Prospective Grant of Exclusive License: Field of Use: Development of a Live Microbicide for Preventing Sexual Transmission of HIV, 7048-7049 [E7-2486]
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7048
Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices
The authorizing statute is Section 330 of
the Public Health Service Act, as
amended.
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Send comments to Susan G. Queen,
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Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: February 2, 2007.
Caroline Lewis,
Acting Associate Administrator for
Administration and Financial Management.
[FR Doc. E7–2553 Filed 2–13–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Field of Use: Development of
a Live Microbicide for Preventing
Sexual Transmission of HIV
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
ycherry on PROD1PC64 with PRELIMS
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c) (1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
license to practice the invention
embodied in:
(1) U.S. Patent No. 5,821,081, filed
April 26, 1996, issued Oct. 13, 1998,
entitled ‘‘Nucleic Acids Encoding
Antiviral Proteins and Peptides, Vectors
and Host Cells Comprising Same, and
Methods of Producing the Antiviral
Proteins and Peptides’’ (E–117–1995/1–
US–01) (Inventors: Michael R. Boyd,
Kirk R. Gustafson, Robert H. Shoemaker,
and James B. McMahon) (NCI);
(2) U.S. Patent No. 5,843,882, filed
April 27, 1995, issued Dec. 01, 1998,
entitled ‘‘Antiviral Proteins and
Peptides, DNA, DNA-coding Sequences
Therefore, and Uses thereof ‘‘ (E–117–
1995/0–US–01) (Inventors: Michael R.
Boyd, Kirk R. Gustafson, Robert H.
Shoemaker, and James B. McMahon)
(NCI);
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17:27 Feb 13, 2007
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1,002
234
1,002
Responses
per
respondent
Frm 00043
Fmt 4703
Total
responses
1
1
........................
(3) U.S. Patent No. 5,998,587, filed
Nov. 13, 1997, issued Dec. 7, 1999,
entitled ‘‘Anti-cyanovirin Antibody’’ (E–
117–1995/1–US–02) (Inventors: Michael
R. Boyd, Kirk R. Gustafson, Robert H.
Shoemaker, and James B. McMahon)
(NCI);
(4) U.S. Patent No. 6,015,876, filed
Oct. 27, 1999, issued Jan. 18, 2000,
entitled ‘‘Method of Using Cyanovirins’’
(E–117–1995/0–US–02) (Inventor:
Michael R. Boyd, Kirk R. Gustafson,
Robert H. Shoemaker, and James B.
McMahon) (NCI);
(5) U.S. Patent No. 6,780,847, filed
March 22, 2001, issued August 24, 2004,
entitled ‘‘Glycosylation-Resistant
Cyanovirins and Related Conjugates,
Compositions, Nucleic Acids, Vectors,
Host Cells, Methods of Production and
Methods of Using Nonglycosylated
Cyanovirins’’ (E–074–1999/3–US–01)
(Inventors: Michael R. Boyd, Barry
O’Keefe, Toshiyuki Mori (NCI) and
Angela Gronenborn (NIDDK));
(6) U.S. Patent No. 7,048,935, filed
July 1, 2002, issued May 23, 2006,
entitled ‘‘Cyanovirin Conjugates and
Matrix-Anchored Cyanovirin and
Related Compositions and Methods of
Use’’ (E–074–1999/1–US–03) (Inventor:
Michael R. Boyd (NCI);
(7) U.S. Patent No. 7,105,169, filed
September 12, 2001, issued September
12, 2006, entitled ‘‘Cyanovirins
Conjugates and Matrix-Anchored
Cyanovirins and Methods of Use’’ (E–
074–1999/1–US–02) (Inventor: Michael
R. Boyd (NCI);
(8) U.S. Patent No. 6,743,577, filed
October 27, 1999, issued June 1, 2004,
entitled ‘‘ Methods of Using Cyanovirins
to Inhibit Viral Infection’’ (E–074–1999/
0–US–03) (Inventor: Michael R. Boyd
(NCI);
(9) U.S. Patent No. 6,420,336, filed
October 27, 1999, issued July 16, 2002,
entitled ‘‘Methods Of Using Cyanovirins
Topically To Inhibit Viral Infection’’ (E–
074–1999/3–US–01) (Inventor: Michael
R. Boyd (NCI)
to Osel, Inc. (Hereafter Osel), having a
place of business in Santa Clara of
California. The patent rights in these
PO 00000
appropriate for monitoring and
evaluating performance and reporting
on annual trends.
Estimates of annualized reporting
burden are as follows:
Sfmt 4703
1002
234
1,326
Hours per
responses
Total burden
hours
27
18
........................
27,054
4,212
31,266
inventions have been assigned to the
United States of America.
Only written comments and/or
application for a license, which are
received by the NIH Office of
Technology Transfer on or before April
16, 2007 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Sally Hu, Ph.D., M.B.A., Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
E-mail: hus@od.nih.gov; Telephone:
(301) 435–5606; Facsimile: (301) 402–
0220.
DATES:
The
prospective exclusive license will be
royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within 60 days from the date of this
published Notice, NIH receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR 404.7.
Cyanovirin-N (CV-N) is a novel,
naturally occurring anti-HIV protein
that was originally isolated from Nastoc
ellipipsosporum, a blue-green algae.
Cyanovirin is a protein with potent
neutralizing activity against HIV1 and 2
by blocking the fusion reaction between
HIV and CD4 target cells. Cyanorvirin is
in the pre-IND development phase with
several animal toxicology and irritation
studies completed; initial chemical
purification processes developed; and
no human data to date. Dr. Boyd and his
colleagues have demonstrated that a
simple aqueous gel formulation of CVN completely protected macaques
against intravaginally or intarectally
transmitted SHIV 89–9P (a chimeric
simian/human immunodeficiency virus
that causes ‘‘AIDS’’ in simians). Also
importantly, there was no indication of
any toxicity or other adverse effects of
the CV-N to the macaques in these
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14FEN1.SGM
14FEN1
Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices
preclinical microbicide evaluation
studies. CV-N has the potential to
become a microbicide useful in
preventing sexual transmission of HIV.
An effective anti-HIV microbicide could
slow down the spread of the virus in the
population, especially in the developing
world, before an effective vaccine is
available.
The field of use may be limited to the
topical use of commensal bacteria that
express cyanovirin-N.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: February 2, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–2486 Filed 2–13–07; 8:45 am]
BILLING CODE 4140–01–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.
AGENCY:
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.
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.
ycherry on PROD1PC64 with PRELIMS
ADDRESSES:
VerDate Aug<31>2005
17:27 Feb 13, 2007
Jkt 211001
Integrase Inhibitors for the Treatment
of Retroviral Infection Including
Human Immunodeficiency Virus-1
Description of Technology: Available
for licensing and commercial
development are stilbenedisulfonic acid
derivatives for treatment of human
immunodeficiency virus-1 (HIV–1) and
other retroviral infections. Current HIV–
1 therapeutic treatments target the viral
protease and reverse transcriptase
enzymes, which are essential for
retroviral infection. However, these
drugs often have limitations due to drug
resistant variants, which render drugs
ineffective. Additionally, such drugs are
often toxic when administered in
combination therapies. Thus, efficacious
inhibitors of retroviral infection that are
devoid of toxicity are presently needed.
The subject invention describes
stilbenedisulfonic acid derivatives,
which target the integrase enzyme of
retroviruses. Similar to protease and
reverse transcriptase activity, integrase
function is essential for retroviral
infection. Integrase catalyzes integration
of reverse transcribed viral DNA into a
host cell’s genome. For this reason,
integrase is considered a rational
therapeutic target for HIV–1 infection.
Further, integrase is a favorable target
because the enzyme has no human
cellular counterpart, which could
interact with a potential integrase
inhibitor and cause harmful side effects.
Recent clinical data with an integrase
inhibitor from Merck shows impressive
clinical activity. The Merck compound
is different from the current invention
and is projected for FDA approval mid
2007. Thus, the subject invention is
valuable for safe and effective treatment
of HIV–1 and other retroviral infections.
Application: Treatment of HIV
infection.
Development Status: The technology
is ready for use in drug discovery and
development.
Inventors: Yves Pommier (NCI), Elena
Semenova (NCI), Christophe Marchand
(NCI).
Patent Status: U.S. Provisional
Application No. 60/849,718 filed 04 Oct
2006 (HHS Reference No. E–264–2006/
0-US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Sally Hu, Ph.D.;
301/435–5606; HuS@mail.nih.gov.
Broadly Cross-Reactive Neutralizing
Antibodies Against Human
Immunodeficiency Virus Selected by
ENV-CD4-CO-Receptor Complexes
Description of Technology: This
invention provides a novel anti-HIV
human monoclonal antibody named X5.
PO 00000
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7049
This antibody demonstrates promise
over conventional anti-HIV antibodies
because the X5 antibody exhibits a
unique binding activity compared to its
counterparts. It has been established
that the initial stage of HIV–1 entry into
cells is mediated by a complex between
the viral envelope glycoprotein (Env)
such as gp120-gp41, a receptor CD4 and
a co-receptor CCR5. The X5 antibody
binds to an epitope on gp120 that is
induced by interaction between gp120
and the receptor CD4 and enhanced by
the co-receptor CCR5. The X5 antibody
also shows strong activity at very low
levels (in the range from 0.0001–0.1 Mg/
ml concentration is dependent on the
isolate). Because it is a human antibody,
it can be administered directly into
patients so that it is an ideal candidate
for clinical trials. It also can be easily
produced because it was obtained by
screening of phage display libraries and
its sequence is known. Finally, since it
has neutralized all virus envelope
glycoproteins, including those from
primary isolates of different clades, the
epitope is highly conserved and
resistance is unlikely to develop.
Therefore, this antibody and/or its
derivatives including fusion proteins
with CD4 are good candidates for
clinical development.
Additional information on the current
research in Dr. Dimitrov’s laboratory
may be found at https://wwwlecb.ncifcrf.gov/dimitrov/dimitrov.html.
Applications: Antibody for HIV
research, diagnostics and therapeutic
development.
Development Status: Preclinical data
is available at this time.
Inventors: Dimiter Dimitrov (NCI),
Xiadong Xiao (NCI), Yuuei Shu (NCI),
Sanjay Phogat (NIAID), et al.
Patent Status: Patent Cooperation
Treaty Serial No. PCT/US02/33165 filed
16 Oct 2002; National Stage Filing in
United States, India, Canada, Australia,
Europe (HHS Reference No. E–130–
2001/0).
Availability: Available for licensing
and commercial development,
excluding the field of use of the
development of the PEGylated X5,
PEGylated X5 derivatives, mutants of
PEGylated X5 or a derivative.
Licensing Contact: Sally Hu, Ph.D.;
301/435–5606; HuS@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Center for Cancer Research
Nanobiology Program (CCRNP) is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
antibodies for HIV research, diagnostics
and therapeutic development. Please
contact John D. Hewes, Ph.D. at (301)
E:\FR\FM\14FEN1.SGM
14FEN1
]]>Agencies
[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7048-7049]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2486]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Field of Use: Development
of a Live Microbicide for Preventing Sexual Transmission of HIV
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c) (1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive license to practice the invention embodied in:
(1) U.S. Patent No. 5,821,081, filed April 26, 1996, issued Oct.
13, 1998, entitled ``Nucleic Acids Encoding Antiviral Proteins and
Peptides, Vectors and Host Cells Comprising Same, and Methods of
Producing the Antiviral Proteins and Peptides'' (E-117-1995/1-US-01)
(Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker,
and James B. McMahon) (NCI);
(2) U.S. Patent No. 5,843,882, filed April 27, 1995, issued Dec.
01, 1998, entitled ``Antiviral Proteins and Peptides, DNA, DNA-coding
Sequences Therefore, and Uses thereof `` (E-117-1995/0-US-01)
(Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker,
and James B. McMahon) (NCI);
(3) U.S. Patent No. 5,998,587, filed Nov. 13, 1997, issued Dec. 7,
1999, entitled ``Anti-cyanovirin Antibody'' (E-117-1995/1-US-02)
(Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker,
and James B. McMahon) (NCI);
(4) U.S. Patent No. 6,015,876, filed Oct. 27, 1999, issued Jan. 18,
2000, entitled ``Method of Using Cyanovirins'' (E-117-1995/0-US-02)
(Inventor: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and
James B. McMahon) (NCI);
(5) U.S. Patent No. 6,780,847, filed March 22, 2001, issued August
24, 2004, entitled ``Glycosylation-Resistant Cyanovirins and Related
Conjugates, Compositions, Nucleic Acids, Vectors, Host Cells, Methods
of Production and Methods of Using Nonglycosylated Cyanovirins'' (E-
074-1999/3-US-01) (Inventors: Michael R. Boyd, Barry O'Keefe, Toshiyuki
Mori (NCI) and Angela Gronenborn (NIDDK));
(6) U.S. Patent No. 7,048,935, filed July 1, 2002, issued May 23,
2006, entitled ``Cyanovirin Conjugates and Matrix-Anchored Cyanovirin
and Related Compositions and Methods of Use'' (E-074-1999/1-US-03)
(Inventor: Michael R. Boyd (NCI);
(7) U.S. Patent No. 7,105,169, filed September 12, 2001, issued
September 12, 2006, entitled ``Cyanovirins Conjugates and Matrix-
Anchored Cyanovirins and Methods of Use'' (E-074-1999/1-US-02)
(Inventor: Michael R. Boyd (NCI);
(8) U.S. Patent No. 6,743,577, filed October 27, 1999, issued June
1, 2004, entitled `` Methods of Using Cyanovirins to Inhibit Viral
Infection'' (E-074-1999/0-US-03) (Inventor: Michael R. Boyd (NCI);
(9) U.S. Patent No. 6,420,336, filed October 27, 1999, issued July
16, 2002, entitled ``Methods Of Using Cyanovirins Topically To Inhibit
Viral Infection'' (E-074-1999/3-US-01) (Inventor: Michael R. Boyd (NCI)
to Osel, Inc. (Hereafter Osel), having a place of business in Santa
Clara of California. The patent rights in these inventions have been
assigned to the United States of America.
DATES: Only written comments and/or application for a license, which
are received by the NIH Office of Technology Transfer on or before
April 16, 2007 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Sally Hu, Ph.D., M.B.A., Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804; E-mail: hus@od.nih.gov; Telephone:
(301) 435-5606; Facsimile: (301) 402-0220.
SUPPLEMENTARY INFORMATION: The prospective exclusive license will be
royalty bearing and will comply with the terms and conditions of 35
U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be
granted unless, within 60 days from the date of this published Notice,
NIH receives written evidence and argument that establishes that the
grant of the license would not be consistent with the requirements of
35 U.S.C. 209 and 37 CFR 404.7.
Cyanovirin-N (CV-N) is a novel, naturally occurring anti-HIV
protein that was originally isolated from Nastoc ellipipsosporum, a
blue-green algae. Cyanovirin is a protein with potent neutralizing
activity against HIV1 and 2 by blocking the fusion reaction between HIV
and CD4 target cells. Cyanorvirin is in the pre-IND development phase
with several animal toxicology and irritation studies completed;
initial chemical purification processes developed; and no human data to
date. Dr. Boyd and his colleagues have demonstrated that a simple
aqueous gel formulation of CV-N completely protected macaques against
intravaginally or intarectally transmitted SHIV 89-9P (a chimeric
simian/human immunodeficiency virus that causes ``AIDS'' in simians).
Also importantly, there was no indication of any toxicity or other
adverse effects of the CV-N to the macaques in these
[[Page 7049]]
preclinical microbicide evaluation studies. CV-N has the potential to
become a microbicide useful in preventing sexual transmission of HIV.
An effective anti-HIV microbicide could slow down the spread of the
virus in the population, especially in the developing world, before an
effective vaccine is available.
The field of use may be limited to the topical use of commensal
bacteria that express cyanovirin-N.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response to
this notice will not be made available for public inspection, and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: February 2, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-2486 Filed 2-13-07; 8:45 am]
BILLING CODE 4140-01-P
