National Institute of Aging (NIA), National Institute of Mental Health (NIMH), and National Center for Advancing Translational Sciences (NCATS): Cooperative Research and Development Agreement (CRADA) and Licensing Opportunity for Ketamine for the Treatment of Depression and Other Anxiety-Related Disorders, 76949-76950 [2016-26628]
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76949
Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices
Tribes and Tribal organizations must
respond if they wish to operate a fully
funded program. This paperwork
collection activity is set to expire in
December, 2016.
Respondents: Tribes and Tribal
Organizations.
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total
burden hours
45 CFR 309 Amended Plan ............................................................................
45 CFR 309 New Plan ....................................................................................
63
2
1
1
120
480
7,560
960
Total ..........................................................................................................
........................
........................
600
8,520
Estimated Total Annual Burden Hours ..............................................
........................
........................
600
8,520
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proposed collection may be obtained by
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Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
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Robert Sargis,
Reports Clearance Officer.
AGENCY:
[FR Doc. 2016–26615 Filed 11–3–16; 8:45 am]
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SUMMARY:
VerDate Sep<11>2014
17:52 Nov 03, 2016
[FR Doc. 2016–26686 Filed 11–3–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Aging (NIA),
National Institute of Mental Health
(NIMH), and National Center for
Advancing Translational Sciences
(NCATS): Cooperative Research and
Development Agreement (CRADA) and
Licensing Opportunity for Ketamine for
the Treatment of Depression and Other
Anxiety-Related Disorders
National Institutes of Health,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Robert Sargis,
Reports Clearance Officer.
Jkt 241001
Notice.
The National Institute of
Aging (NIA), National Institute of
Mental Health (NIMH), and National
Center for Advancing Translational
Sciences (NCATS) of the National
Institutes of Health (NIH), University of
Maryland at Baltimore (UMB) and their
collaborators are seeking Cooperative
Research and Development Agreement
(CRADA) partners to collaborate in the
preclinical and clinical development of
ketamine metabolite (2R, 6R-HNK) for
the treatment of depression and other
anxiety-related disorders.
DATES: Interested candidate partners
must submit a statement of interest and
capability, no more than five pages long,
to the NCATS point of contact before
January 3, 2017 for consideration.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and co-
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
development research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn: Sury Vepa,
Ph.D., J.D., Senior Licensing and
Patenting Manager, National Center for
Advancing Translational Sciences, NIH,
9800 Medical Center Drive, Rockville,
MD 20850, Phone: 301–217–9197, Fax:
301–217–5736, or email
NCATSPartnerships@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
As per the
Anxiety and Depression Association of
America, Major depressive disorder
affects 14.8 million people in America,
including children, adults, and the
elderly. A number of therapies currently
exist to treat depression, although they
suffer drawbacks such as requiring
weeks to take action. One particular
therapy includes the approved drug,
ketamine, which has demonstrated
robust and acute antidepressant activity.
However, its efficacy is bridled with
significant disadvantages including its
addictive potential and its dissociative
activities. This is the case even when
administered at low doses, which limits
the potential widespread use of
ketamine as an antidepressant
medication.
In order to improve the treatment of
depression, it is important to explore
the mechanism by which ketamine
exerts its antidepressant effects. That is
precisely what the NIH and UMB
scientists and collaborators are
investigating, and have found that the
metabolism of ketamine is critical to its
antidepressant effects, and that the
(2R,6R)-2-amino-2-(2-chlorophenyl)-6hydroxycyclohexanone ((2R,6R)hydroxynorketamine (HNK)) metabolite,
reversed depression-like behaviors in
mice without triggering anesthetic,
dissociative, or addictive side effects
associated with ketamine. Specifically,
the researchers found that the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\04NON1.SGM
04NON1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
76950
Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices
metabolite does not inhibit the noncompetitive glutamatergic N-methyl-Daspartate (NMDA) receptor, and it exerts
rapid actions that activate the a-amino
3-hydroxy-5-methyl-4-isoxazole
propionic acid (AMPA) receptors.
Results indicate a non-NMDA receptor
dependent mechanism underlying
ketamine’s antidepressant properties,
which involve bioactivity of a specific
metabolite (2R, 6R-HNK) could be
exploited for drug development.
Additionally, the researchers have
established appropriate salt, crystal and
polymorph forms of the agent and
multiple methods of synthesis. Full
ADME and polypharmacology
assessment is complete as well as preformulations studies.
To expedite the research,
development and commercialization of
2R,6R-hydroxynorketamine (a
metabolite of ketamine), the National
Institutes of Health, UMB and their
collaborators are seeking one or more
CRADA and/or license agreements with
appropriate pharmaceutical or
biotechnology companies in accordance
with the regulations governing the
transfer of Government-developed
technology and its public sector
objectives, as outlined below. The
purpose of a CRADA is to find a partner
to collaborate in the development and
commercialization of a technology that
is in early phases of clinical
development. Under the CRADA, key
activities related to the clinical
development of 2R,6R-HNK as a
therapeutic to treat a variety of mental
health conditions including depressive
disorders will be performed.
Collaborators should have proven
experience in drug development with
specialized expertise within depression
and/or related mental health disorders.
Owing to NIH’s commitment to public
dissemination of data, a key criterion
will be that all outcomes from the
collaborative effort will be published
including the outcomes of all clinical
trials. Further, it is the goal of NIH,
UMB and other collaborators to develop
the technology to the fullest extent (as
therapeutic for multiple clinical
indications including, but not limited
to, anxiety, suicidal ideation,
anhedonia, PTSD, addiction,
neuropathic pain, among others).
How to Apply: Interested potential
CRADA collaborators will receive
detailed information on the current
status of the project after signing a
confidentiality disclosure agreement
(CDA) with NIH, UMB and other
collaborators. Interested candidate
partners must submit a statement of
interest and capability, no more than
five pages long, to the NCATS point of
VerDate Sep<11>2014
17:52 Nov 03, 2016
Jkt 241001
contact before January 3, 2017 for
consideration. Guidelines for the
preparation of a full CRADA proposal
will be communicated by the NIH to
respondents that have demonstrated
sufficient mutual interests and
capabilities that indicate the partnering
entity will appropriately and
substantially contribute to the proposed
collaboration. Capability statements
submitted after the due date may be
considered if a suitable CRADA
collaborator has not been identified by
NIH and UMB among the initial pool of
respondents.
Respondents interested in submitting
a CRADA proposal should be aware that
it may be necessary for them to secure
a patent license to the backgroundpatent applications in order to
commercialize products arising from a
CRADA. Licensing of background
technology patent rights related to this
CRADA opportunity and claimed in the
pending patent applications are
available for either exclusive or nonexclusive licensing and licensing by
NIH is subject to 35 U.S.C. 207 and 37
CFR part 404. CRADA partners are
afforded an option to negotiate an
exclusive license from the NIH for
inventions arising from the performance
of the CRADA research plan.
The full CRADA proposal should
include a capability statement with a
detailed description of: (1)
Collaborator’s Expertise with mental
health disorders such as depression, (2)
Collaborators’ expertise in preclinical
development efforts including
toxicology and chemistry,
manufacturing and controls (CMC), (3)
Expertise in regulatory affairs,
particularly at the IND filing and early
stage clinical trials stages, (4)
Collaborator’s ability to support,
directly or through contract
mechanisms, and upon the successful
completion of relevant milestones, the
ongoing pharmacokinetics and
biological studies, long term toxicity
studies, process chemistry and other
pre-clinical development studies
needed to obtain regulatory approval of
a given therapy so as to ensure a high
probability of eventual successful
commercialization and; (5)
Collaborator’s ability to provide
adequate funding to support some preclinical studies of the project as well as
clinical trials.
Publications
Frm 00040
Patent Status
(1) ‘‘Use Of (2R,6R)-HNK, (S)Dehydronorketamine and (R,S)ketamine metabolites in the treatment of
depression and neuropathic pain’’;
Irving W. Wainer, Ruin Moaddel,
Michel Bernier, Carlos A. Zarate, Mary
Tanga, Marc C. Torjman, Michael
Goldberg; Assignees: National Institute
of Aging (NIA), National Institute of
Mental Health (NIMH), SRI
International, University of Medicine
and Dentistry of New Jersey (UMDNJ);
U.S. Provisional Patent Application #
61/547,336; Filed: October 14, 2011;
NIH Reference # E–092–2011.
(2) ‘‘Methods of using (2S,6S)-HNK
and (2R,6R)-HNK to treat various
depressive disorders and anxiety
disorders’’; Craig Thomas, Todd D.
Gould, Irving W. Wainer, Carlos A.
Zarate, Ruin Moaddel, Patrick Morris,
Panos Zanos; Assignees: National
Institute of Aging (NIA), National
Institute of Mental Health (NIMH),
National Center for Advancing
Translational Sciences (NCATS),
University of Maryland at Baltimore
(UMB); U.S. Provisional Patent
Application # 62/313317; Filed: March
25, 2016; NIH Reference #E–036–2016.
(3) ‘‘Crystal forms and methods of
synthesis of (2R, 6R)-HNK and (2S,6S)HNK’’; Craig Thomas, Patrick Morris,
Carlos A. Zarate, Ruin Moaddel, Todd
D. Gould, Panos Zanos; Assignees:
National Center for Advancing
Translational Sciences (NCATS),
National Institute of Mental Health
(NIMH), National Institute of Aging
(NIA), University of Maryland at
Baltimore (UMB); U.S. Provisional
Patent Application #62/313309; Filed:
March 25, 2016; NIH Reference #E–116–
2016.
Dated: October 31, 2016.
Pamela McInnes,
Deputy Director, Office of the Director,
National Center for Advancing Translational
Sciences.
[FR Doc. 2016–26628 Filed 11–3–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Zanos P, Moaddel R, Morris PJ, Georgiou P,
Fischell J, Elmer GI, Manickavasagom A,
Yuan P, Pribut HJ, Singh NS, Dossou
KSS, Fang Y, Huang X–P, Mayo CL,
Wainer IW, Albuquerque EX, Thompson
SM, Thomas CJ, Zarate CA, Gould TD.
PO 00000
NMDA receptor inhibition-independent
antidepressant actions of a ketamine
metabolite. Nature, May 4, 2016, doi:
10:1038/nature17998.
Fmt 4703
Sfmt 4703
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Notices]
[Pages 76949-76950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26628]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Aging (NIA), National Institute of Mental
Health (NIMH), and National Center for Advancing Translational Sciences
(NCATS): Cooperative Research and Development Agreement (CRADA) and
Licensing Opportunity for Ketamine for the Treatment of Depression and
Other Anxiety-Related Disorders
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Aging (NIA), National Institute of
Mental Health (NIMH), and National Center for Advancing Translational
Sciences (NCATS) of the National Institutes of Health (NIH), University
of Maryland at Baltimore (UMB) and their collaborators are seeking
Cooperative Research and Development Agreement (CRADA) partners to
collaborate in the preclinical and clinical development of ketamine
metabolite (2R, 6R-HNK) for the treatment of depression and other
anxiety-related disorders.
DATES: Interested candidate partners must submit a statement of
interest and capability, no more than five pages long, to the NCATS
point of contact before January 3, 2017 for consideration.
FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent
applications listed below may be obtained by contacting: Attn: Sury
Vepa, Ph.D., J.D., Senior Licensing and Patenting Manager, National
Center for Advancing Translational Sciences, NIH, 9800 Medical Center
Drive, Rockville, MD 20850, Phone: 301-217-9197, Fax: 301-217-5736, or
email NCATSPartnerships@mail.nih.gov. A signed Confidential Disclosure
Agreement may be required to receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: As per the Anxiety and Depression
Association of America, Major depressive disorder affects 14.8 million
people in America, including children, adults, and the elderly. A
number of therapies currently exist to treat depression, although they
suffer drawbacks such as requiring weeks to take action. One particular
therapy includes the approved drug, ketamine, which has demonstrated
robust and acute antidepressant activity. However, its efficacy is
bridled with significant disadvantages including its addictive
potential and its dissociative activities. This is the case even when
administered at low doses, which limits the potential widespread use of
ketamine as an antidepressant medication.
In order to improve the treatment of depression, it is important to
explore the mechanism by which ketamine exerts its antidepressant
effects. That is precisely what the NIH and UMB scientists and
collaborators are investigating, and have found that the metabolism of
ketamine is critical to its antidepressant effects, and that the
(2R,6R)-2-amino-2-(2-chlorophenyl)-6-hydroxycyclohexanone ((2R,6R)-
hydroxynorketamine (HNK)) metabolite, reversed depression-like
behaviors in mice without triggering anesthetic, dissociative, or
addictive side effects associated with ketamine. Specifically, the
researchers found that the
[[Page 76950]]
metabolite does not inhibit the non-competitive glutamatergic N-methyl-
D-aspartate (NMDA) receptor, and it exerts rapid actions that activate
the [alpha]-amino 3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA)
receptors. Results indicate a non-NMDA receptor dependent mechanism
underlying ketamine's antidepressant properties, which involve
bioactivity of a specific metabolite (2R, 6R-HNK) could be exploited
for drug development. Additionally, the researchers have established
appropriate salt, crystal and polymorph forms of the agent and multiple
methods of synthesis. Full ADME and polypharmacology assessment is
complete as well as pre-formulations studies.
To expedite the research, development and commercialization of
2R,6R-hydroxynorketamine (a metabolite of ketamine), the National
Institutes of Health, UMB and their collaborators are seeking one or
more CRADA and/or license agreements with appropriate pharmaceutical or
biotechnology companies in accordance with the regulations governing
the transfer of Government-developed technology and its public sector
objectives, as outlined below. The purpose of a CRADA is to find a
partner to collaborate in the development and commercialization of a
technology that is in early phases of clinical development. Under the
CRADA, key activities related to the clinical development of 2R,6R-HNK
as a therapeutic to treat a variety of mental health conditions
including depressive disorders will be performed. Collaborators should
have proven experience in drug development with specialized expertise
within depression and/or related mental health disorders. Owing to
NIH's commitment to public dissemination of data, a key criterion will
be that all outcomes from the collaborative effort will be published
including the outcomes of all clinical trials. Further, it is the goal
of NIH, UMB and other collaborators to develop the technology to the
fullest extent (as therapeutic for multiple clinical indications
including, but not limited to, anxiety, suicidal ideation, anhedonia,
PTSD, addiction, neuropathic pain, among others).
How to Apply: Interested potential CRADA collaborators will receive
detailed information on the current status of the project after signing
a confidentiality disclosure agreement (CDA) with NIH, UMB and other
collaborators. Interested candidate partners must submit a statement of
interest and capability, no more than five pages long, to the NCATS
point of contact before January 3, 2017 for consideration. Guidelines
for the preparation of a full CRADA proposal will be communicated by
the NIH to respondents that have demonstrated sufficient mutual
interests and capabilities that indicate the partnering entity will
appropriately and substantially contribute to the proposed
collaboration. Capability statements submitted after the due date may
be considered if a suitable CRADA collaborator has not been identified
by NIH and UMB among the initial pool of respondents.
Respondents interested in submitting a CRADA proposal should be
aware that it may be necessary for them to secure a patent license to
the background-patent applications in order to commercialize products
arising from a CRADA. Licensing of background technology patent rights
related to this CRADA opportunity and claimed in the pending patent
applications are available for either exclusive or non-exclusive
licensing and licensing by NIH is subject to 35 U.S.C. 207 and 37 CFR
part 404. CRADA partners are afforded an option to negotiate an
exclusive license from the NIH for inventions arising from the
performance of the CRADA research plan.
The full CRADA proposal should include a capability statement with
a detailed description of: (1) Collaborator's Expertise with mental
health disorders such as depression, (2) Collaborators' expertise in
preclinical development efforts including toxicology and chemistry,
manufacturing and controls (CMC), (3) Expertise in regulatory affairs,
particularly at the IND filing and early stage clinical trials stages,
(4) Collaborator's ability to support, directly or through contract
mechanisms, and upon the successful completion of relevant milestones,
the ongoing pharmacokinetics and biological studies, long term toxicity
studies, process chemistry and other pre-clinical development studies
needed to obtain regulatory approval of a given therapy so as to ensure
a high probability of eventual successful commercialization and; (5)
Collaborator's ability to provide adequate funding to support some pre-
clinical studies of the project as well as clinical trials.
Publications
Zanos P, Moaddel R, Morris PJ, Georgiou P, Fischell J, Elmer GI,
Manickavasagom A, Yuan P, Pribut HJ, Singh NS, Dossou KSS, Fang Y,
Huang X-P, Mayo CL, Wainer IW, Albuquerque EX, Thompson SM, Thomas
CJ, Zarate CA, Gould TD. NMDA receptor inhibition-independent
antidepressant actions of a ketamine metabolite. Nature, May 4,
2016, doi: 10:1038/nature17998.
Patent Status
(1) ``Use Of (2R,6R)-HNK, (S)-Dehydronorketamine and (R,S)-ketamine
metabolites in the treatment of depression and neuropathic pain'';
Irving W. Wainer, Ruin Moaddel, Michel Bernier, Carlos A. Zarate, Mary
Tanga, Marc C. Torjman, Michael Goldberg; Assignees: National Institute
of Aging (NIA), National Institute of Mental Health (NIMH), SRI
International, University of Medicine and Dentistry of New Jersey
(UMDNJ); U.S. Provisional Patent Application # 61/547,336; Filed:
October 14, 2011; NIH Reference # E-092-2011.
(2) ``Methods of using (2S,6S)-HNK and (2R,6R)-HNK to treat various
depressive disorders and anxiety disorders''; Craig Thomas, Todd D.
Gould, Irving W. Wainer, Carlos A. Zarate, Ruin Moaddel, Patrick
Morris, Panos Zanos; Assignees: National Institute of Aging (NIA),
National Institute of Mental Health (NIMH), National Center for
Advancing Translational Sciences (NCATS), University of Maryland at
Baltimore (UMB); U.S. Provisional Patent Application # 62/313317;
Filed: March 25, 2016; NIH Reference #E-036-2016.
(3) ``Crystal forms and methods of synthesis of (2R, 6R)-HNK and
(2S,6S)-HNK''; Craig Thomas, Patrick Morris, Carlos A. Zarate, Ruin
Moaddel, Todd D. Gould, Panos Zanos; Assignees: National Center for
Advancing Translational Sciences (NCATS), National Institute of Mental
Health (NIMH), National Institute of Aging (NIA), University of
Maryland at Baltimore (UMB); U.S. Provisional Patent Application #62/
313309; Filed: March 25, 2016; NIH Reference #E-116-2016.
Dated: October 31, 2016.
Pamela McInnes,
Deputy Director, Office of the Director, National Center for Advancing
Translational Sciences.
[FR Doc. 2016-26628 Filed 11-3-16; 8:45 am]
BILLING CODE 4140-01-P
