Prospective Grant of an Exclusive License: “Vasostatin as Marrow Protectant” and “Use of Calreticulin and Calreticulin Fragments To Inhibit Endothelial Cell Growth and Angiogenesis and Suppress Tumor Growth”, 96-97 [04-28686]
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96
Federal Register / Vol. 70, No. 1 / Monday, January 3, 2005 / Notices
Activation of Recombinant Diphtheria
Toxin Fusion Proteins by Specific
Proteases Highly Expressed on the
Surface of Tumor Cells
Stephen Leppla, Shi-Hui Liu, Manuel
Osorio, and Jennifer Avallone
(NIDCR)
U.S. Provisional Application No. 60/
468,577 filed 06 May 2003 (DHHS
Reference No. E–331–2002/0–US–01)
PCT Application No. PCT/US04/01430
filed 06 May 2004 (DHHS Reference
No. E–331–2002/0–PCT–02)
Licensing Contact: Brenda Hefti; (301)
435–4632; heftib@mail.nih.gov.
This invention relates to diphtheria
toxin fusion proteins comprising a
diphtheria toxin (DT) cell-killing
component and a cell-binding
component such as granulocyte
macrophage colony-stimulating factor
(GM–CSF), interleukin 2 (IL–2), or
epidermal growth factor (EGF).
Receptors for the latter three materials
are present on many types of cancer
cells; therefore, these fusion proteins
bind preferentially to these cancer cells.
A key feature is that these toxins are
altered so as to require activation by a
cell-surface protease that is
overexpressed on many types of
cancers. Examples of such proteases
include matrix metalloproteinases and
urokinase plasminogen activator.
Consequently, these novel cytotoxins
kill tumors expressing receptors for
either GM–CSF, IL–2, or EGF along with
the cell-surface protease. Because killing
requires the presence of both a receptor
and a cancer-cell enriched protease, and
few normal tissues contain both, there is
less toxicity to normal cells. Thus, a
larger amount of the agent may be used
for cancer therapy without inducing
side effects. In other words, these
cytotoxins have a higher therapeutic
index than toxins that are targeted to
cells using a single strategy.
BASE, a New Cancer Gene, and Uses
Thereof
Ira Pastan, Kristi Egland, James Vincent,
Byungkook Lee, and Robert
Strausberg (NCI)
PCT Application No. PCT/US03/39476
filed 10 Dec 2003 (DHHS Reference
No. E–321–2002/0–PCT–02)
Licensing Contact: Brenda Hefti; (301)
435–4632; heftib@mail.nih.gov
The present invention identifies a
new gene expressed in breast cancers.
The gene undergoes alternative splicing,
and is expressed as one of two
polypeptides. Both splice variants
appear to be secreted proteins, and
therefore good potential therapeutic
targets. The patent application claims
BASE polypeptides, nucleic acids, gene
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14:47 Dec 30, 2004
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therapy and vaccine uses, and
antibodies. This novel gene target might
be useful as a breast cancer marker for
diagnostics, or as a target for breast
cancer therapeutics.
Applications for the HMGN1 Pathway
Michael Bustin (NCI)
U.S. Provisional Patent Application No.
60/455,728 filed 17 Mar 2003 (DHHS
Reference No. E–208–2002/0–US–01)
PCT Application No. PCT/US04/08060
filed 17 Mar 2004, which published as
WO 2004/083398 on 30 Sep 2004
(DHHS Reference No. E–208–2002/0–
PCT–02)
Licensing Contact: Brenda Hefti; (301)
435–4632; heftib@mail.nih.gov
HMGN1 is a protein that binds to
nucleosomes, changes chromatin
structure and affects transcription, and
the expression of this protein changes
during differentiation. Mice lacking this
protein have increased growth capacity
of several skin components, including
epidermis, epidermal appendages, and
dermis. Conceivably, this change could
be related to an alteration of stem cell
differentiation or to cell cycling events.
The current invention relates to
interference with this pathway, which
might lead to increased stem cell
differentiation and increased hair
cycling and growth in humans as well.
This invention might be useful to
increase hair growth, enhance wound
healing for epidermal and dermal
wounds, and enhance stem cell
populations for tissue regeneration, gene
targeting, or gene therapeutic
indications.
Dated: December 20, 2004.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 04–28684 Filed 12–30–04; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
License: ‘‘Vasostatin as Marrow
Protectant’’ and ‘‘Use of Calreticulin
and Calreticulin Fragments To Inhibit
Endothelial Cell Growth and
Angiogenesis and Suppress Tumor
Growth’’
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
part 404.7(a)(1)(i), announces that the
Department of Health and Human
Services is contemplating the grant of an
exclusive license to practice the
inventions embodied in U.S. Patent No.
6,596,690 B2 entitled ‘‘Vasostatin as
Marrow Protectant’’ (DHHS Reference
E–230–2000/0); U.S. Patent Application
No. 09/807,148 filed April 5, 2001,
entitled ‘‘Use of Calreticulin and
Calreticulin fragments to inhibit
endothelial cell growth and
angiogenesis and suppress tumor
growth’’ (DHHS Reference E–082–1998/
0–US–03); PCT Application No. PCT/
US99/23240 filed October 5, 1999
entitled ‘‘Use of Calreticulin and
Calreticulin fragments to inhibit
endothelial cell growth and
angiogenesis and suppress tumor
growth’’ (DHHS Reference E–082–1998/
0–PCT–02); to BioAccelerate, Inc., a
venture capital group controlling the
following twelve companies:
Bioenvision, Enhance Biotech, Evolve
Oncology, CNS Thera, Innova Lifestyle,
Inncardio, Anvira, Neuro Bioscience,
Biocardio, Oncbio, Innovative Oncology
and Genar Oncology. The patent rights
in these inventions have been assigned
to the United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to
development and sale of a
pharmaceutical product useful in
protecting bone marrow stem cells from
the toxic effects of chemotherapy and
radiotherapy.
DATES: Only written comments and/or
license applications which are received
by the National Institutes of Health on
or before March 4, 2005 will be
considered.
ADDRESSES: Requests for copies of the
patent and/or patent applications,
inquiries, comments and other materials
relating to the contemplated exclusive
license should be directed to: Mojdeh
Bahar, J.D., Technology Licensing
Specialist, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804. Telephone:
(301) 435–2950; Facsimile: (301) 402–
0220; E-mail: baharm@od.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology claimed in the
aforementioned patents is based on the
discovery of the calreticulin N-domain
(vasostatin) and the three previously
uncharacterized properties of
calreticulin. First, calreticulin N-domain
is shown to stimulate the proliferation
and survival in vitro of hematopoietic
cells in the presence of previously
identified growth factors. Second,
Vasostatin is shown to protect
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03JAN1
Federal Register / Vol. 70, No. 1 / Monday, January 3, 2005 / Notices
hematopoietic cells in vitro from
toxicity induced by a variety of
chemotherapeutic agents. Third,
Vasostatin is shown to protect a subject
from toxicity to the hematopoietic
system induced by chemotherapy or
irradiation.
The prospective exclusive license will
be royalty-bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be
granted unless within sixty (60) days
from the date of this published notice,
the NIH receives written evidence and
argument that establish that the grant of
the license would not be consistent with
the requirements of 35 U.S.C. 209 and
37 CFR part 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: December 20, 2004.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 04–28686 Filed 12–30–04; 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, DHHS.
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,
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14:47 Dec 30, 2004
Jkt 205001
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.
Novel Compounds and Methods for
Treating Alzheimer’s and Related
Diseases
Nigel H. Greig et al. (NIA)
U.S. Provisional Application filed 22
Oct 2004 (DHHS Reference No. E–
172–2004/0–US–01)
Licensing Contact: Norbert Pontzer;
(301) 435–5502;
pontzern@mail.nih.gov.
The brain cholinergic system is
thought to play an important role in
learning and memory. The loss of
cholinergic neurons early in the course
of Alzheimer’s Disease may thus be an
etiological factor in the cognitive
decline that is the hallmark of that
disease. Therefore, potentiating
cholinergic transmission has been the
main pharmacological approach for the
treatment of AD patients. Inhibition of
acetylcholinesterase (AChE) or
butyrylcholinesterase (BChE) enhances
cholinergic transmission by reducing
enzymatic degradation of acetylcholine.
AChE inhibitors are now used
clinically to help restore cognitive
function in AD patients. However the
therapeutic index for inhibition of AChE
is quite low. Drugs with this mechanism
of action have to have the proper
pharmacodynamic properties to achieve
even a marginally useful clinical effect
without unacceptable side effects. The
presence of BChE in brain tissue makes
this enzyme another possible target for
increasing the activity of the cholinergic
system.
The present invention provides a
series of novel and potent tricyclic
compounds that have a range of
selectivity for inhibiting AchE, as
compared to BchE, and possess
neuroprotective activity in cell culture
models. Also provided are methods of
using these compounds to treat a
number of different medical conditions
such as Alzheimer’s Disease, mild
cognitive impairment, and other
dementia-related disorders.
In addition to licensing, the
technology is available for further
development through collaborative
research with the inventors via a
Cooperative Research and Development
Agreement (CRADA).
Novel Methods for Reducing
Inflammation and Treating Diseases
such as Parkinson’s and Alzheimer’s
Disease
Jau-Shyong Hong et al. (NIEHS)
PO 00000
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97
U.S. Provisional Application No. 60/
570,566 filed 12 May 2004 (DHHS
Reference No. E–130–2004/0–US–01)
Licensing Contact: Norbert Pontzer;
(301) 435–5502;
pontzern@mail.nih.gov.
Activated microglia mediate
inflammation in the CNS by secreting
various cytokines and free radicals that
could damage neurons. Brains from
patients with Parkinson disease show
microglia reaction, and previous studies
by this laboratory show microglia
activation leads to inflammation
mediated dopaminergic degeneration.
Thus identification of drugs that reduce
microglia activation could prevent or
reverse neuronal degeneration in
Parkinson’s Disease, Alzheimer’s
Disease, ischemia and other
degenerative CNS disorders.
Considerable research has shown the
ability of various peptides to attenuate
microglia activation and prevent
neuronal degeneration in vitro with a bimodal dose response curve. These
peptides demonstrate maximum effects
at femto-molar and micro-molar
concentrations. These inventors have
now discovered small-peptide and nonpeptide molecules that also inhibit
microglia and prevent neuronal
degeneration with the same bi-modal
dose response curve. The non-peptide
compounds have also been shown to
prevent dopamine neuronal
degeneration in animal models. The
present invention provides
compositions and methods for
inhibiting inflammatory mechanisms
and treating inflammation-related
condition by administering ultra-low
(femto-molar) doses of at least one
compound of the invention. These
compounds include morphinans, opioid
peptides, and the tripeptide GGF.
In addition to licensing, the
technology is available for further
development through collaborative
research with the inventors via a
Cooperative Research and Development
Agreement (CRADA).
Multi-Domain Amphipathic Helical
Peptides and Methods of Their Use
Alan Remaley et al. (NHLBI)
U.S. Provisional Application filed 15
Oct 2004 (DHHS Reference No. E–
114–2004/0–US–01)
Licensing Contact: Fatima Sayyid; (301)
435–4521; sayyidf@mail.nih.gov.
Mutations in the ABCA1 transporter
lead to diseases characterized by the
accumulation of excess cellular
cholesterol, low levels of HDL and an
increased risk for cardiovascular
disease. Currently, there are a wide
variety of treatments for dyslipidemia,
which include, but are not limited to,
E:\FR\FM\03JAN1.SGM
03JAN1
]]>Agencies
[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Notices]
[Pages 96-97]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-28686]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive License: ``Vasostatin as Marrow
Protectant'' and ``Use of Calreticulin and Calreticulin Fragments To
Inhibit Endothelial Cell Growth and Angiogenesis and Suppress Tumor
Growth''
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), announces that the Department of Health and Human
Services is contemplating the grant of an exclusive license to practice
the inventions embodied in U.S. Patent No. 6,596,690 B2 entitled
``Vasostatin as Marrow Protectant'' (DHHS Reference E-230-2000/0); U.S.
Patent Application No. 09/807,148 filed April 5, 2001, entitled ``Use
of Calreticulin and Calreticulin fragments to inhibit endothelial cell
growth and angiogenesis and suppress tumor growth'' (DHHS Reference E-
082-1998/0-US-03); PCT Application No. PCT/US99/23240 filed October 5,
1999 entitled ``Use of Calreticulin and Calreticulin fragments to
inhibit endothelial cell growth and angiogenesis and suppress tumor
growth'' (DHHS Reference E-082-1998/0-PCT-02); to BioAccelerate, Inc.,
a venture capital group controlling the following twelve companies:
Bioenvision, Enhance Biotech, Evolve Oncology, CNS Thera, Innova
Lifestyle, Inncardio, Anvira, Neuro Bioscience, Biocardio, Oncbio,
Innovative Oncology and Genar Oncology. The patent rights in these
inventions have been assigned to the United States of America.
The prospective exclusive license territory may be worldwide and
the field of use may be limited to development and sale of a
pharmaceutical product useful in protecting bone marrow stem cells from
the toxic effects of chemotherapy and radiotherapy.
DATES: Only written comments and/or license applications which are
received by the National Institutes of Health on or before March 4,
2005 will be considered.
ADDRESSES: Requests for copies of the patent and/or patent
applications, inquiries, comments and other materials relating to the
contemplated exclusive license should be directed to: Mojdeh Bahar,
J.D., Technology Licensing Specialist, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804. Telephone: (301) 435-2950; Facsimile: (301)
402-0220; E-mail: baharm@od.nih.gov.
SUPPLEMENTARY INFORMATION: The technology claimed in the aforementioned
patents is based on the discovery of the calreticulin N-domain
(vasostatin) and the three previously uncharacterized properties of
calreticulin. First, calreticulin N-domain is shown to stimulate the
proliferation and survival in vitro of hematopoietic cells in the
presence of previously identified growth factors. Second, Vasostatin is
shown to protect
[[Page 97]]
hematopoietic cells in vitro from toxicity induced by a variety of
chemotherapeutic agents. Third, Vasostatin is shown to protect a
subject from toxicity to the hematopoietic system induced by
chemotherapy or irradiation.
The prospective exclusive license will be royalty-bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part
404.7. The prospective exclusive license may be granted unless within
sixty (60) days from the date of this published notice, the NIH
receives written evidence and argument that establish that the grant of
the license would not be consistent with the requirements of 35 U.S.C.
209 and 37 CFR part 404.7.
Applications for a license in the field of use filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. Comments and objections submitted to
this notice will not be made available for public inspection and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: December 20, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 04-28686 Filed 12-30-04; 8:45 am]
BILLING CODE 4140-01-P
