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28 August 2008
[Federal Register: August 28, 2008 (Volume 73, Number 168)]
[Notices]
[Page 50829-50830]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au08-80]
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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.
Botulinum Toxoid
Description of Technology: Vaccination is the only approach that
can be used to prevent botulism. A pentavalent botulinum toxoid
comprised of formalin-detoxified botulinum neurotoxin (BoNT) BoNT/A, B,
C, D and E hemagglutinin (Hmg) complexes has been used to immunize
laboratory and military personnel since 1961, but this has never been
licensed by the United States Food and Drug Administration (FDA).
Vaccination immediately after toxin exposure has no protective benefit
because the immune response is relatively slow compared to the rate of
intoxication. The only treatment that is available upon intoxication is
antibody therapy, which entails the injection of equine-derived
botulinum antitoxin (BAT) or human-derived botulinum immunoglobulin
(BIG) to remove toxin from the blood. Antibody therapy does not
alleviate symptoms of botulism, but can limit the amount of toxin that
enters nerve terminals and thus may lessen the severity and shorten the
duration of paralysis.
Since a vaccine can be used to either protect a human population or
produce a BAT or BIG product, it is important to have reliable methods
to evaluate the antigenic integrity of botulinum vaccines. An in vitro
assay that can serve in this capacity would be useful for evaluating
the consistency of the antigen throughout the manufacturing process, as
well as generating data that may reduce in vivo testing.
Available for licensing are a variety of new toxoids useful as
botulinum vaccine antigens, for BAT or BIG production, or for
development of tests to evaluate antigenicity of botulinum vaccines.
The toxoids of the invention are derived from the Serotype A and B 150
kDa neurotoxin proteins. The resulting toxoids are antigenically
identical to the native toxin as measured by inhibition ELISA in spite
of showing
[[Page 50830]]
a reduction of toxicity by more than 100,000-fold. Sandwich ELISA
analysis indicated that the featured toxoids were two- to three-fold
less antigenic than the native neurotoxin compared to commercially
available toxoids, which were about 100-fold less antigenic.
Preclinical studies have been performed using the toxoids of the
invention. Mice were immunized twice, on Day Zero (0) and Day Fourteen
(14). By Day Twenty-Eight (28), relatively high toxin-specific IgG
titers were detected in animals that had received any of the in-house
toxoids, with greater than 99% being IgG1 and the remainder IgG2. These
immunized mice remained asymptomatic after being challenged with Fifty
(50) to One Million (1,000,000) median lethal dose (LD50) units of the
900 kDa neurotoxin. In contrast, animals immunized with several
different batches of commercially available toxoids did not develop
measurable toxin-specific antibody titers; however, these mice did
survive neurotoxin challenges with Two (2) LD50 units, but died when
challenged with Six (6) LD50 units.
This application claims the formalin-detoxified botulinum
compositions described above and an in vitro method for characterizing
the toxoids. Also claimed are methods of making the botulinum
compositions, and methods of producing antitoxin to botulinum toxin.
Applications: ELISA development, production of equine or human-
derived botulinum antitoxin, development of next generation botulism
vaccines.
Development Status: Toxoids have been prepared and preclinical
studies have been performed. Standard antibody reagents for ELISA assay
development have been prepared.
Inventors: James E. Keller (FDA/CBER).
Publication: JE Keller. Characterization of New Formalin Botulinum
Neurotoxin Toxoids. Clin Vaccine Immunol. 2008 Jul 30; Epub ahead of
print, doi:10.1128/CVI.00117-08.
Patent Status: U.S. Provisional Application No. 61/036,904 filed 14
Mar 2008 (HHS Reference No. E-325-2007/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity: The FDA Center for Biologics
Evaluation and Research is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize botulinum toxoids. Please contact Alice
Welch, PhD at 301-827-0359 or Alice.Welch@fda.hhs.gov for more
information.
Magnetic Resonance Imaging Methods and Systems for Estimating Cone of
Uncertainty
Description of Technology: In diffusion tensor MRI imaging it is
desirable to determine and display the fiber tract dispersion, e.g.,
the eigenvectors and the associated uncertainties. For example, the
unit eigenvector may be displayed with a cone of uncertainty around its
tip. This conveys the notion that the direction of fiber is not known
precisely. However, the known methods are directed to computation and
visualization of a circular cone of uncertainty. These methods are
suitable for practical computation and visualization of an elliptical
cone of uncertainty. The current invention overcomes this problem by
providing (1) a reconstruction procedure to construct the covariance
matrix of a major eigenvector for each voxel of a region of interest of
a subject, (2) a visualization technique to visualize the elliptical
cone of uncertainty of the eigenvector, and (3) two reconstruction
procedures to compute the normalized areal and circumferential measures
of the elliptical cone of uncertainty. The methods can be used to
diagnose medical disorders associated with anomalous changes in water
diffusion. The methods can also be used in applications in material
science and earth science (geomagnetism).
Applications: Magnetic Resonance Imaging; Diagnostics; Material
science; Earth science (Geomagnetism).
Inventor: Cheng Guan Koay (NICHD).
Publications:
1. CG Koay et al. The elliptical cone of uncertainty and its
normalized measures in diffusion tensor imaging. IEEE Trans Med
Imaging. 2008 Jun;27(6):834-846.
2. CG Koay et al. Error propagation framework for diffusion tensor
imaging via diffusion tensor representations. IEEE Trans Med Imaging.
2007 Aug;26(8):1017-1034.
3. CG Koay et al. A unifying theoretical and algorithmic framework
for least squares methods of estimation in diffusion tensor imaging. J
Magn Reson. 2006 Sep;182(1):115-125.
Patent Status: U.S. Provisional Application No. 60/996,169 filed 05
Nov 2007 (HHS Reference No. E-273-2007/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The NICHD, Section on Tissue
Biophysics and Biomimetics, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize this technology. Please contact
Alan E. Hubbs, PhD at 301-594-4263 or hubbsa@mail.nih.gov for more
information.
Dated: August 18, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-19915 Filed 8-27-08; 8:45 am]
BILLING CODE 4140-01-P