded by the 
NY ESO-1/CAG-3 gene represent potential cancer vaccines, protecting an 
individual from development of cancer by inhibiting the growth of cells 
or tumors which express the NY ESO-1/CAG-3 antigen. Also embodied in 
the invention are pharmaceutical compositions comprising the NY ESO-1/
CAG-3 antigen, peptide, or an antigenic cancer epitope thereof in 
combination with one or more immunostimulatory molecules. These 
compositions represent potential anticancer therapeutics, stimulating 
NY ESO-1/CAG-3-specific T cells to elicit an anti-cancer immunogenic 
response and thereby eliminating or reducing the cancer. While these 
vaccines and pharmaceutical compositions may be developed for use 
against a variety of cancers, data obtained to date indicate that they 
may be of particular value for use against melanoma.
    Methods for diagnosing cancer via the detection of NY ESO-1/CAG-3 
are also embodied in the invention.

Method for Inhibiting Angiogenesis

Elise C. Kohn, Lance A Liotta, and Riccardo Alessandro (NCI)
U.S. Patent No. 5,744,492 issued 28 Apr 1998 (expires 28 Apr 2015) 
(DHHS Reference No. E-220-1993/1-US-01)
Licensing Contact: John Stansberry; (301) 435-5236; 
[email protected] and

Combinatorial Therapy for Protein Signaling Diseases

Arpita Mehta (NCI), Lance Liotta (NCI), Emmanuel Petricoin (FDA)
U.S. Provisional Application No. 60/453,629 filed 10 Mar 2003 (DHHS 
Reference No. E-039-2003/0-US-01)
Licensing Contact: Michael Shmilovich; (301) 435-5019; 
[email protected].

    Angiogenesis is a composite of regulated proliferation and 
regulated invasion occurring in a variety of normal and pathologic 
conditions. In this invention, the claimed compound and its related 
analogs are useful for inhibiting angiogenesis in a host and offer a 
novel approach to the treatment of cancer, diabetic retinopathy, 
hemangiomata, vasculidities, macular degeneration and other disease 
associate with angiogenesis. Additionally, the compound has shown 
efficacy at lower doses when co-administered with other anti-
angiogenesis agents.
    Refer to issued patent 5,744,492 (April 28, 1998), and journal 
articles: PNAS (1995) 92(5):1307-11, and In Vivo (1996) 10(2):153-60.

    Dated: October 22, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-24166 Filed 10-28-04; 8:45 am]
BILLING CODE 4140-01-P