Government-Owned Inventions; Availability for Licensing, 32126-32128 [E7-11195]
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32126
Federal Register / Vol. 72, No. 111 / Monday, June 11, 2007 / Notices
the HRSA Web site at https://
www.hrsa.gov/grants, or through
Grants.gov at: https://www.grants.gov. In
FY 2007, up to 120 New Access Points
in High Poverty Counties are estimated
to be funded. HRSA anticipates
awarding a minimum of $24 million for
this activity in FY 2007 and
applications were due May 23, 2007.
Subject to the availability of funds, up
to 25 Planning Grants in High Poverty
Counties will be funded, with
applications that were due May 16,
2007. All applications were to be
submitted electronically through
Grants.gov by the established due dates.
Summary of the Funding Priority
A funding priority is defined as the
favorable adjustment of combined
review scores of individually approved
applications when applications meet
specified criteria. An adjustment is
made by a set, pre-determined number
of points. The New Access Point in High
Poverty Counties funding opportunity
has one funding priority of five (5)
points for ‘‘Multi-County Applications.’’
In order to be considered for this
funding priority, applicants must
demonstrate that a minimum of 15
percent of the total target population
will come from a county(ies) other than
the eligible high poverty county in
which the new access point will be
located. Applicants requesting
consideration of a funding priority must
initiate the request and provide the
expected distribution of the target
population among the counties to be
served by the high poverty county new
access point project.
FOR FURTHER INFORMATION CONTACT:
Preeti Kanodia, Division of Policy and
Development, Bureau of Primary Health
Care, Health Resources and Services
Administration. Ms. Kanodia may be
contacted by e-mail at
PKanodia@hrsa.gov or via telephone at
(301) 594–4300.
Dated: June 5, 2007.
Elizabeth M. Duke,
Administrator.
rmajette on DSK8KYBLC1PROD with MISCELLANEOUS
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Healthcare Integrity and Protection
Data Bank: Announcement of
Proactive Disclosure Service Opening
Date and User Fees
Office of Inspector General
(OIG), HHS.
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Notice.
SUMMARY: The Office of Inspector
General (OIG) is announcing the
availability of a Proactive Disclosure
Service (PDS) Prototype for customers of
the Healthcare Integrity and Protection
Data Bank (HIPDB). The PDS was
developed for the National Practitioner
Data Bank (NPDB) in response to
customers’ interest in real-time
monitoring of practitioner credentials.
As a result of the technical
interoperability of the NPDB and
HIPDB, the PDS feature is also being
made available to HIPDB customers.
DATES: This fee will be effective June 11,
2007.
FOR FURTHER INFORMATION CONTACT: Joel
Schaer, OIG Office of External Affairs,
(202) 619–0089, or Mark Pincus, HRSA,
Bureau of Health Professions, (301) 443–
2300.
SUPPLEMENTARY INFORMATION: The PDS
has been initially offered as a prototype
to authorized NPDB entities, as set forth
in a HRSA notice published in the
Federal Register on March 7, 2007 (72
FR 10227). In accordance with
implementation of the PDS prototype,
authorized HIPDB customers can also
now choose to enroll all of their
practitioners, providers, and suppliers
in PDS, or enroll some of their
practitioners, providers, and suppliers
while continuing to periodically query
on others using the regular query
methods. Customers with PDS-enrolled
subjects will be notified within one
business day of the HIPDB’s receipt of
a report on any of their enrollees. While
customers can expect to receive reports
sooner with PDS, the format of and
information contained in a report will
remain the same.
The annual subscription fee during
the prototype period will be $3.25 per
practitioner, provider, or supplier. The
rate is subject to change after the
prototype period is complete. The query
fee for periodic queries will continue to
remain at $4.75 per name.
PDS Enrollment Availability
[FR Doc. E7–11220 Filed 6–8–07; 8:45 am]
AGENCY:
ACTION:
The PDS prototype became available
to NPDB queries effective April 30,
2007. An invitation to participate in this
prototype was extended first to
organizations that assisted HRSA with
designing and pricing, which occurred
between 2003 and 2005. All entities
registered with the HIPDB and/or the
NPDB have been invited to participate
to meet a predetermined number for
subjects to be monitored. Once this
number is achieved, enrollment in the
prototype will close. It is anticipated
that the PDS prototype period will last
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approximately 18 to 24 months before it
is opened to all authorized Data Bank
entities.
User Fee Amount
An annual subscription fee of $3.25
per subject will be charged upon
enrollment. This fee includes the cost of
an initial query, which automatically
will be incurred when a subject is first
enrolled, and all reports received on the
enrolled subject over the course of the
one-year subscription period. The fee
was determined through economic
analysis of the average annual rate of
queries performed by health care
entities in relationship to the current
query fee that is based on the actual cost
for services. The Department will accept
payment for the subscription fee from
entities via credit card or electronic
funds transfer. When the prototype
period concludes, the Department may
change the subscription fee. Any
changes will be announced through
notice in the Federal Register.
Dated: May 14, 2007.
Daniel R. Levinson,
Inspector General.
[FR Doc. E7–11207 Filed 6–8–07; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
E:\ERIC\11JNN1.SGM
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Federal Register / Vol. 72, No. 111 / Monday, June 11, 2007 / Notices
A Sensitive, High Throughput
Pseudovirus-Based Papillomavirus
Neutralization Assay for HPV 16 and
HPV 18
Description of Technology: This
invention is a research tool for
measuring protective antibody
responses against Human Papilloma
Viruses (HPV). Sensitive highthroughput neutralization assays, based
upon pseudoviruses carrying a secreted
alkaline phosphatase (SEAP) reporter
gene, were developed and validated by
the inventors for HPV 16, HPV 18, and
bovine papillomavirus 1 (BPV1). In a
96-well plate format, the assay was
reproducible and appears to be as
sensitive as, but more type-specific
than, a standard papillomavirus-like
particle (VLP)-based enzyme-linked
immunosorbent assay (ELISA). The
SEAP pseudovirus-based neutralization
assay should be a practical method for
quantifying potentially protective
antibody responses in HPV natural
history and prophylactic vaccine
studies.
Inventors: John T. Schiller (NCI),
Douglas R. Lowy (NCI), Christopher
Buck (NCI), Diana V. Pastrana (NCI), et
al.
Publication: The assay is further
described in Pastrana et al., ‘‘Reactivity
of human sera in a sensitive, highthroughput pseudovirus-based
papillomavirus neutralization assay for
HPV16 and HPV18,’’ Virology. 2004 Apr
10;321(2):205–216.
Patent Status: HHS Reference No. E–
137–2004/0—Research Material.
Licensing Status: This assay is
available nonexclusively through a
biological materials license.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
rmajette on DSK8KYBLC1PROD with MISCELLANEOUS
Development of a Novel High
Throughput Assay To Measure CellInfection With Vaccinia Strains
Expressing Reporter Genes
Description of Technology: Critical to
developing a vaccine against viral
infections is an assay to measure the
neutralizing antibody present in blood
of vaccine recipients. The currently
available tests are labor intensive and
require 5–6 days to complete. The
inventors have designed a high
throughput vaccinia neutralization
assay, which offers several advantages
over the assays that are currently used.
It is completed in as little as 24 hours,
it is sensitive, highly reproducible,
requires only 50 µl of plasma and uses
automated readout. This assay is based
on the use of recombinant vaccinia virus
(vSC56) expressing a bacterial gene
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coding for the enzyme b-galactosidase
(b-Gal) under the control of a synthetic
early/late promotor. Another
recombinant virus expressing an
inducible reporter gene (Luciferase) is
also being tested in neutralization assay.
These assays may be of value in the
clinical trials of new smallpox vaccines,
for evaluations of new vaccinia
immunoglobulin (VIG) and anti-viral
agents under development. The
technology itself may be adapted for
construction of neutralization assays for
other viruses and intracellular
pathogens.
Inventor: Hana Golding (FDA).
Publications:
1. J Manischewitz et al. Development
of a novel vaccinia-neutralization assay
based on reporter-gene expression. J
Infect Dis. 2003 Aug 1;188(3):440–448.
2. Y Edghill-Smith et al. Modeling a
safer smallpox vaccination regimen, for
human immunodeficiency virus type 1infected patients, in
immunocompromised macques. J Infect
Dis. 2003 Oct 15;188(8):1181–1191.
3. JC Goldsmith et al. Intravenous
immunoglobulin products contain
neutralizing antibodies to vaccinia. Vox
Sang. 2004 Feb;86(2):125–129.
4. Y Edghill-Smith et al. Smallpox
vaccine does not protect macaques with
AIDS from a lethal monkeypox virus
challenge. J Infect Dis. 2005 Feb
1;191(3):372–381.
5. Y Edghill-Smith et al. Smallpox
vaccine-induced antibodies are
necessary and sufficient for protection
against monkeypox virus. Nat Med.
2005 Jul;11(7):740–747.
6. CA Meseda et al. Enhanced
immunogenicity and protective effect
conferred by vaccination with
combinations of modified vaccinia
Ankara and licensed smallpox vaccine
Dryvax in a mouse model. Virology.
2005 Sep 1;339(2):164–175.
7. KH Waibel et al. Clinical and
immunological comparison of smallpox
vaccination administered to the outer
versus the inner upper arms of vaccinia¨
naıve adults. Clin Infect Dis. 2006 Feb
15;42(4):e16–20.
8. JM Heraud et al. Subunit
recombinant vaccine protects against
monkeypox . J.Immunol. 2006 Aug
15;177(4):2552–2564.
9. VL Kan et al. Durable neutralizing
antibodies after remote smallpox
vaccination among adults with and
without HIV infection. AIDS. 2007 Feb
19;21(4):521–524.
Patent Status: U.S. Provisional Patent
Application 60/429,767 filed 27 Nov
2002 (HHS Reference No. E–300–2002/
0–US–01); PCT Application No. PCT/
US03/37677 filed 24 Nov 2003, which
published as WO 2004/053454 on 24
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32127
Jun 2004 (HHS Reference No. E–300–
2002/0–PCT–02); U.S. Patent
Application No. 10/536,860 filed 06 Jan
2006 (HHS Reference No. E–300–2002/
0–US–05).
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The CBER/FDA Laboratory of Retrovirus
Research is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop or evaluate novel antivaccinia agents including monoclonal
antibodies and vaccines. Please contact
Hana Golding at Tel: 301–827–0784 or
E-mail: hana.golding@fda.hhs.gov for
more information.
Vectors for Delivering Viral and
Oncogenic Inhibitors
Description of Technology: The
invention concerns cell transduction
vectors which are capable of inhibiting
viral replication in cells transduced
with these vectors, and which also are
capable of inhibiting the growth of
cancer cells. Specifically, these
expressions vectors produce protective
genes which interfere with viral
replication. These genes are tightly
regulated by HIV–1 Tat and Rev
proteins, which if produced after
infection can induce expression of the
protective genes. The vectors contain
either a single gene (delta-gag), or a
combination of two different genes
(delta-gag and RNAse) which interfere
with HIV–1 replication at different
stages of the HIV–1 life cycle. Following
transduction of target cells, the mRNA
for the protective genes is incorporated
into the newly budding virion along
with the viral genomic mRNA.
Following infection of neighboring cells,
the mRNA for the protective gene can be
reverse transcribed and integrated into
these cells, thereby increasing the
proportion of cells containing the
protective gene.
In providing protection against viral
replication, the vectors embodied in this
invention could be used in gene therapy
against HIV and against other viral
diseases. In addition, the vectors could
be used for introducing specific genes
into neoplastic cells and thereby be
effective in treating cancer and other
diseases.
Inventors: Susanna M. Rybak, Andrea
Cara, Gabriella L. Gusella, Dianne L.
Newton (NCI).
Patent Status: U.S. Patent No.
6,953,687 issued 11 Oct 2005 (HHS
Reference No. E–117–1996/0–US–07);
U.S. Patent Application No. 11/043,858
filed 24 Jan 2005 (HHS Reference No. E–
117–1996/0–US–08).
E:\ERIC\11JNN1.SGM
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32128
Federal Register / Vol. 72, No. 111 / Monday, June 11, 2007 / Notices
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Dated: June 4, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–11195 Filed 6–8–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meetings
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Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of meetings of the
National Cancer Institute Board of
Scientific Advisors.
The meetings will be open to the
public, 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: National Cancer
Institute Board of Scientific Advisors;
TARGET Ad Hoc Subcommittee Meeting.
Date: June 27, 2007.
Time: 7 p.m. to 9: 30 p.m.
Agenda: To discuss activities related to the
BSA TARGET Ad Hoc Subcommittee.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, Md 20814.
Contact Person: Malcolm M. Smith, PhD,
MD, Executive Secretary, Associate Branch
Chief, Pediatric Section, Clinical
Investigation Branch, Clinical Therapy
Evaluation Program, NCI, 6130 Executive
Blvd, EPN, 7th Floor, Rm. 7025, Bethesda,
MD 20852, 301–496–2522,
smithm@ctep.nci.nih.gov.
Name of Committee: National Cancer
Institute Board of Scientific Advisors.
Date: June 28–29, 2007.
Time: June 28, 2007, 8 a.m. to 6 p.m.
Agenda: Director’s Report: Ongoing and
New Business; Reports of Program Review,
Group(s); and Budget Presentation; Reports of
Special Initiatives; RFA and RFP Concept
Reviews; and Scientific Presentations.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Time: June 29, 2007, 8:30 a.m. to 1 p.m.
Agenda: Reports of Special Initiatives; RFA
and RFP Concept Reviews; and Scientific
Presentations.
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Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Contact Person: Paulette S. Gray, PhD,
Executive Secretary, Director, Division of
Extramural Activities, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Rm. 8001,
301–496–5147, grayp@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID. driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
deainfo.nci.nih.gov/advisory/bsa.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: June 1, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–2873 Filed 6–8–07; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; 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
meetings.
The meetings 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 concerning individuals
associated with the grant applications,
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the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcholism Special
Emphasis Panel, Epigenetic Mechanisms in
the Neurobiology of Alcohol Tolerance and
Dependence. (RFA–AA–07–011 & AA–07–
012).
Date: July 16, 2007.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892.
(Telephone Conference Call).
Contact Person: Beata Buzas, PhD,
Scientific Review Administrator, National
Institutes on Alcohol Abuse and Alcoholism,
National Institutes of Health, 5635 Fishers
Lane, RM 3041, Rockville, MD 20852, 301–
443–0800, bbuzas@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants,
National Institutes of Health, HHS)
Dated: June 1, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–2872 Filed 6–8–07; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
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
Deafness and Other Communication
Disorders Special Emphasis Panel; Chemical
Senses.
Date: June 27, 2007.
Time: 12 p.m. to 1:30 p.m.
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]]>Agencies
[Federal Register Volume 72, Number 111 (Monday, June 11, 2007)]
[Notices]
[Pages 32126-32128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11195]
-----------------------------------------------------------------------
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.
[[Page 32127]]
A Sensitive, High Throughput Pseudovirus-Based Papillomavirus
Neutralization Assay for HPV 16 and HPV 18
Description of Technology: This invention is a research tool for
measuring protective antibody responses against Human Papilloma Viruses
(HPV). Sensitive high-throughput neutralization assays, based upon
pseudoviruses carrying a secreted alkaline phosphatase (SEAP) reporter
gene, were developed and validated by the inventors for HPV 16, HPV 18,
and bovine papillomavirus 1 (BPV1). In a 96-well plate format, the
assay was reproducible and appears to be as sensitive as, but more
type-specific than, a standard papillomavirus-like particle (VLP)-based
enzyme-linked immunosorbent assay (ELISA). The SEAP pseudovirus-based
neutralization assay should be a practical method for quantifying
potentially protective antibody responses in HPV natural history and
prophylactic vaccine studies.
Inventors: John T. Schiller (NCI), Douglas R. Lowy (NCI),
Christopher Buck (NCI), Diana V. Pastrana (NCI), et al.
Publication: The assay is further described in Pastrana et al.,
``Reactivity of human sera in a sensitive, high-throughput pseudovirus-
based papillomavirus neutralization assay for HPV16 and HPV18,''
Virology. 2004 Apr 10;321(2):205-216.
Patent Status: HHS Reference No. E-137-2004/0--Research Material.
Licensing Status: This assay is available nonexclusively through a
biological materials license.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Development of a Novel High Throughput Assay To Measure Cell-Infection
With Vaccinia Strains Expressing Reporter Genes
Description of Technology: Critical to developing a vaccine against
viral infections is an assay to measure the neutralizing antibody
present in blood of vaccine recipients. The currently available tests
are labor intensive and require 5-6 days to complete. The inventors
have designed a high throughput vaccinia neutralization assay, which
offers several advantages over the assays that are currently used. It
is completed in as little as 24 hours, it is sensitive, highly
reproducible, requires only 50 [mu]l of plasma and uses automated
readout. This assay is based on the use of recombinant vaccinia virus
(vSC56) expressing a bacterial gene coding for the enzyme b-
galactosidase (b-Gal) under the control of a synthetic early/late
promotor. Another recombinant virus expressing an inducible reporter
gene (Luciferase) is also being tested in neutralization assay. These
assays may be of value in the clinical trials of new smallpox vaccines,
for evaluations of new vaccinia immunoglobulin (VIG) and anti-viral
agents under development. The technology itself may be adapted for
construction of neutralization assays for other viruses and
intracellular pathogens.
Inventor: Hana Golding (FDA).
Publications:
1. J Manischewitz et al. Development of a novel vaccinia-
neutralization assay based on reporter-gene expression. J Infect Dis.
2003 Aug 1;188(3):440-448.
2. Y Edghill-Smith et al. Modeling a safer smallpox vaccination
regimen, for human immunodeficiency virus type 1-infected patients, in
immunocompromised macques. J Infect Dis. 2003 Oct 15;188(8):1181-1191.
3. JC Goldsmith et al. Intravenous immunoglobulin products contain
neutralizing antibodies to vaccinia. Vox Sang. 2004 Feb;86(2):125-129.
4. Y Edghill-Smith et al. Smallpox vaccine does not protect
macaques with AIDS from a lethal monkeypox virus challenge. J Infect
Dis. 2005 Feb 1;191(3):372-381.
5. Y Edghill-Smith et al. Smallpox vaccine-induced antibodies are
necessary and sufficient for protection against monkeypox virus. Nat
Med. 2005 Jul;11(7):740-747.
6. CA Meseda et al. Enhanced immunogenicity and protective effect
conferred by vaccination with combinations of modified vaccinia Ankara
and licensed smallpox vaccine Dryvax in a mouse model. Virology. 2005
Sep 1;339(2):164-175.
7. KH Waibel et al. Clinical and immunological comparison of
smallpox vaccination administered to the outer versus the inner upper
arms of vaccinia-na[iuml]ve adults. Clin Infect Dis. 2006 Feb
15;42(4):e16-20.
8. JM Heraud et al. Subunit recombinant vaccine protects against
monkeypox . J.Immunol. 2006 Aug 15;177(4):2552-2564.
9. VL Kan et al. Durable neutralizing antibodies after remote
smallpox vaccination among adults with and without HIV infection. AIDS.
2007 Feb 19;21(4):521-524.
Patent Status: U.S. Provisional Patent Application 60/429,767 filed
27 Nov 2002 (HHS Reference No. E-300-2002/0-US-01); PCT Application No.
PCT/US03/37677 filed 24 Nov 2003, which published as WO 2004/053454 on
24 Jun 2004 (HHS Reference No. E-300-2002/0-PCT-02); U.S. Patent
Application No. 10/536,860 filed 06 Jan 2006 (HHS Reference No. E-300-
2002/0-US-05).
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity: The CBER/FDA Laboratory of
Retrovirus Research is seeking statements of capability or interest
from parties interested in collaborative research to further develop or
evaluate novel anti-vaccinia agents including monoclonal antibodies and
vaccines. Please contact Hana Golding at Tel: 301-827-0784 or E-mail:
hana.golding@fda.hhs.gov for more information.
Vectors for Delivering Viral and Oncogenic Inhibitors
Description of Technology: The invention concerns cell transduction
vectors which are capable of inhibiting viral replication in cells
transduced with these vectors, and which also are capable of inhibiting
the growth of cancer cells. Specifically, these expressions vectors
produce protective genes which interfere with viral replication. These
genes are tightly regulated by HIV-1 Tat and Rev proteins, which if
produced after infection can induce expression of the protective genes.
The vectors contain either a single gene (delta-gag), or a combination
of two different genes (delta-gag and RNAse) which interfere with HIV-1
replication at different stages of the HIV-1 life cycle. Following
transduction of target cells, the mRNA for the protective genes is
incorporated into the newly budding virion along with the viral genomic
mRNA. Following infection of neighboring cells, the mRNA for the
protective gene can be reverse transcribed and integrated into these
cells, thereby increasing the proportion of cells containing the
protective gene.
In providing protection against viral replication, the vectors
embodied in this invention could be used in gene therapy against HIV
and against other viral diseases. In addition, the vectors could be
used for introducing specific genes into neoplastic cells and thereby
be effective in treating cancer and other diseases.
Inventors: Susanna M. Rybak, Andrea Cara, Gabriella L. Gusella,
Dianne L. Newton (NCI).
Patent Status: U.S. Patent No. 6,953,687 issued 11 Oct 2005 (HHS
Reference No. E-117-1996/0-US-07); U.S. Patent Application No. 11/
043,858 filed 24 Jan 2005 (HHS Reference No. E-117-1996/0-US-08).
[[Page 32128]]
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Dated: June 4, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-11195 Filed 6-8-07; 8:45 am]
BILLING CODE 4140-01-P
