Government-Owned Inventions; Availability for Licensing, 9660-9661 [05-3832]
Download as PDF
<![CDATA[
9660
Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Notices
Bioorg. Med. Chem. (15 May 2004) 12
(10): 2645–2652.
Dated: February 17, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–3830 Filed 2–25–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
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.
Mouse Lactoferrin Antibody
Christina T. Teng (NIEHS), DHHS
Reference No. E–158–2004/0—Research
Tool. Licensing Contact: Marlene ShinnAstor; 301/435–4426;
shinnm@mail.nih.gov.
Lactoferrin, an iron-binding
glycoprotein, kills bacteria and
modulates inflammatory and immune
responses. It is expressed in mucosa
membrane and is present in saliva,
tears, vaginal secretion and neutrophils.
It modulates immune and inflammatory
response by down-regulating several
cytokines. Therefore, lactoferrin is an
important protein in first line of defense
and protecting health. Changes in
lactoferrin expression could also be
used as a marker of gene activation,
especially estrogen-induced gene
activity in the uterus.
VerDate jul<14>2003
16:34 Feb 25, 2005
Jkt 205001
The inventors have uniquely purified
a novel 70 kDa estrogen-stimulated
glycoprotein, lactoferrin, from mouse
uterine luminal fluid. CM-Affi-Gel Blue
column chromatography provided a
simple one step separation of lactoferrin
from the other luminal and serum
proteins. Furthermore, a polyclonal
antibody was created in rabbit, which
has been utilized for immunostaining,
Western blot, and elisa assays on
human, mouse, rat, and hamster tissues.
The cDNA to both human and mouse
were cloned. Probes designed to detect
the methylation status or
polymorphisms of the human lactoferrin
gene are available and can be used as
diagnostic tool in cancer study.
The inventor has available polyclonal
antibodies for both human and mouse,
as well as purified mouse lactoferrin
protein.
References: (1) Teng, CT et al. 1986.
Purification and properties of an
oestrogen-stimulated mouse uterine
glycoprotein (approx. 70 kDa).
Biochemical Journal. 240:413–422. (2)
Teng, et al. 2002. Differential expression
and estrogen response of lactoferrin
gene in the female reproductive tract of
mouse, rat, and hamster. Biology of
Reproduction. 67:1439–1449.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Antibody to Estrogen Related Receptor
Alpha
Christina T. Teng (NIEHS), DHHS
Reference No. E–157–2004/0—Research
Tool.
Licensing Contact: Marlene ShinnAstor; 301/435–4426;
shinnm@mail.nih.gov.
Estrogen related receptor alpha
(ERRalpha) is a family member of the
steroid/thyroid nuclear receptor
superfamily. Estrogen related receptors
are thought to regulate similar target
genes in the absence of known ligands.
For example, the inventors previously
cloned the human estrogen receptorrelated orphan receptor alpha1 cDNA
and demonstrated that it enhances
estrogen responsiveness of the
lactoferrin gene promoter in transfected
human endometrial carcinoma cells.
The inventors have produced a
peptide and fusion protein rabbit
polyclonal antibody against ERRalpha1C terminal (anti-ERRalpha-CT), which
has been utilized for immunostaining,
Chromatin immunoprecipitation (ChIP),
immunoprecipitation/immunoblottin
(IP/IB) and Western blot. This antibody
targets the C-terminus of the protein
which is a conserved region in human
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
and mouse. The antibody will be a
valuable tool to study the expression
and function of the protein in rodent
models, whereas the human antibody is
already commercially available. The
inventors also have available mouse
cDNA for ERRalpha1 which can be used
to detect mRNA.
Reference: Shigeta, H, et al. 1997. The
mouse estrogen receptor-related orphan
receptor alpha1: molecular cloning and
estrogen responsiveness. Journal of
Molecular Endocrinology. 19:299–309.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
A Novel, Preservative-Free Steroid
Formulation for Use as an AntiInflammatory
Michael R. Robinson (NEI), George
Grimes (CC), Luisa Gravlin (CC), Gopal
Potti (CC), Peng Yuan (CC) and Karl
Csaky (NEI), U.S. Provisional Patent
Application No. 60/628,741 filed 17
Nov 2004 (DHHS Reference No. E–094–
2003/0–US–01).
Licensing Contact: Susan Carson; 301/
435–5020; carsonsu@mail.nih.gov.
Corticosteroids, such as
dexamethasone, methylprednisolone
and triamcinolone acetonide (TAC),
have been used for many years in the
treatment of inflammation and in
relieving pain caused by inflammation
(for example chronic back and joint
pain). Intraocular inflammation is also
treated with steroids; however, there are
no commercial corticosteroid
preparations approved by the FDA for
use in the eye and off-label use of
current commercial formulations can be
accompanied by toxic side effects,
which can lead to vision loss.
Inflammation is present in eye diseases
including uveitis, diabetic retinopathy,
venous occlusive disease and agerelated macular degeneration, which are
estimated to affect more than 200,000
patients in the U.S. alone. This number
is likely to increase as the population
ages, and there remains a need for a
cost-effective, safe, efficient steroid
formulation for treating these
conditions.
NIH researchers at the National Eye
Institute and the Clinical Center have
devised a novel preservative-free
formulation of the generic steroid TAC
with an improved safety profile that
permits intravitreal injection. The
invention is a pharmaceutical
composition free of preservatives and
dispersion agents (TAC–PF) that are
thought to be responsible for certain
toxic side effects. Pre-clinical ocular
toxicology and pharmacokinetic studies
E:\FR\FM\28FEN1.SGM
28FEN1
Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Notices
have been performed using a
commercial formulation (KenalogTM) as
a comparator with the invention. No
ocular toxicity was seen with TAC–PF.
The inventors have an IND in place and
have positive results in the treatment of
diabetic macular edema with a single
dose of TAC–PF. The targeted
indications for the present novel TAC
formulation include diabetic
retinopathy and macular edema, uveitis
and age-related macular degeneration.
Additionally, this formulation, which
benefits from an improved safety
profile, could possibly be used in other
indications where steroid injections are
used to control inflammation.
This formulation is available for
licensing and claims are directed to a
pharmaceutical composition free of
classical preservatives and comprising a
glucocorticoid or angiostatic steroid.
Claims are also directed to methods of
making and treating a variety of ocular
conditions and other inflammatory
conditions including pain by a variety
of routes of administration, including
intravitreally, intrathecally, etc.
In addition to licensing, this
technology is available for further
development through collaborative
research with the inventors.
Dated: February 17, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 05–3832 Filed 2–25–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
January 25, 2005, 1 p.m. to January 25,
2005, 4 p.m. National Institutes of
Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD,
20852 which was published in the
Federal Register on January 12, 2005, 70
FR 2178.
The meeting will be held on March 8,
2005, at the Neuroscience Center,
Rockville, MD, from 1 p.m. to 5 p.m. as
a telephone conference call. The
meeting is closed to the public.
VerDate jul<14>2003
16:34 Feb 25, 2005
Jkt 205001
Dated: February 22, 2005.
Laverne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–3881 Filed 2–28–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
National Institute of Environmental
Health Sciences (NIEHS); National
Institutes of Health (NIH); NTP
Interagency Center for the Evaluation
of Alternative Toxicological Methods
(NICEATM); Second Request for Data
on Chemicals Evaluated by In Vitro or
In Vivo Ocular Irritancy Test Methods
Summary
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) and
NICEATM are collaborating with the
European Center for the Validation of
Alternative Methods (ECVAM) to
evaluate the validation status of in vitro
methods for assessing ocular irritation/
corrosion. Data was previously
requested (Federal Register, Vol. 69, No.
57, pp. 13859–13861, March 24, 2004,
available at https://iccvam.niehs.nih.
gov/) and used to prepare draft
Background Review Documents (BRD)
for four methods [(1) The Bovine
Corneal Opacity and Permeability
(BCOP) test; (2) the Isolated Rabbit Eye
(IRE) test or the Rabbit Enucleated Eye
Test (REET); (3) the Isolated Chicken
Eye (ICE) test or the Chicken Enucleated
Eye Test (CEET); and (4) the Hen’s Egg
Test—Chorion Allantoic Membrane
(HET–CAM)], and to compile a database
of in vivo data. ICCVAM and NICEATM
are now finalizing these BRDs and want
to ensure the inclusion of all available
data. NICEATM is therefore issuing this
second request for data generated using
standardized in vitro and in vivo test
methods used to identify severe,
moderate, mild, or non-irritating
substances. Test methods for identifying
severe (irreversible) ocular irritation/
corrosion for which data are sought
include, but are not limited to: (1) The
BCOP test; (2) the IRE test; (3) the ICE
test; and (4) the HET–CAM. In addition,
high quality data from standardized
ocular irritancy test methods using
rabbits (e.g., EPA 1998; UN 2003) and in
vivo data generated from procedures/
protocols that might alleviate or reduce
pain and suffering (e.g., topical and
systemic analgesic) in test animals are
requested. These data will be used to
evaluate the validation status of existing
in vitro test methods for ocular
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
9661
irritancy/corrosion and to develop a list
of substances with high quality in vivo
data that can be considered as reference
chemicals for future validation studies.
Data from other in vitro methods used
to assess reversible ocular irritation
effects or non-irritation are also
requested.
Submission of Chemical and Protocol
Information and Test Data
Data and other information submitted
in response to this notice should be sent
to NICEATM [Dr. William S. Stokes,
Director, NICEATM, NIEHS, 79 T. W.
Alexander Drive, P.O. Box 12233, MD
EC–17, Research Triangle Park, NC
27709, (phone) 919–541–2384, (fax)
919–541–0947, iccvam@niehs.nih.gov]
and received by March 30, 2005. Data
and other information received by this
date will be compiled and added to the
database maintained by NICEATM and
utilized where appropriate for the final
BRDs on the four methods listed above.
Data received after this date will also be
considered and used where applicable
for future evaluation activities. All
information submitted in response to
this notice will be made publicly
available upon request to NICEATM.
When submitting data or information
on protocols, please reference this
Federal Register notice and provide
appropriate contact information (name,
affiliation, mailing address, phone, fax,
e-mail, and sponsoring organization, as
applicable). NICEATM prefers data to be
submitted as copies of pages from study
notebooks and/or study reports, if
available. Each submission for a
chemical should preferably include the
following information, as appropriate:
• Common and trade name
• Chemical Abstracts Service Registry
Number (CASRN)
• Chemical and/or product class
• Commercial source
• In vitro test protocol used
• Rabbit eye test protocol used
• Human eye test protocol used
• Individual animal/human or in
vitro responses at each observation time
(i.e., raw data).
• The extent to which the study
complies with national/international
Good Laboratory Practice (GLP)
guidelines
• Date and testing organization
Those persons submitting data on
chemicals tested for ocular irritancy in
rabbits are referred to the ICCVAM/
NICEATM Web site (https://
iccvam.niehs.nih.gov/methods/
eyeirrit.htm) for an example of the type
of experimental animal study
information and data requested in this
notice.
E:\FR\FM\28FEN1.SGM
28FEN1
]]>Agencies
[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Notices]
[Pages 9660-9661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, DHHS.
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.
Mouse Lactoferrin Antibody
Christina T. Teng (NIEHS), DHHS Reference No. E-158-2004/0--
Research Tool. Licensing Contact: Marlene Shinn-Astor; 301/435-4426;
shinnm@mail.nih.gov.
Lactoferrin, an iron-binding glycoprotein, kills bacteria and
modulates inflammatory and immune responses. It is expressed in mucosa
membrane and is present in saliva, tears, vaginal secretion and
neutrophils. It modulates immune and inflammatory response by down-
regulating several cytokines. Therefore, lactoferrin is an important
protein in first line of defense and protecting health. Changes in
lactoferrin expression could also be used as a marker of gene
activation, especially estrogen-induced gene activity in the uterus.
The inventors have uniquely purified a novel 70 kDa estrogen-
stimulated glycoprotein, lactoferrin, from mouse uterine luminal fluid.
CM-Affi-Gel Blue column chromatography provided a simple one step
separation of lactoferrin from the other luminal and serum proteins.
Furthermore, a polyclonal antibody was created in rabbit, which has
been utilized for immunostaining, Western blot, and elisa assays on
human, mouse, rat, and hamster tissues. The cDNA to both human and
mouse were cloned. Probes designed to detect the methylation status or
polymorphisms of the human lactoferrin gene are available and can be
used as diagnostic tool in cancer study.
The inventor has available polyclonal antibodies for both human and
mouse, as well as purified mouse lactoferrin protein.
References: (1) Teng, CT et al. 1986. Purification and properties
of an oestrogen-stimulated mouse uterine glycoprotein (approx. 70 kDa).
Biochemical Journal. 240:413-422. (2) Teng, et al. 2002. Differential
expression and estrogen response of lactoferrin gene in the female
reproductive tract of mouse, rat, and hamster. Biology of Reproduction.
67:1439-1449.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Antibody to Estrogen Related Receptor Alpha
Christina T. Teng (NIEHS), DHHS Reference No. E-157-2004/0--
Research Tool.
Licensing Contact: Marlene Shinn-Astor; 301/435-4426;
shinnm@mail.nih.gov.
Estrogen related receptor alpha (ERRalpha) is a family member of
the steroid/thyroid nuclear receptor superfamily. Estrogen related
receptors are thought to regulate similar target genes in the absence
of known ligands. For example, the inventors previously cloned the
human estrogen receptor-related orphan receptor alpha1 cDNA and
demonstrated that it enhances estrogen responsiveness of the
lactoferrin gene promoter in transfected human endometrial carcinoma
cells.
The inventors have produced a peptide and fusion protein rabbit
polyclonal antibody against ERRalpha1-C terminal (anti-ERRalpha-CT),
which has been utilized for immunostaining, Chromatin
immunoprecipitation (ChIP), immunoprecipitation/immunoblottin (IP/IB)
and Western blot. This antibody targets the C-terminus of the protein
which is a conserved region in human and mouse. The antibody will be a
valuable tool to study the expression and function of the protein in
rodent models, whereas the human antibody is already commercially
available. The inventors also have available mouse cDNA for ERRalpha1
which can be used to detect mRNA.
Reference: Shigeta, H, et al. 1997. The mouse estrogen receptor-
related orphan receptor alpha1: molecular cloning and estrogen
responsiveness. Journal of Molecular Endocrinology. 19:299-309.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
A Novel, Preservative-Free Steroid Formulation for Use as an Anti-
Inflammatory
Michael R. Robinson (NEI), George Grimes (CC), Luisa Gravlin (CC),
Gopal Potti (CC), Peng Yuan (CC) and Karl Csaky (NEI), U.S. Provisional
Patent Application No. 60/628,741 filed 17 Nov 2004 (DHHS Reference No.
E-094-2003/0-US-01).
Licensing Contact: Susan Carson; 301/435-5020;
carsonsu@mail.nih.gov.
Corticosteroids, such as dexamethasone, methylprednisolone and
triamcinolone acetonide (TAC), have been used for many years in the
treatment of inflammation and in relieving pain caused by inflammation
(for example chronic back and joint pain). Intraocular inflammation is
also treated with steroids; however, there are no commercial
corticosteroid preparations approved by the FDA for use in the eye and
off-label use of current commercial formulations can be accompanied by
toxic side effects, which can lead to vision loss. Inflammation is
present in eye diseases including uveitis, diabetic retinopathy, venous
occlusive disease and age-related macular degeneration, which are
estimated to affect more than 200,000 patients in the U.S. alone. This
number is likely to increase as the population ages, and there remains
a need for a cost-effective, safe, efficient steroid formulation for
treating these conditions.
NIH researchers at the National Eye Institute and the Clinical
Center have devised a novel preservative-free formulation of the
generic steroid TAC with an improved safety profile that permits
intravitreal injection. The invention is a pharmaceutical composition
free of preservatives and dispersion agents (TAC-PF) that are thought
to be responsible for certain toxic side effects. Pre-clinical ocular
toxicology and pharmacokinetic studies
[[Page 9661]]
have been performed using a commercial formulation
(KenalogTM) as a comparator with the invention. No ocular
toxicity was seen with TAC-PF. The inventors have an IND in place and
have positive results in the treatment of diabetic macular edema with a
single dose of TAC-PF. The targeted indications for the present novel
TAC formulation include diabetic retinopathy and macular edema, uveitis
and age-related macular degeneration. Additionally, this formulation,
which benefits from an improved safety profile, could possibly be used
in other indications where steroid injections are used to control
inflammation.
This formulation is available for licensing and claims are directed
to a pharmaceutical composition free of classical preservatives and
comprising a glucocorticoid or angiostatic steroid. Claims are also
directed to methods of making and treating a variety of ocular
conditions and other inflammatory conditions including pain by a
variety of routes of administration, including intravitreally,
intrathecally, etc.
In addition to licensing, this technology is available for further
development through collaborative research with the inventors.
Dated: February 17, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 05-3832 Filed 2-25-05; 8:45 am]
BILLING CODE 4140-01-P
