Prospective Grant of Start-up Exclusive License: Therapeutics and PMA-Approved Diagnostics for Alzheimer's Disease (intranasal delivery), Parkinson's Disease, Neuropathy,Neuropathic Pain, Peripheral Neuropathy, Diabetic Neuropathy, Neurapraxia, Axonotmesis and Neurotmesis, 20658 [2016-08097]
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20658
Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up
Exclusive License: Therapeutics and
PMA-Approved Diagnostics for
Alzheimer’s Disease (intranasal
delivery), Parkinson’s Disease,
Neuropathy,Neuropathic Pain,
Peripheral Neuropathy, Diabetic
Neuropathy, Neurapraxia,
Axonotmesis and Neurotmesis
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institute of
Neurological Disorders and Stroke
(NINDS), National Institutes of Health
(NIH), Department of Health and Human
Services, is contemplating the grant of a
start-up exclusive license to AestasRx
Inc., which is located in North Carolina,
to practice the inventions embodied in
the following patents: U.S. Patent
8,597,660, issued December 3, 2013
(HHS reference E–144–2010/0–US–02).
The patent rights in these inventions
have been assigned to the United States
of America. The prospective start-up
exclusive license territory may be
worldwide and the field of use may be
limited to therapeutics (including smallmolecule TFP5 mimetics) and PMAapproved diagnostics for Alzheimer’s
disease (intranasal delivery only),
Parkinson’s Disease, neuropathy,
neuropathic pain, peripheral
neuropathy, diabetic neuropathy,
neurapraxia, axonotmesis and
neurotmesis.
SUMMARY:
Only written comments and/or
applications for a license which are
received by NINDS Technology Transfer
on or before April 25, 2016 will be
considered.
DATES:
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated start-up exclusive license
should be directed to: Susan Ano, Ph.D.,
NINDS Technology Transfer, 31 Center
Drive, Suite 8A52, MSC2540, Bethesda,
MD 20892; Telephone: (301) 435–5515;
Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention discloses treating
neurodegenerative diseases by
administering cyclin dependent kinase
5 (Cdk5) inhibitory peptides derived
from P35, the activator of Cdk5.
Abnormally hyperactive Cdk5 has been
shown to be associated with a variety of
mstockstill on DSK4VPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:48 Apr 07, 2016
Jkt 238001
neurodegenerative disorders. This
invention describes isolated peptide
fragments, pharmaceutical compositions
and methods for use of such for treating
subjects with a neurodegenerative
disease, such as Alzheimer’s disease
(AD), Amyotrophic Lateral Sclerosis
(ALS) and Parkinson’s disease (PD). An
inhibitory fragment, TFP5, disclosed in
this invention, has been shown to
ameliorate symptoms of AD in disease
animal models without any evidence of
toxicity. In particular, TFP5 treatment of
rat cortical neurons reduced
hyperactivation of Cdk5 upon neuronal
stress and insults. Following
intraperitoneal (ip) injection, TFP5 was
capable of crossing the blood-brain
barrier and localizing within the brain
where it was found to rescue memory
deficits and pathology in a double
transgenic mouse (APP/PS1) AD model.
The prospective start-up exclusive
license may be granted unless within
fifteen (15) days from the date of this
published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated start-up
exclusive license. Comments and
objections submitted to this notice will
not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: April 4, 2016.
Susan Ano,
Technology Development Coordinator,
NINDS Technology Transfer, National
Institutes of Health.
[FR Doc. 2016–08097 Filed 4–7–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Cooperative Research and
Development Agreement (CRADA)
Opportunity for Development of an
Assay To Detect Genetic Markers
Related to Elevated Serum Tryptase in
Familial Tryptasemia and Mast Cell
Activation Disorders
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases (NIAID),
a component of the National Institutes
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
of Health (NIH), Department of Health
and Human Services (HHS) seeks to
enter into a CRADA with a commercial
partner to collaborate on the
development and commercialization of
an assay to detect a genetic variation
related to mast cell activation disorders.
DATES: Interested CRADA collaborators
must submit a confidential proposal
summary to the NIAID (attention Amy
F. Petrik at the address below) on or
before 8 June 2016 for consideration.
Guidelines for preparing full CRADA
proposals will be communicated shortly
thereafter to all respondents with whom
initial confidential discussions will
have established sufficient mutual
interest. CRADA proposals submitted
thereafter may be considered if a
suitable CRADA collaborator has not
been selected.
ADDRESSES: Questions should be
addressed to Amy F. Petrik, Ph.D.,
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Suite 6D, Rockville, MD
20892–9804, Tel: (240) 627–3721 or
email: petrika@niaid.nih.gov.
SUPPLEMENTARY INFORMATION:
Approximately 4–6% of the general
Western population exhibit elevated
basal levels of serum tryptase. As a mast
cell mediator, tryptase is expected to be
transiently elevated following allergic
stimuli. Sustained elevation of serum
tryptase levels can be associated with
symptoms of mast cell mediator release
(such as flushing, itching and swelling),
neuropsychiatric symptoms (such as
chronic pain, anxiety and
dysautonomia) and gastrointestinal (GI)
symptoms (including functional GI
disorders like irritable bowel syndrome
as well as eosinophilic GI disease) as
well as an increased risk for systemic
anaphylaxis.
The NIAID Investigators have recently
reported that these symptomatic
tryptase elevations can be inherited in
an autosomal dominant fashion and are
associated with the phenotype
described above (Lyons, J.J., et al. J
Allergy Clin Immunol, 133 (2014), pp.
1471–1474). Through next generation
sequencing and linkage analysis the
NIAID Investigators identified a
structural variant cosegregating with
disease. They then developed an assay,
based on digital droplet PCR, to identify
individuals with this variant, and
estimate that 5–8% of Caucasians may
have it, and be at risk for being
symptomatic.
Under the CRADA, the assay will be
developed toward licensure. Due to the
relatively high prevalence of serum
tryptase elevation, NIAID Investigators
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Page 20658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08097]
[[Page 20658]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up Exclusive License: Therapeutics and
PMA-Approved Diagnostics for Alzheimer's Disease (intranasal delivery),
Parkinson's Disease, Neuropathy,Neuropathic Pain, Peripheral
Neuropathy, Diabetic Neuropathy, Neurapraxia, Axonotmesis and
Neurotmesis
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institute of Neurological Disorders and
Stroke (NINDS), National Institutes of Health (NIH), Department of
Health and Human Services, is contemplating the grant of a start-up
exclusive license to AestasRx Inc., which is located in North Carolina,
to practice the inventions embodied in the following patents: U.S.
Patent 8,597,660, issued December 3, 2013 (HHS reference E-144-2010/0-
US-02).
The patent rights in these inventions have been assigned to the
United States of America. The prospective start-up exclusive license
territory may be worldwide and the field of use may be limited to
therapeutics (including small-molecule TFP5 mimetics) and PMA-approved
diagnostics for Alzheimer's disease (intranasal delivery only),
Parkinson's Disease, neuropathy, neuropathic pain, peripheral
neuropathy, diabetic neuropathy, neurapraxia, axonotmesis and
neurotmesis.
DATES: Only written comments and/or applications for a license which
are received by NINDS Technology Transfer on or before April 25, 2016
will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated start-up
exclusive license should be directed to: Susan Ano, Ph.D., NINDS
Technology Transfer, 31 Center Drive, Suite 8A52, MSC2540, Bethesda, MD
20892; Telephone: (301) 435-5515; Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention discloses treating
neurodegenerative diseases by administering cyclin dependent kinase 5
(Cdk5) inhibitory peptides derived from P35, the activator of Cdk5.
Abnormally hyperactive Cdk5 has been shown to be associated with a
variety of neurodegenerative disorders. This invention describes
isolated peptide fragments, pharmaceutical compositions and methods for
use of such for treating subjects with a neurodegenerative disease,
such as Alzheimer's disease (AD), Amyotrophic Lateral Sclerosis (ALS)
and Parkinson's disease (PD). An inhibitory fragment, TFP5, disclosed
in this invention, has been shown to ameliorate symptoms of AD in
disease animal models without any evidence of toxicity. In particular,
TFP5 treatment of rat cortical neurons reduced hyperactivation of Cdk5
upon neuronal stress and insults. Following intraperitoneal (ip)
injection, TFP5 was capable of crossing the blood-brain barrier and
localizing within the brain where it was found to rescue memory
deficits and pathology in a double transgenic mouse (APP/PS1) AD model.
The prospective start-up exclusive license may be granted unless
within fifteen (15) days from the date of this published notice, the
NIH receives written evidence and argument that establishes that the
grant of the license would not be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated start-up exclusive license. Comments and objections
submitted to this notice will not be made available for public
inspection and, to the extent permitted by law, will not be released
under the Freedom of Information Act, 5 U.S.C. 552.
Dated: April 4, 2016.
Susan Ano,
Technology Development Coordinator, NINDS Technology Transfer, National
Institutes of Health.
[FR Doc. 2016-08097 Filed 4-7-16; 8:45 am]
BILLING CODE 4140-01-P
