[Federal Register Volume 72, Number 150 (Monday, August 6, 2007)]
[Notices]
[Pages 43647-43650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15208]
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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
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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.
Immortalized Cell Line for Retroviral Studies
Description of Technology: This technology describes immortalized
human umbilical cord-blood T lymphocytes transformed with the
retrovirus human T-cell leukemia-lymphoma virus (HTLV). These cells
contain the HTLV genome and synthesize viral RNA but are restricted in
their expression of viral structure proteins. This cell line should be
useful in the study of retrovirus expression. Please visit the NIH AIDS
Research and Reference Reagent Program Web site (http://www.aidsreagent.org; catalog #404) for additional information.
Applications: Viral expression studies; Study of viral proteins and
nucleic acids involved in T-cell immortalization.
Inventors: Genoveffa Franchini (NCI).
Publications:
1. SZ Salahuddin et al. Restricted expression of human T-cell
leukemia--lymphoma virus (HTLV) in transformed human umbilical cord
blood lymphocytes. Virology 1983 Aug;129(1):51-64.
2. NIH AIDS Research and Reference Reagent Program Web site.
Patent Status: HHS Reference No. E-272- 2007/0--Research Tool.
Licensing Status: Available for licensing.
Licensing Contact: Susan Ano, Ph.D.; 301/435-5515;
[email protected].
Device and Method for Protecting Against Coronary Artery Compression
During Transcatheter Mitral Valve Annuloplasty
Description of Technology: Catheter-based mitral valve
regurgitation treatments that use a coronary sinus trajectory or
coronary sinus implant can have unwanted effects because the coronary
sinus and its branches have been found to cross the outer diameter of
major coronary arteries in a majority of humans. As a result, pressure
applied by any prosthetic device in the coronary sinus (such as tension
on the annuloplasty device) can compress the underlying coronary artery
and induce myocardial ischemia or infarction.
Available for licensing and commercial development are devices and
methods that avoid constricting coronary artery branches during
coronary sinus-based annuloplasty. These devices and methods protect
coronary artery branches from constriction during trans-sinus mitral
annuloplasty. The device protects a coronary vessel from compression
during mitral annuloplasty in which an annuloplasty element, such as a
tensioning device, extends at least partially through the coronary
sinus over a coronary artery. The device is a surgically sterile bridge
configured for placement within the coronary sinus at a location where
the coronary sinus passes over a coronary artery, so that the
protection device provides a support for a mitral annuloplasty element,
such as a compressive prosthesis, including a tension element when it
is placed under tension. The protection device has an arch of
sufficient rigidity and dimensions to support the tensioning element
over the coronary artery, redistribute tension away from an underlying
coronary artery, and inhibit application of pressure to the underlying
artery, for example when an annuloplasty tension element is placed
under tension during mitral annuloplasty.
In particular, the protective device can be a support interposed in
the
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coronary sinus between the annuloplasty device and the coronary artery.
The device may be substantially tubular so that the tensioning element
is contained within the protective device and supported in spaced
relationship to the coronary artery. An arch may be configured to
extend between a proximal end and a distal end that are substantially
collinear with one another so that the ends form stabilizing members
such as feet that retain the bridge in position over the coronary
artery.
The device may be used in methods of improving the function of a
mitral valve in a subject in which an annuloplasty element, for example
an element that exerts compressive remodeling forces on the mitral
valve (such as a tensioning element), is introduced at least partially
around the mitral valve, for example at least partially through the
coronary sinus and over a coronary artery. The protective device is
placed between the annuloplasty element and the coronary artery, with
the annuloplasty element supported by the bridge of the device.
Compressive remodeling forces are exerted by the annuloplasty device
(for example by applying tension to alter the shape or configuration of
the mitral valve annulus to reduce its circumference) while supporting
the annuloplasty element on the bridge to inhibit application of
pressure to the coronary artery. The function of the mitral valve in
the patient is thereby improved without impairing coronary blood flow.
The annuloplasty element can be introduced at least partially
around the mitral valve by advancing the annuloplasty element in an
endovascular catheter through the vascular system to the heart and
introducing the annuloplasty element and the protective device from the
catheter into the coronary sinus through a coronary sinus ostium. In
those embodiments in which the protective device includes an internal
lumen, the annuloplasty element extends through the lumen of the
protective device over the coronary artery so that the annuloplasty
element is supported by the protective device. The protective device
can be integrated directly into the annuloplasty element, such as a
resilient or expandable device, or a tensioning element or tensioning
material.
In other embodiments, this disclosure provides a method of
improving function of a mitral valve in a subject who has mitral
regurgitation by performing a mitral valve cerclage annuloplasty. In a
particular disclosed example of the procedure, a guiding catheter is
percutaneously inserted through the vasculature of a subject. The
guiding catheter is introduced through the coronary sinus into the
great cardiac vein, and a steerable microcatheter or other coaxial
guiding catheter or steering device introduces a guidewire into a basal
blood vessel such as the first septal coronary vein. From there the
guidewire traverses under imaging guidance the septal myocardium or
annulus fibrosis and reenters the right ventricle or right atrium. The
guidewire is then retrieved using a vascular snare and the guiding
catheter and guidewire are replaced with a tensioning system. The
protective device is then introduced through the guiding catheter over
or in tandem with the tensioning system so as to protect an underlying
coronary artery when tension is introduced to perform the annuloplasty.
Applications: Cardiac valve repair; Interventional Cardiology;
Cardiac Surgery.
Development Status: Early-stage; Pre-clinical data available;
Prototype.
Inventors: June-Hong Kim, Robert J. Lederman, Ozgur Kocaturk
(NHLBI).
Patent Status: U.S. Provisional Application No. 60/858,716 filed 14
Nov 2006. (HHS Reference No. E-249-2006/0-US-01); U.S. Provisional
Application No. 60/932,611 filed 31 May 2007 (HHS Reference No. E-249-
2006/1-US-01); The issued and pending patent rights are solely owned by
the United States Government.
Licensing Status: Available for licensing on an exclusive or non-
exclusive basis.
Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019;
[email protected].
Collaborative Research Opportunity: The NHLBI Cardiovascular Branch
is seeking statements of capability or interest from parties interested
in collaborative research to further development, evaluate, or
commercialize catheter-based cardiovascular devices. Please contact Peg
Koelble, NHLBI Office of Technology Transfer and Development, at 301-
594-4095 or [email protected].
A Shuttle Plasmid, Recombinant MVA/HIV1 Clinical Vaccine Constructs and
a Mechanism for Enhanced Stability of Foreign Gene Inserts by Codon
Alternation and for Insertion of the Foreign Gene Between Two Vaccinia
Virus Essential Genes
Description of Technology: Since the onset of the AIDS epidemic
more than two decades ago, enormous efforts have been directed to
making a vaccine that will protect against human immunodeficiency
virus-1 (HIV); an effective vaccine is thought to require the induction
of cellular and humoral responses. Vaccine candidates have included a
variety of HIV immunogens delivered as DNA, attenuated poxviruses,
adenoviruses, vesicular stomatitis virus, proteins, and various
combinations thereof. The inventors' efforts to design an HIV vaccine
have focused on modified vaccinia virus Ankara (MVA) as a vector.
The patent application describes (1) The shuttle plasmid, pLW73,
used for insertion of a foreign gene between two essential vaccinia
virus genes (in this case, I8R, G1L), (2) an MVA/Ugandan Clade D (UGD)
construct, and (3) an MVA/HIV 75 AG construct using pLW73 as a vector.
Additionally, the invention provides two methods: (1) A method useful
for large-scale production of recombinant vaccinia viruses, and (2) a
method for stabilizing foreign gene inserts that undergo mutation after
repeated passages, again useful in large-scale production of
recombinant vaccinia viruses.
Application: Immunization against HIV.
Developmental Status: Vaccine candidates have been synthesized and
preclinical studies have been performed. The vaccine candidates of this
invention are slated to enter Phase I clinical trials in the next year.
Inventors: Bernard Moss, Patricia Earl, Linda Wyatt (NIAID).
Patent Status: U.S. Patent Application No. 60/840,093 filed 25 Aug
2006 (HHS Reference No. E-248-2006/0-US-01); U.S. Patent Application
No. 60/840,755 filed 28 Aug 2006 (HHS Reference No. E-248-2006/1-US-
01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter J. Soukas, J.D.; 301/435-4646;
[email protected].
Molecular Probes for Identification or Isolation of Membrane Proteins
Description of Technology: This technology describes a new class of
molecular probes designed around an iodonaphthyl succinate antigen that
can be used to label and tag proteins using a variety of conventional
protein modification chemistries. The technology is offered as a
combination of probe + monoclonal antibodies against the probe (three
clones). The probe can be used for labeling and tagging cell surface
and integral membrane proteins as well as soluble proteins. The
monoclonal antibodies were tested and found effective for
immunoprecipitation, western blot, and
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flow cytometry. Once tagged, the modified proteins can be detected or
isolated using an antibody reactive with the probe. Several possible
probes and monoclonal antibodies that react with them are described.
These probes and their corresponding antibodies have significant
advantages over the biotin-avidin system.
Advantages: Reversibility of binding for protein isolation; Lack of
high, non-specific binding to cell surfaces; Ability to incorporate
isotopic 125 I label in the probe for tracking tagged
proteins in vivo.
Applications: Protein labeling; Protein isolation.
Development Status: In vitro data available.
Inventors: Yossef Raviv et al. (NCI).
Patent Status: U.S. Provisional Application No. 60/906,166 filed 09
Mar 2007 (HHS Reference No. E-162-2006/0-US-01).
Licensing Contact: Susan Ano, Ph.D.; 301/435-5515;
[email protected].
Cross-protective Influenza Vaccine That Protects Against Lethal H5N1
Challenge
Description of Technology: Concerns about a potential influenza
pandemic and its prevention are a regular part of health news, with
bird (avian) influenza (prominently including H5N1 strains) being a
major concern. Vaccination is one of the most effective ways to
minimize suffering and death from influenza. Currently, there is not an
effective way to vaccinate against avian influenza without knowing what
subtype and strain will circulate. The technology described here
relates to use of influenza A matrix 2 (M2) protein of a sequence
derived from one subtype to induce immunity protective against
infection with other subtypes, an approach made possible by the fact
that M2 is highly conserved among different influenza strains. The M2
component can be expressed from a DNA vaccine or recombinant viral
vector, can be a protein or peptide, or can involve immunizing with one
form and boosting with another, for example a DNA or viral vector
followed by or preceded by a polypeptide. The M2 component can be used
either alone or in combination with other influenza components, and can
be administered with or without adjuvant. Specifically, mouse studies
showed that the DNA vaccine priming followed by recombinant adenoviral
boosting with constructs expressing M2 from an H1N1 strain protected
against a lethal challenge with an H5N1 strain. Such cross-protection
would be beneficial in a seasonal or pandemic influenza vaccine
product. The current approach offers several advantages over
traditional influenza vaccine approaches, including (a) ease and speed
of production without need for eggs, (b) vaccine manufacture not based
upon surveillance to determine dominant strain(s), and (c)
effectiveness despite antigenic shift for the components HA and NA of
circulating viruses.
Application: Influenza vaccine.
Development Status: Animal (mouse) data available.
Inventors: Suzanne L. Epstein et al. (CBER/FDA).
Patent Status: U.S. Provisional Application No. 60/786,152 filed 27
Mar 2006 (HHS Reference No. E-076-2006/0-US-01); PCT Application No.
PCT/US2007/007679 filed 27 Mar 2007 (HHS Reference No. E-076-2006/1-
PCT-01).
Licensing Contact: Susan Ano, PhD; 301/435-5515; [email protected].
Collaborative Research Opportunity: The Center for Biologics
Evaluation and Research, Office of Cellular, Tissue, and Gene
Therapies, Division of Cellular and Gene Therapies, Gene Therapy and
Immunogenicity Branch, is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize matrix 2 (M2) vaccines protective against
influenza A subtypes, including high-pathogenicity avian strains,
differing from the strain from which the vaccine was derived. Please
contact Dr. Suzanne Epstein at 301-827-0450 or
[email protected] for more information.
Targeting Poly-Gamma-Glutamic Acid To Treat Staphylococcus Epidermidis
and Related Infections
Description of Invention: Over the past decade, Staphylococcus
epidermidis has become the most prevalent pathogen involved in
nosocomial infections. Usually an innocuous commensal microorganism on
human skin, this member of the coagulase-negative group of
staphylococci can cause severe infection after penetration of the
epidermal protective barriers of the human body. In the U.S. alone, S.
epidermidis infections on in-dwelling medical devices, which represent
the main type of infection with S. epidermidis, cost the public health
system approximately $1 billion per year. Importantly, S. epidermidis
is frequently resistant to common antibiotics.
Immunogenic compositions and methods for eliciting an immune
response against S. epidermidis and other related staphylococci are
claimed. The immunogenic compositions can include immunogenic
conjugates of poly-[gamma]-glutamic acid (such as [gamma]DLPGA)
polypeptides of S. epidermidis, or related staphylococci that express a
[gamma]PGA polypeptide. The [gamma]PGA conjugates elicit an effective
immune response against S. epidermidis, or other staphylococci, in
subjects to which the conjugates are administered. A method of treating
an infection caused by a Staphylococcus organism that expresses CAP
genes is also disclosed. The method can include selecting a subject who
is at risk of or has been diagnosed with the infection by the
Staphylococcus organism which expresses [gamma]PGA from the CAP genes.
Further, the expression of a [gamma]PGA polypeptide by the organism can
then be altered.
Application: Prophylactics against S. epidermidis.
Developmental Status: Preclinical studies have been performed.
Inventors: Michael Otto, Stanislava Kocianova, Cuong Vuong, Jovanka
Voyich, Yufeng Yao, Frank DeLeo (NIAID).
Publication: S Kocianova et al. Key role of poly-gamma-DL-glutamic
acid in immune evasion and virulence of Staphylococcus epidermidis. J
Clin Invest. 2005 Mar;115(3):688-694.
Patent Status: PCT Patent Application No. PCT/US2006/026900 filed
10 Jul 2006 (HHS Reference No. E-263-2005/0-PCT-02).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
[email protected].
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases, Laboratory of Human Bacterial
Pathogenesis, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize the use of poly-[gamma]-glutamic acid of
staphylococci. Please contact Dr. Michael Otto at [email protected]
for more information.
Improved Expression Vectors for Mammalian Use
Description of Technology: This technology relates to improving
levels of gene expression using a combination of a constitutive RNA
transport element (CTE) with a mutant form of another RNA transport
element (RTE). The combination of these elements results in a
synergistic effect on stability of mRNA transcripts, which in turn
leads to increased expression levels. Using HIV-1 gag as reporter mRNA,
one mutated RTE in combination with a CTE was
[[Page 43650]]
found to improve expression of unstable mRNA by about 500-fold.
Similarly this combination of elements led to synergistically elevated
levels of HIV-1 Env expression. The function of CTEs and RTEs is
conserved in mammalian cells, so this technology is a simple and useful
way of obtaining high levels of expression of otherwise poorly
expressed genes and can be used in a number of applications such as but
not limited to improvements of gene therapy vectors, expression vectors
for mammalian cells.
Applications: Gene therapy; DNA vaccines; Protein expression.
Development Status: In vitro data available.
Inventor: Barbara Felber et al. (NCI).
Patent Status: U.S. Utility Application No. 10/557,129, filed 16
Nov 2005, from PCT Application No. PCT/US04/15776 filed 19 May 2004,
which published as WO2004/113547 on 29 Dec 2004 (HHS Reference No. E-
223-2003/1-US-03).
Licensing Status: Available for licensing.
Licensing Contact: Susan Ano, PhD; 301/435-5515; [email protected].
Collaborative Research Opportunity: The National Cancer Institute
Vaccine Branch is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize this technology. Please contact John D.
Hewes, PhD at 301-435-3121 or [email protected] for more information.
Dated: July 31, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-15208 Filed 8-3-07; 8:45 am]
BILLING CODE 4140-01-P