66446 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

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 nonexclusive 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; kindraj@mail.nih.gov. 

The present invention relates to 

compositions and methods for the 

treatment of a neoplastic disease state 

(i.e. tumors) using RNA interferencemediated 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 adenoassociated 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; baharm@mail.nih.gov. 

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 

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. 

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. 

Method To Disrupt Protein-Protein 

Interactions and Its Use To Identify 

Compounds Able To Inhibit HIV–1 Rev 

Protein Multimerization 

George Pavlakis and Leonid Suvoroz 

(NCI). 

HHS Reference No. E–303–2005/0—

Research Tool. 

Licensing Contact: Sally Hu; 301/435–

5606; hus@mail.nih.gov. 

The invention provides a FRET-based 

assay for the study of Rev-Rev 

interaction in vitro, based on YFP and 

CFP expression constructs for Rev. 

Using this assay, Rev-derived small 

peptides that can inhibit Rev-Rev 

interactions and disrupt dimerization 

were discovered. This assay can be used 

as an in vitro assay for studying proteinprotein interactions in general, and for 

the discovery of inhibitors or agonists of 

such interactions as potential drugs 

against HIV infections, as well as for the 

Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 66447 

discovery of Rev dimerization 

inhibitors. Thus this assay can be useful 

for drug screening. 

NIH will not seek patent protection 

for this invention, and it will be 

available for licensing through a 

Biological Materials License (BML) or 

though a Material Transfer Agreement 

(MTA). 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Furin Inhibitors and Alpha-Defensin 

for Preventing Papilloma Virus 

Infection 

Patricia Day, Rebecca Richards, John 

Schiller, Douglas Lowy, Christopher 

Buck (NCI). 

U.S. Provisional Application No. 60/ 

692,846 filed 21 Jun 2005 (HHS 

Reference No. E–104–2005/1–US–01). 

Licensing Contact: Michael Shmilovich; 

301/435–5019; 

shmilovm@mail.nih.gov. 

Available for licensing and 

commercial development are 

intellectual properties that claim 

compositions and methods for 

preventing papilloma virus (PV) 

infection in humans using furin 

inhibitors or alpha-defensins. PV 

viruses include a minor capsid protein 

L2 which requires a functional 

intracellular furin (a cell-encoded 

proprotein convertase present in 

endosomes) for escape from the 

endosomal spaces into the cytoplasm 

and viral infection. Accordingly, a 

disruption of viral infection by the 

inhibition of furin with molecules such 

as decanoyl-RVKR-CMK is potentially 

useful as a broad spectrum anti-HPV 

prophylactic. 

Alpha-defensins, which are naturally 

secreted by the cervix, are reported to 

have potent and non-type specific antiHPV properties. They can be 

administered as a topic microbicide to 

prevent infection by many HPV 

genotypes, including types not covered 

by the vaccines currently in Phase III 

clinical trials. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Identification of a Fusion/Entry 

Receptor for Human Herpesvirus-8 

Edward A. Berger, Johnan Kaleeba 

(NIAID). 

U.S. Provisional Application No. 60/ 

681,098 filed 13 May 2005 (HHS 

Reference No. E–051–2005/0–US–01). 

Licensing Contact: Robert M. Joynes; 

301/594–6565; joynesr@mail.nih.gov. 

This invention relates to stable, 

nonhuman cell lines and transgenic 

mammals having cells that coexpress 

human xCT as valuable tools for the 

continuing research of Kaposi’s Sarcoma 

Herpes Virus (KSHV) infection and the 

development of more effective antiKSHV therapeutics. Kaposi’s sarcoma 

(KS) is the most common malignancy in 

AIDS patients and manifests as highly 

proliferative vascular lesions that 

appear on body extremities. KSHV is 

invariably present in all known clinical 

forms of KS and sero-conversion to 

KSHV antigens is considered a risk 

factor for development of the lesions. 

KSHV is believed to enter target cells by 

direct fusion of virion membrane with 

the target cell plasma membrane. The 

susceptibility of KSHV infection 

depends on the cell surface expression 

of the human xCT molecule. xCT plays 

a role in the membrane fusion step of 

KSHV infection. The identification of 

xCT as a receptor for KSHV may pave 

the way for deciphering the mechanism 

of KSHV pathogenesis. 

This discovery has led to various 

potential commercial applications for 

this invention including the following: 

• Cell lines expressing recombinant 

xCT for analysis of KSHV entry/ 

infection 

• Construction of xCT transgenic 

small animals for testing of KSHV 

inhibitors 

• Use of peptides or fragments 

derived from extracellular regions of 

xCT as KSHV inhibitors 

• Use of specific antibodies 

(including human versions) against xCT 

as KSHV inhibitors 

• Use of small molecules targeted to 

xCT as KSHV inhibitors 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Potent HIV–1 Entry Inhibitors and 

Immunogens 

Dimiter S. Dimitrov et al. (NCI). 

U.S. Patent Application No. 10/506,651 

filed 05 Mar 2002; Publication 

Number US–2005–0106160 (HHS 

Reference No. E–039–2002/0–US–02). 

Licensing Contact: Susan Ano; 301/435–

5515; anos@mail.nih.gov. 

This technology relates to tethered 

antigenic constructs where flexible 

linkers join gp120 and the ectodomain 

of gp41. The HIV–1 envelope 

Glycoprotein (Env) undergoes 

conformational changes while driving 

entry. The inventors developed these 

constructs to mimic some of the 

intermediate Env conformations. 

Tethered Envs with long (15 to 26 

amino acid) linkers were stable and 

potently inhibited fusion mediated by 

R5, X4 and R5X4 Envs, most likely by 

exposure of gp41 structures that bind 

DP178 and cluster II mAbs. The fusion 

proteins with long linkers exhibited 

enhanced exposure of DP178 and 

cluster II mAbs binding gp41 structures 

that are critical for entry. These findings 

suggest the existence of conserved 

structures that are critical for HIV–1 

entry, and could be used as novel 

immunogens for elicitation of broadly 

neutralizing antibodies and as antigens 

for selection of potent neutralizing 

antibodies by phage display. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

A Novel Post-Transcriptional 

Regulatory Element (PRE) and Its Use 

in Expression Cassettes and 

Recombinant Viruses 

George N. Pavlakis et al. (NCI). 

U.S. Patent Number 6,919,442, issued 

July 19, 2005; EP Patent Application 

Serial Number 99924362.9 (HHS 

Reference Number E–143–1998/0). 

Licensing Contact: Susan Ano; 301/435–

5515; anos@mail.nih.gov. 

This invention concerns a novel posttranscriptional regulatory element (PRE) 

that can function as a RNA nucleocytoplasmic transport element (NCTE) 

and its inclusion in expression cassettes 

and recombinant viruses, including in 

recombinant attenuated HIV strains. 

HIV regulates its expression by 

controlling the nuclear transport of 

unspliced mRNA encoding structural 

proteins utilizing the Rev/RRE system. 

RRE (Rev Responsible Element) is an 

HIV encoded NCTE, which is part of 

every HIV RNA encoding the structural 

genes (gag/pol and env). Rev is an HIV 

encoded protein that binds to RRE. This 

interaction is essential for the nucleocytoplasmic transport of the RREcontaining viral mRNAs and the 

expression of Gag/Pol and Env proteins 

in transport. The invention discusses an 

attenuated HIV produced by disabling 

rev/RRE by point mutations and 

inserting in its place the novel PRE of 

the invention. The resultant HIV is 

attenuated between 50 and 200 fold 

compared to wild-type HIV. In addition 

to HIV, the novel PRE element can 

increase expression from many mRNAs 

not efficiently transported on their own. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

66448 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices 

research opportunities with the 

inventors. 

Dated: October 25, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 05–21832 Filed 11–1–05; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel, SBIR Topic 

186 Phase II: Target Based High Throughput 

Screening for the Identification of 

Radioprotector. 

Date: November 22, 2005. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: C. Michael Kerwin, PhD, 

MPH, Scientific Review Administrator, 

Special Review and Logistics Branch, 

Division of Extramural Activities, National 

Cancer Institute, National Institute of Health, 

6116 Executive Boulevard, Room 8057, MSC 

8329, Bethesda, MD 20892–8329. (301) 496–

7421. kerwinm@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: October 25, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21825 Filed 11–1–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, ROS and 

Aging. 

Date: November 9, 2005. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892, (Telephone Conference 

Call). 

Contact Person: Alessandra M. Bini, PhD, 

Scientific Review Office, National Institute of 

Aging, National Institutes of Health, 7201 

Wisconsin Avenue, Bethesda MD 20892, 

301–402–7708, binia@nia.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Aging Emphasis Panel, ‘‘DNA and aging 

brain’’. 

Date: November 28–29, 2005. 

Time: 6 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Chevy Chase, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Louise L. Hsu, PhD, Health 

Scientist Administrator, Scientific Review 

Office, National Institute on Aging, Gateway 

Building, 7201 Wisconsin Avenue/Suite 

2C212, Bethesda, MD 20892, (301) 496–7705, 

hsul@exmur.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: October 25, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21824 Filed 11–1–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, Mechanisms of 

Mammalian Sperm Capacitation. 

Date: November 23, 2005. 

Time: 10 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Rockville, 

MD 20852, (Telephone Conference Call). 

Contact Person: Jon M. Ranhand, PhD, 

Scientist Review Administrator, Division of 

Scientific Review, National Institute of Child 

Health and Human Development, NIH, 6100 

Executive Boulevard, Room 5B01, Bethesda, 

MD 20892, (301) 435–6884. 

ranhandj@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: October 25, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21826 Filed 11–1–05; 8:45 am] 

BILLING CODE 4140–01–M