[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