[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Notices]
[Pages 66445-66446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21831]


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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.

Antibodies Against Insulin-Like Growth Factor II and Uses Thereof

Dimiter S. Dimitrov et al. (NCI).
U.S. Provisional Application No. 60/709,226 filed 17 Aug 2005 (HHS 
Reference No. E-217-2005/0-US-01).
Licensing Contact: Michelle A. Booden; 301/451-7337; 
<a href="/cdn-cgi/l/email-protection#86e4e9e9e2e3e8ebc6ebe7efeaa8e8efeea8e1e9f0"><span class="__cf_email__" data-cfemail="99fbf6f6fdfcf7f4d9f4f8f0f5b7f7f0f1b7fef6ef">[email protected]</span></a>.

    The type 1 insulin-like growth factor (IGF) receptor (IGF1R) is 
over-expressed by many tumors and mediates proliferation, motility, and 
protection from apoptosis. Agents that inhibit IGF1R expression or 
function can potentially block tumor growth and metastasis. Its major 
ligand, IGF-II, is over-expressed by multiple tumor types. Previous 
studies indicate that inhibition of IGF-II binding to its cognizant 
receptor negatively modulates signal transduction through the IGF 
pathway and concomitant cell growth.
    The present invention relates to the identification of multiple, 
novel fully human monoclonal antibodies that are specific for IGF-II 
and do not cross-react with IGF-1 or insulin. The present invention 
also describes methods employing these novel antibodies to inhibit IGF-
1R phosphorylation and

[[Page 66446]]

concomitant cell growth and motility. The invention also encompasses 
other IGF-II antibodies or derivatives of the original antibodies and 
methods of using said antibodies to block binding of ligands. 
Additional embodiments describe methods for treating various human 
diseases associated with aberrant cell growth and motility including 
breast, prostate, and leukemia carcinomas. Thus, these novel IGF-II 
antibodies may provide a therapeutic intervention for multiple 
carcinomas without the negative side effects associated with IGF I and 
insulin inhibition.
    This technology is available for licensing under an exclusive or 
non-exclusive patent license.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

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 (HHS 
Reference No. E-192-2004/0-US-01); PCT Application No. PCT/US2005/
016924 filed 13 May 2005 (HHS Reference No. E-192-2004/0-PCT-02).
Licensing Contact: Jesse S. Kindra; 301/435-5559; <a href="/cdn-cgi/l/email-protection#ec878582889e8d86ac818d8580c2828584c28b839a"><span class="__cf_email__" data-cfemail="2d464443495f4c476d404c444103434445034a425b">[email protected]</span></a>.

    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 decrease cell growth and increase 
sensitivity to standard chemotherapies.

Serine Protease Inhibitors

Peter P. Roller, Peng Li (NCI).
PCT Patent Application No. PCT/US2004/34108 filed 15 Oct 2004 (HHS 
Reference No. E-272-2002/1-PCT-01).
Licensing Contact: Mojdeh Bahar; 301/435-2950; <a href="/cdn-cgi/l/email-protection#a5c7c4cdc4d7c8e5c8c4ccc98bcbcccd8bc2cad3"><span class="__cf_email__" data-cfemail="abc9cac3cad9c6ebc6cac2c785c5c2c385ccc4dd">[email protected]</span></a>.

    This disclosure concerns novel serine protease inhibitors and 
methods for using the inhibitors to reduce tumor progression and/or 
metastasis. Embodiments of the inhibitors are highly effective, 
selective inhibitors of matriptase, which has been implicated in tissue 
remodeling associated with the growth of cancerous tumors and cancer 
metastasis.
    Angiogenesis and tumor invasion require that the normal tissue 
surrounding the tumor be broken down in a process referred to as tissue 
remodeling. Tissue remodeling is accomplished by a host of enzymes that 
break down the proteins in the normal tissue barriers comprising the 
extracellular matrix. Among the enzymes associated with degradation of 
the extracellular matrix and tissue remodeling are a number of 
proteases. The expression of some of these proteases has been 
correlated with tumor progression.
    The disclosed compounds can be used to inhibit matriptase, MTSP1, 
or both, in vitro and in vivo and thus can be used in the prevention or 
treatment of conditions characterized by abnormal or pathological 
serine protease activity. For example, the compounds are useful for 
prevention or treatment of conditions characterized by the pathological 
degradation of the extracellular matrix, such as conditions 
characterized by neovascularization or angiogenesis, including 
cancerous conditions, particularly metastatic cancerous conditions 
where matriptase is implicated. The disclosed compounds can be used to 
decrease the degradation of the cellular matrix and thereby reduce 
concomitant tumor progression and metastasis. Conditions characterized 
by abnormal or pathological serine protease activity that can be 
treated according to the disclosed method include those characterized 
by abnormal cell growth and/or differentiation, such as cancers and 
other neoplastic conditions. Typical examples of cancers that may be 
treated according to the disclosed inhibitors and method include colon, 
pancreatic, prostate, head and neck, gastric, renal, and brain cancers.

    Dated: October 25, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-21831 Filed 11-1-05; 8:45 am]
BILLING CODE 4140-01-P


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