[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59794-59796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24987]
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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. 209 and 37 CFR part 404 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
[[Page 59795]]
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.
SUPPLEMENTARY INFORMATION: Technology descriptions follow.
Novel Radio-Labeled Agents for Imaging Alzheimer's Disease-Associated
Amyloid
Description of Technology: This technology introduces novel radio-
labeled agents for imaging amyloid deposits in the brains of
Alzheimer's disease patients. These are small molecule, radio-ligand
compounds that are analogs of benzo[d]thiazole. They are highly
specific to amyloid, have low background noise, do not undergo rapid
defluoridation and do not produce residual radioactivity in the brain.
In addition, the compounds are stable and may be readily synthesized
from commercially available starting materials. These compounds may be
used in many noninvasive imaging techniques including: Magnetic
resonance spectroscopy (MRS) or imaging (MRI) or positron emission
tomography (PET) or single-photon emission computed tomography (SPECT)
to measure amyloid. Non-invasive detection of Alzheimer's disease-
associated amyloid plaques in the brain would be valuable for early
diagnosis, monitoring, and for clinical development of therapeutic
drugs.
Potential Commercial Applications: Imaging agents for use in
magnetic resonance spectroscopy (MRS), or imaging (MRI), positron
emission tomography (PET) or single -photon emission computed
tomography (SPECT).
Competitive Advantages: Highly specificity to amyloid, low
background, do not undergo rapid defluoridation and do not produce
residual radioactivity in the brain.
Development Stage: Early-stage.
Inventors: Lisheng Cai and Victor W. Pike (NIMH).
Publications:
1. Cai L, et al. Synthesis and structure-affinity relationships of
new 4-(6-iodo-H-imidazo[1,2-a]pyridin-2-yl)-N-dimethylbenzeneamine
derivatives as ligands for human beta-amyloid plaques. J Med Chem. 2007
Sep 20;50(19):4746-58. [PMID 17722900]
2. Cai L, et al. Synthesis and evaluation of N-methyl and S-methyl
11C-labeled 6-methylthio-2-(4'-N,N-dimethylamino)phenylimidazo[1,2-
a]pyridines as radioligands for imaging beta-amyloid plaques in
Alzheimer's disease. J Med Chem. 2008 Jan 10;51(1):148-58. [PMID
18078311]
Intellectual Property:
HHS Reference No. E-225-2011/0--US Provisional Application No.
61/535,569 filed 16 Sep 2011
HHS Reference No. E-225-2011/1--PCT Application No. PCT/
US2012/055124 filed 13 Sep 2012, which published as WO 2013/0401830 on
21 Mar 2013; US Patent Application No. 14/345,004 filed 23 Apr 2014
Related Technology: HHS Reference No. E-156-2006/0--US Patent No.
8,703,096 issued 22 Apr 2014; US Patent Application No. 14/223,782
filed 24 Mar 2014; Various international patents/applications issued/
pending.
Licensing Contact: Jennifer Wong; 301-435-4633;
[email protected].
Collaborative Research Opportunity: The National Institute of
Mental Health (NIMH) is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate or commercialize Beta-amyloid Imaging Agents. For
collaboration opportunities, please contact Suzanne L. Winfield, Ph.D.
at [email protected] or 301-402-4324.
Human Research Information System (HuRIS)
Summary: Researchers at the National Institute on Drug Abuse (NIDA)
seek licensing or co-development of a Human Research Information System
(HuRIS) software that automates all major functions of a clinical-
research entity. The system is designed for commercial healthcare
providers, community treatment centers, and clinical research
facilities.
Description of Technology: The available system is the Human
Research Information System (HuRIS), an integrated advanced clinical/
research informatics series of systems--that is, an intelligent
electronic environment for the collection, organization and retrieval
of information in clinical/scientific decision support--which enables
data and resource sharing in real time among authorized users at our
clinics. (Individual systems or subsystems may be licensable.) Users on
both the clinical side (e.g. doctors writing medication orders or
nurses recording participants' vital signs) and on the research side
(e.g. researchers conducting data analysis or completing reporting
requirements) have access to the information on demand. At the core of
this informatics infrastructure reside the clinical charts and research
records of participants compiled over the entire history of their study
participation, and sometimes across multiple studies. The computerized
recording of participants' information starts from the time of their
initial consent for screening. Data collected by our intake personnel
under a screening protocol become part of the participants' clinical
research records. This recording continues as participants are admitted
to a clinical trial and persists throughout their progress within the
prescribed activities until they are discharged. The electronic
recording of participants' activities enables the use of this
information as a research resource to different groups at different
locations, in current and future protocols, as permitted by human
subjects' protection regulations. The HuRIS has a number of intelligent
decision systems built-in for real-time or on-demand query as well as
HL-7 communications with external laboratories for data exchange, and
it seamlessly communicates with our Human Biospecimen Tracking System.
User permissions to access various components of the system are
centrally controlled and all access is logged.
Potential Commercial Applications:
Hospital Information Management
Clinical Research Information Management
Pharmacy Management System
Biospecimens Tracking System
Laboratory Information Management
Behavioral Modification/Addiction Treatment
Competitive Advantages:
Mature solution developed with contributions by numerous
physicians, scientists, and treatment professionals at all levels
Low-cost mechanism
Proven advantage in prior clinical studies
Development Stage:
Ready for commercialization
Prototype
Clinical
Inventors: Massoud R. Vahabzadeh, Mustapha Mezghanni, Jia-Ling Lin,
Michelle K. Leff (all of NIDA)
Publications:
1. Massoud Vahabzadeh, Jia-Ling Lin, Mustapha Mezghanni, Carlo
Contoreggi, and Michelle Leff, ``An EHR-Based Multi-Site Recruiting
System for Clinical Trials,'' Proc. 20th IEEE International Symposium
on Computer-Based Medical Systems, June 2007, pages 331-6.
2. Massoud Vahabzadeh, Jia-Ling Lin, Mustapha Mezghanni, David
Epstein, and Kenzie Preston, ``Automation in an Addiction Treatment
Research Clinic:
[[Page 59796]]
Computerized Contingency Management, Ecological Momentary Assessment,
and a Protocol Workflow System,'' Drug and Alcohol Review, 28(1):3-11,
January 2009.
Intellectual Property: HHS Reference No. E-266-2014/0--Software. No
patent protection is being sought.
Contact Information: Vio Conley, M.S.; NCI Technology Transfer
Center; Phone: 240-276-5531; Email: [email protected].
Keywords: Software, Clinical Information System, Research
Information System, Medical Decision Support System (DSS), Electronic
Hospital Records (EHR), Physicians Order Entry (POE), Pharmacy
Information System, Laboratory Information Management (LIM),
Biospecimen Tracking System, Substance abuse, Drug addiction, Mental
health, mPAL, HuRIS.
Optimized Gene Therapy Vector for the Treatment of Glycogen Storage
Disease Type Ia
Description of Technology: NIH researchers have developed an adeno-
associated viral (AAV) vector for the treatment of glycogen storage
disease type Ia (GSD-Ia). GSD-Ia is an inherited disorder of metabolism
associated with life-threatening hypoglycemia, hepatic malignancy, and
renal failure caused by the deficiency of glucose-6-phosphatase-alpha
(G6Pase-alpha or G6PC). This new AAV vector that expresses human
G6Pase-alpha directed by the tissue-specific human G6PC promoter/
enhancer incorporates two improvements: (1) It expresses a variant of
G6Pase-alpha with enhanced enzymatic activity; (2) it is codon
optimized to achieve higher enzyme expression levels and enhanced
enzymatic activity.
Current therapy, which primarily consists of dietary modification,
fails to prevent long-term complications in many patients, including
growth failure, gout, pulmonary hypertension, renal dysfunction,
osteoporosis, and hepatocellular adenomas (HCA). Gene therapy-based
techniques, which directly address the underlying genetic deficiency
driving the disorder, offer the prospect of long-term remission in
patients with GSD-Ia.
Potential Commercial Applications: Gene therapy vector for the
treatment of GSD-Ia.
Competitive Advantages:
Protein coding sequence modified for enhanced enzymatic
activity.
Codon optimized for increased enzyme expression in target
organs.
Inventor: Janice J. Chou (NICHD)
Development Stage: In vivo data available (animal).
Publications:
1. Lee YM et al. Prevention of hepatocellular adenoma and
correction of metabolic abnormalities in murine glycogen storage
disease type Ia by gene therapy. Hepatology 2012 Nov;56(5):1719-29.
[PMID 22422504].
2. Lee YM, et al. The upstream enhancer elements of the G6PC
promoter are critical for optimal G6PC expression in murine glycogen
storage disease type Ia. Mol Genet Metab. 2013 Nov;110(3):275-80. [PMID
23856420].
Intellectual Property: HHS Reference No. E-039-2015/0-US-01--US
Provisional Patent Application 62/096,400 filed December 23, 2014.
Related Technologies: HHS Reference No. E-552-2013/0--US
Provisional Patent Application No. 61/908,861 filed November 26, 2013;
PCT Application No. PCT/US2014/067415 filed November 25, 2014.
Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076;
[email protected].
Collaborative Research Opportunity: The National Institute of Child
Health and Human Development is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize gene therapy vectors for the
treatment of glycogen storage disease type Ia. For collaboration
opportunities, please contact Joseph M. Conrad, III, Ph.D., J.D. at
[email protected].
Dated: September 25, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-24987 Filed 10-1-15; 8:45 am]
BILLING CODE 4140-01-P