Government-Owned Inventions; Availability for Licensing, 72713-72715 [2011-30357]
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72713
Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Respondents
Activity
Number of
Responses per
Respondent
Total annual
responses
235
1
235
Request for reduction of fees collected under section 743 of the FD&C Act .......................................
1 There
Total hours
2
470
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 510 facilities will
be subject to the reinspection and the
recall fees under section 743 of the
FD&C Act. Of these facilities, we
estimate that 46 percent will be small
businesses with annual gross sales
under $250,000. Therefore, 46 percent
of 510 equals to 235 respondents. Each
respondent will submit 1 request for
reduction of fees. Total annual
responses are 235. The average burden
is 2 hours, giving a total of 470 hours
annual burden.
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30411 Filed 11–23–11; 8:45 am]
BILLING CODE 4165–15–P
Government-Owned Inventions;
Availability for Licensing
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
Health Resources and Services
Administration
Statement of Delegation of Authority
I hereby delegate to the
Administrator, Health Resources and
Services Administration (HRSA), and
the Director, Centers for Disease Control
and Prevention (CDC), with authority to
redelegate, the authority vested in the
Secretary under Title III, Part P, Section
399T (42 U.S.C. 280g–8), titled ‘‘Support
for Patients Receiving a Positive
Diagnosis of Down Syndrome or Other
Prenatally or Postnatally Diagnosed
Conditions,’’ of the Public Health
Service Act, as amended, insofar as such
authority pertains to the functions of
HRSA and CDC, respectively. HRSA and
CDC will coordinate and collaborate
with each other and with the National
Institutes of Health, as appropriate, in
implementing this authority.
This delegation excludes the authority
to issue regulations, to establish
advisory committees and councils, and
appoint their members, and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines.
Jkt 226001
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.
SUMMARY:
Centers for Disease Control and
Prevention
14:31 Nov 23, 2011
Dated: November 14, 2011.
Kathleen Sebelius,
Secretary.
National Institutes of Health
BILLING CODE 4160–01–P
VerDate Mar<15>2010
I hereby affirm and ratify any actions
taken by the Administrator, HRSA, the
Director, CDC, or other HRSA and CDC
officials, which involve the exercise of
these authorities prior to the effective
date of this delegation.
This delegation is effective upon date
of signature.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–30471 Filed 11–22–11; 11:15 am]
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Average
burden per
response
Genetically Engineered Mouse Model
for Use as an Alternative Screening
Method for Evaluating P-glycoprotein
(P-gp) Substrate Toxicity in
Avermectin-sensitive Dogs
Description of Technology: A pitfall to
avermectins is central nervous system
PO 00000
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(CNS) toxicities in herding dogs. As a
result, all new avermectins must be
tested in a ‘‘Collie Safety Study’’ to
determine the degree of CNS toxicity.
The toxicity is due to a 4 base pair
mutation in the ATP-binding cassette,
sub-family B member 1 (ABCB1) gene.
This gene encodes for the Pglycoprotein (P-gp) that affects
absorption, distribution and elimination
of certain drugs. Researchers at FDA
have developed an alternate animal
model that includes two transgenic
mouse models, one containing the
mutant form of the canine ABCB1 gene
(Yancy 1 line) and the other containing
the canine wild-type gene (Yancy 2
line). The paired mouse system can be
utilized to assess the safety of
avermectins and other canine drugs by
determining the toxicity to canines with
the mutated form of the ABCB1 gene.
Ivermectin, a derivative of the
avermectin family of heartworm drugs
used to treat and control parasitic
infections, was used to verify this
mouse model. This technology will
enhance the population predictions
derived from clinical safety data and
serve to reduce the use of dogs in
avermectin derivative safety studies that
are part of the Investigational New
Animal Drug (INAD) approval process.
Potential Commercial Applications:
Drug screening technology to assess the
toxicity of canine drugs to canines with
the mutated form of the ABCB1 gene.
Competitive Advantages: Use as an
alternative in vivo model to canines for
assessment of drug safety in the
presence of the ABCB1 mutation.
Development Stage: In vivo data
available (animal).
Inventor: Haile F. Yancy (FDA).
Publication: Orzechowski K, et al., in
press Am J Vet Res.
Intellectual Property: HHS Reference
No. E–292–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Jaime Greene; (301)
435–5559; greenejaime@mail.nih.gov.
Collaborative Research Opportunity:
The FDA Center for Veterinary
Medicine is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
E:\FR\FM\25NON1.SGM
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Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Notices
wreier-aviles on DSK7SPTVN1PROD with NOTICES
commercialize this alternative mouse
model. For collaboration opportunities,
please contact Haile F. Yancy at
haile.yancy@fda.hhs.gov or (301) 210–
4096.
Treatment of Tuberculosis—Adjuvant
Therapies To Increase the Efficiency of
Antibiotic Treatments
Description of Technology: There is
growing evidence that resistance to
Mycobacterium tuberculosis infection is
governed in large part by the regulation
of host cell death. Lipid mediators
called eicosanoids are thought to play a
central role in this process. The subject
invention is a novel method of
enhancing the efficacy of antibiotic
treatments for Mycobacterium
tuberculosis infection by coadministering an inhibitor of 5lipoxygenase and a COX–2 dependent
prostaglandin. Inhibition of 5lipoxygenase and treatment with
prostaglandin E2 results in alteration of
the eicosanoid balance. The synergistic
effects of altering the eicosanoid balance
and treatment with antibiotics is
believed to result in more efficient
reduction of the bacterial burden and
thus, the period of antibiotic
administration and antibiotic dosage
could potentially be reduced. In vivo
data from mouse models can be
provided upon request.
Potential Commercial Applications:
The subject invention can be used as an
adjuvant therapy for existing antibiotic
treatment regimens against tuberculosis.
Competitive Advantages: The
disclosed method can be applied to
increase the efficacy of existing
antibiotic treatments for tuberculosis,
potentially reducing both the duration
and dosage of the antibiotic treatment.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: Katrin D. Mayer, Bruno
Bezerril D. Andrade, F. Alan Sher, and
Daniel L. Barber (NIAID).
Intellectual Property:
• HHS Reference No. E–189–2011/0
—U.S. Provisional Patent Application
No. 61/515,229 filed 04 Aug 2011.
• HHS Reference No. E–189–2011/1
—U.S. Provisional Patent Application
No. 61/515,237 filed 04 Aug 2011.
Licensing Contact: Kevin W. Chang,
Ph.D.; (301) 435–5018;
changke@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
VerDate Mar<15>2010
14:31 Nov 23, 2011
Jkt 226001
commercialize adjuvant therapy for
antibiotic treatment regimens against
tuberculosis. For collaboration
opportunities, please contact Katrin
Mayer, Ph.D. at mayerk@niaid.nih.gov
or (301) 594–8061.
DPEP1 and TPX2 as Prognostic
Biomarkers for Pancreatic Ductal
Adenocarcinoma
Description of Technology: Scientists
at NIH have developed prognostic
biomarkers and a candidate therapeutic
target for pancreatic ductal
adenocarcinoma (PDAC). PDAC is a
devastating cancer, and patients have an
average survival of six months. The 5year survival for PDAC patients is only
6%. This high lethality in pancreatic
cancer is due to the late diagnosis and
lack of any effective treatment. Greater
than 80% of patients are diagnosed in
an advanced stage of the disease. The
instant invention is a discovery of
biomarkers to make prognostic
conclusions about the progression of
PDAC by measuring the expression of
DPEP1 and TPX2. Patients with
decreased DPEP1 and increased TPX2
expression have poorer outcome.
Furthermore, DPEP1 and TPX2 are
controlled by the MAPK pathway. A
MAPK inhibitor can be used as a
treatment because it can lead to
increased DPEP1 and decreased TPX2
expression, which is associated with
better survival.
Potential Commercial Applications
• Prognostic biomarker to identify
high-risk patients.
• Identification of MAPK inhibitor(s)
altering DPEP1 and TPX2 expression.
Competitive Advantages
• Combination of measuring DPEP1
and TPX2 expression levels results in
improved prognosis prediction.
• Development of expression level
patterns during tumorigenesis that are
representative of PDAC.
Development Stage: In vivo data
available (human).
Inventors: Syed P. Hussain and Geng
Zhang (NCI).
Publication: DPEP1 and TPX2 as
Independent Predictors of CancerSpecific Mortality in Pancreatic Ductal
Adenocarcinoma, submitted April 2011.
Intellectual Property: HHS Reference
No. E–171–2011/0—U.S. Patent
Application No. 61/512,302 filed 27 July
2011.
Licensing Contact: Uri Reichman,
Ph.D., MBA; (301) 435–4616;
reichmau@mail.nih.gov.
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AAV Mediated CTLA–4 Gene Transfer
¨
To Treat Sjogren’s Syndrome
¨
Description of Technology: Sjogren’s
syndrome is an autoimmune disease
that affects over 2 million Americans,
primarily over the age of 40. One of the
¨
major outcomes of Sjogren’s syndrome
is xerostomia (dry mouth) that is caused
by immune system attack on moisture
producing salivary glands. Researchers
at the National Institute of Dental and
Craniofacial Research have developed a
therapy that alleviates xerostomia in a
¨
murine model of Sjogren’s syndrome.
This technology consists of a local
delivery of adeno-associated virus
(AAV) mediated cytotoxic Tlymphocyte antigen 4 ImmunoglobulinG (CTLA4IgG) fusion protein to salivary
glands. The system effectively blocks
CTLA4 ligand interactions with T cell
surface receptors, resulting in immune
suppression and reversal of
autoimmune-related xerostomia.
Targeted delivery of the AAV–CTLA4–
IgG system makes this invention a novel
therapeutic for the prevention of
xerostomia-associated pain and
¨
discomfort caused by Sjogren’s
syndrome.
Potential Commercial Applications:
Prevention of salivary gland destruction
and xerostomia development in patients
¨
with Sjogren’s syndrome.
Competitive Advantages
• Current treatments temporarily
reduce the discomfort of xerostomia but
do not prevent the deleterious effects of
this disorder.
• AAV gene transfer to salivary
glands is highly efficient.
• AAV therapy is safe and
noninflammatory.
Development Stage
• In vitro data available.
• In vivo data available (animal).
Inventors: Hongen Yin and John
Chiorini (NIDCR).
Publications
1. Zheng C, et al. Assessment of the safety
and biodistribution of a regulated AAV2
gene transfer vector after delivery to
murine submandibular glands. Toxicol
Sci. 2011 Sep;123(1):247–255. [PMID:
21625005]
2. Kanaya K, et al. Combined gene therapy
with adenovirus vectors containing
CTLA4Ig and CD40Ig prolongs survival
of composite tissue allografts in rat
model. Transplantation. 2003 Feb
15;75(3):275–281. [PMID: 12589145]
3. Genovese MC, et al. Abatacept for
rheumatoid arthritis refractory to tumor
necrosis factor alpha inhibition. N Engl
J Med. 2005 Sep 15;353(11):1114–1123.
[PMID: 16162882]
E:\FR\FM\25NON1.SGM
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Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Notices
Intellectual Property: HHS Reference
No. E–087–2011/0—U.S. Provisional
Application No. 61/476,168 filed 15
April 2011.
Licensing Contact: Jaime Greene; (301)
435–5559; greenejaime@mail.nih.gov.
Collaborative Research Opportunity:
The NIDCR is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact David Bradley at
bradleyda@nidcr.nih.gov.
Dated: November 18, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–30357 Filed 11–23–11; 8:45 am]
BILLING CODE 4140–01–P
Training, National Institutes of Health, Nat.
Inst. of Environmental Health Sciences, 615
Davis Dr., KEY615/3112, Research Triangle
Park, NC 27709, (919) 541–4980, collman@
niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation— Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
72715
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Diabetes and Obesity.
Date: December 14, 2011.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Krish Krishnan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, (301) 435–
1041, krishnak@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 17, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Dated: November 17, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2011–30348 Filed 11–23–11; 8:45 am]
[FR Doc. 2011–30352 Filed 11–23–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Interagency Breast Cancer and
Environmental Research Coordinating
Committee.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
National Institute of Environmental
Health Sciences; Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
National Institutes of Health
U.S. Customs and Border Protection
Center For Scientific Review; Notice of
Closed Meetings
Agency Information Collection
Activities: Cargo Manifest/Declaration,
Stow Plan, Container Status Messages
and Importer Security Filing
Name of Committee: Interagency Breast
Cancer and Environmental Research
Coordinating Committee.
Date: December 13, 2011.
Time: 3 p.m. to 5 p.m.
Agenda: The purpose of the meeting is to
continue the work of the Research
Translation, Dissemination, and Policy
Implications Subcommittee as it addresses a
broad set of objectives related to the overall
mandate of the IBCERC. The meeting agenda
will be available on the Web at https://www.
niehs.nih.gov/about/orgstructure/boards/
ibcercc/.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709. (This meeting will be
conducted remotely. To attend the meeting,
please RSVP via email to ibcercc@niehs.nih.
gov at least 10 days in advance and
instructions for joining the meeting will be
provided.)
Contact Person: Gwen Collman, Ph.D.,
Director, Division of Extramural Research &
VerDate Mar<15>2010
14:31 Nov 23, 2011
Jkt 226001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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 patentablematerial,
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: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: AIDS/HIV.
Date: December 13–14, 2011.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact: Kenneth A Roebuck, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
PO 00000
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U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day Notice and request for
comments; Extension of an existing
collection of information: 1651–0001.
AGENCY:
As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning the Cargo
Manifest/Declaration, Stow Plan,
Container Status Messages and Importer
Security Filing. This request for
comment is being made pursuant to the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13).
DATES: Written comments should be
received on or before January 24, 2012,
to be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Regulations and
Rulings, Office of International Trade,
799 9th Street NW., 5th Floor,
Washington, DC 20229–1177.
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Pages 72713-72715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30357]
-----------------------------------------------------------------------
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.
Genetically Engineered Mouse Model for Use as an Alternative Screening
Method for Evaluating P-glycoprotein (P-gp) Substrate Toxicity in
Avermectin-sensitive Dogs
Description of Technology: A pitfall to avermectins is central
nervous system (CNS) toxicities in herding dogs. As a result, all new
avermectins must be tested in a ``Collie Safety Study'' to determine
the degree of CNS toxicity. The toxicity is due to a 4 base pair
mutation in the ATP-binding cassette, sub-family B member 1 (ABCB1)
gene. This gene encodes for the P-glycoprotein (P-gp) that affects
absorption, distribution and elimination of certain drugs. Researchers
at FDA have developed an alternate animal model that includes two
transgenic mouse models, one containing the mutant form of the canine
ABCB1 gene (Yancy 1 line) and the other containing the canine wild-type
gene (Yancy 2 line). The paired mouse system can be utilized to assess
the safety of avermectins and other canine drugs by determining the
toxicity to canines with the mutated form of the ABCB1 gene.
Ivermectin, a derivative of the avermectin family of heartworm drugs
used to treat and control parasitic infections, was used to verify this
mouse model. This technology will enhance the population predictions
derived from clinical safety data and serve to reduce the use of dogs
in avermectin derivative safety studies that are part of the
Investigational New Animal Drug (INAD) approval process.
Potential Commercial Applications: Drug screening technology to
assess the toxicity of canine drugs to canines with the mutated form of
the ABCB1 gene.
Competitive Advantages: Use as an alternative in vivo model to
canines for assessment of drug safety in the presence of the ABCB1
mutation.
Development Stage: In vivo data available (animal).
Inventor: Haile F. Yancy (FDA).
Publication: Orzechowski K, et al., in press Am J Vet Res.
Intellectual Property: HHS Reference No. E-292-2011/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Jaime Greene; (301) 435-5559;
greenejaime@mail.nih.gov.
Collaborative Research Opportunity: The FDA Center for Veterinary
Medicine is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate or
[[Page 72714]]
commercialize this alternative mouse model. For collaboration
opportunities, please contact Haile F. Yancy at haile.yancy@fda.hhs.gov
or (301) 210-4096.
Treatment of Tuberculosis--Adjuvant Therapies To Increase the
Efficiency of Antibiotic Treatments
Description of Technology: There is growing evidence that
resistance to Mycobacterium tuberculosis infection is governed in large
part by the regulation of host cell death. Lipid mediators called
eicosanoids are thought to play a central role in this process. The
subject invention is a novel method of enhancing the efficacy of
antibiotic treatments for Mycobacterium tuberculosis infection by co-
administering an inhibitor of 5-lipoxygenase and a COX-2 dependent
prostaglandin. Inhibition of 5-lipoxygenase and treatment with
prostaglandin E2 results in alteration of the eicosanoid balance. The
synergistic effects of altering the eicosanoid balance and treatment
with antibiotics is believed to result in more efficient reduction of
the bacterial burden and thus, the period of antibiotic administration
and antibiotic dosage could potentially be reduced. In vivo data from
mouse models can be provided upon request.
Potential Commercial Applications: The subject invention can be
used as an adjuvant therapy for existing antibiotic treatment regimens
against tuberculosis.
Competitive Advantages: The disclosed method can be applied to
increase the efficacy of existing antibiotic treatments for
tuberculosis, potentially reducing both the duration and dosage of the
antibiotic treatment.
Development Stage:
Early-stage.
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: Katrin D. Mayer, Bruno Bezerril D. Andrade, F. Alan
Sher, and Daniel L. Barber (NIAID).
Intellectual Property:
HHS Reference No. E-189-2011/0 --U.S. Provisional Patent
Application No. 61/515,229 filed 04 Aug 2011.
HHS Reference No. E-189-2011/1 --U.S. Provisional Patent
Application No. 61/515,237 filed 04 Aug 2011.
Licensing Contact: Kevin W. Chang, Ph.D.; (301) 435-5018;
changke@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize adjuvant therapy for antibiotic
treatment regimens against tuberculosis. For collaboration
opportunities, please contact Katrin Mayer, Ph.D. at
mayerk@niaid.nih.gov or (301) 594-8061.
DPEP1 and TPX2 as Prognostic Biomarkers for Pancreatic Ductal
Adenocarcinoma
Description of Technology: Scientists at NIH have developed
prognostic biomarkers and a candidate therapeutic target for pancreatic
ductal adenocarcinoma (PDAC). PDAC is a devastating cancer, and
patients have an average survival of six months. The 5-year survival
for PDAC patients is only 6%. This high lethality in pancreatic cancer
is due to the late diagnosis and lack of any effective treatment.
Greater than 80% of patients are diagnosed in an advanced stage of the
disease. The instant invention is a discovery of biomarkers to make
prognostic conclusions about the progression of PDAC by measuring the
expression of DPEP1 and TPX2. Patients with decreased DPEP1 and
increased TPX2 expression have poorer outcome. Furthermore, DPEP1 and
TPX2 are controlled by the MAPK pathway. A MAPK inhibitor can be used
as a treatment because it can lead to increased DPEP1 and decreased
TPX2 expression, which is associated with better survival.
Potential Commercial Applications
Prognostic biomarker to identify high-risk patients.
Identification of MAPK inhibitor(s) altering DPEP1 and
TPX2 expression.
Competitive Advantages
Combination of measuring DPEP1 and TPX2 expression levels
results in improved prognosis prediction.
Development of expression level patterns during
tumorigenesis that are representative of PDAC.
Development Stage: In vivo data available (human).
Inventors: Syed P. Hussain and Geng Zhang (NCI).
Publication: DPEP1 and TPX2 as Independent Predictors of Cancer-
Specific Mortality in Pancreatic Ductal Adenocarcinoma, submitted April
2011.
Intellectual Property: HHS Reference No. E-171-2011/0--U.S. Patent
Application No. 61/512,302 filed 27 July 2011.
Licensing Contact: Uri Reichman, Ph.D., MBA; (301) 435-4616;
reichmau@mail.nih.gov.
AAV Mediated CTLA-4 Gene Transfer To Treat Sj[ouml]gren's Syndrome
Description of Technology: Sj[ouml]gren's syndrome is an autoimmune
disease that affects over 2 million Americans, primarily over the age
of 40. One of the major outcomes of Sj[ouml]gren's syndrome is
xerostomia (dry mouth) that is caused by immune system attack on
moisture producing salivary glands. Researchers at the National
Institute of Dental and Craniofacial Research have developed a therapy
that alleviates xerostomia in a murine model of Sj[ouml]gren's
syndrome. This technology consists of a local delivery of adeno-
associated virus (AAV) mediated cytotoxic T-lymphocyte antigen 4
Immunoglobulin-G (CTLA4IgG) fusion protein to salivary glands. The
system effectively blocks CTLA4 ligand interactions with T cell surface
receptors, resulting in immune suppression and reversal of autoimmune-
related xerostomia. Targeted delivery of the AAV-CTLA4-IgG system makes
this invention a novel therapeutic for the prevention of xerostomia-
associated pain and discomfort caused by Sj[ouml]gren's syndrome.
Potential Commercial Applications: Prevention of salivary gland
destruction and xerostomia development in patients with Sj[ouml]gren's
syndrome.
Competitive Advantages
Current treatments temporarily reduce the discomfort of
xerostomia but do not prevent the deleterious effects of this disorder.
AAV gene transfer to salivary glands is highly efficient.
AAV therapy is safe and noninflammatory.
Development Stage
In vitro data available.
In vivo data available (animal).
Inventors: Hongen Yin and John Chiorini (NIDCR).
Publications
1. Zheng C, et al. Assessment of the safety and biodistribution of a
regulated AAV2 gene transfer vector after delivery to murine
submandibular glands. Toxicol Sci. 2011 Sep;123(1):247-255. [PMID:
21625005]
2. Kanaya K, et al. Combined gene therapy with adenovirus vectors
containing CTLA4Ig and CD40Ig prolongs survival of composite tissue
allografts in rat model. Transplantation. 2003 Feb 15;75(3):275-281.
[PMID: 12589145]
3. Genovese MC, et al. Abatacept for rheumatoid arthritis refractory
to tumor necrosis factor alpha inhibition. N Engl J Med. 2005 Sep
15;353(11):1114-1123. [PMID: 16162882]
[[Page 72715]]
Intellectual Property: HHS Reference No. E-087-2011/0--U.S.
Provisional Application No. 61/476,168 filed 15 April 2011.
Licensing Contact: Jaime Greene; (301) 435-5559;
greenejaime@mail.nih.gov.
Collaborative Research Opportunity: The NIDCR is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize this technology.
For collaboration opportunities, please contact David Bradley at
bradleyda@nidcr.nih.gov.
Dated: November 18, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-30357 Filed 11-23-11; 8:45 am]
BILLING CODE 4140-01-P
