Government-Owned Inventions; Availability for Licensing, 18564-18565 [2011-7921]
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18564
Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices
Licensing Contact: Sally H. Hu, PhD,
M.B.A.; 301–435–5606;
hus@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute on Aging is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
Methods of Inhibiting Proinflammatory
Cytokine Expression Using Ghrelin.
Please contact Nikki Guyton at 301–
435–3101 or guytonn@mail.nih.gov for
more information.
Relevant Reviews
Emcdonald on DSK2BSOYB1PROD with NOTICES
Jun 16; 281(24):16681–16690. [PubMed:
16527811]
3. Dixit VD, Yang H, Sun Y,
Weeraratna AT, Smith RG, Taub DD.
Ghrelin promotes thymopoiesis during
aging. J Clin Invest. 2007 Oct;
117(10):2778–2790. [PubMed:
17823656] Note: Article highlighted in
this issue of JCI.
4. Yang H, Dixit VD, Patel K,
Vandanmagsar B, Collins G, Sun Y,
Smith RG, Taub DD. Reduction in
hypophyseal growth hormone and
prolactin expression due to deficiency
in ghrelin receptor signaling is
associated with Pit-1 suppression:
relevance to the immune system. Blood
Behav Immun. 2008 Nov; 22(8):1138–
1145. [PubMed: 18602461]
5. Dixit VD, Yang H, Cooper-Jenkins
A, Giri BB, Patel K, Taub DD. Reduction
of T cell-derived ghrelin enhances
proinflammatory cytokine expression:
implications for age-associated increases
in inflammation. Blood. 2009 May 21;
113(21):5202–5205. [PubMed:
19324904]
Government-Owned Inventions;
Availability for Licensing
6. Dixit V and Taub DD. Ghrelin and
immunity: a young player in an old
field. Exp. Gerontol. 2005 Nov;
40(11):900–910. [PubMed: 16233968]
7. Taub DD. Novel connections
between the neuroendocrine and
immune systems: the ghrelin
immunoregulatory network. Vitam
Horm. 2008; 77:325–346. [PubMed:
17983863]
8. Taub DD. Neuroendocrine
interactions in the immune system. Cell
Immunol. 2008 Mar–Apr; 252(1–2):1–6.
[PubMed: 18619587] Note: Image from
article used on the cover of this issue.
9. Redelman D, Welniak LA, Taub D,
Murphy WJ. Neuroendocrine hormones
such as growth hormone (GH) and
prolactin (PRL) are integral members of
the immunological cytokine network.
Cell Immunol. 2008 Mar–Apr; 252(1–
2):111–121. [PubMed: 18313040]
10. Patel K and Taub DD. Role of
neuropeptides, hormones, and growth
factors in regulating thymopoiesis in
middle to old age. F1000 Biol Rep. 2009
May 28; 1. pii: 42. [PubMed: 20948643]
11. Taub DD, Murphy WJ, Longo DL.
Rejuvenation of the aging thymus:
growth hormone-mediated and ghrelinmediated signaling pathways. Curr Opin
Pharmacol. 2010 Aug; 10(4):408–424.
[PubMed: 20595009]
Patent Status: U.S. Patent Application
No. 11/596,310 filed 06 Jun 2008 (HHS
Reference No. E–016–2004/0–US–07)
and related international applications.
Licensing Status: Available for
licensing.
VerDate Mar<15>2010
18:47 Apr 01, 2011
Jkt 223001
Dated: March 29, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–7925 Filed 4–1–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Diagnostic and Prognostic Serum
Biomarkers for Cancer Patients Treated
With Cancer Vaccines
Description of Technology: Although
antibodies are a critical element of the
immune response, the role of antibody
responses in cancer vaccines is still
unknown. Carbohydrate antigens, which
are directly or indirectly involved in
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
most types of cancer vaccines, are a
class of antigens that has been largely
understudied but play a significant role
in the immune response of cancer
vaccines.
This invention involves the
identification of serum biomarkers for
cancer that target carbohydrate antigens.
The biomarkers are specific subpopulations of serum antibodies present
in the serum of patients that bind to
various glycan and/or glycoprotein
antigens, such as the Forssman antigen.
The biomarkers are useful for (a)
predicting a patient’s immune responses
to a cancer vaccine, (b) measuring the
efficacy of a cancer vaccine, and (c)
determining the prognosis and longterm survival of cancer patients.
Applications:
• Diagnostic and prognostic test to
monitor the progression and long-term
survival of cancer patients.
• Predictive indicator of cancer
patients’ immune response to a cancer
vaccine.
• Indicator to monitor the efficacy of
a cancer vaccine.
Advantages: The technology is backed
by clinical data.
Development Status: Preliminary
clinical data; validation studies are
ongoing (confirmed findings in two
independent patient groups).
Market: Cancer Vaccines are emerging
as the forefront treatment regimens for
several cancers. Provenge® was recently
approved by the FDA for the treatment
of prostate cancer. There are several
other cancer vaccines in clinical trials.
This technology can be developed
into a pioneering test, as no such test to
monitor prognosis and efficacy of cancer
vaccines currently exists in the market.
Inventors: Jeff Gildersleeve, et al.
(NCI).
Publications: No publications directly
related to this technology.
Patent Status:
• U.S. Provisional Application No.
61/371,537 filed August 6, 2010 (HHS
Reference No. E–234–2010/0–US–01).
• U.S. Provisional Application No.
61/443,955 filed February 17, 2011
(HHS Reference No. E–234–2010/1–US–
01).
Licensing Status: Available for
licensing.
Licensing Contact: Sabarni Chatterjee,
M.B.A., PhD; 301–435–5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Chemical Biology Laboratory, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize anti-glycan serum
antibodies as biomarkers for cancer or
E:\FR\FM\04APN1.SGM
04APN1
Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices
A New Class of Antibiotics: NaturallyOccurring Chrysophaetins and Their
Analogues
Description of Invention: This
invention, offered for licensing and
commercial development, relates to a
new class of naturally occurring
antimicrobial compounds called
Chrysophaetins, and to their synthetic
analogues. Isolated from an alga species,
the mechanism of action of these
compounds is through the inhibition of
bacterial cytoskeletal protein FtsZ, an
enzyme necessary for the replication of
bacteria. FtsZ is responsible for Z-ring
assembly in bacteria, which leads to
bacterial cell division. Highly conserved
among all bacteria, FtsZ is a very
attractive antimicrobial target.
The chrysophaetin exhibits
antimicrobial activity against drug
resistant bacteria, methicillin-resistant
Staphylococcus aureus (MRSA) and
vancomycin-resistant Enterococcus
faecalis (VRE), as well as other drug
susceptible strains. The general
structure of the natural compound is
shown below:
Emcdonald on DSK2BSOYB1PROD with NOTICES
BILLING CODE 4140–01–C
The inventors are working on a
synthetic route for the compound and
analogs. They have made progress and
now have two halves of the molecule.
These will be further dimerized to
produce a synthetic chrysophaentin. It
is expected that the analogues will show
similar antimicrobial activity to the
natural products and will utilize the
same mechanism of action.
The market potential for the disclosed
compounds is huge ($24 billion in 2008)
due to the very limited number of new
antibiotics developed in recent decades
and the increased epidemic of infectious
diseases. In fact, infectious diseases are
the leading cause of death worldwide.
In the United States alone, more people
die from MRSA than from HIV (Journal
of the American Medical Association,
2007) and more than 90,000 people die
each year from hospital acquired
VerDate Mar<15>2010
19:50 Apr 01, 2011
Jkt 223001
bacterial infections (Centers for Disease
Control). A development of new drugs
with distinct mechanism of action and
efficacy against resistant bacterial
strains may therefore be commercially
attractive.
Advantages include:
• Structurally distinct antimicrobial
compounds.
• Attack newly validated antibacterial
targeted protein FtsZ.
• These compounds have a unique
mechanism of action which works by
inhibiting FtsZ GTPase activity.
• The chrysophaentins can be
obtained by synthetic routes through
dimerization of their synthetic shorter
analogues.
Applications:
• Therapeutic potential for curing
bacterial infections in vivo, including
for clinical and veterinary applications.
• Antiseptics in hospital settings.
• Since FtsZ is structurally similar,
but do not share sequence homology to
eukaryotic cytoskeletal protein tubulin,
these compounds may have antitumor
properties against some cancer types or
cell lines.
Development Status:
• Initial isolation and chemical
structural characterization using NMR
spectroscopy have been conducted.
• Antimicrobial testing against
MRSA, Enterococcus faecium, and VRE
were conducted in vitro using a
modified disk diffusion assay and
microbroth liquid dilution assays.
• MIC50 values were determined
using a microbroth dilution assay.
• Mode of action was elucidated and
Saturation Transfer Difference (STD)
NMR was conducted to map the binding
epitope of one of these compounds in
complex with recombinant FtsZ.
• Other experiments on different
areas to further characterize these
compounds and their mode of action are
currently ongoing.
• Shorter analogues of the natural
products have shown to be readily
synthesized and synthetic
chrysophaentins can be obtained from
them by chemical dimerization.
Inventors: Carole A Bewley Clore
(NIDDK); Peter Wipf (U. of Pittsburgh).
Relevant Publications:
1. A. Plaza et al. Chrysophaentins
A–H, antibacterial bisdiarylbutene
macrocycles that inhibit the bacterial
cell division protein FtsZ. J Am Chem
Soc. 2010 Jul 7;132(26):9069–77.
[PubMed: 20536175].
2. DJ Haydon et al. An inhibitor of
FtsZ with potent and selective antistaphylococcal activity. Science. 2008
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Sept 19; 321(5896):1673–1675.
[PubMed: 18801997].
3. NR Stokes et al. Novel inhibitors of
bacterial cytokinesis identified by a cellbased antibiotic screening assay. J Biol
Chem. 2005 Dec 2; 280(48):39709–
39715. [PubMed: 16174771].
4. J Wang et al. Discovery of small
molecule that inhibits cell division by
blocking FtsZ, a novel therapeutic target
of antibiotics. J Biol Chem. 2003 Nov 7;
278(45):44424–44428. [PubMed:
12952956].
5. P Domadia et al. Berberine targets
assembly of Escherichia coli cell
division protein FtsZ. Biochemistry.
2008 Mar 11; 47(10):3225–3234.
[PubMed: 18275156]
6. P Domadia et al. Inhibition of
bacterial cell division protein FtsZ by
cinamaldehyde. Biochem Pharmacol.
2007 Sep 15:74(6):831–840. [PubMed:
17662960]
7. S Urgaonkar et al. Synthesis of
antimicrobial natural products targeting
FtsZ: (+/¥)-dichamanetin and (+/¥)2′″-hydroxy-5″-benzylisouvarinol-B. Org
Lett. 2005 Dec 8;7(25):5609–5612.
[PubMed: 16321003].
Patent Status:
• PCT Application No. PCT/US2011/
026220 filed February 25, 2011 (HHS
Reference No. E–116–2010/0–PCT–02).
• U.S. Provisional Application No.
61/446,978 filed February 25, 2011
(HHS Reference No. E–115–2011/0–US–
01).
Licensing Status: Available for
licensing.
Licensing Contacts:
• Uri Reichman, PhD, MBA; 301–
435–4616; UR7a@nih.gov.
• John Stansberry PhD; 301–435–
5236; js852e@nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases,
Laboratory of Bioorganic Chemistry, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize the
chrysophaentin antibiotics. Please
contact Marguerite J. Miller at 301–451–
3636 or millermarg@niddk.nih.gov for
more information.
Dated: March 29, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–7921 Filed 4–1–11; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\04APN1.SGM
04APN1
EN04AP11.006
HIV vaccines and/or as prognostic
biomarkers. Please contact John Hewes,
PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
18565
Agencies
[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18564-18565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7921]
-----------------------------------------------------------------------
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.
Diagnostic and Prognostic Serum Biomarkers for Cancer Patients Treated
With Cancer Vaccines
Description of Technology: Although antibodies are a critical
element of the immune response, the role of antibody responses in
cancer vaccines is still unknown. Carbohydrate antigens, which are
directly or indirectly involved in most types of cancer vaccines, are a
class of antigens that has been largely understudied but play a
significant role in the immune response of cancer vaccines.
This invention involves the identification of serum biomarkers for
cancer that target carbohydrate antigens. The biomarkers are specific
sub-populations of serum antibodies present in the serum of patients
that bind to various glycan and/or glycoprotein antigens, such as the
Forssman antigen.
The biomarkers are useful for (a) predicting a patient's immune
responses to a cancer vaccine, (b) measuring the efficacy of a cancer
vaccine, and (c) determining the prognosis and long-term survival of
cancer patients.
Applications:
Diagnostic and prognostic test to monitor the progression
and long-term survival of cancer patients.
Predictive indicator of cancer patients' immune response
to a cancer vaccine.
Indicator to monitor the efficacy of a cancer vaccine.
Advantages: The technology is backed by clinical data.
Development Status: Preliminary clinical data; validation studies
are ongoing (confirmed findings in two independent patient groups).
Market: Cancer Vaccines are emerging as the forefront treatment
regimens for several cancers. Provenge[supreg] was recently approved by
the FDA for the treatment of prostate cancer. There are several other
cancer vaccines in clinical trials.
This technology can be developed into a pioneering test, as no such
test to monitor prognosis and efficacy of cancer vaccines currently
exists in the market.
Inventors: Jeff Gildersleeve, et al. (NCI).
Publications: No publications directly related to this technology.
Patent Status:
U.S. Provisional Application No. 61/371,537 filed August
6, 2010 (HHS Reference No. E-234-2010/0-US-01).
U.S. Provisional Application No. 61/443,955 filed February
17, 2011 (HHS Reference No. E-234-2010/1-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Sabarni Chatterjee, M.B.A., PhD; 301-435-5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Chemical Biology Laboratory, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize anti-glycan serum antibodies as
biomarkers for cancer or
[[Page 18565]]
HIV vaccines and/or as prognostic biomarkers. Please contact John
Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.
A New Class of Antibiotics: Naturally-Occurring Chrysophaetins and
Their Analogues
Description of Invention: This invention, offered for licensing and
commercial development, relates to a new class of naturally occurring
antimicrobial compounds called Chrysophaetins, and to their synthetic
analogues. Isolated from an alga species, the mechanism of action of
these compounds is through the inhibition of bacterial cytoskeletal
protein FtsZ, an enzyme necessary for the replication of bacteria. FtsZ
is responsible for Z-ring assembly in bacteria, which leads to
bacterial cell division. Highly conserved among all bacteria, FtsZ is a
very attractive antimicrobial target.
The chrysophaetin exhibits antimicrobial activity against drug
resistant bacteria, methicillin-resistant Staphylococcus aureus (MRSA)
and vancomycin-resistant Enterococcus faecalis (VRE), as well as other
drug susceptible strains. The general structure of the natural compound
is shown below:
[GRAPHIC] [TIFF OMITTED] TN04AP11.006
BILLING CODE 4140-01-C
The inventors are working on a synthetic route for the compound and
analogs. They have made progress and now have two halves of the
molecule. These will be further dimerized to produce a synthetic
chrysophaentin. It is expected that the analogues will show similar
antimicrobial activity to the natural products and will utilize the
same mechanism of action.
The market potential for the disclosed compounds is huge ($24
billion in 2008) due to the very limited number of new antibiotics
developed in recent decades and the increased epidemic of infectious
diseases. In fact, infectious diseases are the leading cause of death
worldwide. In the United States alone, more people die from MRSA than
from HIV (Journal of the American Medical Association, 2007) and more
than 90,000 people die each year from hospital acquired bacterial
infections (Centers for Disease Control). A development of new drugs
with distinct mechanism of action and efficacy against resistant
bacterial strains may therefore be commercially attractive.
Advantages include:
Structurally distinct antimicrobial compounds.
Attack newly validated antibacterial targeted protein
FtsZ.
These compounds have a unique mechanism of action which
works by inhibiting FtsZ GTPase activity.
The chrysophaentins can be obtained by synthetic routes
through dimerization of their synthetic shorter analogues.
Applications:
Therapeutic potential for curing bacterial infections in
vivo, including for clinical and veterinary applications.
Antiseptics in hospital settings.
Since FtsZ is structurally similar, but do not share
sequence homology to eukaryotic cytoskeletal protein tubulin, these
compounds may have antitumor properties against some cancer types or
cell lines.
Development Status:
Initial isolation and chemical structural characterization
using NMR spectroscopy have been conducted.
Antimicrobial testing against MRSA, Enterococcus faecium,
and VRE were conducted in vitro using a modified disk diffusion assay
and microbroth liquid dilution assays.
MIC50 values were determined using a microbroth
dilution assay.
Mode of action was elucidated and Saturation Transfer
Difference (STD) NMR was conducted to map the binding epitope of one of
these compounds in complex with recombinant FtsZ.
Other experiments on different areas to further
characterize these compounds and their mode of action are currently
ongoing.
Shorter analogues of the natural products have shown to be
readily synthesized and synthetic chrysophaentins can be obtained from
them by chemical dimerization.
Inventors: Carole A Bewley Clore (NIDDK); Peter Wipf (U. of
Pittsburgh).
Relevant Publications:
1. A. Plaza et al. Chrysophaentins A-H, antibacterial
bisdiarylbutene macrocycles that inhibit the bacterial cell division
protein FtsZ. J Am Chem Soc. 2010 Jul 7;132(26):9069-77. [PubMed:
20536175].
2. DJ Haydon et al. An inhibitor of FtsZ with potent and selective
anti-staphylococcal activity. Science. 2008 Sept 19; 321(5896):1673-
1675. [PubMed: 18801997].
3. NR Stokes et al. Novel inhibitors of bacterial cytokinesis
identified by a cell-based antibiotic screening assay. J Biol Chem.
2005 Dec 2; 280(48):39709-39715. [PubMed: 16174771].
4. J Wang et al. Discovery of small molecule that inhibits cell
division by blocking FtsZ, a novel therapeutic target of antibiotics. J
Biol Chem. 2003 Nov 7; 278(45):44424-44428. [PubMed: 12952956].
5. P Domadia et al. Berberine targets assembly of Escherichia coli
cell division protein FtsZ. Biochemistry. 2008 Mar 11; 47(10):3225-
3234. [PubMed: 18275156]
6. P Domadia et al. Inhibition of bacterial cell division protein
FtsZ by cinamaldehyde. Biochem Pharmacol. 2007 Sep 15:74(6):831-840.
[PubMed: 17662960]
7. S Urgaonkar et al. Synthesis of antimicrobial natural products
targeting FtsZ: (+/-)-dichamanetin and (+/-)-2'''-hydroxy-5''-
benzylisouvarinol-B. Org Lett. 2005 Dec 8;7(25):5609-5612. [PubMed:
16321003].
Patent Status:
PCT Application No. PCT/US2011/026220 filed February 25,
2011 (HHS Reference No. E-116-2010/0-PCT-02).
U.S. Provisional Application No. 61/446,978 filed February
25, 2011 (HHS Reference No. E-115-2011/0-US-01).
Licensing Status: Available for licensing.
Licensing Contacts:
Uri Reichman, PhD, MBA; 301-435-4616; UR7a@nih.gov.
John Stansberry PhD; 301-435-5236; js852e@nih.gov.
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases, Laboratory of Bioorganic
Chemistry, is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize the chrysophaentin antibiotics. Please contact Marguerite
J. Miller at 301-451-3636 or millermarg@niddk.nih.gov for more
information.
Dated: March 29, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-7921 Filed 4-1-11; 8:45 am]
BILLING CODE 4140-01-P