[Federal Register Volume 69, Number 246 (Thursday, December 23, 2004)]
[Notices]
[Pages 76949-76950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28068]


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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, HHS.

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.

Non-Small Cell Lung Cancer Cell Line H3255

Herbert K. Oie et al. (NCI)
DHHS Reference No. E-028-2005/0--Research Tool
Licensing Contact: Mojdeh Bahar; 301/435-2950; [email protected].

    This invention, the H3255 cell line, was initiated from malignant 
cells isolated from the pleural effusion from a non-smoker Caucasian 
female. The cultured tumor cells, identified as Non-Small Cell Lung 
Carcinoma Cells (NSCLC), were found to have a mutation within the EGFR 
gene that made them very sensitive to certain growth inhibiting drugs, 
such as gefitinib (iressa). Cell lines sensitive to growth inhibitors 
could be used in the treatment of cancer as potential chemotherapeutic 
agents.

LRATlerin, Related Compounds and Methods of Use

Denise P. Simmons (NCI)
U.S. Provisional Application No. 60/613,256 filed 27 Sep 2004 (DHHS 
Reference No. E-349-2004/0-US-01)
Licensing Contact: Mojdeh Bahar; 301/435-2950; [email protected].

    The invention discloses combinations of anti-tumor agents and anti-

[[Page 76950]]

proliferative peptides, methods for making such compounds, and methods 
for using these compounds for the treatment of hyper-proliferative 
diseases such as cancer or psoriasis. A current limitation on cancer 
therapy is that therapeutic agents may not target tumor cells 
specifically or enter the cells efficiently. A strategy that combines 
the therapeutic agent with a moiety that mediates cellular entry is one 
method to overcome this limitation. However, the efficacy of the 
therapeutic agent within the cells can be reduced by the linkage to the 
moiety that mediates cellular entry. The compounds of the current 
invention are designed to enter cells efficiently, and upon entry, to 
uncouple the therapeutic agent from the cellular targeting moiety.
    Rottlerin, a protein kinase C inhibitor, selectively induces 
apoptosis of metastasized melanoma cells of epithelial morphology (DHHS 
Ref. No. E-311-2003), and is a potential therapeutic agent. Peptides 
derived from the known tumor suppressor genes H-Ha-Rev107 and H-TIG3, 
that are homologous to a peptide of LRAT (lecithin:retinol acyl 
transferase) cross the cell membrane and localize to the nucleus. These 
peptides, which inhibit the growth of melanoma cells (described in DHHS 
Ref. No. E-052-2002), could also serve as intracellular delivery 
agents.
    The current invention discloses a novel composition of rottlerin 
and LRAT peptide (named LRATlerin). LRATlerin is designed so that the 
LRAT peptide can release the rottlerin upon cellular entry. LRATlerin 
has enhanced properties not exhibited by rottlerin or the peptide alone 
including the ability to induce apoptosis of primary site and 
metastasized tumor cells that are epithelioid or fibroblastoid, without 
apparent toxicity normal healthy cells. Thus, the compositions of the 
current invention have the potential to be highly effective therapies 
for proliferative diseases.

Modulating Expression of the Metastasis Suppressor MxA

Jane B. Trepel et al. (NCI)
DHHS Reference No. E-257-2004/0-US-01 (U.S. Provisional Patent 
Application)
Licensing Contact: Mojdeh Bahar; 301/435-2950; [email protected].

    The invention discloses compounds that could be used to inhibit 
metastases. The compounds of the current invention were discovered by 
high-throughput screening of a novel cell line engineered with a MxA 
reporter. The compounds could be used to treat metastatic cancers 
including prostate and melanomas by increasing MxA expression.
    MxA expression reduces cell motility and metastases in a mouse 
model. Cells expressing MxA produced smaller tumors in engrafted mice 
compared to controls. When injected into mouse spleens, cells 
expressing MxA showed a significantly delayed metastasis, and the mice 
survived significantly longer than controls. Expression of MxA reduced 
cellular motility of prostate cancer cell lines in vitro and reduced 
cellular motility and invasiveness of the highly metastatic melanoma 
cell line LOX.
    Background information for this technology can be found in DHHS 
Reference No. E-292-2001.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

Modified Myelin Basic Protein Molecules

Michael J. Lenardo et al. (NIAID)
DHHS Ref. No. E-033-1996/0-US-01
    Licensing Contact: Mojdeh Bahar; 301/435-2950; [email protected].

    This invention is directed to compositions and methods for clinical 
assessment, diagnosis and treatment of Multiple Sclerosis (MS). The 
compositions are molecules related to the 21.5 kDA fetal isoform of 
human myelin basic protein (MBP), and include nucleic acids and 
polypeptides. The nucleic acids are useful in the efficient production 
of modified and unmodified MBP polypeptides and the polypeptides are 
useful for assaying T cells for responsiveness to MBP epitopes. They 
are further useful as therapeutic agents that act by inducing T cell 
responses, including apoptosis, as a means of treating MS.

Modified Proteolipid Protein Molecules

Michael J. Lenardo et al. (NIAID)
DHHS Ref. No. E-128-1996/1-US-01
Licensing Contact: Mojdeh Bahar; 301/435-2950; [email protected].

    This invention is directed to compositions and methods for clinical 
assessment, diagnosis and treatment of Multiple Sclerosis (MS). The 
compositions are molecules related to the human proteolipid protein 
(PLP), and include nucleic acids and polypeptides. The nucleic acids 
are useful in the production of modified PLP polypeptides and the 
polypeptides are useful for assaying T cells for responsiveness to PLP 
epitopes. They are further useful as therapeutic agents that act by 
inducing T cell responses, including apoptosis, as a means of treating 
MS.

    Dated: December 15, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-28068 Filed 12-22-04; 8:45 am]
BILLING CODE 4140-01-P