Government-Owned Inventions; Availability for Licensing, 49724-49726 [E7-16929]
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49724
Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Notices
Dated: August 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–17038 Filed 8–28–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Availability of Draft Policy
Documents for Comment
Health Resources and Services
Administration (HRSA), HHS.
ACTION: This is a Notice of Availability
and request for comments on draft
Agency Guidance (‘‘Policy Information
Notices’’ (PINs)) to describe the policy
and processes pertaining to requests
from federally-funded health centers to
change the scope of their Federal
project. The PINs, ‘‘Defining Scope of
Project and Policy for Requesting
Changes,’’ ‘‘Change in Scope Requests:
Policy for Adding a New Target
Population,’’ and ‘‘Specialty Services
and Health Centers’ Scope of Project,’’
are available on the Internet at https://
bphc.hrsa.gov.
AGENCY:
Comments must be received by
September 28, 2007.
ADDRESSES: Please send your comments
to the following e-mail address:
DPDgeneral@hrsa.gov.
SUMMARY: HRSA believes that
community input is valuable to the
development of policies and policy
documents related to the
implementation of HRSA programs,
including the Health Center Program.
Therefore, we are requesting comments
on the PINs referenced above. After
review and consideration of all
comments received, the PINs may be
amended to incorporate
recommendations from the public. Once
the PINs are finalized, they will be made
available on HRSA’s Web site, along
with the Agency’s ‘‘Response to Public
Comments.’’ The ‘‘Response to Public
Comments’’ will summarize the major
comments received and describe the
Agency’s response, including any
corresponding changes made to the
PINs. Where comments do not result in
a revision to the PINs, explanations will
be provided.
Background: HRSA administers the
Health Center Program, which supports
more than 3,800 health care delivery
sites, including community health
centers, migrant health centers, health
care for the homeless centers, and
public housing primary care centers.
jlentini on PROD1PC65 with NOTICES
DATES:
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Health centers serve clients that are
primarily low-income and minorities,
and deliver preventive and primary care
services to patients regardless of their
ability to pay. Charges for health care
services are set according to income.
The purpose of the recently published
draft PINs is to describe the policy and
processes pertaining to requests from
federally-funded health centers to
change the scope of their Federal
project, including requests to include
new specialty services and/or a new
target population within the scope of
the Federal project.
FOR FURTHER INFORMATION CONTACT: For
questions regarding this notice, please
contact the Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, at 301–594–4300.
Dated: August 21, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–17092 Filed 8–28–07; 8:45 am]
BILLING CODE 4165–15–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:
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.
Collagen-Induced Platelet Aggregation
Inhibitor From Mosquito Salivary
Glands
Description of Technology: Exposed
collagen in injured blood vessels
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provides a substrate for platelets to
adhere and aggregate initiating the first
step in thrombosis, the formation of
blood clots inside a blood vessel.
Despite the essential role of platelets in
vascular injury, excessive platelet
aggregation may also result in
thrombotic diseases such as stroke and
heart attack.
Available for licensing is a collagen
binding protein, named aegyptin, which
selectively inhibits collagen-platelet
aggregation, but not platelet aggregation
induced by other agonists. Collagen
initiates recruitment of circulating
platelets and triggers platelet activation.
Collagen also plays a critical role in
angiogenesis. Aegyptin blocks the
interaction of collagen with its major
ligands, von Willebrand factor,
glycoprotein VI (GPVI), and integrin
a2b1. These three ligands are of
particular importance because von
Willebrand factor plays a critical role in
tethering platelets to collagen, GPVI is
the major signaling platelet receptor,
and integrin a2b1 mediates platelet
adhesion and contributes to activation.
Since these ligands play a critical role
in the early stages of thrombus
formation, aegyptin represents a
potentially highly effective therapeutic
that can prevent and treat patients with
thrombotic disease. Alternatively,
aegyptin is potentially useful in
conditions where collagen plays a
critical role in angiogenesis or in
conditions where excessive deposition
of collagen plays a pathological role (e.g.
pancreatic carcinoma).
Applications:
Adjuvant to ‘‘Clot busting’’
therapeutics.
Method to prevent and/or treat
cardiovascular/thrombotic disease.
Method to treat patients undergoing
invasive cardiovascular procedures ( e.g.
angioplasty).
Model to study collagen-dependent
platelet aggregation or collagenmediated angiogenesis.
Advantages:
Highly effective therapeutics can
negatively modulate thrombosis in its
early stages by preventing collagen
interaction with three major ligands
involved in thrombus/clot formation.
Aegyptin’s potential use as a
prototype for drug delivery as an oral
therapeutic, which can reduce the need
for invasive surgeries that dilate blood
vessels such as stents or catheters.
Market:
Thrombolytic/antithrombotic
therapies are worth billions of dollars,
common therapeutics include heparin,
warfarin, and plasminogen activators.
Anticancer and antiangiogenic
therapies.
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Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Notices
Cardiac disease is the number one
cause of death in the U.S.
Pancreatic cancer is one of the most
lethal cancers, where only 23% patients
will survive after one year of diagnosis,
and 4% survive after five years of
diagnosis.
An estimated 37,170 Americans will
be newly diagnosed with pancreatic
cancer in 2007.
An estimated 33,370 deaths from
pancreatic cancer in the U.S. in 2007.
Pancreatic cancer is the fourth leading
cause of cancer death in the U.S.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Eric Calvo et al. (NIAID).
Related Publications:
1. A manuscript directly related to
this technology will be available as soon
as it is accepted for publication.
2. E Calvo. Collagen-platelet
aggregation inhibitor from mosquito
salivary glands. Biacore T100 seminar
series, November 2006, St. Louis,
Missouri.
3. S Yoshida and H Watanabe. Robust
salivary gland-specific transgene
expression in Anopheles stephensi
mosquito. Insect Mol Biol. 2006
Aug;15(4):403–410.
4. D Sun et al. Expression of
functional recombinant mosquito
salivary apyrase: A potential therapeutic
platelet aggregation inhibitor. Platelets.
2006 May;17(3):178–184.
Patent Status: U.S. Provisional
Application No. 60/198,629 filed 09 Jul
2007 (HHS Reference No. E–172–2007/
0–US–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 of Allergy and
Infectious Diseases, Laboratory of
Malaria and Vector Research, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize the platelet aggregation
inhibitor Aegyptin. Please contact Dr.
Jose Ribeiro, Head, Vector Biology
Section, at 301–496–9389 or
jribeiro@niaid.nih.gov for more
information.
jlentini on PROD1PC65 with NOTICES
Bifunctional Compounds That Bind to
Hormone Receptors
Description of Technology: The
development and progression of
prostate cancer is dependent on the
androgen receptor (AR), a liganddependent transcription factor. In the
inactive form AR resides in the cytosolic
region of the cell and when activated,
AR is imported into the nucleus. Initial
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hormonal therapy for prostate cancer
involves lowering serum levels of
testosterone to shut down AR activity.
Despite initial patient responses to
testosterone-depleting therapies,
prostate cancer becomes refractory to
hormonal therapy. Notably, AR is
reactivated in hormone-refractory
prostate cancer and reinstates its
proliferative and survival activity.
Available for licensing is a novel
chemical compound which is
bifunctional and binds to AR. This
compound is comprised of tubulinbinding and steroid receptor-binding
moieties. This compound is designed to
antagonize AR function in a
nonclassical manner by several
mechanisms and kills hormonerefractory prostate cells better than both
functional moieties. This compound is a
first-in-class of bifunctional steroid
receptor binding agents that can
antagonize steroid receptors in a variety
of hormone-dependent diseases, such as
breast and prostate cancer.
Applications:
Therapeutic compounds that
selectively target steroid receptorexpressing cancer cells resulting in
decreased toxicity.
Method to treat hormone resistant
prostate cancer and potentially other
steroid receptor dependent diseases
such as breast cancer.
Market:
Prostate cancer is the second most
common type of cancer among men,
wherein one in six men will be
diagnosed with prostate cancer.
An estimated 218,890 new cases of
prostate cancer and 27,050 deaths due
to prostate cancer in the U.S. in 2007.
An estimated 180,510 new cases of
breast cancer and 40,060 deaths due to
breast cancer in the U.S. in 2007.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Nima Sharifi et al. (NCI).
Patent Status: U.S. Provisional
Application No. 60/958,351 filed 03 Jul
2007 (HHS Reference No. E–163–2007/
0–US–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 Medical Oncology Branch, National
Cancer Institute is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize treatments of resistant
prostate cancer. Please contact John D.
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
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49725
Specific Binding Agents for KSHV
vIL–6 That Neutralize a Biological
Activity
Description of Technology: Kaposi’s
sarcoma-associated herpes virus (KSHV)
is an oncogenic herpes virus originally
identified in AIDS associated Kaposi’s
sarcoma (KS) lesions, the most common
tumor associated with HIV infection.
KSHV encodes various proteins that
have characteristics associated with
cellular growth and transformation,
including viral (v) IL–6 (KSHV vIL–6).
These viral proteins display structural
homology to their cellular counterparts,
and human and vIL–6 are
multifunctional cytokines that have
been shown to induce vascular
endothelial growth factor and other
factors.
Available for licensing are binding
agents that neutralize vIL–6 biological
activities, methods of diagnosing and
treating KSHV disorders, and methods
to monitor KSHV patient response to
treatment. Deregulation of cellular IL–6
expression is known to contribute to
tumor development, suggesting that
KSHV-derived vIL–6 could be part of a
viral strategy to promote malignant
transformation. Neutralizing activity of
anti-vIL–6 antibodies may provide a
potential therapeutic for KSHV
disorders such as HIV, Castleman’s
disease, and primary effusion
lymphoma.
Applications:
Therapeutic compositions to treat
KSHV disorders such as KS,
Castleman’s disease, and primary
effusion lymphoma.
Method to diagnose and treat KSHV
disorders.
Method to monitor patient response to
KSHV treatment.
Market:
Approximately 476,095 persons
currently living with HIV/AIDS in the
United States.
Estimated annual incidence rate for
KS is 5 cases per 100,000/year in the
U.S.; KS contributes to approximately
30% of AIDS related deaths.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Giovanna Tosato (NCI) et
al.
Publications:
1. Y Aoki and G Tosato. Therapeutic
options for human herpesvirus-8/
Kaposi’s sarcoma-associated
herpesvirus-related disorders. Expert
Rev Anti Ther. 2004 Apr;2(2):213–225.
2. Y Aoki et al. Detection of viral
interleukin-6 in Kaposi sarcomaassociated herpesvirus-linked disorders.
Blood. 2001 Apr 1;97(7):2173–2176.
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49726
Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Notices
jlentini on PROD1PC65 with NOTICES
3. Y Aoki et al. Kaposi’s sarcomaassociated herpesvirus-encoded
interleukin-6. J Hemathother Stem Cell
Res. 2000;9(2):137–145.
Patent Status:
U.S. Patent No. 6,939,547 issued 06
Sep 2005 (HHS Reference No. E–180–
2000/0–US–03).
U.S. Patent No. 7,108,981 issued 19
Sep 2006 (HHS Reference No. E–180–
2000/0–US–04).
U.S. Patent No. 7,235,365 issued 26
Jun 2007 (HHS Reference No. E–180–
2000/0–US–05).
U.S. Patent Application No. 11/
803,732 filed 14 May 2007 (HHS
Reference No. E–180–2000/0–US–06).
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 Cancer Institute’s
Laboratory of Cellular Oncology is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
therapeutics for Kaposi’s sarcomaassociated herpes virus (KSHV). Please
contact John D. Hewes, Ph.D. at 301–
435–3121 or hewesj@mail.nih.gov for
more information.
Interferon Alpha Hybrids
Description of Technology: Available
for licensing are hybrid interferon alpha
(INF-a) polypeptides constructed by
combinations of INFa21b and INFa2c,
and mutants of these hybrids. These
hybrid constructs have resulted in novel
IFNs that either combine different
biological properties from the parent
proteins or have significantly different
biological activity from both the parents
in anti-proliferative, anti-viral, or
competitive binding properties. For
instance, the hybrid designated HY–3
has higher anti-proliferative activity in
Daudi, WISH, and primary human
lymphocyte cells exhibiting
approximately 6 times higher antiproliferative activity than either parent
IFN. These IFN hybrids provide a
powerful tool for studying the structurefunction relationship of these
molecules. The engineered IFN-a
proteins may have important new
therapeutic applications and may
provide greater insights into
understanding of the clinical activities
of existing IFN-as.
Also available for licensing are hybrid
INF-a nucleic acids encoding the hybrid
polypeptides as well as cells, vectors,
pharmaceutical compositions with these
nucleic acid sequences.
Applications:
Anti-viral and cancer therapeutics.
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Research tool to study IFN-a
functions.
Market:
Interferon alpha market was worth
$2.1 billion in 2005.
Industry focus is novel subtype or
interferon alpha variants with improved
pharmacodynamic and safety
properties.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Kathryn C. Zoon et al.
(FDA).
Publications:
1. R Hu et al. Protein engineering of
interferon alphas. Methods Mol Med.
2005;116:69–80.
2. R Hu et al. Human IFN-alpha
protein engineering: The amino acid
residues at positions 86 and 90 are
important for antiproliferative activity. J
Immunol. 2001 Aug 1;167(3):1482–
1489.
3. Hu et al. Divergence of binding,
signaling, and biological responses to
recombinant human hybrid IFN. J
Immunol. 1999 Jul 15;163(2):854–860.
Patent Status:
U.S. Patent No. 7,235,232 issued 26
Jun 2007 (HHS Reference No. E–068–
1998/0–US–04)
U.S. Patent No. 6,685,933 issued 03
Feb 2004 (HHS Reference No. E–068–
1998/0–US–03).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jennifer Wong;
301/435–4633; wongje@mail.nih.gov.
AGENCY:
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use. This
collection was modified during the 60day comment period to change the
annual burden hours from ten to twelve.
This change will capture the increase in
burden hour and cost to respondents.
Title: Approval and Coordination of
Requirements to use the NETC for
Extracurricular Training Activities.
OMB Number: 1660–0029.
Abstract: The National Emergency
Training Center (NETC) is a FEMA
facility, which houses all FEMA
employees in headquarters, regions,
field establishments, and other
individuals and organizations
authorized to use the facility, which
provides training and educational
programs in emergency response,
preparedness, fire prevention and
control, disaster response, and longterm disaster recovery.
Affected Public: State, Local or Tribal
Government, Individuals or households,
Business or other for-profit, Not-forprofit institutions, Farms, and Federal
Government.
Number of Respondents: 60.
Estimated Time per Respondent:
FEMA Form75–10, 6 minutes and
FEMA Form 75–11, 6 minutes.
Estimated Total Annual Burden
Hours: 12 minutes.
Frequency of Response: On occasion.
Comments: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: Nathan Lesser, Desk
Officer, Department of Homeland
Security/FEMA, and sent via electronic
mail to oira_submission@omb.eop.gov
or faxed to (202) 395–6974. Comments
must be submitted on or before
September 28, 2007.
SUMMARY: The Federal Emergency
Management Agency (FEMA) has
submitted the following information
collection to the Office of Management
and Budget (OMB) for review and
clearance in accordance with the
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Chief, Records
Management, FEMA, 500 C Street, SW.,
Room 609, Washington, DC 20472,
facsimile number (202) 646–3347, or email address FEMA-InformationCollections@dhs.gov.
Dated: August 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–16929 Filed 8–28–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
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]]>Agencies
[Federal Register Volume 72, Number 167 (Wednesday, August 29, 2007)]
[Notices]
[Pages 49724-49726]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16929]
-----------------------------------------------------------------------
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.
Collagen-Induced Platelet Aggregation Inhibitor From Mosquito Salivary
Glands
Description of Technology: Exposed collagen in injured blood
vessels provides a substrate for platelets to adhere and aggregate
initiating the first step in thrombosis, the formation of blood clots
inside a blood vessel. Despite the essential role of platelets in
vascular injury, excessive platelet aggregation may also result in
thrombotic diseases such as stroke and heart attack.
Available for licensing is a collagen binding protein, named
aegyptin, which selectively inhibits collagen-platelet aggregation, but
not platelet aggregation induced by other agonists. Collagen initiates
recruitment of circulating platelets and triggers platelet activation.
Collagen also plays a critical role in angiogenesis. Aegyptin blocks
the interaction of collagen with its major ligands, von Willebrand
factor, glycoprotein VI (GPVI), and integrin [alpha]2[beta]1. These
three ligands are of particular importance because von Willebrand
factor plays a critical role in tethering platelets to collagen, GPVI
is the major signaling platelet receptor, and integrin [alpha]2[beta]1
mediates platelet adhesion and contributes to activation. Since these
ligands play a critical role in the early stages of thrombus formation,
aegyptin represents a potentially highly effective therapeutic that can
prevent and treat patients with thrombotic disease. Alternatively,
aegyptin is potentially useful in conditions where collagen plays a
critical role in angiogenesis or in conditions where excessive
deposition of collagen plays a pathological role (e.g. pancreatic
carcinoma).
Applications:
Adjuvant to ``Clot busting'' therapeutics.
Method to prevent and/or treat cardiovascular/thrombotic disease.
Method to treat patients undergoing invasive cardiovascular
procedures ( e.g. angioplasty).
Model to study collagen-dependent platelet aggregation or collagen-
mediated angiogenesis.
Advantages:
Highly effective therapeutics can negatively modulate thrombosis in
its early stages by preventing collagen interaction with three major
ligands involved in thrombus/clot formation.
Aegyptin's potential use as a prototype for drug delivery as an
oral therapeutic, which can reduce the need for invasive surgeries that
dilate blood vessels such as stents or catheters.
Market:
Thrombolytic/antithrombotic therapies are worth billions of
dollars, common therapeutics include heparin, warfarin, and plasminogen
activators.
Anticancer and antiangiogenic therapies.
[[Page 49725]]
Cardiac disease is the number one cause of death in the U.S.
Pancreatic cancer is one of the most lethal cancers, where only 23%
patients will survive after one year of diagnosis, and 4% survive after
five years of diagnosis.
An estimated 37,170 Americans will be newly diagnosed with
pancreatic cancer in 2007.
An estimated 33,370 deaths from pancreatic cancer in the U.S. in
2007.
Pancreatic cancer is the fourth leading cause of cancer death in
the U.S.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Eric Calvo et al. (NIAID).
Related Publications:
1. A manuscript directly related to this technology will be
available as soon as it is accepted for publication.
2. E Calvo. Collagen-platelet aggregation inhibitor from mosquito
salivary glands. Biacore T100 seminar series, November 2006, St. Louis,
Missouri.
3. S Yoshida and H Watanabe. Robust salivary gland-specific
transgene expression in Anopheles stephensi mosquito. Insect Mol Biol.
2006 Aug;15(4):403-410.
4. D Sun et al. Expression of functional recombinant mosquito
salivary apyrase: A potential therapeutic platelet aggregation
inhibitor. Platelets. 2006 May;17(3):178-184.
Patent Status: U.S. Provisional Application No. 60/198,629 filed 09
Jul 2007 (HHS Reference No. E-172-2007/0-US-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 of
Allergy and Infectious Diseases, Laboratory of Malaria and Vector
Research, is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize the platelet aggregation inhibitor Aegyptin. Please
contact Dr. Jose Ribeiro, Head, Vector Biology Section, at 301-496-9389
or jribeiro@niaid.nih.gov for more information.
Bifunctional Compounds That Bind to Hormone Receptors
Description of Technology: The development and progression of
prostate cancer is dependent on the androgen receptor (AR), a ligand-
dependent transcription factor. In the inactive form AR resides in the
cytosolic region of the cell and when activated, AR is imported into
the nucleus. Initial hormonal therapy for prostate cancer involves
lowering serum levels of testosterone to shut down AR activity. Despite
initial patient responses to testosterone-depleting therapies, prostate
cancer becomes refractory to hormonal therapy. Notably, AR is
reactivated in hormone-refractory prostate cancer and reinstates its
proliferative and survival activity.
Available for licensing is a novel chemical compound which is
bifunctional and binds to AR. This compound is comprised of tubulin-
binding and steroid receptor-binding moieties. This compound is
designed to antagonize AR function in a nonclassical manner by several
mechanisms and kills hormone-refractory prostate cells better than both
functional moieties. This compound is a first-in-class of bifunctional
steroid receptor binding agents that can antagonize steroid receptors
in a variety of hormone-dependent diseases, such as breast and prostate
cancer.
Applications:
Therapeutic compounds that selectively target steroid receptor-
expressing cancer cells resulting in decreased toxicity.
Method to treat hormone resistant prostate cancer and potentially
other steroid receptor dependent diseases such as breast cancer.
Market:
Prostate cancer is the second most common type of cancer among men,
wherein one in six men will be diagnosed with prostate cancer.
An estimated 218,890 new cases of prostate cancer and 27,050 deaths
due to prostate cancer in the U.S. in 2007.
An estimated 180,510 new cases of breast cancer and 40,060 deaths
due to breast cancer in the U.S. in 2007.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Nima Sharifi et al. (NCI).
Patent Status: U.S. Provisional Application No. 60/958,351 filed 03
Jul 2007 (HHS Reference No. E-163-2007/0-US-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 Medical Oncology Branch,
National Cancer Institute is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize treatments of resistant prostate
cancer. Please contact John D. Hewes, PhD at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Specific Binding Agents for KSHV vIL-6 That Neutralize a Biological
Activity
Description of Technology: Kaposi's sarcoma-associated herpes virus
(KSHV) is an oncogenic herpes virus originally identified in AIDS
associated Kaposi's sarcoma (KS) lesions, the most common tumor
associated with HIV infection. KSHV encodes various proteins that have
characteristics associated with cellular growth and transformation,
including viral (v) IL-6 (KSHV vIL-6). These viral proteins display
structural homology to their cellular counterparts, and human and vIL-6
are multifunctional cytokines that have been shown to induce vascular
endothelial growth factor and other factors.
Available for licensing are binding agents that neutralize vIL-6
biological activities, methods of diagnosing and treating KSHV
disorders, and methods to monitor KSHV patient response to treatment.
Deregulation of cellular IL-6 expression is known to contribute to
tumor development, suggesting that KSHV-derived vIL-6 could be part of
a viral strategy to promote malignant transformation. Neutralizing
activity of anti-vIL-6 antibodies may provide a potential therapeutic
for KSHV disorders such as HIV, Castleman's disease, and primary
effusion lymphoma.
Applications:
Therapeutic compositions to treat KSHV disorders such as KS,
Castleman's disease, and primary effusion lymphoma.
Method to diagnose and treat KSHV disorders.
Method to monitor patient response to KSHV treatment.
Market:
Approximately 476,095 persons currently living with HIV/AIDS in the
United States.
Estimated annual incidence rate for KS is 5 cases per 100,000/year
in the U.S.; KS contributes to approximately 30% of AIDS related
deaths.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Giovanna Tosato (NCI) et al.
Publications:
1. Y Aoki and G Tosato. Therapeutic options for human herpesvirus-
8/Kaposi's sarcoma-associated herpesvirus-related disorders. Expert Rev
Anti Ther. 2004 Apr;2(2):213-225.
2. Y Aoki et al. Detection of viral interleukin-6 in Kaposi
sarcoma-associated herpesvirus-linked disorders. Blood. 2001 Apr
1;97(7):2173-2176.
[[Page 49726]]
3. Y Aoki et al. Kaposi's sarcoma-associated herpesvirus-encoded
interleukin-6. J Hemathother Stem Cell Res. 2000;9(2):137-145.
Patent Status:
U.S. Patent No. 6,939,547 issued 06 Sep 2005 (HHS Reference No. E-
180-2000/0-US-03).
U.S. Patent No. 7,108,981 issued 19 Sep 2006 (HHS Reference No. E-
180-2000/0-US-04).
U.S. Patent No. 7,235,365 issued 26 Jun 2007 (HHS Reference No. E-
180-2000/0-US-05).
U.S. Patent Application No. 11/803,732 filed 14 May 2007 (HHS
Reference No. E-180-2000/0-US-06).
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 Cancer Institute's
Laboratory of Cellular Oncology is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize therapeutics for Kaposi's sarcoma-
associated herpes virus (KSHV). Please contact John D. Hewes, Ph.D. at
301-435-3121 or hewesj@mail.nih.gov for more information.
Interferon Alpha Hybrids
Description of Technology: Available for licensing are hybrid
interferon alpha (INF-[alpha]) polypeptides constructed by combinations
of INF[alpha]21b and INF[alpha]2c, and mutants of these hybrids. These
hybrid constructs have resulted in novel IFNs that either combine
different biological properties from the parent proteins or have
significantly different biological activity from both the parents in
anti-proliferative, anti-viral, or competitive binding properties. For
instance, the hybrid designated HY-3 has higher anti-proliferative
activity in Daudi, WISH, and primary human lymphocyte cells exhibiting
approximately 6 times higher anti-proliferative activity than either
parent IFN. These IFN hybrids provide a powerful tool for studying the
structure-function relationship of these molecules. The engineered IFN-
[alpha] proteins may have important new therapeutic applications and
may provide greater insights into understanding of the clinical
activities of existing IFN-[alpha]s.
Also available for licensing are hybrid INF-[alpha] nucleic acids
encoding the hybrid polypeptides as well as cells, vectors,
pharmaceutical compositions with these nucleic acid sequences.
Applications:
Anti-viral and cancer therapeutics.
Research tool to study IFN-[alpha] functions.
Market:
Interferon alpha market was worth $2.1 billion in 2005.
Industry focus is novel subtype or interferon alpha variants with
improved pharmacodynamic and safety properties.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Kathryn C. Zoon et al. (FDA).
Publications:
1. R Hu et al. Protein engineering of interferon alphas. Methods
Mol Med. 2005;116:69-80.
2. R Hu et al. Human IFN-alpha protein engineering: The amino acid
residues at positions 86 and 90 are important for antiproliferative
activity. J Immunol. 2001 Aug 1;167(3):1482-1489.
3. Hu et al. Divergence of binding, signaling, and biological
responses to recombinant human hybrid IFN. J Immunol. 1999 Jul
15;163(2):854-860.
Patent Status:
U.S. Patent No. 7,235,232 issued 26 Jun 2007 (HHS Reference No. E-
068-1998/0-US-04)
U.S. Patent No. 6,685,933 issued 03 Feb 2004 (HHS Reference No. E-
068-1998/0-US-03).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jennifer Wong; 301/435-4633;
wongje@mail.nih.gov.
Dated: August 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-16929 Filed 8-28-07; 8:45 am]
BILLING CODE 4140-01-P
