[Federal Register Volume 69, Number 147 (Monday, August 2, 2004)]
[Notices]
[Pages 46168-46169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17466]


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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 Model of PRKAR1A Down-Regulation

    Constantine Stratakis et al. (NICHD); DHHS Reference No. E-266-
2004/0--Research Tool; Licensing Contact: Mojdeh Bahar; 301/435-2950; 
[email protected].
    The invention represents the first animal model of cyclic AMP 
(cAMP)-induced tumorigenesis, and the first animal model of protein 
kinase A (PKA)-related tumorigenesis. The cAMP/PKA system is of seminal 
importance for cellular function and signaling, and is involved in many 
systems and diseases. This discovery is expected to facilitate the 
development of drugs useful in treating endocrine and other tumors.

Compositions and Methods for Diagnosis and Treatment of Chemotherapy-
Resistant Neoplastic Disease

    John Park (NINDS); U.S. Provisional Application No. 60/571,296 
filed 15 May 2004 (DHHS Reference No. E-192-2004/0-US-01); Licensing 
Contact: Jesse S. Kindra; 301/435-5559; [email protected].
    The present invention relates to compositions and methods for the 
treatment of a neoplastic disease state (i.e., tumors) using RNA 
interference-mediated down regulation of stathmin expression. This 
invention also discloses methods for determining the presence or 
predisposition to a neoplastic disease state.
    Stathmin is a cytoplasmic protein that is highly expressed in many 
different types of tumors such as leukemias, lung cancers and brain 
tumors. Stathmin is believed to be involved in the regulation of the 
cell cycle via its interactions with microtubules. Lowering the 
expression of stathmin in tumor cells using RNA interference (RNAi) 
technology causes a decrease in tumor cell growth and also causes such 
cells to become more sensitive to the effects of standard 
chemotherapeutic agents.
    Accordingly, the delivery of stathmin RNAi oligonucleotides either 
alone or in combination with standard chemotherapies may be used to 
treat patients with various tumors. For example, retroviruses or adeno-
associated viruses containing stathmin RNAi oligonucleotides could be 
delivered to brain tumors in order to

[[Page 46169]]

decrease cell growth and increase sensitivity to standard 
chemotherapies.

Compositions of Matter and Methods of Use of Fluorescent Protein 
Kinases

    Derek Braun and Peter Blumberg (NCI); U.S. Provisional Application 
filed 19 May 2004 (DHHS Reference No. E-093-2004/0-US-01); Licensing 
Contact: Mojdeh Bahar; 301/435-2950; [email protected].
    The invention describes the development of fusion proteins, as well 
as polynucleotides encoding such fusion proteins, between protein 
kinase C (PKC) isoforms and variants of green fluorescent protein for 
the purpose of detecting protein kinase C activation within intact 
cells via fluorescence resonance energy transfer (FRET). Repeatable 
dose-dependent change of FRET with a number of PKC ligands, including 
phorbol esters and bryostatin, have been demonstrated. The invention is 
useful as a drug discovery tool for evaluating therapeutics that target 
PKCs.

Methods for the Identification and Use of Compounds Suitable for the 
Treatment of Drug Resistant Cells

    Gergely Szakacs et al. (NCI); DHHS Reference No. E-075-2004/0-US-01 
filed 18 June 2004; Licensing Contact: Jesse S. Kindra; 301-435-5559; 
[email protected].
    There is an important need to overcome cancer multiple drug 
resistance (MDR). ATP-binding cassette (ABC) transporters are a family 
of transporter proteins that contribute to drug resistance via ATP-
dependent drug efflux pumps. Accordingly, based on the expression 
profile of 48 ABC transporters in sixty (60) cell lines, the present 
invention provides a method to identify (1) drugs that retain action in 
cells expressing MDR proteins, (2) compounds that reduce MDR by 
interfering with the efflux pumps. In addition, the invention describes 
a method to identify compounds whose antiproliferative effect is 
potentiated by the ABCB1/MDR1 transporter. These compounds might avoid 
the well-documented side-effects observed in clinical trials of 
``classical'' MDR1 inhibitors and may serve as leads for development of 
novel anti-cancer agents to treat resistant disease.

Methods and Devices for Molecular Diagnosis and Prognosis of Lymphoid 
Malignancies

    Louis M. Staudt et al. (NCI); U.S. Provisional Application No. 60/
506,377 filed 03 Sep. 2003 (DHHS Reference No. E-234-2003/0-US-01); 
Licensing Contact: Jeffrey Walenta; 301/435-4633; 
[email protected].
    Human lymphomas and leukemias are a diverse set of cancers. Many of 
these cancers, while expressing a similar phenotype between different 
individuals, have a diverse underlying genetic basis for the disease. 
This diverse genetic basis has implications on the effective treatment 
of the various phenotypes of lymphoma. For example, a drug that was 
effective against one individual's phenotype of lymphoma will not be 
effective against a similar lymphoma in another individual. An 
invention that helps clinicians classify a lymphoproliferative disorder 
would provide the basis for a ``pharmacogenomic'' method for treating 
such cancers.
    The patent application listed in this abstract describes the 
preliminary results of an ongoing effort to establish a molecular basis 
for classifying all lymphoproliferative disorders. Gene expression 
profiles, using a gene set of over 27,000 genes, have been established 
from a large population of lymphoproliferative tumor samples collected 
from patients at numerous healthcare institutions worldwide. Clinical 
outcomes were correlated to the gene expression profile data 
representing a plurality of lymphoid malignancy subtypes of previously 
known or unknown lymphoproliferative disorders. Finally, an analysis 
procedure was developed to predict the clinical outcomes based on a 
patients specific lymphoid tumor gene expression profile.
    This patent application describes a method to predict the survival 
of patient with a lymphoproliferative disorder.

    Dated: July 23, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-17466 Filed 7-30-04; 8:45 am]
BILLING CODE 4140-01-P