Government-Owned Inventions; Availability for Licensing, 42718 [2016-15442]
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42718
Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
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.
FOR FURTHER INFORMATION CONTACT:
Licensing information may be obtained
by emailing the indicated licensing
contact at the National Heart, Lung, and
Blood, Office of Technology Transfer
and Development Office of Technology
Transfer, 31 Center Drive, Room 4A29,
MSC2479, Bethesda, MD 20892–2479;
telephone: 301–402–5579. A signed
Confidential Disclosure Agreement may
be required to receive any unpublished
information.
SUPPLEMENTARY INFORMATION:
Technology description follows.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
Long Acting Therapeutic Conjugates
With Evans Blue
This invention is a platform
technology that pertains to the
advantages of conjugating therapeutics
to Evans Blue thus providing long
lasting pharmacokinetic profiles by
complexing with albumin. Notably,
albumin bound therapeutic- or prodrugEvans Blue conjugates provide a
complex with a total molecular size
above 60 kDa thus eliminating the risk
for renal clearance. Interestingly, since
albumin also crosses the blood-brain
barrier and since all circulating Evans
Blue is bound to albumin, Evans Blue
bound therapeutics or prodrugs can also
cross the blood-brain barrier. By way for
example but not limitation, Evans Blue
can be conjugated to insulin, GLP-1,
exendin-4, exendin (9-39), octreotide,
bombesin, RGD peptide
(arginylglycylaspartic acid), vascular
endothelial growth factor (VEGF),
interferon (IFN), tumor necrosis factor
(TNF), asparaginase, or adenosine
deaminase, exenatide, dipeptidyl
peptidase-4 inhibitors, neuropilin,
epidermal growth factor, islet
neogenesis associated protein, alpha-1
antitrypsin, anti-inflammatory agents,
glulisine, glucagons, local cytokines,
modulators of cytokines, anti-apoptotic
VerDate Sep<11>2014
20:01 Jun 29, 2016
Jkt 238001
molecules, aptamers, asparaginase,
adenosine deaminase, interferon a2a,
interferon a2b, granulocyte colony
stimulating factor, growth hormone
receptor antagonists, doxorubicin,
paclitaxel, gemcitabine, camptothecin,
and temozolomide. Evans Blue
conjugates according to this invention
can additionally include radionuclides
like 18F, 76Br, 124I, 125I, or 131I, or
117mSn for tracking or use in
diagnostics.
Potential Commercial Applications:
—Diabetes therapeutics
—Cancer therapeutics
—CNS therapeutics
—Pharmacokinetic/distribution studies
Competitive Advantages:
—long pharmacokinetic profile
—no renal clearance of circulating drug
Development Stage:
• Early stage
Inventors: Xiaoyuan Chen, Lixin Lang,
Gang NIU (all of NIBIB).
Intellectual Property: HHS Reference
No. E–143–2015/0; U.S. Provisional
Patent Application 62/182,694 filed
June 22, 2015; International Patent
Application PCT/US2016/38475 filed
June 21, 2016.
Licensing Contact: Michael
Shmilovich, Esq, CLP; 301–435–5019;
shmilovm@mail.nih.gov.
Dated: June 23, 2016.
Michael Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
[FR Doc. 2016–15442 Filed 6–29–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Data and Information on
Technologies Used for Identifying
Potential Developmental Toxicants
The National Toxicology
Program (NTP) Interagency Center for
the Evaluation of Alternative
Toxicological Methods (NICEATM)
requests available data and information
on approaches and/or technologies
currently used for identifying potential
developmental toxicants. Submitted
information will be used to assess the
state of the science and determine
technical needs for non-animal test
methods used to evaluate the potential
of chemicals to induce adverse effects in
offspring.
DATES: Receipt of information: Deadline
is August 15, 2016.
SUMMARY:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
Data and information
should be submitted electronically to
niceatm@niehs.nih.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Warren Casey, Director, NICEATM;
email: warren.casey@nih.gov; telephone:
(919) 316–4729.
SUPPLEMENTARY INFORMATION:
Background: NICEATM, which fosters
the evaluation and promotion of
alternative test methods for regulatory
use, is supporting efforts to develop,
validate, and implement alternative
approaches for identifying potential
developmental toxicants. The goal of
these alternative approaches is to
replace, reduce, or refine the use of
animals in testing. Testing a chemical’s
potential to cause developmental
toxicity is required by multiple
regulatory agencies and may require the
use of large numbers of animals.
Request for Information: NICEATM
requests available data and information
on approaches and/or technologies
currently used to identify potential
developmental toxicants. Respondents
should provide information on any
activities relevant to the development or
validation of alternatives to in vivo
developmental toxicity test methods
currently required by regulatory
agencies, including data from nonanimal chemical tests for developmental
hazard potential. NICEATM also
requests any available data resulting
from in vivo developmental studies,
ethical human or animal studies, or
accidental human exposures, using the
same chemicals.
Respondents to this request for
information should include their name,
affiliation (if applicable), mailing
address, telephone, email, and
sponsoring organization (if any) with
their communications. The deadline for
receipt of the requested information is
August 15, 2016. Responses to this
notice will be posted at: https://
ntp.niehs.nih.gov/go/dev-nonanimal.
Persons submitting responses will be
identified on the Web page by name and
affiliation or sponsoring organization, if
applicable.
Responses to this request are
voluntary. No proprietary, classified,
confidential, or sensitive information
should be included in responses. This
request for information is for planning
purposes only and is not a solicitation
for applications or an obligation on the
part of the U.S. Government to provide
support for any ideas identified in
response to the request. Please note that
the U.S. Government will not pay for
the preparation of any information
submitted or for its use of that
information.
ADDRESSES:
E:\FR\FM\30JNN1.SGM
30JNN1
Agencies
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Page 42718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15442]
[[Page 42718]]
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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, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
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.
FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained
by emailing the indicated licensing contact at the National Heart,
Lung, and Blood, Office of Technology Transfer and Development Office
of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda,
MD 20892-2479; telephone: 301-402-5579. A signed Confidential
Disclosure Agreement may be required to receive any unpublished
information.
SUPPLEMENTARY INFORMATION: Technology description follows.
Long Acting Therapeutic Conjugates With Evans Blue
This invention is a platform technology that pertains to the
advantages of conjugating therapeutics to Evans Blue thus providing
long lasting pharmacokinetic profiles by complexing with albumin.
Notably, albumin bound therapeutic- or prodrug-Evans Blue conjugates
provide a complex with a total molecular size above 60 kDa thus
eliminating the risk for renal clearance. Interestingly, since albumin
also crosses the blood-brain barrier and since all circulating Evans
Blue is bound to albumin, Evans Blue bound therapeutics or prodrugs can
also cross the blood-brain barrier. By way for example but not
limitation, Evans Blue can be conjugated to insulin, GLP-1, exendin-4,
exendin (9-39), octreotide, bombesin, RGD peptide
(arginylglycylaspartic acid), vascular endothelial growth factor
(VEGF), interferon (IFN), tumor necrosis factor (TNF), asparaginase, or
adenosine deaminase, exenatide, dipeptidyl peptidase-4 inhibitors,
neuropilin, epidermal growth factor, islet neogenesis associated
protein, alpha-1 antitrypsin, anti-inflammatory agents, glulisine,
glucagons, local cytokines, modulators of cytokines, anti-apoptotic
molecules, aptamers, asparaginase, adenosine deaminase, interferon
[alpha]2a, interferon [alpha]2b, granulocyte colony stimulating factor,
growth hormone receptor antagonists, doxorubicin, paclitaxel,
gemcitabine, camptothecin, and temozolomide. Evans Blue conjugates
according to this invention can additionally include radionuclides like
\18\F, \76\Br, \124\I, \125\I, or \131\I, or \117m\Sn for tracking or
use in diagnostics.
Potential Commercial Applications:
--Diabetes therapeutics
--Cancer therapeutics
--CNS therapeutics
--Pharmacokinetic/distribution studies
Competitive Advantages:
--long pharmacokinetic profile
--no renal clearance of circulating drug
Development Stage:
Early stage
Inventors: Xiaoyuan Chen, Lixin Lang, Gang NIU (all of NIBIB).
Intellectual Property: HHS Reference No. E-143-2015/0; U.S.
Provisional Patent Application 62/182,694 filed June 22, 2015;
International Patent Application PCT/US2016/38475 filed June 21, 2016.
Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019;
shmilovm@mail.nih.gov.
Dated: June 23, 2016.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood
Institute, Office of Technology Transfer and Development.
[FR Doc. 2016-15442 Filed 6-29-16; 8:45 am]
BILLING CODE 4140-01-P