Government-Owned Inventions; Availability for Licensing, 38230-38233 [E8-15201]
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Federal Register / Vol. 73, No. 129 / Thursday, July 3, 2008 / Notices
Dated: June 27, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–15178 Filed 7–2–08; 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.
ACTION: Notice.
AGENCY:
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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.
A Prophylactic and Therapeutic for
Preventing and Treating Tularemia by
Rapid Activation of Host Cells and
Antigen Recognition
Description of Technology: The
invention is a composition and method
for prophylactic and therapeutic
treatment of tularemia caused by
Francisella tularensis comprised of
Cationic Liposome DNA Complexes
(CLDC) complexed with noncoding
DNA and membrane antigens isolated
from F. tularensis strain LVS (MPF). F.
tularensis is category A pathogen (as
designated by the NIH) that was
previously weaponized by both the
former Soviet Union and the United
States of America and is currently a
potential bioweapon and bioterrorism
threat. Furthermore, tularemia is
endemic to the U.S. (majority of the
cases occurring in the Midwest) and
Europe. The prophylactic and
therapeutic activities of this invention
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rely in part on rapid activation of host
cells and recognition of bacterial
antigens. In vivo studies in mice show
that CLDC + MPF elicit protective
immunity against pneumonic tularemia
when administered shortly (days) prior
to exposure to aerosols of virulent F.
tularensis. The method can be
applicable for eliciting immune
response in other infectious diseases.
Applications:
Prophylactic and therapeutic for
Tularemia.
Biodefense agent.
Method is applicable to other
infectious diseases, particularly for
pathogens that are enveloped or
encapsulated (i.e. Pseudomonas
aeruginosa, Neisseria meningiditis,
Yersinia pestis and Influenza).
Advantages:
Rapid induction of protective
immunity against F. tularensis.
Avoids antibiotic resistance
associated with current therapies.
Development Status: In vitro and in
vivo data are available.
Market:
Prophylactic and treatment for
tularemia and other infectious diseases.
Biodefense.
Inventors: Catherine M. Bosio
(NIAID).
Publication: PowerPoint slide
presentation of invention can be
provided upon request.
Patent Status: U.S. Provisional
Application No. 61/030,984 filed 24 Feb
2008 (HHS Reference No. E–095–2008/
0–US–01).
Licensing Status: This invention is
available for exclusive or non-exclusive
licensing.
Licensing Contact: Sally Hu, PhD.;
301–435–5606, HuS@mail.nih.gov.
A New Method for Screening of Antitumor Agents
Description of Technology:
Astrocytomas and glioblastoma
multiforme are the most common forms
of malignant brain cancer, and are often
unresponsive to surgical removal and
pharmacological therapy. The 5 year
survival rate of glioblastoma is 5%,
thus, making it necessary for the
identification of more effective antitumor agents. Individuals with the
familial cancer syndrome
neurofibromatosis type 1 are
predisposed to developing multiple
tumors including astrocytoma and
glioblastoma.
Scientists at NCI have discovered a
new technology that will help screen
multiple anti-tumor and antineurofibromatosis agents in a high
throughput assay by using an
astrocytoma cell line (KR158) that
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expresses the luciferase gene under the
influence of dual promoters, E2F and
CMV.
This new technology distinguishes
between cytostatic and cytotoxic
compounds, thereby significantly
reducing the time and cost required to
screen anti-tumor agents.
Advantages:
Quantifiable.
Can be used in high throughput
assays.
Distinguishes between cytostatic and
cytotoxic activity of compounds.
Applications:
Cancer therapeutics.
Gene therapy.
Screening of anti-tumor agents.
Screening of anti-neurofibromatosis
agents.
Pharmacology of drugs.
Market: Neurofibromatoses is
inherited by many affected individuals
and occurs in 1 in 3500 individuals. In
addition, between 30 and 50 percent of
new cases arise spontaneously through
mutation in an individual’s genes which
can then be passed on to succeeding
generations, leading to increased tumor
risk. Astrocytomas and glioblastoma
multiforme are the most common
malignant brain tumor in adults with
very poor prognosis.
Development Status: Late-stage.
Inventors: Jessica J. Hawes and
Karlyne M. Reilly (NCI).
Patent Status: HHS Reference No. E–
038–2008/0—Research Tool. Patent
protection is not being sought for this
technology.
Licensing Status: Available for nonexclusive licensing.
Licensing Contact: John Stansberry,
Ph.D.; 301–435–5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Mouse
Cancer Genetics Program is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize anti-astrocytoma or antineurofibromatosis therapy. Please
contact John D. Hewes, PhD., at 301–
435–3121 or hewesj@mail.nih.gov for
more information.
A Novel Therapeutic Strategy for the
Treatment of Hyperpigmentation and
Melanoma
Description of Technology: The
present invention describes that the
transcription factor SOX9 is expressed
by normal human melanocytes in vitro
and in the skin in vivo, and that overexpression of SOX9 decreases the
proliferation of mouse and human
melanoma cell lines via several
pathways. Furthermore, SOX9 (or its
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bioactive derivatives) appears to be
potentially useful in inducing skin
pigmentation, may inhibit the
proliferation of melanoma cells and
increase their sensitivity to retinoic
acid, which could be used to treat
melanoma.
Advantages and Applications:
SOX9 (or its bioactive derivative)
might be useful in increasing skin
pigmentation in acquired
hypopigmentary disorders such as
vitiligo (1–2% of world population) or
post-inflammatory hypopigmentation.
A novel gene therapy based treatment
for Melanoma: Experimental results
show that cells over-expressing SOX9
do not form tumors in human skin
reconstructs or in mice as do wild type
or GFP-transduced melanoma cells.
SOX–9 therapy in combination with
retinoic acid can be an effective
therapeutic strategy for treating
melanoma.
Development Status: The technology
is currently in the pre-clinical stage of
development. Animal studies have been
performed and the inventors are
currently pursuing gene therapy
approaches with SOX9 which may be
useful in the treatment of melanoma.
Inventors: Vincent J. Hearing and
Thierry Passeron (NCI).
Patent Status: U.S. Provisional
Application No. 60/963,280 filed 03
Aug 2007 (HHS Reference No. E–150–
2007/0–US–01).
Licensing Status: Available for
exclusive and non-exclusive licensing.
Licensing Contact: Whitney Hastings,
Ph.D.; 301–451–7337;
hastingw@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 regulation of SOX9
function as a strategy to treat melanoma,
modulate skin pigmentation and/or
ameliorate skin pigmentary disorders.
Please contact John D. Hewes, Ph.D. at
301–435–3121 or hewesj@mail.nih.gov
for more information.
Method for Predicting and Detecting
Tumor Metastasis
Description of Technology: Detecting
cancer prior to metastasis greatly
increases the efficacy of treatment and
the chances of patient survival.
Although numerous biomarkers have
been reported to identify aggressive
tumor types and predict prognosis, each
biomarker is specific for a particular
type of cancer, and no universal marker
that can predict metastasis in a number
of cancers has been identified. In
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addition, due to a lack of reliability,
several markers are typically required to
determine the prognosis and course of
therapy.
Available for licensing are
carboxypeptidase E (CPE) inhibitor
compositions and methods to prognose
and treat cancer as well as methods to
determine the stage of cancer. The
inventors discovered that CPE
expression levels increase according to
the presence of cancer and metastasis
wherein CPE is upregulated in tumors
and CPE levels are further increased in
metastatic cancer. This data has been
demonstrated both in vitro and in vivo
experiments and in liver, breast,
prostate, colon, and head and neck
cancers. Metastatic liver cells treated
with CPE siRNA reversed the cells from
being metastatic and arrested cells from
further metastasis. Thus, CPE as a
biomarker for predicting metastasis and
its inhibitors have an enormous
potential to increase patient survival.
Applications:
Method to prognose multiple types of
cancer and determine likelihood of
metastasis.
Compositions that inhibit CPE such as
siRNA.
Method to prevent and treat cancer
with CPE inhibitors.
Market:
An estimated 1,437,180 new cases
and 565,650 deaths from cancer are
projected to occur in the U.S. in 2008;
Global cancer market is worth more
than eight percent of total global
pharmaceutical sales;
Cancer industry is predicted to
expand to $85.3 billion by 2010.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Y. Peng Loh (NICHD) et al.
Publication: Manuscript in
preparation.
Patent Status: PCT Application No.
PCT/US2008/051438 filed 18 Jan 2008,
claiming priority to 19 Jan 2007 (HHS
Reference No. E–096–2007/3–PCT–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute for Child Health
and Human Development, Section on
Cellular Neurobiology, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize CPE as a biomarker for
predicting metastasis. Please contact
John D. Hewes, Ph.D. at 301–435–3121
or hewesj@mail.nih.gov for more
information.
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Novel O-GLcNAcase Inhibitor and
Fluorogenic Substrate as a Tool for
Diagnosing Type 2 Diabetes
Description of Technology: NIH
researchers have synthesized a novel
analogue of O-(2-acet-amido-2-deoxy-Dglycopyrano-sylidene)amino-Nphenylcarbamate (PUGNAc), which
bears an extension on the N-acetyl
moiety. This modified PUGNAc acts as
a selective inhibitor of O-GlcNAcase; an
enzyme that removes Nacetylglucosamine from nuclear and
cytoplasmic proteins, and whose
inhibition is associated with the
development of Type 2 diabetes. The
most desirable feature of this new
compound is its ability to specifically
inhibit O-GlcNAcase without targeting
the related hexosaminidase A (HEX A)
and hexoaminidase B (HEX B) enzymes.
This unique property distinguishes it
from the original PUGNAc and other
compounds which inhibit O-GlcNAcase
as well as other enzymes. It also has a
smaller inhibitory effect on OGlcNAcase compared to the original
PUGNAc. These properties make the
modified PUGNAc useful for diagnostic
or therapeutic applications involving
Type 2 diabetes.
A fluorescent derivative of the
modified PUGNAc has also been
developed. Modified PUGNAc,
conjugated to a fluorescent moiety such
as 4-methylumbelliferone, can serve as
a substrate for O-GlcNAcase without
inhibiting HEX A. This allows the
fluorescently labeled compound to be
used for measuring O-GlcNAcase
enzyme activity, and thus provide a
means of diagnosing Type 2 diabetes in
human blood or tissue samples.
Previous reagents have monitored other
Type 2 diabetes related enzymes, but
with much less specificity. Recent
studies that link mutations of the
MGEA5 gene (which codes for OGlcNAcase) to Type 2 diabetes provide
further support for the use of the
fluorescent derivative as a potent tool
for diagnosing the disease. The
fluorogenic derivative may also be used
as a novel imaging agent for assessing OGlcNAcase function in-vivo.
Applications:
Diagnosis of type 2 diabetes.
In vivo imaging of O-GlcNAcase
enzyme function.
Development Status: Early stage.
Inventors: John A. Hanover et al.
(NIDDK).
Publication: Eun Ju Kim, Melissa
Perreira, Craig J. Thomas, and John A.
Hanover. An O-GlcNAcase-specific
inhibitor and substrate engineered by
the extension of the N-acetyl moiety. J.
Am. Chem. Soc. 2006 Apr
5;128(13):4234–4235.
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Patent Status: U.S. Patent Application
No. 11/654,647 filed 18 Jan 2007 (HHS
Reference No. E–229–2006/0–US–01).
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 NIDDK Laboratory of Cell
Biochemistry and Biology is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize modified PUGNAc for
prevention or treatment of Type 2
diabetes. Please contact Rochelle
Blaustein at 301–451–3636 or
Rochelle.Blaustein@nih.gov for more
information.
Use of Human Gamma Satellite
Insulator Sequences To Prevent Gene
Silencing and Allow for Long Term
Expression of Integrated Transgenes
Description of Technology: The lack
of stable expression of transgenes in
target cell lines remains a serious
problem for gene therapy and cellular
reprogramming approaches. Once
integrated into chromosomes, the
expression of these transgenes may be
regulated by epigenetic effects of the
surrounding chromatin. These position
effects, which include transgene
silencing and expression variegation,
are often associated with changes in the
chromatin structure, and are capable of
inhibiting gene expression and
neutralizing the intended effect of the
inserted transgene.
Experimental results suggest that gene
position effects can be partially
overcome by flanking the transgene with
regulatory elements called chromatin
insulators which work by establishing
defined domains of transcriptional
activity within the eukaryotic genome.
These insulators can partially overcome
position effects by shielding the
promoters from the influence of
neighboring regulatory elements, or by
preventing the spread of
heterochromatin which can lead to
subsequent gene silencing.
This invention discloses the use of
gamma satellite DNA, residing in the
pericentromeric region of human
chromosomes, as highly efficient
chromatin insulators. These insulators
have a remarkable ability to overcome
position effects and prevent the
silencing of transgenes. When human
chromosome 8 gamma satellite
sequences were used as flanking DNA
for eGFP (enhanced green fluorescent
protein) gene expression in mouse
erythroleukemia (MEL) cells, stable
transgene expression was recorded for
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well over eight months. Until recently,
no chromatin insulator sequences were
known to completely prevent gene
silencing on a long term basis in
transfected cells. The human gammasatellite sequences demonstrate a higher
efficiency than any known chromatin
insulator identified so far in intergenic
regions, and may have invaluable
applications in the fields of gene
therapy, protein expression, and cellular
reprogramming where adequate
expression of the transgene is essential
for long term therapeutic or
developmental success.
Applications:
Gene therapy.
Protein expression.
Cellular reprogramming.
Development Status: Prolonged
transgene expression attained in mouse
erythroleukemia (MEL) cells.
Inventors: Vladimir L. Larionov, JungHyun Kim, Tom Ebersole (NCI).
Publications:
1. G Felsenfeld, B Burgess-Beusse,
C Farrell, M Gaszner, R Ghirlando,
S Huang, C Jin, M Litt, F Magdinier,
V Mutskov, Y Nakatani, H Tagami,
A West, T Yusufzai. Chromatin
boundaries and chromatin domains.
Cold Spring Harb Symp Quant Biol.
2004;69:245–250.
2. T Ebersole, Y Okamoto, VN
Noskov, N Kouprina, JH Kim, SH Leem,
JC Barrett, H Masumoto, V Larionov.
Rapid generation of long synthetic
tandem repeats and its application for
analysis in human artificial
chromosome formation. Nucleic Acids
Res. 2005 Sep 1;33(15):e130,
doi:10.1093/nar/gni129.
Patent Status:
U.S. Provisional Application No. 60/
890,176 filed 15 Feb 2007 (HHS
Reference No. E–154–2006/0–US–01).
PCT Application No. PCT/US2008/
054170 filed 15 Feb 2008 (HHS
Reference No. E–154–2006/0–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 Molecular Pharmacology
is seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
gamma-satellite DNA insulators for
stable transgene expression in ectopic
chromosomal sites and in Human
Artificial Chromosomes (HACs). Please
contact John D. Hewes, Ph.D. at 301–
435–3121 or hewesj@mail.nih.gov for
more information.
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Single Nucleotide Polymorphism
Detection by DNA Melting Analysis
Description of Technology: A Single
Nucleotide Polymorphism (SNP) is
defined as a single base pair difference
occurring between members of the same
species, or between paired
chromosomes in an individual. Some
SNPs have been associated with disease
traits, and may predispose an individual
to a disease or may influence that
individual’s response to therapeutic
agents. There are several highthroughput methods that can detect
SNPs of moderate to high abundance,
where the polymorphism frequency is
greater than ten percent. However, SNPs
that alter gene expression or affect the
structure of a gene product are often of
much lower abundance, with allele
frequency of around one percent. Thus,
there is a need to devise highthroughput, inexpensive and efficient
methods for their detection.
The patent discloses methods for
accurately detecting nucleotide
sequence variations, such as
polymorphisms, deletions, insertions or
inversions, by comparison of DNA
melting profiles. Methods of detecting
single nucleotide sequence variations
within arrays are also disclosed, as are
methods of detecting mutations
correlated with genetic disease.
Applications:
Detection of SNPs and small
insertions, deletions, and inversions in
a DNA sequence.
Prediction of the etiology or prognosis
of certain diseases, or determination of
disease traits among individuals.
Advantages:
Useful for detecting rarely-occurring
SNPs.
High throughput, simple method that
measures DNA melting efficiently,
without using intervening steps such as
gels, columns etc.
Inventors: Robert H. Lipsky et al.
(NIAAA)
Patent Status: U.S. Patent No.
7,273,699 issued 25 Sep 2007 (HHS
Reference No. E–251–2001/0 US–02).
Licensing Status: Available for
exclusive, co-exclusive, or nonexclusive licensing.
Licensing Contact: Jasbir (Jesse) S.
Kindra, J.D., M.S.; 301–435–5170;
kindraj@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute on Alcohol Abuse
and Alcoholism Section on Molecular
Genetics is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize single nucleotide
polymorphism detection by melting
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analysis. Please contact Dr. Robert
Lipsky at 301/402–5591 or
rlipsky@mail.nih.gov for more
information.
Dated: June 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–15201 Filed 7–2–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Public Teleconference Regarding
Licensing and Collaborative Research
Opportunities for: Methods and
Compositions Relating to Detecting
Dihydropyrimidine Dehydrogenase
(DPD)
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
mstockstill on PROD1PC66 with NOTICES
Technology Summary
This technology relates to a method of
detecting DPD Splicing Mutations.
Technology Description
Scientists at the National Cancer
Institute have discovered a method
detecting DPD Splicing Mutations. This
method can identify patients with such
mutations, and thereby alert the health
care provider that the patient will have
an adverse reaction to the
chemotherapeutic agent, 5–Fluorouracil.
The invention relates to methods and
compositions that are useful for
detecting deficiencies in DPD levels in
mammals including humans. Cancer
patients having a DPD deficiency are at
risk of a severe toxic reaction to the
commonly used anticancer agent 5fluorouracil (5–FU). The technology
encompasses DPD genes from human
and pig, methods for detecting the level
of nucleic acids that encode DPD in a
patient, and nucleic acids that are useful
as probes for this purpose.
Novel applications of the methods
include:
• Screening of patients prior to the
administration of the chemotherapeutic
agent, 5–Fluorouracil.
• Diminishing and potentially
eliminating the severe side effects of 5–
Fluorauracil in patients.
Competitive Advantage of Our
Technology
5–Fluorouracil (5–FU) is a therapeutic
for the treatment of multiple cancers,
including breast and colon cancers. In
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the United States, approximately
275,000 cancer patients receive 5–FU
annually. It is estimated that three
percent (3%) of those patients develop
some degree of toxic reaction. Patients
suffering toxic reactions are difficult
and expensive to treat further.
Approximately, 15% of those
developing toxic reaction, will die as a
result of exposure to 5–FU. Death is
typically caused by cardiotoxicity. More
than 1,300 patients in the United States
die each year as a result of 5–FU
toxicity. These deaths are all potentially
avoidable if patients that are likely to
get adverse reaction with 5–FU
treatment are detected prior to
treatment.
Patent Estate
This technology consists of the
following patents and patent
applications:
I. United States Patent Number
5,856,454 entitled ‘‘cDNA for Human
and Pig Dihydropyrimidine
Dehydrogenase,’’ issued January 5, 1999
(HHS Ref. No. E–157–1994/0–US–01);
II. United States Patent Number
6,015,673 entitled ‘‘Cloning and
Expression of cDNA for Human
Dihydropyrimidine Dehydrogenase,’’
issued January 18, 2000 (HHS Ref. No.
E–157–1994/0–US–03);
III. United States Patent Number
6,787,306 entitled ‘‘Methods and
Compositions for Detecting
Dihydropyrimidine Dehydrogenase
Splicing Mutations,’’ issued September
7, 2004 (HHS Ref. No. E–157–1994/1–
US–01);
IV. United States Pre-Grant
Publication number 2005/0136433A1
corresponding to application serial
number 10/911237 entitled ‘‘Methods
and Compositions for Detecting
Dihydropyrimidine Dehydrogenase
Splicing Mutations,’’ published June 23,
2005 (HHS Ref. No. E–157–1994/1–US–
19) and all issued and pending
counterparts in Europe, Canada, and
Australia.
Next Step: Teleconference
There will be a teleconference where
the principal investigator will explain
this technology. Licensing and
collaborative research opportunities will
also be discussed. If you are interested
in participating in this teleconference
please call or e-mail Mojdeh Bahar;
(301) 435–2950; baharm@mail.nih.gov.
OTT will then e-mail you the date, time
and number for the teleconference.
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38233
Dated: June 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer.
National Institutes of Health.
[FR Doc. E8–15182 Filed 7–2–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; Deferred AA3 Applications.
Date: July 16, 2008.
Time: 1 to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Room 3042, Rockville, MD
20852 (Telephone Conference Call).
Contact Person: Katrina L. Foster, PhD,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Room
3042, Rockville, MD 20852, 301–443–4032,
katrina@mail.nih.gov.
The applications being reviewed in EEO2
were initially assigned to panel AA3. The
appropriate expertise was not available in
AA3; thus, these applications were removed
and are being reviewed in a SEP meeting.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants,
National Institutes of Health, HHS)
Dated: June 25, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–14924 Filed 7–2–08; 8:45 am]
BILLING CODE 4140–01–M
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]]>Agencies
[Federal Register Volume 73, Number 129 (Thursday, July 3, 2008)]
[Notices]
[Pages 38230-38233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15201]
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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.
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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.
A Prophylactic and Therapeutic for Preventing and Treating Tularemia by
Rapid Activation of Host Cells and Antigen Recognition
Description of Technology: The invention is a composition and
method for prophylactic and therapeutic treatment of tularemia caused
by Francisella tularensis comprised of Cationic Liposome DNA Complexes
(CLDC) complexed with noncoding DNA and membrane antigens isolated from
F. tularensis strain LVS (MPF). F. tularensis is category A pathogen
(as designated by the NIH) that was previously weaponized by both the
former Soviet Union and the United States of America and is currently a
potential bioweapon and bioterrorism threat. Furthermore, tularemia is
endemic to the U.S. (majority of the cases occurring in the Midwest)
and Europe. The prophylactic and therapeutic activities of this
invention rely in part on rapid activation of host cells and
recognition of bacterial antigens. In vivo studies in mice show that
CLDC + MPF elicit protective immunity against pneumonic tularemia when
administered shortly (days) prior to exposure to aerosols of virulent
F. tularensis. The method can be applicable for eliciting immune
response in other infectious diseases.
Applications:
Prophylactic and therapeutic for Tularemia.
Biodefense agent.
Method is applicable to other infectious diseases, particularly for
pathogens that are enveloped or encapsulated (i.e. Pseudomonas
aeruginosa, Neisseria meningiditis, Yersinia pestis and Influenza).
Advantages:
Rapid induction of protective immunity against F. tularensis.
Avoids antibiotic resistance associated with current therapies.
Development Status: In vitro and in vivo data are available.
Market:
Prophylactic and treatment for tularemia and other infectious
diseases.
Biodefense.
Inventors: Catherine M. Bosio (NIAID).
Publication: PowerPoint slide presentation of invention can be
provided upon request.
Patent Status: U.S. Provisional Application No. 61/030,984 filed 24
Feb 2008 (HHS Reference No. E-095-2008/0-US-01).
Licensing Status: This invention is available for exclusive or non-
exclusive licensing.
Licensing Contact: Sally Hu, PhD.; 301-435-5606, HuS@mail.nih.gov.
A New Method for Screening of Anti-tumor Agents
Description of Technology: Astrocytomas and glioblastoma multiforme
are the most common forms of malignant brain cancer, and are often
unresponsive to surgical removal and pharmacological therapy. The 5
year survival rate of glioblastoma is 5%, thus, making it necessary for
the identification of more effective anti-tumor agents. Individuals
with the familial cancer syndrome neurofibromatosis type 1 are
predisposed to developing multiple tumors including astrocytoma and
glioblastoma.
Scientists at NCI have discovered a new technology that will help
screen multiple anti-tumor and anti-neurofibromatosis agents in a high
throughput assay by using an astrocytoma cell line (KR158) that
expresses the luciferase gene under the influence of dual promoters,
E2F and CMV.
This new technology distinguishes between cytostatic and cytotoxic
compounds, thereby significantly reducing the time and cost required to
screen anti-tumor agents.
Advantages:
Quantifiable.
Can be used in high throughput assays.
Distinguishes between cytostatic and cytotoxic activity of
compounds.
Applications:
Cancer therapeutics.
Gene therapy.
Screening of anti-tumor agents.
Screening of anti-neurofibromatosis agents.
Pharmacology of drugs.
Market: Neurofibromatoses is inherited by many affected individuals
and occurs in 1 in 3500 individuals. In addition, between 30 and 50
percent of new cases arise spontaneously through mutation in an
individual's genes which can then be passed on to succeeding
generations, leading to increased tumor risk. Astrocytomas and
glioblastoma multiforme are the most common malignant brain tumor in
adults with very poor prognosis.
Development Status: Late-stage.
Inventors: Jessica J. Hawes and Karlyne M. Reilly (NCI).
Patent Status: HHS Reference No. E-038-2008/0--Research Tool.
Patent protection is not being sought for this technology.
Licensing Status: Available for non-exclusive licensing.
Licensing Contact: John Stansberry, Ph.D.; 301-435-5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Mouse Cancer Genetics Program is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize anti-astrocytoma or anti-
neurofibromatosis therapy. Please contact John D. Hewes, PhD., at 301-
435-3121 or hewesj@mail.nih.gov for more information.
A Novel Therapeutic Strategy for the Treatment of Hyperpigmentation and
Melanoma
Description of Technology: The present invention describes that the
transcription factor SOX9 is expressed by normal human melanocytes in
vitro and in the skin in vivo, and that over-expression of SOX9
decreases the proliferation of mouse and human melanoma cell lines via
several pathways. Furthermore, SOX9 (or its
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bioactive derivatives) appears to be potentially useful in inducing
skin pigmentation, may inhibit the proliferation of melanoma cells and
increase their sensitivity to retinoic acid, which could be used to
treat melanoma.
Advantages and Applications:
SOX9 (or its bioactive derivative) might be useful in increasing
skin pigmentation in acquired hypopigmentary disorders such as vitiligo
(1-2% of world population) or post-inflammatory hypopigmentation.
A novel gene therapy based treatment for Melanoma: Experimental
results show that cells over-expressing SOX9 do not form tumors in
human skin reconstructs or in mice as do wild type or GFP-transduced
melanoma cells.
SOX-9 therapy in combination with retinoic acid can be an effective
therapeutic strategy for treating melanoma.
Development Status: The technology is currently in the pre-clinical
stage of development. Animal studies have been performed and the
inventors are currently pursuing gene therapy approaches with SOX9
which may be useful in the treatment of melanoma.
Inventors: Vincent J. Hearing and Thierry Passeron (NCI).
Patent Status: U.S. Provisional Application No. 60/963,280 filed 03
Aug 2007 (HHS Reference No. E-150-2007/0-US-01).
Licensing Status: Available for exclusive and non-exclusive
licensing.
Licensing Contact: Whitney Hastings, Ph.D.; 301-451-7337;
hastingw@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 regulation of SOX9 function as
a strategy to treat melanoma, modulate skin pigmentation and/or
ameliorate skin pigmentary disorders. Please contact John D. Hewes,
Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.
Method for Predicting and Detecting Tumor Metastasis
Description of Technology: Detecting cancer prior to metastasis
greatly increases the efficacy of treatment and the chances of patient
survival. Although numerous biomarkers have been reported to identify
aggressive tumor types and predict prognosis, each biomarker is
specific for a particular type of cancer, and no universal marker that
can predict metastasis in a number of cancers has been identified. In
addition, due to a lack of reliability, several markers are typically
required to determine the prognosis and course of therapy.
Available for licensing are carboxypeptidase E (CPE) inhibitor
compositions and methods to prognose and treat cancer as well as
methods to determine the stage of cancer. The inventors discovered that
CPE expression levels increase according to the presence of cancer and
metastasis wherein CPE is upregulated in tumors and CPE levels are
further increased in metastatic cancer. This data has been demonstrated
both in vitro and in vivo experiments and in liver, breast, prostate,
colon, and head and neck cancers. Metastatic liver cells treated with
CPE siRNA reversed the cells from being metastatic and arrested cells
from further metastasis. Thus, CPE as a biomarker for predicting
metastasis and its inhibitors have an enormous potential to increase
patient survival.
Applications:
Method to prognose multiple types of cancer and determine
likelihood of metastasis.
Compositions that inhibit CPE such as siRNA.
Method to prevent and treat cancer with CPE inhibitors.
Market:
An estimated 1,437,180 new cases and 565,650 deaths from cancer are
projected to occur in the U.S. in 2008;
Global cancer market is worth more than eight percent of total
global pharmaceutical sales;
Cancer industry is predicted to expand to $85.3 billion by 2010.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Y. Peng Loh (NICHD) et al.
Publication: Manuscript in preparation.
Patent Status: PCT Application No. PCT/US2008/051438 filed 18 Jan
2008, claiming priority to 19 Jan 2007 (HHS Reference No. E-096-2007/3-
PCT-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The National Institute for
Child Health and Human Development, Section on Cellular Neurobiology,
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize CPE as a biomarker for predicting metastasis. Please
contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for
more information.
Novel O-GLcNAcase Inhibitor and Fluorogenic Substrate as a Tool for
Diagnosing Type 2 Diabetes
Description of Technology: NIH researchers have synthesized a novel
analogue of O-(2-acet-amido-2-deoxy-D-glycopyrano-sylidene)amino-N-
phenylcarbamate (PUGNAc), which bears an extension on the N-acetyl
moiety. This modified PUGNAc acts as a selective inhibitor of O-
GlcNAcase; an enzyme that removes N-acetylglucosamine from nuclear and
cytoplasmic proteins, and whose inhibition is associated with the
development of Type 2 diabetes. The most desirable feature of this new
compound is its ability to specifically inhibit O-GlcNAcase without
targeting the related hexosaminidase A (HEX A) and hexoaminidase B (HEX
B) enzymes. This unique property distinguishes it from the original
PUGNAc and other compounds which inhibit O-GlcNAcase as well as other
enzymes. It also has a smaller inhibitory effect on O-GlcNAcase
compared to the original PUGNAc. These properties make the modified
PUGNAc useful for diagnostic or therapeutic applications involving Type
2 diabetes.
A fluorescent derivative of the modified PUGNAc has also been
developed. Modified PUGNAc, conjugated to a fluorescent moiety such as
4-methylumbelliferone, can serve as a substrate for O-GlcNAcase without
inhibiting HEX A. This allows the fluorescently labeled compound to be
used for measuring O-GlcNAcase enzyme activity, and thus provide a
means of diagnosing Type 2 diabetes in human blood or tissue samples.
Previous reagents have monitored other Type 2 diabetes related enzymes,
but with much less specificity. Recent studies that link mutations of
the MGEA5 gene (which codes for O-GlcNAcase) to Type 2 diabetes provide
further support for the use of the fluorescent derivative as a potent
tool for diagnosing the disease. The fluorogenic derivative may also be
used as a novel imaging agent for assessing O-GlcNAcase function in-
vivo.
Applications:
Diagnosis of type 2 diabetes.
In vivo imaging of O-GlcNAcase enzyme function.
Development Status: Early stage.
Inventors: John A. Hanover et al. (NIDDK).
Publication: Eun Ju Kim, Melissa Perreira, Craig J. Thomas, and
John A. Hanover. An O-GlcNAcase-specific inhibitor and substrate
engineered by the extension of the N-acetyl moiety. J. Am. Chem. Soc.
2006 Apr 5;128(13):4234-4235.
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Patent Status: U.S. Patent Application No. 11/654,647 filed 18 Jan
2007 (HHS Reference No. E-229-2006/0-US-01).
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 NIDDK Laboratory of Cell
Biochemistry and Biology is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize modified PUGNAc for prevention or
treatment of Type 2 diabetes. Please contact Rochelle Blaustein at 301-
451-3636 or Rochelle.Blaustein@nih.gov for more information.
Use of Human Gamma Satellite Insulator Sequences To Prevent Gene
Silencing and Allow for Long Term Expression of Integrated Transgenes
Description of Technology: The lack of stable expression of
transgenes in target cell lines remains a serious problem for gene
therapy and cellular reprogramming approaches. Once integrated into
chromosomes, the expression of these transgenes may be regulated by
epigenetic effects of the surrounding chromatin. These position
effects, which include transgene silencing and expression variegation,
are often associated with changes in the chromatin structure, and are
capable of inhibiting gene expression and neutralizing the intended
effect of the inserted transgene.
Experimental results suggest that gene position effects can be
partially overcome by flanking the transgene with regulatory elements
called chromatin insulators which work by establishing defined domains
of transcriptional activity within the eukaryotic genome. These
insulators can partially overcome position effects by shielding the
promoters from the influence of neighboring regulatory elements, or by
preventing the spread of heterochromatin which can lead to subsequent
gene silencing.
This invention discloses the use of gamma satellite DNA, residing
in the pericentromeric region of human chromosomes, as highly efficient
chromatin insulators. These insulators have a remarkable ability to
overcome position effects and prevent the silencing of transgenes. When
human chromosome 8 gamma satellite sequences were used as flanking DNA
for eGFP (enhanced green fluorescent protein) gene expression in mouse
erythroleukemia (MEL) cells, stable transgene expression was recorded
for well over eight months. Until recently, no chromatin insulator
sequences were known to completely prevent gene silencing on a long
term basis in transfected cells. The human gamma-satellite sequences
demonstrate a higher efficiency than any known chromatin insulator
identified so far in intergenic regions, and may have invaluable
applications in the fields of gene therapy, protein expression, and
cellular reprogramming where adequate expression of the transgene is
essential for long term therapeutic or developmental success.
Applications:
Gene therapy.
Protein expression.
Cellular reprogramming.
Development Status: Prolonged transgene expression attained in
mouse erythroleukemia (MEL) cells.
Inventors: Vladimir L. Larionov, Jung-Hyun Kim, Tom Ebersole (NCI).
Publications:
1. G Felsenfeld, B Burgess-Beusse, C Farrell, M Gaszner, R
Ghirlando, S Huang, C Jin, M Litt, F Magdinier, V Mutskov, Y Nakatani,
H Tagami, A West, T Yusufzai. Chromatin boundaries and chromatin
domains. Cold Spring Harb Symp Quant Biol. 2004;69:245-250.
2. T Ebersole, Y Okamoto, VN Noskov, N Kouprina, JH Kim, SH Leem,
JC Barrett, H Masumoto, V Larionov. Rapid generation of long synthetic
tandem repeats and its application for analysis in human artificial
chromosome formation. Nucleic Acids Res. 2005 Sep 1;33(15):e130,
doi:10.1093/nar/gni129.
Patent Status:
U.S. Provisional Application No. 60/890,176 filed 15 Feb 2007 (HHS
Reference No. E-154-2006/0-US-01).
PCT Application No. PCT/US2008/054170 filed 15 Feb 2008 (HHS
Reference No. E-154-2006/0-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 Molecular Pharmacology is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize gamma-satellite
DNA insulators for stable transgene expression in ectopic chromosomal
sites and in Human Artificial Chromosomes (HACs). Please contact John
D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more
information.
Single Nucleotide Polymorphism Detection by DNA Melting Analysis
Description of Technology: A Single Nucleotide Polymorphism (SNP)
is defined as a single base pair difference occurring between members
of the same species, or between paired chromosomes in an individual.
Some SNPs have been associated with disease traits, and may predispose
an individual to a disease or may influence that individual's response
to therapeutic agents. There are several high-throughput methods that
can detect SNPs of moderate to high abundance, where the polymorphism
frequency is greater than ten percent. However, SNPs that alter gene
expression or affect the structure of a gene product are often of much
lower abundance, with allele frequency of around one percent. Thus,
there is a need to devise high-throughput, inexpensive and efficient
methods for their detection.
The patent discloses methods for accurately detecting nucleotide
sequence variations, such as polymorphisms, deletions, insertions or
inversions, by comparison of DNA melting profiles. Methods of detecting
single nucleotide sequence variations within arrays are also disclosed,
as are methods of detecting mutations correlated with genetic disease.
Applications:
Detection of SNPs and small insertions, deletions, and inversions
in a DNA sequence.
Prediction of the etiology or prognosis of certain diseases, or
determination of disease traits among individuals.
Advantages:
Useful for detecting rarely-occurring SNPs.
High throughput, simple method that measures DNA melting
efficiently, without using intervening steps such as gels, columns etc.
Inventors: Robert H. Lipsky et al. (NIAAA)
Patent Status: U.S. Patent No. 7,273,699 issued 25 Sep 2007 (HHS
Reference No. E-251-2001/0 US-02).
Licensing Status: Available for exclusive, co-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 Institute on
Alcohol Abuse and Alcoholism Section on Molecular Genetics is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
single nucleotide polymorphism detection by melting
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analysis. Please contact Dr. Robert Lipsky at 301/402-5591 or
rlipsky@mail.nih.gov for more information.
Dated: June 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-15201 Filed 7-2-08; 8:45 am]
BILLING CODE 4140-01-P
