Government-Owned Inventions; Availability for Licensing, 30427-30428 [E6-8167]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 102 / Friday, May 26, 2006 / Notices
from the public. There are no other
changes.
FOR FURTHER INFORMATION CONTACT:
Janet L. Scudiero, Center for Devices
and Radiological Health (HFZ–410),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–1184, ext. 176, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512521. Please call the Information
Line for up-to-date information on this
meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 19, 2006, FDA
announced that a meeting of the
Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory
Committee would be held on June 2,
2006, from 8:30 a.m. to 3:30 p.m. On
page 20111, in the second and third
columns, the Procedure portion is
amended to read as follows:
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before May 19, 2006. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of the committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before May 19,
2006.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: May 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–8088 Filed 5–25–06; 8:45 am]
BILLING CODE 4160–01–S
jlentini on PROD1PC65 with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
VerDate Aug<31>2005
16:12 May 25, 2006
Jkt 208001
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.
Tetrahalogenated Compounds Useful as
Inhibitors
Description of Technology: Cancer is
the second leading cause of death in
United States and it is estimated that
there will be approximately 600,000
deaths caused by cancer in 2006. A
major drawback of the existing
chemotherapies is the cytotoxic sideeffects that are associated with them.
Thus, there is a need to develop new
therapeutic approaches with reduced
side-effects.
Anti-angiogenic therapy is a recent
approach in cancer therapeutics
targeting the formation of blood vessels
that are necessary for tumor growth.
Recently, the anti-angiogenic molecule
bevacizumab (Avastin) has gained
approval from the FDA for the first-line
treatment of metastatic colon cancer in
combination with standard
chemotherapy. Another promising antiangiogenic molecule is thalidomide.
Thalidomide has been approved as an
anti-cancer agent and for other use in
Europe and Australia. However, its use
as a drug has been limited by its effect
as a teratogen, necessitating the
development of new thalidomide
analogs with improved efficacy and
reduced toxicity.
This technology describes synthesis of
several tetrahalogenated thalidomide
derivatives that are potentially more
anti-angiogenic than thalidomide. More
specifically, two series of analogs based
on two major common pharmacophores
have been synthesized. One series
preserves the thalidomide common
structure, while the other series
contains a different common structure
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
30427
(tetrafluorobenzamides). Several analogs
from both series have shown significant
anti-angiogenic properties, in vitro. This
technology has therapeutic potential for
a broad spectrum of cancer related
diseases alone, or in combination with
existing therapies.
Applications: Novel tetrahalogenated
thalidomide analogs containing the
thalidomide pharmacophore with
improved anti-angiogenic activity;
Novel tetrahalogenated thalidomide
analogs containing a different common
structure (tetrafluorobenzamides) with
considerable anti-angiogenic activity;
Use of the compounds for the treatment
of several cancers; Use of the
compounds for the treatment other
diseases including autoimmune
diseases.
Market: 600,000 deaths from cancer
related diseases estimated in 2006. The
technology platform involving novel
anti-angiogenic small molecule cancer
therapy technology has a potential
market of more than 2 billion U.S.
dollars. The technology platform has
additional market in treating several
other clinical problems such as
autoimmune diseases.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: William D. Figg (NCI), Erin
Lepper (SAIC), et al.
Publications:
SS Ng et al., ‘‘Antitumor effects of
thalidomide analogs in human prostate
cancer xenografts implanted in
immunodeficient mice,’’ Clin Cancer
Res. 2004 Jun 15; 10 (12 Pt 1):4192–7.
WL Dahut et al., ‘‘Randomized phase
II trial of docetaxel plus thalidomide in
androgen-independent prostate cancer,’’
J Clin Oncol. 2004 Jul 1; 22 (13): 2532–
9.
S Kumar et al., ‘‘Antimyeloma activity
of two novel N-substituted and
tetraflourinated thalidomide analogs,’’
Leukemia 2005 Jul; 19 (7):1253–61.
Patent Status: U.S. Provisional
Application filed 13 Apr 2006 (HHS
Reference No. E–080–2006/0–US–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: David A.
Lambertson, PhD.; 301–435–4632;
lambertsond@od.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Center for
Cancer Research, Medical Oncology
Branch, Molecular Pharmacology
Section is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize tetrafluorinated
compounds as anti-cancer therapeutics.
E:\FR\FM\26MYN1.SGM
26MYN1
30428
Federal Register / Vol. 71, No. 102 / Friday, May 26, 2006 / Notices
Please contact Dr. W. Figg at 301–402–
3623 for more information.
jlentini on PROD1PC65 with NOTICES
Anti-Notch-1 Monoclonal Antibodies
for Inducing Cellular Differentiation
and Apoptosis
Description of Technology: As cancer
cells progress towards more aggressive
forms, they often become highly
resistant to drug or radiation-induced
apoptosis, generally through the loss of
function p53, a gene which can trigger
apoptosis in response to DNA damage.
Thus, novel strategies to induce
apoptosis in tumor cells, especially p53deficient cells, is an attractive and an
active area of research.
Using a model constituted by a p53deficient mouse leukemia cell line, PHS
scientists found that: (1) Antisense
synthetic DNA oligonucleotides and
stable incorporation of an antisense
gene (a model for gene therapy)
targeting notch-1, when given together
with a differentiation-inducing
antitumor drug, cause the cells to
respond by massive apoptosis rather
than differentiation; (2) stable
incorporation of an antisense notch-1
gene increases apoptosis in these cells
even in the absence of any antitumor
drugs. This suggests that antisense
Notch-1 treatment, by antisense
oligonucleotides or by gene therapy,
may be used alone or together with anticancer drugs to cause apoptosis in
tumor cells.
This invention provides
compositions, pharmaceutical
compositions, and methods for
stimulating/increasing cell
differentiation, and is particularly
related to the treatment of tumors which
have increased Notch-1 expression. A
polyclonal and/or monoclonal antibody
generated against human Notch-1
Epidermal Growth Factor (‘‘EGF’’) that
recognizes an extracellular epitope of
Notch-1 and that stimulates target cell
differentiation in the presence of a
differentiation inducing agent is
disclosed as is the hybridoma which
produces these antibodies.
Inventors: Lucio L Miele and Chana Y.
Fuchs (FDA).
Patent Status: PCT Application No.
PCT/US99/23162 filed 01 Oct 1999,
which published as WO 00/20576 on 13
Apr 2000 (HHS Reference No. E–176–
1998/1–PCT–01); U.S. Patent
Application No. 11/069,208 filed 28 Feb
2005, claiming priority to 02 Oct 1998
(HHS Reference No. E–176–1998/1–US–
08).
Licensing Contact: David A.
Lambertson, PhD.; 301–435–4632;
lambertsond@od.nih.gov.
VerDate Aug<31>2005
16:12 May 25, 2006
Jkt 208001
Novel Bis-Acridones as Anti-Tumor
Agents: Potential for Treating Drug
Resistant Tumors
Description of Technology: Cancer is
the second leading cause of death in
United States and it is estimated that
there will be approximately 600,000
deaths caused by cancer in 2006.
Current chemotherapies are mostly
based on the use of small molecules. A
major drawback of these existing
chemotherapies is the acquired or
inherent resistance of certain tumors
against these drugs. Treating resistant
tumors has been a major challenge in
the successful management of cancer,
necessitating the development of new
therapies to treat resistant tumors and
thus expanding the life expectancy of
cancer patients.
The present invention discloses novel
derivatives of Bis-acridones and related
molecules and their pharmaceutically
acceptable salts and their use as antitumor agents. Some of the derivatives
have high anti-tumor activity both in
vitro and in vivo. In addition to its antitumor activity these above mentioned
compounds have been shown to be
potent irreversible inhibitors of Pglycoprotein, a member of the ABC
transporter protein family that has a
major role in conferring multi-drug
resistance. Therefore, these compounds
have the potential of being used in
combination with traditional
chemotherapy to treat drug resistant
tumors. In addition, to its antineoplastic property some of the
derivatives of this family of compounds
have been shown to have anti-HIV
property.
Inventors: Christopher J. Michejda et
al. (NCI).
Publications:
WM Cholody et al.,
‘‘Bisimidazoacridones and related
compounds: New antineoplastic agents
with high selectivity against colon
tumors,’’ J Med Chem. 1995 Aug 4; 38
(16): 3043–52.
JA Turpin et al., ‘‘Inhibition of
acute-, latent-, and chronic-phase
human immunodeficiency virus type 1
(HIV–1) replication by a
bistriazoloacridone analog that
selectively inhibits HIV–1
transcription,’’ Antimicrob Agents
Chemother. 1998 Mar; 42 (3):487–94.
Patent Status: U.S. Patent No.
5,508,289 issued 16 Apr 1996 (HHS
Reference No. E–106–1994/0–US–01);
European Patent No. 0750612 issued.
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Michelle A.
Booden, PhD.; 301–451–7337;
boodenm@mail.nih.gov.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Collaborative Research Opportunity:
The National Cancer Institute, Center for
Cancer Research is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize certain derivatives of
Bis-acridones and related molecules as
well as their pharmaceutically
acceptable salts as anti-tumor agents.
Please contact Kathy Higinbotham at
301–846–5465 or higinbok@mail.nih.gov
for more information.
Dated: May 19, 2006.
David R. Sadowski,
Acting Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. E6–8167 Filed 5–25–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
Antibodies That Specifically Recognize
S100A15, a Protein Involved in
Epidermal Differentiation and
Inflammation
Description of Technology: This
technology describes rabbit polyclonal
antibodies that recognize the human
and mouse S100A15 proteins. S100A15
is involved in epidermal differentiation
E:\FR\FM\26MYN1.SGM
26MYN1
]]>Agencies
[Federal Register Volume 71, Number 102 (Friday, May 26, 2006)]
[Notices]
[Pages 30427-30428]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8167]
-----------------------------------------------------------------------
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.
Tetrahalogenated Compounds Useful as Inhibitors
Description of Technology: Cancer is the second leading cause of
death in United States and it is estimated that there will be
approximately 600,000 deaths caused by cancer in 2006. A major drawback
of the existing chemotherapies is the cytotoxic side-effects that are
associated with them. Thus, there is a need to develop new therapeutic
approaches with reduced side-effects.
Anti-angiogenic therapy is a recent approach in cancer therapeutics
targeting the formation of blood vessels that are necessary for tumor
growth. Recently, the anti-angiogenic molecule bevacizumab (Avastin)
has gained approval from the FDA for the first-line treatment of
metastatic colon cancer in combination with standard chemotherapy.
Another promising anti-angiogenic molecule is thalidomide. Thalidomide
has been approved as an anti-cancer agent and for other use in Europe
and Australia. However, its use as a drug has been limited by its
effect as a teratogen, necessitating the development of new thalidomide
analogs with improved efficacy and reduced toxicity.
This technology describes synthesis of several tetrahalogenated
thalidomide derivatives that are potentially more anti-angiogenic than
thalidomide. More specifically, two series of analogs based on two
major common pharmacophores have been synthesized. One series preserves
the thalidomide common structure, while the other series contains a
different common structure (tetrafluorobenzamides). Several analogs
from both series have shown significant anti-angiogenic properties, in
vitro. This technology has therapeutic potential for a broad spectrum
of cancer related diseases alone, or in combination with existing
therapies.
Applications: Novel tetrahalogenated thalidomide analogs containing
the thalidomide pharmacophore with improved anti-angiogenic activity;
Novel tetrahalogenated thalidomide analogs containing a different
common structure (tetrafluorobenzamides) with considerable anti-
angiogenic activity; Use of the compounds for the treatment of several
cancers; Use of the compounds for the treatment other diseases
including autoimmune diseases.
Market: 600,000 deaths from cancer related diseases estimated in
2006. The technology platform involving novel anti-angiogenic small
molecule cancer therapy technology has a potential market of more than
2 billion U.S. dollars. The technology platform has additional market
in treating several other clinical problems such as autoimmune
diseases.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: William D. Figg (NCI), Erin Lepper (SAIC), et al.
Publications:
SS Ng et al., ``Antitumor effects of thalidomide analogs in human
prostate cancer xenografts implanted in immunodeficient mice,'' Clin
Cancer Res. 2004 Jun 15; 10 (12 Pt 1):4192-7.
WL Dahut et al., ``Randomized phase II trial of docetaxel plus
thalidomide in androgen-independent prostate cancer,'' J Clin Oncol.
2004 Jul 1; 22 (13): 2532-9.
S Kumar et al., ``Antimyeloma activity of two novel N-substituted
and tetraflourinated thalidomide analogs,'' Leukemia 2005 Jul; 19
(7):1253-61.
Patent Status: U.S. Provisional Application filed 13 Apr 2006 (HHS
Reference No. E-080-2006/0-US-01).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: David A. Lambertson, PhD.; 301-435-4632;
lambertsond@od.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Center for Cancer Research, Medical Oncology Branch, Molecular
Pharmacology Section is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize tetrafluorinated compounds as anti-cancer
therapeutics.
[[Page 30428]]
Please contact Dr. W. Figg at 301-402-3623 for more information.
Anti-Notch-1 Monoclonal Antibodies for Inducing Cellular
Differentiation and Apoptosis
Description of Technology: As cancer cells progress towards more
aggressive forms, they often become highly resistant to drug or
radiation-induced apoptosis, generally through the loss of function
p53, a gene which can trigger apoptosis in response to DNA damage.
Thus, novel strategies to induce apoptosis in tumor cells, especially
p53-deficient cells, is an attractive and an active area of research.
Using a model constituted by a p53-deficient mouse leukemia cell
line, PHS scientists found that: (1) Antisense synthetic DNA
oligonucleotides and stable incorporation of an antisense gene (a model
for gene therapy) targeting notch-1, when given together with a
differentiation-inducing antitumor drug, cause the cells to respond by
massive apoptosis rather than differentiation; (2) stable incorporation
of an antisense notch-1 gene increases apoptosis in these cells even in
the absence of any antitumor drugs. This suggests that antisense Notch-
1 treatment, by antisense oligonucleotides or by gene therapy, may be
used alone or together with anti-cancer drugs to cause apoptosis in
tumor cells.
This invention provides compositions, pharmaceutical compositions,
and methods for stimulating/increasing cell differentiation, and is
particularly related to the treatment of tumors which have increased
Notch-1 expression. A polyclonal and/or monoclonal antibody generated
against human Notch-1 Epidermal Growth Factor (``EGF'') that recognizes
an extracellular epitope of Notch-1 and that stimulates target cell
differentiation in the presence of a differentiation inducing agent is
disclosed as is the hybridoma which produces these antibodies.
Inventors: Lucio L Miele and Chana Y. Fuchs (FDA).
Patent Status: PCT Application No. PCT/US99/23162 filed 01 Oct
1999, which published as WO 00/20576 on 13 Apr 2000 (HHS Reference No.
E-176-1998/1-PCT-01); U.S. Patent Application No. 11/069,208 filed 28
Feb 2005, claiming priority to 02 Oct 1998 (HHS Reference No. E-176-
1998/1-US-08).
Licensing Contact: David A. Lambertson, PhD.; 301-435-4632;
lambertsond@od.nih.gov.
Novel Bis-Acridones as Anti-Tumor Agents: Potential for Treating Drug
Resistant Tumors
Description of Technology: Cancer is the second leading cause of
death in United States and it is estimated that there will be
approximately 600,000 deaths caused by cancer in 2006. Current
chemotherapies are mostly based on the use of small molecules. A major
drawback of these existing chemotherapies is the acquired or inherent
resistance of certain tumors against these drugs. Treating resistant
tumors has been a major challenge in the successful management of
cancer, necessitating the development of new therapies to treat
resistant tumors and thus expanding the life expectancy of cancer
patients.
The present invention discloses novel derivatives of Bis-acridones
and related molecules and their pharmaceutically acceptable salts and
their use as anti-tumor agents. Some of the derivatives have high anti-
tumor activity both in vitro and in vivo. In addition to its anti-tumor
activity these above mentioned compounds have been shown to be potent
irreversible inhibitors of P-glycoprotein, a member of the ABC
transporter protein family that has a major role in conferring multi-
drug resistance. Therefore, these compounds have the potential of being
used in combination with traditional chemotherapy to treat drug
resistant tumors. In addition, to its anti-neoplastic property some of
the derivatives of this family of compounds have been shown to have
anti-HIV property.
Inventors: Christopher J. Michejda et al. (NCI).
Publications:
WM Cholody et al., ``Bisimidazoacridones and related compounds: New
antineoplastic agents with high selectivity against colon tumors,'' J
Med Chem. 1995 Aug 4; 38 (16): 3043-52.
JA Turpin et al., ``Inhibition of acute-, latent-, and chronic-
phase human immunodeficiency virus type 1 (HIV-1) replication by a
bistriazoloacridone analog that selectively inhibits HIV-1
transcription,'' Antimicrob Agents Chemother. 1998 Mar; 42 (3):487-94.
Patent Status: U.S. Patent No. 5,508,289 issued 16 Apr 1996 (HHS
Reference No. E-106-1994/0-US-01); European Patent No. 0750612 issued.
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Michelle A. Booden, PhD.; 301-451-7337;
boodenm@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Center for Cancer Research is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize certain derivatives of Bis-
acridones and related molecules as well as their pharmaceutically
acceptable salts as anti-tumor agents. Please contact Kathy Higinbotham
at 301-846-5465 or higinbok@mail.nih.gov for more information.
Dated: May 19, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-8167 Filed 5-25-06; 8:45 am]
BILLING CODE 4140-01-P
