[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24756-24758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09902]
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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.
FOR FURTHER INFORMATION CONTACT: 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.
Zirconium-89 PET Imaging Agent for Cancer
Description of Technology: This technology is a new generation of
rationally designed chelating agents which improve the complexation of
Zirconium-89 for PET imaging of cancers. The technology uses cyclic or
acyclic chelators made of 4 hydroxamate donors groups for improved
stability compared to the currently used natural product siderophore
desferrioxamine B (DFB), a
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chelator that consists of only 3 hydroxamate donors that fails to
saturate the coordination sphere of Zr(IV). DFB, which has been the
object of many pre-clinical and clinical studies exhibits insufficient
stability resulting in progressive radioisotope accumulation in bone
once injected that can contribute to toxicity and increased background.
The new chelators described in this invention have shown improved
kinetic inertness compared to DFB with stability up to 90% after 7 days
compared to 28% for DFB. In association with an adequate targeting
agent such as an antibody, toxicity to the bone can be reduced and
images with better contrast can be obtained with these new chelators.
Potential Commercial Applications:
Cancer imaging.
PET imaging.
ImmunoPET.
Competitive Advantages:
High stability.
Low toxicity.
Better imaging contrast.
Development Status:
Prototype.
In vitro data available.
Inventors: Francois Guerard (NCI), Yong Sok Lee (CIT), Martin
Brechbiel (NCI).
Publications:
1. Zhou Y, et al. Mapping biological behaviors by application of
longer-lived positron emitting radionuclides. Adv Drug Deliv Rev. In
Press; doi: 10.1016/j.addr.2012.10.012. [PMID 23123291].
2. Deri MA, et al. PET imaging with 89Zr: from radiochemistry to
the clinic. Nucl Med Biol. 2013 Jan;40(1):3-14. [PMID 22998840].
3. Vosjan MJ, et al. Conjugation and radiolabeling of monoclonal
antibodies with zirconium-89 for PET imaging using the bifunctional
chelate p-isothiocyanatobenzyl-desferrioxamine. Nat Protoc. 2010
Apr;5(4):739-43. [PMID 20360768].
4. Nayak TK, et al. PET and MRI of metastatic peritoneal and
pulmonary colorectal cancer in mice with human epidermal growth factor
receptor 1-targeted 89Zr-labeled panitumumab. J Nucl Med. 2012
Jan;53(1):113-20. [PMID 22213822].
5. Evans MJ, et al. Imaging tumor burden in the brain with 89Zr-
transferrin. J Nucl Med. 2013 Jan;54(1):90-5. [PMID 23236019].
6. Guerard F, et al. Investigation of Zr(IV) and 89Zr(IV)
complexation with hydroxamates: progress towards designing a better
chelator than desferrioxamine B for immuno-PET imaging. Chem Commun
(Camb). 2013 Feb 1;49(10):1002-4. [PMID 23250287].
Intellectual Property: HHS Reference No. E-111-2013/0--U.S.
Provisional Application No. 61/779,016 filed 13 Mar 2013.
Related Technologies:
HHS Reference No. E-194-2007/0--U.S. Patent Application
No. 12/667,790 filed 05 Jan 2010.
HHS Reference No. E-226-2006/0--U.S. Patent No. 8,288,530
issued 16 Oct 2012.
HHS Reference No. E-067-1990/0.
Licensing Contact: Michael A. Shmilovich; 301-435-5019;
[email protected].
Collaborative Research Opportunity: The Radioimmune & Inorganic
Chemistry Section, ROB, CCR, NCI, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate or commercialize Zirconium-89 chelation
technology for ImmunoPET imaging and other applications. For
collaboration opportunities, please contact John D. Hewes, Ph.D. at
[email protected].
Novel Methods for Generating Retinal Pigment Epithelium Cells From
Induced Pluripotent Stem Cells
Description of Technology: High efficiency methods for producing
retinal pigment epithelial cells (RPE) from induced pluripotent stem
cells (iPSCs) are disclosed. The RPE is a polarized monolayer in the
vertebrate eye that separates the neural retina from the choroid, and
performs a crucial role in retinal physiology by forming a blood-
retinal barrier and closely interacting with photoreceptors to maintain
visual function. Many ophthalmic diseases, such as age-related macular
degeneration, are associated with a degeneration or deterioration of
the RPE. The iPSCs are produced from somatic cells, including retinal
pigment epithelial cells, such as fetal RPE. These methods involve
producing embryoid bodies from human iPSCs, culturing the embryoid
bodies using specific media to induce differentiation into RPE and
growing the differentiated RPE cells in a defined media to generate
human RPE cells. The investigators also developed methods for detecting
RPE cells and authenticating RPE cells; determining agents that can
affect the production of RPE cells from an iPSC; and identifying an
agent that can increase RPE survival in response to a proteo toxic
insult or stress. The novel methods and RPE cells disclosed here can be
useful for both pre-clinical and clinical studies involving RPE.
Potential Commercial Applications: The methods described here can
be used to:
Produce RPE cells for use in screening for novel ocular
therapeutics and for identifying toxic side effects of drugs.
Produce RPE cells for use in novel cell-based therapies.
Produce cells to study pathophysiology of RPE.
Competitive Advantages: The methods described here:
Dramatically increase the efficiency of iPSC
differentiation into RPE.
Produce superior quality RPE.
Produce RPE cells that are fully authenticated.
Provide ways to perform high throughput screens with RPE
cells.
Development Stage:
Prototype.
Early-stage.
In vitro data available.
Intellectual Property: HHS Reference No. E-251-2012/3--U.S.
Provisional Application No. 61/759,988 filed 01 Feb 2013.
Licensing Contact: Suryanarayana (Sury) Vepa; 301-435-5020;
[email protected].
Collaborative Research Opportunity: The National Eye Institute is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
iPSC to RPE differentiation protocol, its clinical, screening, and
translational applications. For collaboration opportunities, please
contact Alan Hubbs, Ph.D. at [email protected].
Novel Tocopherol and Tocopheryl Quinone Derivatives as Therapeutics for
Lysosomal Storage Disorders
Description of Technology: Novel tocopherol derivatives and
tocopheryl quinone derivatives useful in the decrease of lysosomal
substrate accumulation, the restoration of normal lysosomal size, and
the treatment of lysosomal storage disorders (LSDs) are provided. The
inventors have discovered that tocopherol and tocopheryl quinone
derivatives with side chain modifications (such as terminal tri-
halogenated methyl groups) exhibit improved pharmacokinetics,
modulation of mitochondrial potential and restoration of some LSDs
phenotypes. These molecules by themselves or in combination with
Cyclodextrins (CDs) increase intracellular Ca2+ and enhance exocytosis.
Also, the treatment with these compounds reduced the pathological
changes in the ultrastructure of LSD cells as observed using electron
microscopy analysis. The inventors also found that there is a synergy
between CDs and the new tocopherol analogues when tested on the NPC
cells and cells from six other
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lysosomal storage diseases including Wolman, Niemann Pick Type A,
Farber, TaySachs, MSIIIB and CLN2 (Batten) diseases. These new
tocopherol analogues are as good or better than natural occurring
tocopherols and tocotrienols in reducing cholesterol accumulation in
several LSDs.
Potential Commercial Applications: To develop new therapeutics to
treat LSDs.
Competitive Advantages:
The main advantage of the compounds disclosed here is
their improved pharmacokinetics.
The combination of CD and the novel tocopherol analogues
may reduce the dosage of each drug and thereby reduce the potential
side effects.
Development Stage:
Prototype.
Early-stage.
Pre-clinical.
In vitro data available.
Inventors: Juan Jose Marugan, Wei Zheng, Jingbo Xiao, and John
McKew (NCATS).
Intellectual Property: HHS Reference No. E-148-2012/0--U.S.
Provisional Application No. 61/727,296 filed 16 Nov 2012.
Related Technologies:
HHS Reference No. E-294-2009/0--PCT Application No. PCT/
US2011/044590 filed 19 Jul 2011, which published as WO 2012/012473 on
26 Jan 2012.
HHS Reference No. E-050-2012/0--US Provisional Application
No. 61/679,668 filed 12 Aug 2012.
Licensing Contact: Suryanarayana (Sury) Vepa; 301-435-5020;
[email protected].
Collaborative Research Opportunities: The National Center for
Advancing Translational Sciences (NCATS) is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize Novel Tocopherol
and Tocopheryl Quinone Derivatives as Therapeutics for Lysosomal
Storage Disorders. For collaboration opportunities, please contact the
NCATS Technology Development Coordinator at
[email protected].
Dated: April 23, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-09902 Filed 4-25-13; 8:45 am]
BILLING CODE 4140-01-P