Prospective Grant of Exclusive License: The Use of IL13-PE38 for the Treatment of Asthma and Pulmonary Fibrosis, 14232-14233 [E6-4078]
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sroberts on PROD1PC70 with NOTICES
14232
Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the
treatment of adenocarcinoma and
Ewing’s sarcoma with HMG-CoA
inhibitors.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before May
22, 2006 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
PhD, Technology Licensing Specialist,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4632; Facsimile: (301) 402–0220; E-mail:
lambertsond@od.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology relates to the treatment of
adenocarcinomas and Ewing’s sarcoma
with HMG-CoA inhibitors.
Adenocarcinoma affects the inner lining
or inner surface of a number of organs,
and is responsible for approximately
95% of prostate cancers, over 75% of
pancreatic cancers, and is the most
common form of lung cancer. Ewing’s
sarcoma is a bone tumor typically
attacking the long bones. Current
methods of treating these cancers
include surgery, chemotherapy,
radiation therapy or a combination
thereof.
The current technology involves the
use of HMG-CoA inhibitors (such as
lovastatin or simvastatin) to treat
adenocarcinomas and Ewing’s sarcoma.
HMG-CoA inhibitors have been
approved for use in the treatment of
high cholesterol in humans, with typical
doses of 10mg, 20mg or 40mg. This
technology recommends using higher
doses (based on the weight of the
patient) for the treatment of cancer.
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 sixty (60) days from the date of
this published notice, the 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.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
VerDate Aug<31>2005
19:30 Mar 20, 2006
Jkt 208001
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: March 13, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–4074 Filed 3–20–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Use of IL13–PE38 for the
Treatment of Asthma and Pulmonary
Fibrosis
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
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 (HHS), is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Patent Application
No. 60/337,179 filed December 4, 2001,
entitled ‘‘IL–13 Receptor-Targeted
Immunotoxins Ameliorates Symptoms
of Asthma and of Allergy’’ [HHS
Reference No. E–296–2001/0–US–01],
PCT Application No. PCT/US02/00616
filed February 28, 2002, entitled
‘‘Alleviating Symptoms of TH2-Like
Cytokine Mediated Disorders by
Reducing IL–13 Receptor-Expressing
Cells in the Respiratory Tract’’ [HHS
Reference No. E–296–2001/0–PCT–02],
U.S. Patent Application No. 10/497,804
filed June 4, 2004, entitled ‘‘Alleviating
Symptoms of TH2-Like Cytokine
Mediated Disorders by Reducing IL–13
Receptor-Expressing Cells in the
Respiratory Tract’’ [HHS Reference No.
E–296–2001/0-US–03], Australian
Patent Application No. 2002258011
filed June 8, 2004, entitled ‘‘Alleviating
Symptoms of TH2-Like Cytokine
Mediated Disorders by Reducing IL–13
Receptor-Expressing Cells in the
Respiratory Tract’’ [HHS Reference No.
E–296–2001/0–AU–04], Canadian
Patent Application No. 2469082 filed
February 28, 2002, entitled ‘‘Chimeric
Molecule for the Treatment of TH2-Like
Cytokine Mediated Disorders’’ [HHS
Reference No. E–296–2001/0-CA–05],
and European Patent Application No.
02727815.9 filed June 29, 2004 entitled
‘‘Alleviating Symptoms of TH2-Like
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Cytokine Mediated Disorders by
Reducing IL–13 Receptor-Expressing
Cells in the Respiratory Tract’’ [HHS
Reference No. E–296–2001/0–EP–06],
including background patent rights to
U.S. Patent No. 4,892,827, issued on
January 9, 1990, entitled ‘‘Recombinant
Pseudomonas Exotoxins: Construction
of an Active Immunotoxin with Low
Side Effects’’ [HHS Reference No. E–
385–1986/0–US–01], U.S. Patent No.
5,919,456, issued on July 6, 1999,
entitled ‘‘IL–13 Receptor Specific
Chimeric Proteins’’ [HHS Reference No.
E–266–1994/0–US–07], U.S. Patent
6,518,061, issued on February 11, 2003,
entitled ‘‘IL–13 Receptor Specific
Chimeric Proteins and Uses Thereof’’
[HHS Reference No. E–266–1994/0-US–
08], to NeoPharm, Inc., which has
offices in Waukegan, Illinois. The patent
rights in these inventions have been
assigned and/or exclusively licensed to
the Government of the United States of
America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the
treatment of asthma and pulmonary
fibrosis with IL13–PE38.
This notice replaces the Prospective
Grant notice published in the Federal
Register on Monday, March 6, 2006 (71
FR 11213).
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before May
22, 2006 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: David A. Lambertson,
Ph.D., Technology Licensing Specialist,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4632; Facsimile: (301) 402–0220; E-mail:
lambertsond@od.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology relates to the treatment of
asthma and pulmonary fibrosis. When
airway inflammation occurs (e.g., during
an asthmatic attack or a response to an
allergen), the number of cells that
produce the receptor for IL–13 increases
in the lungs. When IL–13 interacts with
the receptor, an inflammatory response
is induced; when this occurs in the
lungs, it leads to the symptom of
constricted breathing. Blocking the
interaction between IL–13 and its
receptors on the cells has been shown
to reduce the inflammatory response.
A chimeric molecule was developed
that comprised both an IL–13 domain
E:\FR\FM\21MRN1.SGM
21MRN1
Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices
(capable of interacting with its cognate
receptor) and a toxin domain. This
molecule has the capacity to interact
with and kill IL–13 receptor expressing
cells. The invention relates to a method
of treating asthma or pulmonary fibrosis
by administering a chimeric molecule
comprising a toxin linked to an IL–13
targeting moiety (e.g., IL13–PE38). By
administering the toxin in this form,
cells involved in airway inflammation
can be selectively targeted and killed,
thereby alleviating the symptom of
constricted breathing.
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 sixty (60) days from the date of
this published notice, the 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.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted 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: March 14, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–4078 Filed 3–20–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2006–24163]
National Environmental Policy Act;
Environmental Impact Statement on
U.S. Coast Guard Pacific Area
Operations
Coast Guard, DHS.
ACTION: Notice of intent; request for
public comments.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: The Coast Guard announces
its intent to prepare an Environmental
Impact Statement (EIS) to review
possible changes to the Coast Guard’s
operations in the areas of responsibility
for Coast Guard Districts 11 and 13
(California, Oregon and Washington)
and requests public comments. The EIS
VerDate Aug<31>2005
19:01 Mar 20, 2006
Jkt 208001
will analyze the environmental impacts
of Coast Guard vessel and air operations
when engaged in the following missions
and activities: law enforcement,
national security, search and rescue,
aids to navigation, and oil pollution and
vessel grounding response.
Publication of this notice begins the
official scoping process that will help
identify alternatives and refine the
scope of environmental issues to be
addressed in the EIS. This notice
requests public participation in the
scoping process for this Coast Guard
action, provides information on how to
participate, and identifies a set of
preliminary alternatives to serve as a
starting point for discussion.
DATES: Comments and related material
must reach the Docket Management
Facility on or before May 5, 2006.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number USCG–2006–24163 to the
Docket Management Facility at the U.S.
Department of Transportation. To avoid
duplication, please use only one of the
following methods:
(1) Electronically through the Web
site for the Docket Management System
at https://dms.dot.gov.
(2) By mail to the Docket Management
Facility, (USCG–2006–24163), U.S.
Department of Transportation, Room
PL–401, 400 Seventh Street SW.,
Washington, DC 20590–0001.
(3) By fax to the Docket Management
Facility at 202–493–2251.
(4) By delivery to room PL–401 on the
Plaza level of the Nassif Building, 400
Seventh Street SW., Washington, DC,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The telephone number is 202–366–
9329.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice,
contact Frank Esposito, Coast Guard,
(fesposito@comdt.uscg.mil) or 2100 2nd
St., SW., Washington, DC 20593. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–493–0402.
SUPPLEMENTARY INFORMATION:
Request for Comments
All comments received will be posted,
without change, to https://dms.dot.gov
and will include any personal
information you have provided. We
have an agreement with the Department
of Transportation (DOT) to use the
Docket Management Facility. Please see
DOT’s ‘‘Privacy Act’’ paragraph below.
Submitting comments: If you submit a
comment, please include your name and
address, identify the docket number for
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
14233
this notice (USCG–2006–24163) and
give the reason for each comment. You
may submit your comments by
electronic means, mail, fax, or delivery
to the Docket Management Facility at
the address under ADDRESSES; but
please submit your comments by only
one means. If you submit them by mail
or delivery, submit them in an unbound
format, no larger than 81⁄2 by 11 inches,
suitable for copying and electronic
filing. If you submit them by mail and
would like to know that they reached
the Facility, please enclose a stamped,
self-addressed postcard or envelope. We
will consider all comments received
during the comment period.
Viewing comments and documents:
To view comments, go to https://
dms.dot.gov at any time, click on
‘‘Simple Search,’’ enter the last five
digits of the docket number for this
rulemaking, and click on ‘‘Search.’’ You
may also visit the Docket Management
Facility in room PL–401 on the Plaza
level of the Nassif Building, 400
Seventh Street SW., Washington, DC,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
Privacy Act: Anyone can search the
electronic form of all comments
received into any of our dockets by the
name of the individual submitting the
comment (or signing the comment, if
submitted on behalf of an association,
business, labor union, etc.). You may
review the Department of
Transportation’s Privacy Act Statement
in the Federal Register published on
April 11, 2000 (65 FR 19477), or you
may visit https://dms.dot.gov.
If you wish to be added to the mailing
list for this project, you may make a
request through the project Web site, by
mail to the docket at Docket
Management Facility, (USCG–2006–
24163), U.S. Department of
Transportation, Room PL–401, 400
Seventh Street SW., Washington, DC
20590–0001, or by fax to the Docket
Management Facility at 202–493–2251.
Background
The Coast Guard is one of the
country’s five armed services and the
nation’s oldest maritime agency.
Positioned within the Department of
Homeland Security, the Coast Guard is
the only maritime service with
regulatory and law enforcement
authority, military capabilities, and
humanitarian operations. Coast Guard
activities encompass critical elements of
Homeland Security operations in littoral
regions, including port security and
safety, marine environmental response,
maritime interception, coastal control,
and maritime force protection. More
than two centuries of littoral operations
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[Federal Register Volume 71, Number 54 (Tuesday, March 21, 2006)]
[Notices]
[Pages 14232-14233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4078]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Use of IL13-PE38 for
the Treatment of Asthma and Pulmonary Fibrosis
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 (HHS), is contemplating the
grant of an exclusive patent license to practice the inventions
embodied in U.S. Patent Application No. 60/337,179 filed December 4,
2001, entitled ``IL-13 Receptor-Targeted Immunotoxins Ameliorates
Symptoms of Asthma and of Allergy'' [HHS Reference No. E-296-2001/0-US-
01], PCT Application No. PCT/US02/00616 filed February 28, 2002,
entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders
by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract''
[HHS Reference No. E-296-2001/0-PCT-02], U.S. Patent Application No.
10/497,804 filed June 4, 2004, entitled ``Alleviating Symptoms of TH2-
Like Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing
Cells in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-US-
03], Australian Patent Application No. 2002258011 filed June 8, 2004,
entitled ``Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders
by Reducing IL-13 Receptor-Expressing Cells in the Respiratory Tract''
[HHS Reference No. E-296-2001/0-AU-04], Canadian Patent Application No.
2469082 filed February 28, 2002, entitled ``Chimeric Molecule for the
Treatment of TH2-Like Cytokine Mediated Disorders'' [HHS Reference No.
E-296-2001/0-CA-05], and European Patent Application No. 02727815.9
filed June 29, 2004 entitled ``Alleviating Symptoms of TH2-Like
Cytokine Mediated Disorders by Reducing IL-13 Receptor-Expressing Cells
in the Respiratory Tract'' [HHS Reference No. E-296-2001/0-EP-06],
including background patent rights to U.S. Patent No. 4,892,827, issued
on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxins:
Construction of an Active Immunotoxin with Low Side Effects'' [HHS
Reference No. E-385-1986/0-US-01], U.S. Patent No. 5,919,456, issued on
July 6, 1999, entitled ``IL-13 Receptor Specific Chimeric Proteins''
[HHS Reference No. E-266-1994/0-US-07], U.S. Patent 6,518,061, issued
on February 11, 2003, entitled ``IL-13 Receptor Specific Chimeric
Proteins and Uses Thereof'' [HHS Reference No. E-266-1994/0-US-08], to
NeoPharm, Inc., which has offices in Waukegan, Illinois. The patent
rights in these inventions have been assigned and/or exclusively
licensed to the Government of the United States of America.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to the treatment of asthma and
pulmonary fibrosis with IL13-PE38.
This notice replaces the Prospective Grant notice published in the
Federal Register on Monday, March 6, 2006 (71 FR 11213).
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before May
22, 2006 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: David A. Lambertson, Ph.D., Technology
Licensing Specialist, Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; E-
mail: lambertsond@od.nih.gov.
SUPPLEMENTARY INFORMATION: The technology relates to the treatment of
asthma and pulmonary fibrosis. When airway inflammation occurs (e.g.,
during an asthmatic attack or a response to an allergen), the number of
cells that produce the receptor for IL-13 increases in the lungs. When
IL-13 interacts with the receptor, an inflammatory response is induced;
when this occurs in the lungs, it leads to the symptom of constricted
breathing. Blocking the interaction between IL-13 and its receptors on
the cells has been shown to reduce the inflammatory response.
A chimeric molecule was developed that comprised both an IL-13
domain
[[Page 14233]]
(capable of interacting with its cognate receptor) and a toxin domain.
This molecule has the capacity to interact with and kill IL-13 receptor
expressing cells. The invention relates to a method of treating asthma
or pulmonary fibrosis by administering a chimeric molecule comprising a
toxin linked to an IL-13 targeting moiety (e.g., IL13-PE38). By
administering the toxin in this form, cells involved in airway
inflammation can be selectively targeted and killed, thereby
alleviating the symptom of constricted breathing.
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 sixty
(60) days from the date of this published notice, the 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.
Applications for a license in the field of use filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. Comments and objections submitted 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: March 14, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E6-4078 Filed 3-20-06; 8:45 am]
BILLING CODE 4140-01-P
