Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56475 

SNH and taxol are synergistic at 

inhibiting breast cell cancer growth and 

can potentiate the cytotoxicity of taxol 

in an in vivo human xenograft breast 

cancer mouse model. 

Combination therapy using these 

agents may therefore greatly enhance 

the response rate of different cancers to 

these drugs and may significantly 

reduce side effects by permitting a lower 

therapeutic dose to be administered. 

Available for licensing are compositions 

of matter and methods of use of VIP 

receptor antagonists. 

Dated: September 15, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 05–19172 Filed 9–26–05; 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. 

HIV-Encoded siRNA, microRNA and 

Suppressor of RNA Silencing 

Yamina Bennasser et al. (NIAID) 

U.S. Provisional Application No. 60/ 

677,839 filed 05 May 2005 (HHS 

Reference No. E–203–2005/0–US–01). 

Licensing Contact: Susan Ano; 301/435–

5515; anos@mail.nih.gov. 

The present invention relates to virusencoded siRNA and miRNA species and 

the use of such RNAs in the diagnosis, 

prevention and/or treatment of 

retroviral infection, especially HIV or 

SIV infection. This invention conveys 

the first evidence that HIV–1 encodes 

viral siRNA precursors in its genome 

and that natural HIV–1 infection 

provokes nucleic acid-based immunity 

in human cells. To overcome this 

cellular defense, the HIV–1 Tat protein 

has evolved to include a suppressor of 

RNA silencing (SRS) function. 

Additionally, this invention identifies 

five microRNA (miRNA) precursor 

candidates that regulate cellular gene 

expression at a post-transcriptional 

level. The five miRNA precursors (21–

25 nucleotides in length) are encoded in 

highly conserved regions of HIV such as 

TAR sequence, gag, pol and nef genes. 

These findings indicate that viruses 

utilize RNA interference as a 

mechanism to regulate cellular gene 

expression. 

This technology is further described 

in: Bennasser et al., ‘‘HIV–1 encoded 

candidate micro-RNAs and their cellular 

targets,’’ Retrovirology 2004 Dec 15, 

1(1):43, doi:10.1186/1742–4690–1–43; 

and Bennasser et al., ‘‘Evidence that 

HIV–1 encodes an siRNA and a 

suppressor of RNA silencing,’’

Immunity 2005 May, 22(5):607–619, 

doi:10.1016/j.immuni.2005.03.010. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Miniature Laser-Induced Fluorescence 

Detector 

Paul Smith, Nicole Morgan, Edward 

Wellner, Terry Phillips (ORS) 

U.S. Provisional Application No. 60/ 

682,847 filed 20 May 2005 (HHS 

Reference No. E–129–2005/0–US–01). 

Licensing Contact: Michael Shmilovich; 

301/435–5019; 

shmilovm@mail.nih.gov. 

Available for licensing and 

commercial development is a miniature 

laser-induced fluorescence detector 

having an in-line microfluidic detection 

cell. The detection cell finds application 

in High Performance Liquid 

Chromatography (HPLC), Capillary 

Electrophoresis (CE) and Mass 

Spectroscopy (MS) applications, among 

others. The cell for fluorescence 

measurements can have a measurement 

volume of 1 nL or less and a sample can 

be excited using two excitation 

wavelengths. The detection cell can 

include a 5 mm to 5 cm long capillary 

tube and an excitation fiber proximate 

to the capillary tube. A detection fiber 

is also proximate to the capillary tube, 

and the detection fiber has a diameter 

the same size or larger than the external 

diameter of the capillary tube. A 

plurality of both excitation and 

detection fibers can be used. 

In addition to licensing, the 

technology may be available for further 

development through collaborative 

research opportunities with the 

inventors. 

Cellular Receptor for Varicella-Zoster 

Virus and Cell-to-Cell Spread of Virus 

Jeffery Cohen et al. (NIAID) 

U.S. Provisional Application No. 60/ 

684,526 filed 26 May 2005 (HHS 

Reference No. E–289–2004/0–US–01). 

Licensing Contact: Chekesha S. 

Clingman; 301/435–5018; 

clingmac@mail.nih.gov. 

This technology relates to 

identification of insulin degrading 

enzyme (IDE) as a cellular receptor for 

Varicella-Zoster-Virus (VZV), the 

etiologic agent of varicella (chickenpox) 

and zoster (shingles). Acute infection of 

VZV is followed by cell-associated 

viremia and the development of 

varicella rash. The virus establishes lifelong latency in the nervous system and 

can reactivate to cause zoster. The 

mechanism of VZV entry into target 

cells and spread from cell-to-cell is not 

well understood. The inventors have 

shown that antibodies to IDE and 

recombinant IDE partially inhibit 

infection with the virus in cell culture. 

Reducing the level of IDE in the cell 

(with siRNA), or blocking the ability of 

IDE to bind with a VZV glycoprotein, 

markedly diminishes cell-to-cell spread 

of the virus in cell culture and partially 

inhibits infection of cells with cell-free 

virus. This invention further describes 

molecules that may have a role in the 

treatment or prevention of VZV 

infections, including antibodies to IDE, 

peptides that block IDE–VZV 

interactions, and other molecules that 

block binding activity of IDE. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

A Novel Amplification Method Permits 

Pathogens To Be Detected With 

Microarrays 

Michael J. Brownstein, Charles Xiang, 

and Zhi-Qing Qi (NIMH) 

U.S. Provisional Application No. 60/ 

635,239 filed 09 Dec 2004 (DHHS 

Reference No. E–184–2004/0–US–01). 

Licensing Contact: Cristina 

Thalhammer-Reyero; 301/435–4507; 

thalhamc@mail.nih.gov. 

56476 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 

Available for licensing and 

commercial development is a high 

throughput, microarray-based multiplex 

method of detecting target nucleic acids 

in a sample. In particular, PCR is 

coupled with microarrays for the 

qualitative identification of multiple 

target nucleic acids, with primers 

specific for a target sequence, and used 

to detect genomic nucleic acids of 

pathogens of interest, or transcripts 

derived therefrom. Also claimed are 

oligonucleotide microarrays for use in 

such methods. 

The present method is distinguished 

from other multiplex PCR assays by the 

additional steps to ensure specificity 

and sensitivity, so that a larger number 

of probes can be detected 

simultaneously in each single reaction. 

An important application of this 

method, for which it was developed, is 

the detection of multiple ‘‘Category A 

List’’ agents for the purpose of 

differential diagnosis in case of 

bioterrorism attacks. The method 

comprises: (a) screening the genomes of 

the desired infectious agents to find 

sequences specific for each of them and 

distinct from human sequences; (b) 

designing 60 base long oligonucleotide 

targets, to print on microarrays; and (c) 

including in the microarrays both sense 

and antisense versions of each, as well 

multiple targets per virus, to increase 

reliability. 

Other methods, such as PCR 

amplification followed by separation 

and characterization of DNA products 

by gel electrophoresis, are simple and 

sensitive, but they have a number of 

inherent shortcomings. Highly sensitive 

PCR amplification tends to generate 

nonspecific DNA products, which 

complicate interpretation of the results. 

Additionally, in a typical method for 

detecting pathogens in a sample, PCR 

reactions for each pathogen must be run 

separately from one another due to 

differences in amplification conditions. 

Furthermore, in cases where multiplex 

PCR coupled with a microarray is used 

for the qualitative detection of several 

pathogens, the generation of nonspecific 

DNA products can be a significant 

problem. The current method is a rapid, 

high-throughput method for qualitative 

identification of multiple target nucleic 

acids that is sensitive, highly 

discriminating and robust. 

Methods for Treating Viral-Associated 

Tumors With LFA–1 Inhibiting Statins 

Jeffrey Cohen et al. (NIAID) 

U.S. Provisional Application No. 60/ 

515,013 filed 28 Oct 2003 (HHS 

Reference No. E–312–2003/0–US–01); 

PCT Application No. PCT/US2004/ 

035829 (publication WO2005/042710) 

filed 28 Oct 2004 (HHS Reference No. 

E–312–2003/0–PCT–02). 

Licensing Contact: Susan Ano; 301/435–

5515; anos@mail.nih.gov. 

This technology describes the use of 

certain natural and synthetic statins, 

including simvastatin, other leukocyte 

function antigen-1 (LFA–1) inhibiting 

statins, and compounds derived from 

LFA–1 inhibiting statins and statin-like 

compounds, for treatment or prevention 

of Epstein-Barr Virus (EBV) associated 

tumors, including lymphomas that 

express LFA–1 and transforming 

proteins. Such compounds could also be 

used to treat tumors associated with 

other viruses that express LFA–1. 

Cancers associated with EBV that could 

be treated with the statins by methods 

described herein include gastric 

carcinoma (the second leading cause of 

cancer deaths worldwide), 

nasopharyngeal carcinoma, Hodgkin’s 

disease, lymphoproliferative disease, Tcell lymphoma, and non-Hodgkin’s 

lymphoma. These compounds could 

potentially be used as 

chemotherapeutics with possibly less 

severe side effects than currently 

employed chemotherapies. 

This technology is further described 

in: Katano et al., ‘‘Simvastatin induces 

apoptosis of Epstein-Barr virus (EBV)- 

transformed lymphoblastoid cell lines 

and delays development of EBV 

lymphomas,’’ PNAS, 2004 Apr 6, 

101(14):4966–4971, doi 10.1073/ 

pnas.0401064101. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Attenuated Human Parainfluenza Virus 

(PIV) for Use as Live, Attenuated 

Vaccines and as Vector Vaccines 

U.S. Provisional Application No. 60/ 

643,310 filed 12 Jan 2005 (HHS 

Reference No. E–295–2004/0–US–01) 

Sheila M. Nolan et al. (NIAID) 

and 

U.S. Provisional Application No. 60/ 

412,053 filed 18 Sep 2002 (HHS 

Reference No. E–092–2002/0–US–01); 

U.S. Patent Application No. 10/ 

667,141 filed 18 Sep 2003 (HHS 

Reference No. E–092–2002/0–US–02; 

PCT Application No. PCT/US03/ 

29685 filed 18 Sep 2003, which 

published as WO2004/027037 on 01 

Apr 2004 (HHS Reference No. E–092–

2002/0–PCT–03), and National Stage 

filed in Canada, Europe, Japan, 

Australia, and India 

Mario H. Skiadopoulos et al. (NIAID) 

Licensing Contact: Susan Ano; 301/435–

5515; anos@mail.nih.gov. 

The identified technologies describe 

self-replicating infectious recombinant 

paramyxoviruses with one or more 

attenuating mutations, such as a 

separate variant polynucleotide 

encoding a P protein and a separate 

monocistronic polynucleotide encoding 

a V protein, or at least one temperature 

sensitive mutation and one nontemperature sensitive mutation. 

Compositions and methods for 

recovering, making and using the 

infectious, recombinant 

paramyxoviruses as described are also 

included (e.g. recombinant human 

parainfluenza virus type 2 (HPIV2)). In 

addition, these inventions provide novel 

tools and methods for introducing 

defined, predetermined structural and 

phenotypic changes into an infectious 

HPIV2 candidate for use in 

immunogenic compositions, including 

live attenuated virus vaccines. 

Furthermore, these inventions describe 

the recombinant HPIV2 P+V can be used 

to introduce attenuating mutations to 

develop live attenuated virus vaccines. 

The paramyxoviruses of the invention 

are also useful as vectors for expressing 

heterologous antigens (e.g. RSV, HMPV, 

measles or mumps viruses) in an 

immunogenic composition. As members 

of the paramyxoviruses, HPIVs are 

important pathogens causing severe 

lower respiratory tract infections in 

infants and young children. Despite 

considerable efforts, there are currently 

no parainfluenza virus vaccines 

available. 

Advantages of the subject 

technologies to generate live attenuated 

viruses or vectored vaccine candidates 

via multiple mutations are the design of 

safe and stable viral vaccine candidates. 

Since two common vaccine 

development approaches (viral subunit 

vaccines and inactivated whole virus 

preparations) elicited either short-lived, 

inadequate immunity or unfavorable 

immune responses, the identified 

technologies provide a promising means 

to develop vaccines against HPIVs and 

other human pathogens. In addition, 

live attenuated viruses are the most 

promising candidate vaccines because 

they induce both local and systemic 

immunity and are efficacious even in 

the presence of passively transferred 

serum antibodies, the very situation 

found in the target population of infants 

with maternally derived antibodies. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices 56477 

Imaging With Positron-Emitting 

Taxanes as a Guide to Antitumor 

Therapy 

Jerry M. Collins, Raymond W. Klecker, 

Lawrence Anderson (FDA) 

U.S. Provisional Application No. 60/ 

155,061 filed 21 Sep 1999 (HHS 

Reference No. E–263–1998/0–US–01); 

U.S. Patent Application Nos. 10/ 

088,561 filed 19 Mar 2002 (HHS 

Reference No. E–263–1998/0–US–03) 

and 10/319,812 filed 16 Dec 2002 

(HHS Reference No. E–263–1998/1–

US–01) are pending. 

Licensing Contact: Michael Shmilovich; 

(301) 435–5019; 

shmilovm@mail.nih.gov. 

Available for licensing and 

commercial development is a method 

for using positron-emitting compounds 

to label taxane type drugs. This 

invention also describes methods of 

synthesizing these taxane type 

compounds. Further, methods to guide 

treatment of solid tumors, with labeled 

taxanes, are also disclosed in the 

present application. Advantages of 

using this technology include: (1) 

Avoidance of exposing patients to toxic 

drugs that have no potential for benefit; 

(2) ability to rapidly determine whether 

a given tumor will be likely to respond 

to a particular drug; and (3) the ability 

to monitor the impact of various 

dosages, schedules, and modulators for 

delivery, in situ, at the actual tumor 

under treatment conditions. 

Additional information may be found 

in: Ravert et al., ‘‘Radiosynthesis of 

[ 11C]paclitaxel,’’ J Label Compd and 

Radiopharm, 2002, 45(6):471–477. 

Dated: September 15, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 05–19173 Filed 9–26–05; 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 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 Cancer 

Institute Special Emphasis Panel, Small 

Grants Program for Cancer Epidemiology and 

Cancer Research Small Grant Program. 

Date: November 8–10, 2005. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel & Executive 

Meeting Center, 1750 Rockville Pike, 

Regency Meeting Room, Rockville, MD 

20852. 

Contact Person: Mary Jane Slesinski, PhD, 

Scientific Review Administrator, Special 

Review and Resources Branch, DEA/NCI/ 

NIH, 6116 Executive Boulevard, Room 8045, 

Bethesda, MD 20892, 301/594–1566, 

slesinsm@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: September 16, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–19178 Filed 9–26–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

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 meeting of the 

President’s Cancer Panel. 

The meeting will be open to the pubic 

as indicated below, with attendance 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

Contact Person listed below in advance 

of the meeting. 

Name of Committee: President’s Cancer 

Panel. 

Date: October 24, 2005. 

Open: October 24, 2005, 8 a.m. to 5 p.m. 

Agenda: Strategic Planning-Translating 

Research Team Science/Clinical Research/ 

Infrastructure Needs. 

Place: Hotel Washington, 15th and 

Pennsylvania Ave., NW., Washington, DC 

20004. 

Contact Person: Abby Sandler, PhD, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 

Building 6116, Room 212, 6116 Executive 

Boulevard, Bethesda, MD 20892, 301–451–

9399. 

Any interested person may file written 

comments with the committee by forwarding 

the comments to the Contact Person listed on 

this notice. The comments should include 

the name, address, telephone number and, 

when applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

deainfo.nci.nih.gov/advisory/pcp/pcp.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(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: September 16, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–19179 Filed 9–26–05; 8:45am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

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 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, Clinical 

Trial Data Collection Using Handheld 

Technology. 

Date: October 12, 2005.