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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, HHS.

# 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.

## 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;                     *baharm@mail.nih.gov.*

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;                     *baharm@mail.nih.gov.*

                    The invention discloses combinations of anti-tumor agents and anti-                          ( print 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;                     *baharm@mail.nih.gov.*

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;                     *baharm@mail.nih.gov.*

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;                     *baharm@mail.nih.gov.*

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