[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20667-20669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07917]
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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, 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.
Highly Potent and Selective Deubiquitinating Enzyme Inhibitor
Description of Technology: Available for licensing are inhibitors
that target the USP1/UAF1 deubiquitnating enzyme (DUB) complex. The FDA
approval and commercial success of
[[Page 20668]]
Velcade[supreg], a small molecule proteasome inhibitor, has established
the ubiquitin-proteasome system (UPS) as a valid target for anticancer
treatment. However, proteasome inhibitors in general suffer from a
narrow therapeutic index and acquired resistance. A promising
alternative to proteasome inhibition has been to target the enzymes
upstream of proteasome-mediated protein degradation, i.e. the ubiquitin
conjugation and deconjugation, to generate more specific, less toxic
therapeutic agents. The investigators have developed small molecules
that target the USP1/UAF1 DUB complex that acts upstream of UPS and has
been implicated in the DNA damage response. These compounds are the
most potent and selective DUB inhibitors reported to date. Moreover,
the inhibitors act synergistically with cisplatin, a DNA damaging anti-
cancer drug, to overcome chemoresistance and enhance cytotoxicity.
These results suggest the inhibitors may also improve the efficacy and
potency of other commonly prescribed chemotherapeutic agents that are
known to induce DNA damage.
Potential Commercial Applications:
Method to treat cancer
Method to overcome chemoresistance to cisplatin
Pharmaceutical compositions
Competitive Advantages:
Represents the most potent and selective DUB inhibitor
reported to date.
Promising alternative to proteasome inhibition offering
the potential of more selective and less toxic therapeutic agents.
Acts synergistically with DNA damaging agents to overcome
chemoresistance.
Development Stage:
Early-stage
In vitro data available
Inventors: David Maloney (NCATS), Andrew Rosenthal (NCATS), Ajit
Jadhav (NCATS), Thomas Dexheimer (NCATS), Anton Simeonov (NCATS),
Zhihao Zhuang (University of Delaware), Qin Liang (University of
Delaware), Diane Luci (NCATS)
Intellectual Property: HHS Reference No. E-043-2013/0--US
Provisional Application No. 61/747,052 filed 28 December 2012
Related Technologies:
HHS Reference No. E-208-2007/0--US Patent Application No.
12/669,361 filed 15 January 2010
HHS Reference No. E-156-2012/0--US Provisional Application
No. 61/692,560 filed 23 August 2012
HHS Reference No. E-231-2002/0--US Patent No. 7,498,336
issued 3 March 2009
HHS Reference No. E-070-2005/0--US Patent No. 8,242,160
issued 14 June 2012 and US Patent Application No. 13/547,417 filed 12
July 2012
Licensing Contact: Jennifer Wong, M.S.; 301-435-4633;
[email protected].
Collaborative Research Opportunity: The National Center for
Advancing Translational Sciences is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize this invention. For collaboration
opportunities, please contact Lili Portilla at [email protected].
Therapeutic Applications of a Carboxy-Terminal RTDL Motif
Description of Technology: Mesencephalic Astrocyte-derived
Neurotrophic Factor (MANF) is a secreted neurotrophic factor with known
anti-neurodegenerative properties. The inventors discovered that the C-
terminal RTDL motif of MANF is involved in the anti-degenerative
properties of MANF and association of extracellular MANF with the cell
surface. Isolated peptides, including the C-terminal RTDL motif of
MANF, potentially can be used as a treatment for neurodegenerative
disorders and ischemia.
Potential Commercial Applications: Treating neurodegenerative
diseases, such as Alzheimer's disease, Parkinson's disease, Huntington
disease, etc.
Competitive Advantages: Secreted novel peptides.
Development Stage:
Early-stage
Pre-clinical
In vitro data available
Inventors: Brandon K Harvey, et al. (NIDA)
Intellectual Property: HHS Reference No. E-249-2012/0--US
Provisional Application 61/732, 241 filed 30 Nov 2012
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected]
HIV-Neutralizing Polypeptides: A Novel Use for Platelet Factor 4 or Its
Derivatives
Description of Technology: The subject invention describes the
method for using Platelet Factor 4 (PF4), also called CXCL4, to inhibit
HIV viral entry by blocking GP120 independent of HIV receptor. It also
demonstrates that the active polypeptide fragment(s) of PF-4 could be
used to identify potential peptide mimics or small molecules that could
be used to inhibit HIV infection. PF4 and/or its derivatives may be
developed as a systemic therapy or preventive measure using topical
applications, such as microbicides. In addition, CXCL4 serum/plasma
testing could be used as a clinical marker of HIV disease status to
predict/monitor the efficacy of treatment and determine the prognosis
of a subject with HIV infection.
Potential Commercial Applications:
Treatment and prevention of HIV-1 infection.
Topical application as microbicides.
A vaccine adjuvant to boost the vaccine efficacy.
A clinical marker of HIV disease status or to predict/
monitor the efficacy of treatment or vaccines.
Competitive Advantages:
A new HIV-1 inhibitory molecule that acts through a new
inhibitory mechanism.
Any potential derivative or mimicking compound would be
unique and have the advantage of hitting a previously unrecognized
molecular target in the HIV life cycle.
Development Stage:
Early-stage
In vitro data available
Inventors: Paolo Lusso and David J. Auerbach (NIAID)
Publication: Auerbach DJ, et al. Identification of the platelet-
derived chemokine CXCL4/PF-4 as a broad-spectrum HIV-1 inhibitor. Proc
Natl Acad Sci USA 2012 Jun 12;109(24):9569-74. [PMID 22645343]
Intellectual Property: HHS Reference No. E-140-2012/0--US
Application No. 61/649,150 filed 19 Jun 2012
Related Technology: The CXCL4 sequence is in the public domain.
Licensing Contact: Sally Hu, Ph.D., MBA; 301-435-5606;
[email protected].
Polarimetric Accessory for Colposcope
Description of Technology: Available for licensing and commercial
development is a colposcope accessory device that compensates and
resolves tissue borne specular reflections. In medical diagnostic
procedures for examining the cervix and the tissues of the vagina and
vulva, long working-distance (-30 cm) lighted binocular microscope
(colposcope) that provide up to 25x optical magnification are used to
create an illuminated magnified view. Speculum dilations can give rise
to specular reflections from the tissue surface. The present
polarimetric accessory overcomes this limitation and enhances the
visibility of subsurface structures of the scattering object. Linearly
polarized light is used for cervical illumination and imaging is
[[Page 20669]]
performed through an additional polarizer that separates the specularly
reflected light from the diffusely backscattered light, which
originates in deeper tissue layers, allowing enhanced imaging of the
hidden subsurface tissue structure (texture). The region of interest is
illuminated by linearly polarized light, and backscattered light passes
through the polarization filter to be detected by a digital camera. A
custom optical design preserves the polarization state of the
backscattered light in the microscope, without interfering with the
standard optical path and operation of the microscope, including its
binocular system. Special algorithms to visualize regions of
statistical similarity in the image have been developed. Though the
diffusely backscattered light presents only a small fraction of the
detected light, its analysis, using the customized design and image
processing procedures, provides useful information about internal
structures of biological tissues. The polarimetric accessory includes a
linear polarizer for the illuminating beam, two beam splitters for
preserving polarization state, lens system for imaging, polarization
analyzer, band-pass optical filter, digital camera, and electronic
triggering system.
Potential Commercial Applications: Gynecological examinations
Competitive Advantages:
Image quality
Resolution of tissue structures at close microscopic
distances
Development Stage: Prototype
Inventors: Amir Gandjbakhche (NICHD), Victor Chernomordik (NICHD),
Moinuddin Hassan (NICHD), Alexander Sviridov (NICHD), Zachary Alissi
(NICHD), Paul Smith (NIBIB), Albert Boccara (NICHD)
Publications:
1. Jacques SL, et al. Imaging superficial tissues with polarized
light. Lasers Surg Med. 2000;26(2):119-29. [PMID 10685085]
2. Jacques SL, et al. Imaging skin pathology with polarized light.
J Biomed Opt. 2002 Jul;7(3):329-40. [PMID 12175282]
3. Ramella-Roman JC, et al. Design, testing, and clinical studies
of a handheld polarized light camera. J Biomed Opt. 2004 Nov-
Dec;9(6):1305-10. [PMID 15568952]
4. Sviridov AP, et al. ``Analysis of Biological Tissue Textures
Using Measurements of Backscattered Polarized Light'' (presented at the
Optical Society of America--Biomedical Optics Topical Meeting, Fort
Lauderdale, Florida, March 2006).
5. Sviridov AP, et al. Visualization of biological texture using
correlation coefficient images. J Biomed Opt. 2006 Nov-
Dec;11(6):060504. [PMID 17212522]
Intellectual Property: HHS Reference No. E-084-2012--US Provisional
Patent Application No. 61/620,295 filed 04 Apr 2012
Licensing Contact: Michael A. Shmilovich, Esq., CLP; 301-435-5019;
[email protected]
CpG Oligonucleotides Treatment To Prevent Chemotherapy-Induced
Pulmonary Toxicity
Description of Technology: Bleomycin (BLM) is a chemotherapy agent
used to treat multiple types of cancer, but its side effects are life
threatening for some patients. About 20% of patients undergoing BLM
chemotherapy develop interstitial pneumonitis which may develop to life
threatening fibrosis. In such cases, BLM chemotherapy cannot be
continued.
This invention identifies a method of pre-treatment using
immunostimulatory CpG Oligonucleotide (ODN) molecules to prevent
chemotherapy-induced pulmonary toxicity. Administration of certain ODN
molecules induces inflammation via stimulation of inflammatory genes
(Toll-like receptor 9/TLR9). This stimulation is subsequently down-
regulated. This technology makes use of this counter regulatory
mechanism to reduce the side effects of chemotherapy agents, such as
BML. A properly timed pre-administration of ODN molecules, prior to BML
therapy, prevents the lethal side effect of BLM-induced pulmonary
inflammation and down-regulates promoters of BLM toxicity (IL-17A and
TGF-beta1). Because toxicity from pulmonary inflammation is a side
effect limiting use of many chemotherapeutic agents and ODN molecules
are relatively inexpensive and have a favorable safety profile, this
technology may be useful to improve treatment protocols for many
chemotherapy agents.
Potential Commercial Applications: Therapeutic to reduce harmful
side effects of pulmonary inflammation caused by chemotherapy.
Competitive Advantages:
Pulmonary toxicity during chemotherapy is dangerous side
effect, this technology uses ODN molecules that are relatively
inexpensive and have a favorable safety profile to reduce this side
effect.
This technology may increase the safety and availability
of many chemotherapy treatments.
Development Stage:
Early-stage
In vivo data available (animal)
Inventors: Dennis Klinman and Takeshi Kinjo (NCI)
Publication: Kinjo T, et al. The counter regulatory response
induced by CpG oligonucleotides prevents bleomycin induced pneumopathy.
Respir Res. 2012 Jun 18;13:47. [PMID 22708497]
Intellectual Property: HHS Reference No. E-077-2012/0--U.S.
Provisional Patent Application No. 61/643,088 filed 04 May 2012
Licensing Contact: Edward (Tedd) Fenn; 301-435-5031;
[email protected]
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
CpG oligonucleotides for use to down-modulate inflammatory reactions.
For collaboration opportunities, please contact John D. Hewes, Ph.D. at
[email protected].
Dated: April 1, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-07917 Filed 4-4-13; 8:45 am]
BILLING CODE 4140-01-P