Government-Owned Inventions; Availability for Licensing, 40585-40588 [E8-16134]
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Federal Register / Vol. 73, No. 136 / Tuesday, July 15, 2008 / Notices
Submit written comments on the
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FOR FURTHER INFORMATION CONTACT:
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I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: CGMP for Phase 1
Investigational Drugs’’ dated July 2008.
This guidance provides assistance in
applying CGMP required under section
501(a)(2)(B) of the act (21 U.S.C.
351(a)(2)(B)) in the manufacture of most
investigational new drugs used in phase
1 clinical trials (phase 1 investigational
drugs). The guidance is being issued
concurrently with a final rule that
specifies that the manufacture of most
investigational new drugs manufactured
for use in phase 1 clinical trials do not
have to comply with the specific
regulatory requirements in part 211 (21
CFR part 211).
Because a phase 1 clinical trial
initially introduces an investigational
new drug into human subjects,
appropriate CGMP helps ensure subject
safety. This guidance applies, as part of
CGMP, quality control principles to the
manufacture of phase 1 investigational
drugs (i.e., interpreting and
implementing CGMP consistent with
good scientific methodology), which
foster CGMP activities that are more
appropriate for phase 1 clinical trials,
improve the quality of phase 1
investigational drugs, and facilitate the
initiation of investigational clinical
trials in humans while continuing to
protect trial subjects. For the
manufacture of phase 1 investigational
drugs described in this guidance (see
section III of the guidance), this
guidance will replace the guidance
issued in 1991 (56 FR 7048, February
21, 1991) entitled ‘‘Preparation of
Investigational New Drug Products
(Human and Animal)’’ (the 1991
guidance). However, the 1991 guidance
still applies to the manufacture of
investigational new products (human
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and animal) used in phase 2 and phase
3 clinical trials.
In the Federal Register of January 17,
2006 (71 FR 2552), FDA announced the
availability of the draft guidance
entitled ‘‘INDs—Approaches to
Complying with CGMP During Phase 1’’
dated January 2006. FDA received a
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The guidance is being issued
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III. Comments
Interested persons may submit to the
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ADDRESSES) written or electronic
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Submit a single copy of electronic
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IV. Electronic Access
Persons with access to the Internet
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www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://
www.regulations.gov.
Dated: July 9, 2008.
Jeffrey Shuren,
Associate Comissioner for Policy and
Planning.
[FR Doc. E8–16002 Filed 7–14–08; 8:45 am]
BILLING CODE 4160–01–S
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.
Neutralization of Hepatitis C Virus
(HCV)
Description of Technology: Available
for licensing and commercial
development are anti-hepatitis C virus
(HCV) vaccines, therapeutics and
inhibitors. The invention is based on
mapping studies conducted by the
inventors of two epitopes within HCV
E2: epitope I and epitope II. It has been
discovered that epitope I is involved in
virus neutralization but that epitope II
mediates antibody interference;
probably an adaptation of the virus to
obfuscate the immune system. The
present invention provides
compositions and methods for treating
and or preventing HCV infection caused
by HCV. The invention is directed to a
HCV E2 polypeptide substitution of
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Federal Register / Vol. 73, No. 136 / Tuesday, July 15, 2008 / Notices
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amino acids LFY of the skein LFY in
epitope II. In certain embodiments, the
invention is directed to a HCV E2
polypeptide deletion of amino acids
LFY of the skein LFY in epitope II. In
additional embodiments, the invention
is directed to a HCV E2 polypeptide
addition of amino acids between LFY of
the skein LFY in epitope II. The above
are directed to attenuating or disabling
the interference effect of HCV-E2
epitope II.
In additional embodiments, the
invention is directed to use of epitope
II as a molecular decoyant. In further
embodiments, the invention is directed
to use of epitope II to affinity purify an
immune globulin to deplete interfering
antibodies from and enrich neutralizing
antibodies in the preparation.
Applications: Antiviral; Hepatitis C
Virus (HCV) therapy.
Inventors: Pei Zhang, Marian Major,
Stephen Feinstone (FDA).
Publications:
1. P Zhang et al. Hepatitis C virus
epitope-specific neutralizing antibodies
in Igs prepared from human plasma.
Proc Natl Acad Sci USA. 2007 May
15;104(20):8449–8454.
2. MY Yu et al. Neutralizing
antibodies to hepatitis C virus (HCV) in
immune globulins derived from antiHCV-positive plasma. Proc Natl Acad
Sci USA. 2004 May 18;101(20):7705–
7710.
Patent Status: U.S. Provisional
Application No. 61/002,031 filed 06
Nov 2007 (HHS Reference No. E–276–
2007/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: RC Tang, JD, LLM;
301–435–5031; tangrc@mail.nih.gov.
Collaborative Research Opportunity:
The FDA Center for Biologics
Evaluation and Research, Laboratory of
Plasma Derivatives, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact Michelle Hawley at 301–827–
1991 or michelle.hawley@fda.hhs.gov
for more information.
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Treatment of Skin Conditions Using
DKK1
Description of Technology: This
invention discloses a method for
inducing non-palmoplantar skin (skin of
the trunk, arms, and face etc.) to
develop characteristics of palmoplantar
skin (skin of the soles and palms). This
effect is achieved by use of Dickkopf 1
(DKK1), a protein which is highly
expressed by palmoplantar fibroblasts
and is a known antagonist of the Wnt
signaling pathway. Topical application
of DKK1 to non-palmoplantar skin
induces the development of increased
skin thickness, decreased pigmentation,
and decreased hair growth. These
characteristics are desirable for treating
several dermatological conditions.
The skin thickening caused by topical
application of DKK1 can be useful for
skin grafts, and skin ulcers or abrasions.
Decreased skin pigmentation,
experimentally achieved by either
topical or in vitro application of DKK1,
may be desirable for conditions such as
uneven skin pigmentation, pigmented
birthmarks, or post inflammatory
pigmentation. Suppressed hair growth
may be cosmetically desirable for some
areas of the skin, and in conditions such
hypertrichosis, adrenal hyperplasia, or
polycystic ovarian syndrome. DKK1
treatment may also be important for
treating or preventing certain
melanomas which involve hyperplastic
or pre-malignant lesions.
Applications: Useful for skin grafts,
skin ulcers, skin abrasions, fragrance
dermatitis, vitiligo, etc.; Treatment of
several conditions which require
decreased skin pigmentation; Decreased
hair growth for cosmetic or therapeutic
purposes.
Development Status: Early stage.
Inventors: Vincent J. Hearing et al.
(NCI).
Publication: Y Yamaguchi, T
Passeron, T Hoashi, H Watabe, F
Rouzaud, K Yasumoto, T Hara, C
Tohyama, I Katayama, T Miki, VJ
Hearing. Dickkopf 1 (DKK1) regulates
skin pigmentation and thickness by
affecting Wnt/b-catenin signaling in
keratinocytes. FASEB J. 2008
Apr;22(4):1009–1020.
Patent Status:
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U.S. Provisional Application No. 60/
873,874 filed 07 Dec 2006 (HHS
Reference No. E–321–2006/0–US–01).
PCT Application No. PCT/US2007/
086855 filed 07 Dec 2007 (HHS
Reference No. E–321–2006/0–PCT–02).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jasbir (Jesse) S.
Kindra, J.D., M.S.; 301–435–5170;
kindraj@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute
Laboratory of Cell Biology is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize the use of DKK1 or a
bioactive fragment of DKK1 to treat
abnormal pigmentation of the skin or to
regulate hair growth. Please contact
John D. Hewes, Ph.D. at 301–435–3121
or hewesj@mail.nih.gov for more
information.
Flow-Through Thermal-ExpansionCompensated Microcells for Analytical
Transmission Infrared Spectroscopy
Description of Technology: Available
for licensing and commercial
distribution are optical cells
spectroscopically stable and can be used
for spectroscopic measurement in
transmission, sample reflection, back
plate reflection, emission, or scattering
modes. The cell allows fluid in a sample
space to be exchanged without
separating a front or a back plate from
a spacer, allows a solid sample to be
placed in or removed from the sample
space, requires only a small amount of
sample, and allows for different sample
gaps to be easily and inexpensively set.
Alternatively, the spacers can be
manufactured using a hydrocarbonresistant polymer so that samples
dissolved in organic solvents can be
used without the risk of changing the
spectral properties of the microcell and
solvent leakage from the sample space.
The inventive cell and methods allow
spectral measurements to be taken over
wavelengths ranging at least from the
mid-infrared to the vacuum ultraviolet,
provide a simple path for light traveling
through a sample, and allow fast kinetic
processes to be detected and monitored
reproducibly and sensitively.
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Applications: Analytics;
Spectroscopy; Infrared spectroscopy;
Chemical Imaging; Material
characterization; Quality control;
Chemometrics in chemical and
pharmaceutical manufacturing; Forensic
applications; Tissue pathology
diagnostics
Inventors: Edward Mertz and James
Sullivan (NICHD).
Publications:
1. Makareeva E, Mertz EL, Kuznetsova
NV, Sutter MB, DeRidder AM, Cabral
WA, Barnes AM, McBride DJ, Marini JC,
Leikin S. Structural heterogeneity of
type I collagen triple helix and its role
in osteogenesis imperfecta. J Biol Chem.
2008 Feb 22;283(8):4787–4798.
2. Mertz EL, Leikin S. Interactions of
inorganic phosphate and sulfate anions
with collagen. Biochemistry. 2004 Nov
30;43(47):14901–14912.
Patent Status:
U.S. Patent 7,355,697 issued 08 Apr
2008 (HHS Reference No. E–096–2004/
0–US–01).
International Patent Application No.
PCT/US2005/030218 filed 25 Aug 2005,
which published as WO 2006/026342
on 09 Mar 2006 (HHS Reference No. E–
096–2004/0–PCT–02).
European Patent Application
05786373.9 filed 26 Aug 2005 (HHS
Reference No. E–096–2004/0–EP–03).
U.S. Patent Application No. 11/
826,806 filed 18 Jul 2007 (HHS
Reference No. E–096–2004/1–US–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
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Collaborative Research Opportunity:
The Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, Section on Physical
Biochemistry is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize microcells for infrared
and other spectroscopies and their
applications to pathology diagnostics.
Please contact John D. Hewes, PhD at
301–435–3121 or hewesj@mail.nih.gov
for more information.
Rapid and Sensitive Detection of
Nucleic Acid Sequence Variations
Description of Technology: The ability
to easily detect small mutations in
nucleic acids, such as single base
substitutions, can provide a powerful
tool for use in cancer detection,
perinatal screens for inherited diseases,
and analysis of genetic polymorphisms
such as genetic mapping or for
identification purposes. Current
approaches make use of the mismatch
that occurs between complimentary
strands of DNA when there is a genetic
mutation, the electrophoretic mobility
differences caused by small sequence
changes, and chemicals or enzymes that
can cleave heteroduplex sites. Some of
these methods, however, prove to be too
cumbersome, are unable to pinpoint
mutations, only detect a subset of
mutations, or involve the use of
hazardous materials.
The current invention takes advantage
of the ability of transposons, or mobile
genetic elements, to move from one part
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40587
of the genome to another by the cleavage
and joining of their sequences into the
target site; a reaction facilitated by a
transposase enzyme. The phage Mu
transposase is capable of inserting the
right end sequence of the Mu
transposon into any DNA sequence both
in vitro and in vivo. The surprising
discovery that the Mu transposase
displays a strong preference for
inserting Mu-end DNA into mismatched
sites, the very sites which occur when
DNA is mutated and paired with its
complementary strand that does not
have the corresponding mutation, makes
it a powerful tool for detecting
variations in nucleic acid sequences. In
this system, the transposition of Mu-end
DNA at a site is used to indicate the
presence of a nucleic acid mismatch or
mutation at that site. The invention can
be used with labeled Mu-end DNA to
further facilitate the precise mapping of
the mutations. This specificity allows
Mu to detect even single base mutations
among a large quantity of non-specific
DNA. The Mu detection system is
simple, rapid, and highly sensitive
compared to current methods and can
find a broad range of use in genetic
research and the diagnosis of several
diseases such as cystic fibrosis, spinal
and bulbar muscular dystrophy, human
fragile-X syndrome, and Huntington’s
disease.
Applications:
Fast, simple screening for genetic
mutations in several diseases such as
cystic fibrosis, spinal and bulbar
muscular dystrophy, human fragile-X
syndrome, Huntington’s disease,
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Federal Register / Vol. 73, No. 136 / Tuesday, July 15, 2008 / Notices
40588
Federal Register / Vol. 73, No. 136 / Tuesday, July 15, 2008 / Notices
detection of birth defects, and paternity
testing, etc.
Genetic mapping and identification.
Development Status: Early stage.
Inventors: Katsuhiko Yanagihara and
Kiyoshi Mizuuchi (NIDDK).
Publication: Yanagihara K and
Mizuuchi K. Mismatch-targeted
transposition of Mu: a new strategy to
map genetic polymorphism. Proc Natl
Acad Sci USA. 2002 Aug 20;
99(17):11317–11321.
Patent Status: U.S. Patent No.
7,316,903 issued 08 Jan 2008 (HHS
Reference No. E–071–2003/0–US–02).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jasbir (Jesse) S.
Kindra, JD, MS; 301–435–5170;
kindraj@mail.nih.gov.
Collaborative Research Opportunity:
The Section on Genetic Mechanisms,
LMB, NIDDK is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Mu transposition system
as a tool for mutation detection and
other genetic research/manipulation.
Please contact Kiyoshi Mizuuchi at
kmizu@helix.nih.gov for more
information.
Date: August 7–8, 2008.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Ave, Bethesda, MD 20814.
Contact Person: Gail J. Bryant, MD,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, 6116 Executive Blvd, Room 8107,
MSC 8328, Bethesda, MD 20892–8328, (301)
402–0801, gb30t@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: July 8, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–16134 Filed 7–14–08; 8:45 am]
National Protection and Programs
Directorate; Submission for Review:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on PROD1PC66 with NOTICES
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
A—Cancer Centers.
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Dated: July 9, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–16139 Filed 7–14–08; 8:45 am]
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20528–8540, or e-mail obp@dhs.gov.
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The Office
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]]>Agencies
[Federal Register Volume 73, Number 136 (Tuesday, July 15, 2008)]
[Notices]
[Pages 40585-40588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16134]
-----------------------------------------------------------------------
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.
Neutralization of Hepatitis C Virus (HCV)
Description of Technology: Available for licensing and commercial
development are anti-hepatitis C virus (HCV) vaccines, therapeutics and
inhibitors. The invention is based on mapping studies conducted by the
inventors of two epitopes within HCV E2: epitope I and epitope II. It
has been discovered that epitope I is involved in virus neutralization
but that epitope II mediates antibody interference; probably an
adaptation of the virus to obfuscate the immune system. The present
invention provides compositions and methods for treating and or
preventing HCV infection caused by HCV. The invention is directed to a
HCV E2 polypeptide substitution of
[[Page 40586]]
amino acids LFY of the skein LFY in epitope II. In certain embodiments,
the invention is directed to a HCV E2 polypeptide deletion of amino
acids LFY of the skein LFY in epitope II. In additional embodiments,
the invention is directed to a HCV E2 polypeptide addition of amino
acids between LFY of the skein LFY in epitope II. The above are
directed to attenuating or disabling the interference effect of HCV-E2
epitope II.
In additional embodiments, the invention is directed to use of
epitope II as a molecular decoyant. In further embodiments, the
invention is directed to use of epitope II to affinity purify an immune
globulin to deplete interfering antibodies from and enrich neutralizing
antibodies in the preparation.
Applications: Antiviral; Hepatitis C Virus (HCV) therapy.
Inventors: Pei Zhang, Marian Major, Stephen Feinstone (FDA).
Publications:
1. P Zhang et al. Hepatitis C virus epitope-specific neutralizing
antibodies in Igs prepared from human plasma. Proc Natl Acad Sci USA.
2007 May 15;104(20):8449-8454.
2. MY Yu et al. Neutralizing antibodies to hepatitis C virus (HCV)
in immune globulins derived from anti-HCV-positive plasma. Proc Natl
Acad Sci USA. 2004 May 18;101(20):7705-7710.
Patent Status: U.S. Provisional Application No. 61/002,031 filed 06
Nov 2007 (HHS Reference No. E-276-2007/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: RC Tang, JD, LLM; 301-435-5031;
tangrc@mail.nih.gov.
Collaborative Research Opportunity: The FDA Center for Biologics
Evaluation and Research, Laboratory of Plasma Derivatives, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
this technology. Please contact Michelle Hawley at 301-827-1991 or
michelle.hawley@fda.hhs.gov for more information.
Treatment of Skin Conditions Using DKK1
Description of Technology: This invention discloses a method for
inducing non-palmoplantar skin (skin of the trunk, arms, and face etc.)
to develop characteristics of palmoplantar skin (skin of the soles and
palms). This effect is achieved by use of Dickkopf 1 (DKK1), a protein
which is highly expressed by palmoplantar fibroblasts and is a known
antagonist of the Wnt signaling pathway. Topical application of DKK1 to
non-palmoplantar skin induces the development of increased skin
thickness, decreased pigmentation, and decreased hair growth. These
characteristics are desirable for treating several dermatological
conditions.
The skin thickening caused by topical application of DKK1 can be
useful for skin grafts, and skin ulcers or abrasions. Decreased skin
pigmentation, experimentally achieved by either topical or in vitro
application of DKK1, may be desirable for conditions such as uneven
skin pigmentation, pigmented birthmarks, or post inflammatory
pigmentation. Suppressed hair growth may be cosmetically desirable for
some areas of the skin, and in conditions such hypertrichosis, adrenal
hyperplasia, or polycystic ovarian syndrome. DKK1 treatment may also be
important for treating or preventing certain melanomas which involve
hyperplastic or pre-malignant lesions.
Applications: Useful for skin grafts, skin ulcers, skin abrasions,
fragrance dermatitis, vitiligo, etc.; Treatment of several conditions
which require decreased skin pigmentation; Decreased hair growth for
cosmetic or therapeutic purposes.
Development Status: Early stage.
Inventors: Vincent J. Hearing et al. (NCI).
Publication: Y Yamaguchi, T Passeron, T Hoashi, H Watabe, F
Rouzaud, K Yasumoto, T Hara, C Tohyama, I Katayama, T Miki, VJ Hearing.
Dickkopf 1 (DKK1) regulates skin pigmentation and thickness by
affecting Wnt/[beta]-catenin signaling in keratinocytes. FASEB J. 2008
Apr;22(4):1009-1020.
Patent Status:
U.S. Provisional Application No. 60/873,874 filed 07 Dec 2006 (HHS
Reference No. E-321-2006/0-US-01).
PCT Application No. PCT/US2007/086855 filed 07 Dec 2007 (HHS
Reference No. E-321-2006/0-PCT-02).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jasbir (Jesse) S. Kindra, J.D., M.S.; 301-435-
5170; kindraj@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Laboratory of Cell Biology is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize the use of DKK1 or a bioactive
fragment of DKK1 to treat abnormal pigmentation of the skin or to
regulate hair growth. Please contact John D. Hewes, Ph.D. at 301-435-
3121 or hewesj@mail.nih.gov for more information.
Flow-Through Thermal-Expansion-Compensated Microcells for Analytical
Transmission Infrared Spectroscopy
Description of Technology: Available for licensing and commercial
distribution are optical cells spectroscopically stable and can be used
for spectroscopic measurement in transmission, sample reflection, back
plate reflection, emission, or scattering modes. The cell allows fluid
in a sample space to be exchanged without separating a front or a back
plate from a spacer, allows a solid sample to be placed in or removed
from the sample space, requires only a small amount of sample, and
allows for different sample gaps to be easily and inexpensively set.
Alternatively, the spacers can be manufactured using a hydrocarbon-
resistant polymer so that samples dissolved in organic solvents can be
used without the risk of changing the spectral properties of the
microcell and solvent leakage from the sample space. The inventive cell
and methods allow spectral measurements to be taken over wavelengths
ranging at least from the mid-infrared to the vacuum ultraviolet,
provide a simple path for light traveling through a sample, and allow
fast kinetic processes to be detected and monitored reproducibly and
sensitively.
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Applications: Analytics; Spectroscopy; Infrared spectroscopy;
Chemical Imaging; Material characterization; Quality control;
Chemometrics in chemical and pharmaceutical manufacturing; Forensic
applications; Tissue pathology diagnostics
Inventors: Edward Mertz and James Sullivan (NICHD).
Publications:
1. Makareeva E, Mertz EL, Kuznetsova NV, Sutter MB, DeRidder AM,
Cabral WA, Barnes AM, McBride DJ, Marini JC, Leikin S. Structural
heterogeneity of type I collagen triple helix and its role in
osteogenesis imperfecta. J Biol Chem. 2008 Feb 22;283(8):4787-4798.
2. Mertz EL, Leikin S. Interactions of inorganic phosphate and
sulfate anions with collagen. Biochemistry. 2004 Nov 30;43(47):14901-
14912.
Patent Status:
U.S. Patent 7,355,697 issued 08 Apr 2008 (HHS Reference No. E-096-
2004/0-US-01).
International Patent Application No. PCT/US2005/030218 filed 25 Aug
2005, which published as WO 2006/026342 on 09 Mar 2006 (HHS Reference
No. E-096-2004/0-PCT-02).
European Patent Application 05786373.9 filed 26 Aug 2005 (HHS
Reference No. E-096-2004/0-EP-03).
U.S. Patent Application No. 11/826,806 filed 18 Jul 2007 (HHS
Reference No. E-096-2004/1-US-01).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The Eunice Kennedy Shriver
National Institute of Child Health and Human Development, Section on
Physical Biochemistry is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize microcells for infrared and other
spectroscopies and their applications to pathology diagnostics. Please
contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for
more information.
Rapid and Sensitive Detection of Nucleic Acid Sequence Variations
Description of Technology: The ability to easily detect small
mutations in nucleic acids, such as single base substitutions, can
provide a powerful tool for use in cancer detection, perinatal screens
for inherited diseases, and analysis of genetic polymorphisms such as
genetic mapping or for identification purposes. Current approaches make
use of the mismatch that occurs between complimentary strands of DNA
when there is a genetic mutation, the electrophoretic mobility
differences caused by small sequence changes, and chemicals or enzymes
that can cleave heteroduplex sites. Some of these methods, however,
prove to be too cumbersome, are unable to pinpoint mutations, only
detect a subset of mutations, or involve the use of hazardous
materials.
The current invention takes advantage of the ability of
transposons, or mobile genetic elements, to move from one part of the
genome to another by the cleavage and joining of their sequences into
the target site; a reaction facilitated by a transposase enzyme. The
phage Mu transposase is capable of inserting the right end sequence of
the Mu transposon into any DNA sequence both in vitro and in vivo. The
surprising discovery that the Mu transposase displays a strong
preference for inserting Mu-end DNA into mismatched sites, the very
sites which occur when DNA is mutated and paired with its complementary
strand that does not have the corresponding mutation, makes it a
powerful tool for detecting variations in nucleic acid sequences. In
this system, the transposition of Mu-end DNA at a site is used to
indicate the presence of a nucleic acid mismatch or mutation at that
site. The invention can be used with labeled Mu-end DNA to further
facilitate the precise mapping of the mutations. This specificity
allows Mu to detect even single base mutations among a large quantity
of non-specific DNA. The Mu detection system is simple, rapid, and
highly sensitive compared to current methods and can find a broad range
of use in genetic research and the diagnosis of several diseases such
as cystic fibrosis, spinal and bulbar muscular dystrophy, human
fragile-X syndrome, and Huntington's disease.
Applications:
Fast, simple screening for genetic mutations in several diseases
such as cystic fibrosis, spinal and bulbar muscular dystrophy, human
fragile-X syndrome, Huntington's disease,
[[Page 40588]]
detection of birth defects, and paternity testing, etc.
Genetic mapping and identification.
Development Status: Early stage.
Inventors: Katsuhiko Yanagihara and Kiyoshi Mizuuchi (NIDDK).
Publication: Yanagihara K and Mizuuchi K. Mismatch-targeted
transposition of Mu: a new strategy to map genetic polymorphism. Proc
Natl Acad Sci USA. 2002 Aug 20; 99(17):11317-11321.
Patent Status: U.S. Patent No. 7,316,903 issued 08 Jan 2008 (HHS
Reference No. E-071-2003/0-US-02).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jasbir (Jesse) S. Kindra, JD, MS; 301-435-5170;
kindraj@mail.nih.gov.
Collaborative Research Opportunity: The Section on Genetic
Mechanisms, LMB, NIDDK is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize Mu transposition system as a tool for
mutation detection and other genetic research/manipulation. Please
contact Kiyoshi Mizuuchi at kmizu@helix.nih.gov for more information.
Dated: July 8, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-16134 Filed 7-14-08; 8:45 am]
BILLING CODE 4140-01-P
