Government-Owned Inventions; Availability for Licensing, 4573-4575 [2010-1665]
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Federal Register / Vol. 75, No. 18 / Thursday, January 28, 2010 / Notices
Inventors: Peter D. Burbelo and
Michael J. Iadarola (NIDCR).
Related Publications:
1. Burbelo PD, Leahy HP, Issa AT,
Groot S, Baraniuk JN, Nikolov NP, Illei
GG, Iadarola MJ. Sensitive and robust
luminescent profiling of anti-La and
other autoantibodies in Sjogren’s
syndrome. Autoimmunity. 2009
Sep;42(6):515–524. [PubMed: 19657778]
2. Burbelo PD, Ching KH, Issa AT,
Loftus CM, Li Y, Satoh M, Reeves WH,
Iadarola MJ. Rapid serological detection
of autoantibodies associated with
¨
Sjogren’s syndrome. J Transl Med. 2009
Sep 24;7:83. [PubMed: 19778440]
3. Burbelo PD, Ching KH, Klimavicz
CM, Iadarola MJ. Antibody profiling by
Luciferase Immunoprecipitation
Systems (LIPS). J Vis Exp. 2009 Oct
7;(32); pii: 1549; doi: 10.3791/1549.
[PubMed: 19812534]
Patent Status: U.S. Provisional
Application No. 61/224,649 filed 10 Jul
2009 (HHS Reference No. E–070–2009/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Norbert Pontzer,
J.D., Ph.D.; 301–435–5502;
pontzern@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Dental and
Craniofacial Research, Laboratory of
Sensory Biology, Neurobiology and Pain
Therapeutics Section, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact David W. Bradley, Ph.D. at 301–
402–0540 or bradleyda@nidcr.nih.gov
for more information.
Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–1680 Filed 1–27–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSKH9S0YB1PROD with NOTICES
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
VerDate Nov<24>2008
17:16 Jan 27, 2010
Jkt 220001
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.
Nitric Oxide-Based Therapeutics for
Lung Cancer
Description of Invention: JS–36–25, a
diazeniumdiolate prodrug, is available
for licensing and development of
treatments for lung cancer. The
inventors have demonstrated a potent
tumoristatic activity of JS–36–25 in both
lung cancer cells in vitro and as
xenografts in mice. JS–36–25 treatment
led to 85% reduction of tumor growth
in vivo. The tumoristatic potency of the
compound correlated well with the
level of endogenous reactive oxygen
species (ROS) in the cancer cells. Thus,
in addition to potent tumoristatic
activity when administered alone, this
compound is predicted to have a strong
synergy with therapeutics that act
through generation of ROS, such as
bortezomib, doxorubicin, as well as
high-energy radiation.
Applications: Development of lung
cancer treatments.
Development Status: Pre-clinical.
Market: There are over 160,000 new
cases of lung cancer every year in the
United States alone.
Inventors: Anna E. Maciag et al. (NCI).
Patent Status: U.S. Provisional
Application No. 61/261,175 filed 13
November 2009 (HHS Reference No.
E–025–2010/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Steve Standley,
Ph.D.; 301–435–4074;
sstand@od.nih.gov.
T-Cell-Specific Gfi-1 Knockout Mouse
Description of Invention: This is a
mouse model available to study T-cell
differentiation. Growth factor
independent 1 (GFi-1) is a
transcriptional repressor that is
transiently induced during T-cell
activation. This knockout mouse line is
a GFi-1[flox/flox] introduced into a
mouse Cre controlled by a CD4
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promoter, which allows selective
removal of GFi-1 exclusively in T-cells.
It has thus-far been used to demonstrate
that GFi-1 plays a critical role in
enhancing Th2 cell expansion and
repressing induction of Th17 and
CD103+ iTreg cells.
Applications: Tool for studying T-cell
proliferation and differentiation.
Inventors: Jinfang Zhu and William E.
Paul (NIAID).
Related Publication: J Zhu, TS
Davidson, G Wei, D Jankovic, K Cui, DE
Schones, L Guo, K Zhao, EM Shevach,
WE Paul. Down-regulation of Gfi-1
expression by TGF-beta is important for
differentiation of Th17 and CD103+
inducible regulatory T cells. J Exp Med.
2009 Feb 16;206(2):329–341. [PubMed:
19188499].
Patent Status: HHS Reference No.
E–242–2009/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: This technology is
available as a research tool under a
Biological Materials License.
Licensing Contact: Steve Standley,
Ph.D.; 301–435–4074;
sstand@od.noh.gov.
Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–1668 Filed 1–27–10; 8:45 am]
BILLING CODE 4140–01–P
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
E:\FR\FM\28JAN1.SGM
28JAN1
4574
Federal Register / Vol. 75, No. 18 / Thursday, January 28, 2010 / Notices
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.
Preventing Oral Mucositis With Hybrid
Adenoretroviral Vectors
Description of Invention: Researchers
at the National Institutes of Health have
recently developed a novel method
utilizing adenoretroviral vectors to
safely and swiftly prevent oral mucositis
induced by radiotherapy. This clever
new method developed by National
Institute of Dental and Craniofacial
Research (NIDCR) researchers combines
the advantages of adenoviral and
retroviral vectors to efficiently shuttle
into salivary glands a non-integrating
vector that can produce a therapeutic
protein for intermediate to long-term
treatment. This approach is anticipated
to result in fewer side-effects than
current therapies.
The market for the treatment of
mucositis, the painful inflammation and
ulceration of the mucous membranes
lining the digestive tract, is estimated to
be in excess of $5 billion worldwide. Up
to 80% of all patients receiving
radiotherapy and approximately 40% of
all chemotherapy patients develop oral
mucositis, and almost all patients
receiving radiotherapy for head and
neck cancer and those undergoing stem
cell transplantation develop mucositis.
mstockstill on DSKH9S0YB1PROD with NOTICES
Applications
• Prevention of radiation-induced
oral mucositis.
• Transduction of genes encoding
secretory proteins with clinical uses for
intermediate to long-term treatment
(e.g., 4–8 weeks).
Advantages
• Safe.
• Reduced potential for side-effects.
• Efficient production of transduced
genes.
• Efficient in vivo/in vitro
transduction.
• Extra-chromosomal location.
Development Status: Pre-clinical.
Inventor: Changyu Zheng et al.
(NIDCR).
Patent Status: U.S. Provisional
Application No. 61/176,210 filed 07
May 2009 (HHS Reference No. E–185–
2009/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Patrick McCue,
Ph.D.; 301–435–5560;
McCuepat@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Dental and
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17:16 Jan 27, 2010
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Craniofacial Research is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact David Bradley, Ph.D. at 301–
402–0540 or bradleyda@nidcr.nih.gov
for more information.
Mutations of the ERBB4 Gene in
Melanoma
Description of Invention: Cutaneous
malignant melanoma is the most
common fatal skin cancer, and the
incidence of this disease increases each
year. The average survival time for
patients diagnosed with malignant
melanoma is less than ten months.
Consequently, it is important to identify
and understand genetic alterations
leading to malignant melanoma so that
new treatment strategies can be
developed.
Protein tyrosine kinases (PTKs) have
been associated with a wide variety of
cancers, including melanoma. Using
high-throughput gene sequencing, the
NIH inventors have analyzed PTKs in
melanoma and have identified several
novel somatic alterations, including
alterations in ERBB4. This invention
provides methods of identifying specific
inhibitors to ERBB4 that could be used
to treat patients with ERBB4 mutations.
Given the recent success of small
molecule protein kinase inhibitors and
specifically inhibitors to EGFR, this
invention could be used to further the
development of specific inhibitors to
ERBB4 and improve existing melanoma
treatments for patients with these
mutations.
Applications
• Diagnostic array for the detection of
ERBB4 mutations.
• Method of identifying ERBB4
inhibitors as therapeutic agents to treat
malignant melanoma patients.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market
• Approximately 160,000 new cases
of melanoma are diagnosed worldwide
each year. Malignant melanoma is
increasing faster than any other cancer.
• Melanoma is the most prevalent
cancer among women between the ages
of 25 and 29 and the second most
prevalent cancer among women ages
30–34.
• Cutaneous malignant melanoma is
the most serious form of skin cancer and
accounts for about 75% of all skin
cancer deaths.
• One person dies from melanoma
every hour.
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Inventors: Yardena R. Samuels et al.
(NHGRI).
Related Publication: Prickett TD,
Agrawal NS, Wei X, Yates KE, Lin JC,
Wunderlich JR, Cronin JC, Cruz P,
Rosenberg SA, Samuels Y. Analysis of
the tyrosine kinome in melanoma
reveals recurrent mutations in ERBB4.
Nature Genet. 2009 October;
41(10):1127–1132. [PubMed: 19718025].
Patent Status: PCT Application No.
PCT/US2009/053005 filed 06 Aug 2009
(HHS Reference No. E–272–2008/
0–PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Whitney Hastings,
301–451–7337; hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The Cancer Genetics Branch, National
Human Genome Research Institute
(NHGRI), National Institutes of Health
(NIH) is seeking statements of capability
or interest from parties interested in
collaborative research to further
develop, evaluate and/or commercialize
an ERBB4-based diagnostic, prognostic
and/or theranostic test as well as
identify and/or evaluate ERBB4
inhibitor compounds for testing as
possible candidate malignant melanoma
therapeutic drugs. Please contact Claire
Driscoll at cdriscol@mail.nih.gov or Dr.
Yardena Samuels at
samuelsy@mail.nih.gov for more
information.
Genetically Modified Stem Cells for
Personalized Therapy of Single Gene
Disorders
Description of Invention: This
technology is directed to individualized
therapies of single gene disorders by
introducing a patient’s own genetically
modified adult stem cells to the
damaged tissue. Diseases arising from
single gene disorders affect
approximately 1% of the human
population. Unlike most current
treatments for such diseases, which are
non-specific and symptom-based, this
technology specifically addresses the
underlying pathology of the disorder.
Many single gene diseases are
accompanied by tissue damage and
inflammation. This technology exploits
the inflammatory response, which
includes homing of mesenchymal stem
cells to the site of damage, for
therapeutic purposes. The inventors
have genetically modified adult stem
cells to produce silencing RNA specific
to the defective protein in the damaged
tissue. The silencing RNA can inhibit
the source of the pathology and promote
the growth and differentiation of
genetically modified stem cells adjacent
to the damaged tissue which can
support the tissue healing process.
E:\FR\FM\28JAN1.SGM
28JAN1
Federal Register / Vol. 75, No. 18 / Thursday, January 28, 2010 / Notices
Additionally, the risk of developing
Graft Versus Host Disease is eliminated
by utilizing the patient’s own stem cells.
Proof of concept has been
demonstrated in the vascular type of the
Ehlers-Danlos Syndrome (VEDS). Using
tissues isolated from VEDS patients,
siRNA was shown to correct the
mutational defect. The siRNA not only
inhibited the production of the mutant
protein but also restored the normal,
non-pathological structure of the wildtype protein in the tissue.
This technology may be particularly
applicable to patients with mutations in
structural proteins of the extracellular
matrix, as presented in diseases such as
osteogenesis imperfecta, Marfan
syndrome, and Ehlers-Danlos syndrome
(EDS).
mstockstill on DSKH9S0YB1PROD with NOTICES
Potential Applications and Advantages
• Therapeutic for diseases arising
from single gene disorders.
• Specific to the underlying disease
unlike most current treatments.
• Therapeutic cells are recruited to
the specific site of damage.
• Subsequent differentiation and
localization of stem cells is therapeutic
to the damaged tissue.
Development Status: Pre-clinical;
however, patients with vascular type of
the Ehlers-Danlos syndrome (VEDS) are
being recruited for observational
studies.
Inventors: Wilfried M. Briest and
Mark I. Talan (NIA).
Patent Status: U.S. Provisional
Application No. 61/233,537 filed 13
Aug 2009 (HHS Reference No. E–171–
2008/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov.
HIV–1 Infection Detection Assay for
Seroconverted HIV–1 Vaccine
Recipients
Description of Invention: Available for
licensing and commercial distribution is
a serological test specifically designed
to distinguish between antibodies
generated in HIV vaccine recipients and
those generated in a natural HIV
infection. The method is useful in HIV
vaccine development and clinical
studies as it can readily detect early
breakthrough infections in
seroconverted vaccine recipients, thus
providing the information required to
determine vaccine efficacy. The test kit
includes diagnostic peptide fragments
derived from human immunodeficiency
virus-1 (HIV–1). The peptide epitopes
are primarily derived from the GAG-p6
and gp41 genes. These epitopes are
VerDate Nov<24>2008
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Jkt 220001
broadly reactive with early sera from
HIV infected individuals, but do not
illicit protective antibodies, or
immunologic cytotoxicity, and thus can
readily be excluded from current and
future HIV–1 vaccine candidates.
Applications
• Vaccine efficacy studies; Detection
of early seroconversion in vaccine
recipients.
• Distinguishing between healthy
vaccine recipients and natural HIV
infection.
• Blood bank screening.
Advantages: Cost effective method to
determine vaccines efficacy in clinical
studies.
Market: In spite of the more than
twenty years of efforts to develop HIV
vaccine, such vaccine does not yet exist.
While treatment of HIV/AIDS with
antiretroviral drugs can reduce viral
load and extend life, this approach does
not provide a true cure and cannot stop
the HIV/AIDS pandemic. The medical
community therefore fully recognizes
the urgency to develop an effective
vaccine for HIV/AIDS. In spite of the
many challenges in the development of
such vaccine (out of the 75 vaccine
candidates that entered clinical trials
over the years only 3 have reached the
stage of large-scale efficacy trials and to
date none have prove efficacious) the
efforts in this area will continue to
receive high priority by the public
sector and high level of research
funding. In order to make progress in
this area, public sectors in many
countries as well as not-for-profit NGOs
have in recent years developed
strategies and provided incentives to the
private sector to continue with the
efforts through the creation of publicprivate partnerships. Development of
tools that can facilitate clinical trials,
such as the present invention, may
therefore be a good commercial
opportunity, in particular in light of the
potential market for HIV/AIDS vaccine.
While the market for therapeutic drugs
against HIV/AIDS across the seven
major markets is now approaching $11.0
billion annually and growing at about
12.8% a year, the International AIDS
Vaccine Initiative (IAVI) projects $2.5
billion to $5.5 billion in peak annual
revenues of any new vaccine. This
projection is based on peak demand of
between 38 and 152 million courses
(two doses per one course) depending
on the vaccine profile. The projection
also takes into consideration a tiered
pricing and this projected revenue
represents 5% to 13% of the total global
vaccine market.
Inventors: Hana Golding and Surender
Khurana (FDA).
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4575
Related Publications
1. S Khurana et al. Human
immunodeficiency virus (HIV) vaccine
trials: A novel assay for differential
diagnosis of HIV infections in the face
of vaccine-generated antibodies. J Virol.
2006 March;80(5): 2092–2099. [PubMed:
16474117].
2. S Khurana et al. Novel approach for
differential diagnosis of HIV infections
in the face of vaccine-generated
antibodies: Utility for detection of
diverse HIV–1 subtypes. J Acquir
Immune Defic Syndr. 2006 Nov
1;43(3):304–312. [PubMed: 17019363].
3. S Khurana et al. HIV–SELECTEST
EIA and rapid test: Ability to detect
seroconversion following HIV–1
infection. J Clin Microbiol. 2009 Nov 11.
Epub ahead of print. doi:10.1128/
JCM.01573–09. [PubMed: 19906903].
Patent Status
• U.S. Provisional Application No.
60/607,579 filed 08 Sep 2004 (HHS
Reference No. E–259–2004/0–US–01).
• U.S. Provisional Application No.
60/676,931 filed 03 May 2005 (HHS
Reference No. E–259–2004/1–US–01).
• PCT Application No. PCT/US2005/
031287, which published as WO/2007/
018550 on 15 Feb 2007 (HHS Reference
No. E–259–2004/2–PCT–01); and related
applications: U.S. Patent Application
No. 11/662,370 filed 02 Sep 2005,
published 27 Jun 2007; Australia Patent
Application No. 2005335203, published
04 Apr 2007; Canadian Patent
Application No. 2579676; European
Patent Application No. 2005858397,
published 27 Jun 2007.
• U.S. Provisional Application No.
61,180,233 filed 21 May 2009 (HHS
Reference No. E–259–2004/3–US–01).
Licensing Status: Available for
licensing.
Licensing Contacts: Uri Reichman,
Ph.D., M.B.A.; 301–435–4616;
UR7a@nih.gov; or Michael Shmilovich,
Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–1665 Filed 1–27–10; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\28JAN1.SGM
28JAN1
]]>Agencies
[Federal Register Volume 75, Number 18 (Thursday, January 28, 2010)]
[Notices]
[Pages 4573-4575]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1665]
-----------------------------------------------------------------------
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
[[Page 4574]]
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.
Preventing Oral Mucositis With Hybrid Adenoretroviral Vectors
Description of Invention: Researchers at the National Institutes of
Health have recently developed a novel method utilizing adenoretroviral
vectors to safely and swiftly prevent oral mucositis induced by
radiotherapy. This clever new method developed by National Institute of
Dental and Craniofacial Research (NIDCR) researchers combines the
advantages of adenoviral and retroviral vectors to efficiently shuttle
into salivary glands a non-integrating vector that can produce a
therapeutic protein for intermediate to long-term treatment. This
approach is anticipated to result in fewer side-effects than current
therapies.
The market for the treatment of mucositis, the painful inflammation
and ulceration of the mucous membranes lining the digestive tract, is
estimated to be in excess of $5 billion worldwide. Up to 80% of all
patients receiving radiotherapy and approximately 40% of all
chemotherapy patients develop oral mucositis, and almost all patients
receiving radiotherapy for head and neck cancer and those undergoing
stem cell transplantation develop mucositis.
Applications
Prevention of radiation-induced oral mucositis.
Transduction of genes encoding secretory proteins with
clinical uses for intermediate to long-term treatment (e.g., 4-8
weeks).
Advantages
Safe.
Reduced potential for side-effects.
Efficient production of transduced genes.
Efficient in vivo/in vitro transduction.
Extra-chromosomal location.
Development Status: Pre-clinical.
Inventor: Changyu Zheng et al. (NIDCR).
Patent Status: U.S. Provisional Application No. 61/176,210 filed 07
May 2009 (HHS Reference No. E-185-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560;
McCuepat@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Dental and Craniofacial Research is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize this technology. Please contact
David Bradley, Ph.D. at 301-402-0540 or bradleyda@nidcr.nih.gov for
more information.
Mutations of the ERBB4 Gene in Melanoma
Description of Invention: Cutaneous malignant melanoma is the most
common fatal skin cancer, and the incidence of this disease increases
each year. The average survival time for patients diagnosed with
malignant melanoma is less than ten months. Consequently, it is
important to identify and understand genetic alterations leading to
malignant melanoma so that new treatment strategies can be developed.
Protein tyrosine kinases (PTKs) have been associated with a wide
variety of cancers, including melanoma. Using high-throughput gene
sequencing, the NIH inventors have analyzed PTKs in melanoma and have
identified several novel somatic alterations, including alterations in
ERBB4. This invention provides methods of identifying specific
inhibitors to ERBB4 that could be used to treat patients with ERBB4
mutations. Given the recent success of small molecule protein kinase
inhibitors and specifically inhibitors to EGFR, this invention could be
used to further the development of specific inhibitors to ERBB4 and
improve existing melanoma treatments for patients with these mutations.
Applications
Diagnostic array for the detection of ERBB4 mutations.
Method of identifying ERBB4 inhibitors as therapeutic
agents to treat malignant melanoma patients.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market
Approximately 160,000 new cases of melanoma are diagnosed
worldwide each year. Malignant melanoma is increasing faster than any
other cancer.
Melanoma is the most prevalent cancer among women between
the ages of 25 and 29 and the second most prevalent cancer among women
ages 30-34.
Cutaneous malignant melanoma is the most serious form of
skin cancer and accounts for about 75% of all skin cancer deaths.
One person dies from melanoma every hour.
Inventors: Yardena R. Samuels et al. (NHGRI).
Related Publication: Prickett TD, Agrawal NS, Wei X, Yates KE, Lin
JC, Wunderlich JR, Cronin JC, Cruz P, Rosenberg SA, Samuels Y. Analysis
of the tyrosine kinome in melanoma reveals recurrent mutations in
ERBB4. Nature Genet. 2009 October; 41(10):1127-1132. [PubMed:
19718025].
Patent Status: PCT Application No. PCT/US2009/053005 filed 06 Aug
2009 (HHS Reference No. E-272-2008/ 0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Whitney Hastings, 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The Cancer Genetics Branch,
National Human Genome Research Institute (NHGRI), National Institutes
of Health (NIH) is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate and/or commercialize an ERBB4-based diagnostic, prognostic
and/or theranostic test as well as identify and/or evaluate ERBB4
inhibitor compounds for testing as possible candidate malignant
melanoma therapeutic drugs. Please contact Claire Driscoll at
cdriscol@mail.nih.gov or Dr. Yardena Samuels at samuelsy@mail.nih.gov
for more information.
Genetically Modified Stem Cells for Personalized Therapy of Single Gene
Disorders
Description of Invention: This technology is directed to
individualized therapies of single gene disorders by introducing a
patient's own genetically modified adult stem cells to the damaged
tissue. Diseases arising from single gene disorders affect
approximately 1% of the human population. Unlike most current
treatments for such diseases, which are non-specific and symptom-based,
this technology specifically addresses the underlying pathology of the
disorder.
Many single gene diseases are accompanied by tissue damage and
inflammation. This technology exploits the inflammatory response, which
includes homing of mesenchymal stem cells to the site of damage, for
therapeutic purposes. The inventors have genetically modified adult
stem cells to produce silencing RNA specific to the defective protein
in the damaged tissue. The silencing RNA can inhibit the source of the
pathology and promote the growth and differentiation of genetically
modified stem cells adjacent to the damaged tissue which can support
the tissue healing process.
[[Page 4575]]
Additionally, the risk of developing Graft Versus Host Disease is
eliminated by utilizing the patient's own stem cells.
Proof of concept has been demonstrated in the vascular type of the
Ehlers-Danlos Syndrome (VEDS). Using tissues isolated from VEDS
patients, siRNA was shown to correct the mutational defect. The siRNA
not only inhibited the production of the mutant protein but also
restored the normal, non-pathological structure of the wild-type
protein in the tissue.
This technology may be particularly applicable to patients with
mutations in structural proteins of the extracellular matrix, as
presented in diseases such as osteogenesis imperfecta, Marfan syndrome,
and Ehlers-Danlos syndrome (EDS).
Potential Applications and Advantages
Therapeutic for diseases arising from single gene
disorders.
Specific to the underlying disease unlike most current
treatments.
Therapeutic cells are recruited to the specific site of
damage.
Subsequent differentiation and localization of stem cells
is therapeutic to the damaged tissue.
Development Status: Pre-clinical; however, patients with vascular
type of the Ehlers-Danlos syndrome (VEDS) are being recruited for
observational studies.
Inventors: Wilfried M. Briest and Mark I. Talan (NIA).
Patent Status: U.S. Provisional Application No. 61/233,537 filed 13
Aug 2009 (HHS Reference No. E-171-2008/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov.
HIV-1 Infection Detection Assay for Seroconverted HIV-1 Vaccine
Recipients
Description of Invention: Available for licensing and commercial
distribution is a serological test specifically designed to distinguish
between antibodies generated in HIV vaccine recipients and those
generated in a natural HIV infection. The method is useful in HIV
vaccine development and clinical studies as it can readily detect early
breakthrough infections in seroconverted vaccine recipients, thus
providing the information required to determine vaccine efficacy. The
test kit includes diagnostic peptide fragments derived from human
immunodeficiency virus-1 (HIV-1). The peptide epitopes are primarily
derived from the GAG-p6 and gp41 genes. These epitopes are broadly
reactive with early sera from HIV infected individuals, but do not
illicit protective antibodies, or immunologic cytotoxicity, and thus
can readily be excluded from current and future HIV-1 vaccine
candidates.
Applications
Vaccine efficacy studies; Detection of early
seroconversion in vaccine recipients.
Distinguishing between healthy vaccine recipients and
natural HIV infection.
Blood bank screening.
Advantages: Cost effective method to determine vaccines efficacy in
clinical studies.
Market: In spite of the more than twenty years of efforts to
develop HIV vaccine, such vaccine does not yet exist. While treatment
of HIV/AIDS with antiretroviral drugs can reduce viral load and extend
life, this approach does not provide a true cure and cannot stop the
HIV/AIDS pandemic. The medical community therefore fully recognizes the
urgency to develop an effective vaccine for HIV/AIDS. In spite of the
many challenges in the development of such vaccine (out of the 75
vaccine candidates that entered clinical trials over the years only 3
have reached the stage of large-scale efficacy trials and to date none
have prove efficacious) the efforts in this area will continue to
receive high priority by the public sector and high level of research
funding. In order to make progress in this area, public sectors in many
countries as well as not-for-profit NGOs have in recent years developed
strategies and provided incentives to the private sector to continue
with the efforts through the creation of public-private partnerships.
Development of tools that can facilitate clinical trials, such as the
present invention, may therefore be a good commercial opportunity, in
particular in light of the potential market for HIV/AIDS vaccine. While
the market for therapeutic drugs against HIV/AIDS across the seven
major markets is now approaching $11.0 billion annually and growing at
about 12.8% a year, the International AIDS Vaccine Initiative (IAVI)
projects $2.5 billion to $5.5 billion in peak annual revenues of any
new vaccine. This projection is based on peak demand of between 38 and
152 million courses (two doses per one course) depending on the vaccine
profile. The projection also takes into consideration a tiered pricing
and this projected revenue represents 5% to 13% of the total global
vaccine market.
Inventors: Hana Golding and Surender Khurana (FDA).
Related Publications
1. S Khurana et al. Human immunodeficiency virus (HIV) vaccine
trials: A novel assay for differential diagnosis of HIV infections in
the face of vaccine-generated antibodies. J Virol. 2006 March;80(5):
2092-2099. [PubMed: 16474117].
2. S Khurana et al. Novel approach for differential diagnosis of
HIV infections in the face of vaccine-generated antibodies: Utility for
detection of diverse HIV-1 subtypes. J Acquir Immune Defic Syndr. 2006
Nov 1;43(3):304-312. [PubMed: 17019363].
3. S Khurana et al. HIV-SELECTEST EIA and rapid test: Ability to
detect seroconversion following HIV-1 infection. J Clin Microbiol. 2009
Nov 11. Epub ahead of print. doi:10.1128/JCM.01573-09. [PubMed:
19906903].
Patent Status
U.S. Provisional Application No. 60/607,579 filed 08 Sep
2004 (HHS Reference No. E-259-2004/0-US-01).
U.S. Provisional Application No. 60/676,931 filed 03 May
2005 (HHS Reference No. E-259-2004/1-US-01).
PCT Application No. PCT/US2005/031287, which published as
WO/2007/018550 on 15 Feb 2007 (HHS Reference No. E-259-2004/2-PCT-01);
and related applications: U.S. Patent Application No. 11/662,370 filed
02 Sep 2005, published 27 Jun 2007; Australia Patent Application No.
2005335203, published 04 Apr 2007; Canadian Patent Application No.
2579676; European Patent Application No. 2005858397, published 27 Jun
2007.
U.S. Provisional Application No. 61,180,233 filed 21 May
2009 (HHS Reference No. E-259-2004/3-US-01).
Licensing Status: Available for licensing.
Licensing Contacts: Uri Reichman, Ph.D., M.B.A.; 301-435-4616;
UR7a@nih.gov; or Michael Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Dated: January 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-1665 Filed 1-27-10; 8:45 am]
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