[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.
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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: [email protected].
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