Government-Owned Inventions; Availability for Licensing, 5818-5819 [2013-01620]

Download as PDF 5818 Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Notices discusses methods of detecting DILI by periodic tests of serum enzyme activities and bilirubin concentration, and how changes in the results of those laboratory tests over time, along with symptoms and physical findings, may be used to estimate severity of the injury. It suggests some ‘‘stopping rules’’ for interrupting drug treatment, and the need to obtain sufficient clinical information to assess causation. FDA published a draft of this guidance in 2006, and comments on the draft were taken into consideration when issuing the final guidance in July 2009 (http:// www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ UCM174090.pdf.). FDA is now interested in obtaining stakeholder input on the issues addressed in this guidance, including comments regarding potential revisions to the guidance. II. The Public Conference A. Why are we holding this conference? The purpose of the 2013 conference is to invite participants to present their data and views, and to hold open discussion. tkelley on DSK3SPTVN1PROD with B. Registration, Transcripts, and Additional Information on This Conference and Its Predecessors A registration fee ($600 for industry registrants and $300 for Federal Government and academic registrants) will be charged to help defray the costs of renting meeting spaces and the meals and snacks provided. The fee will also be used to cover travel costs incurred by invited academic (but not Government or Industry) speakers and other expenses. The registration process will be handled by C-Path, an independent, nonprofit organization established in 2005 with public and private philanthropic support from the southern Arizona community, Science Foundation Arizona, and FDA. The presentations and discussions will be transcribed and published on the Internet for public availability after minor editing by the organizers of the meeting. Additional information on the conference, program, and registration procedures may be obtained on the Internet at http://www.c-path.org, and also at http://www.fda.gov by typing into the search box ‘‘liver toxicity’’. (FDA has verified the C-Path Web site address, but is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Material presented at past programs (from 1999 to 2012) may be VerDate Mar<15>2010 17:13 Jan 25, 2013 Jkt 229001 accessed at www.aasld.org. Click on Education/Training and then scroll down to ‘‘Drug Induced Liver Injury 2012 Program.’’ Dated: January 22, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–01640 Filed 1–25–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. 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. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUMMARY: SIRT2 Inhibitors as Novel Therapeutics for Myocardial Infarction and Ischemic Stroke and to Prevent Necrosis Description of Technology: Sirtuin 2 (SIRT2) inhibitors to reduce necrosis and, thereby, as novel therapeutics to treat ischemic stroke and myocardial infarction. Accumulating evidence indicates that programmed necrosis plays a critical role in cell death during ischemia-reperfusion. NIH investigators have shown that the NAD-dependent deacetylase SIRT2 binds constitutively to receptor-interacting protein 3 (RIP3) and that deletion or knockdown of SIRT2 prevents formation of the RIP1– RIP3 complex in mice. These investigators also found that genetic or pharmacological inhibition of SIRT2 blocks cellular necrosis induced by PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 TNF-alpha and RIP1 is a critical target of SIRT2-dependent deacetylation. Further studies also showed that the hearts of Sirt2–/– mice, or wild-type mice treated with a specific pharmacological inhibitor of SIRT2, show marked protection from ischemic injury. These results implicate SIRT2 as an important regulator of programmed necrosis and indicate that SIRT2 inhibitors may constitute a novel approach to protect against necrotic injuries, including ischemic stroke and myocardial infarction. Potential Commercial Applications: • Novel therapeutics to protect against necrotic injuries. • Novel therapeutics to treat ischemic stroke and myocardial infarction. • Novel therapeutics to treat diseases in which necrosis is involved. Competitive Advantages: • None of the currently available drugs address the necrotic damage caused due to ischemia and reperfusion. • Using a SIRT2 inhibitor could limit the damage caused by necrosis and contribute to accelerated recovery in patients suffering from these conditions. Development Stage: • Early-stage • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Drs. Nisha Narayan and Toren Finkel (NHLBI) Publication: Narayan N, et al. The NAD-dependent deacetylase SIRT2 is required for programmed necrosis. Nature. 2012 Dec 13;492(7428):199–204. [PMID 23201684] Intellectual Property: HHS Reference No. E–003–2013/0—U.S. Application No. 61/723,496 filed 17 Nov 2012 Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301–435–5020; vepas@mail.nih.gov Collaborative Research Opportunity: The NHLBI is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize retinoid-related orphan receptors (RORs) function in chronic diseases. For collaboration opportunities, please contact Ms. Peg Koelble at koelblep@mail.nih.gov or 301–594–4095. Multivalent Meningiococcal Conjugates and Methods for Preparing Conjugates Description of Technology: Among 13 isolated meningococcal serogroups, A, B, C, W–135 and Y are the most prevalent. There are three FDAapproved capsular polysaccharide (PS)based vaccines, one tetravalent PS vaccine, and two tetravalent conjugate vaccines for protection against E:\FR\FM\28JAN1.SGM 28JAN1 Federal Register / Vol. 78, No. 18 / Monday, January 28, 2013 / Notices tkelley on DSK3SPTVN1PROD with meningococcal disease caused by groups A, C, W–135 and Y Neisseria meningitidis. Group B capsular PS is similar to the PS structure expressed in certain human tissues, thus making it a poor immunogen. Furthermore, if used as a vaccine, the possibility exists of it inducing an autoimmune response. Thus, a need remains to develop additional meningococcal vaccines, particularly for group B and group X meningococcal serogroups. This application claims immunogenic conjugates including at least one polysaccharide conjugated to a group B factor H binding protein (fHbp). Also claimed are immunogenic conjugates including at least one polysaccharide conjugated to a Neisserial surface protein A (NspA). Additionally, improved methods for preparing conjugates are claimed. Potential Commercial Applications: • Multivalent meningitis vaccine • Research tool Competitive Advantages: • Higher vaccine yield • More efficient conjugation method • Lower cost vaccines Development Stage: • Pre-clinical • In vitro data available • In vivo data available (animal) Inventors: Che-Hung Robert Lee (FDA/CBER), Vavlerian Pinto (EM), Elizabeth Moran (EM), Robert Burden (EM) Intellectual Property: HHS Reference No. E–082–2012/0—U.S. Application No. 61/651,382 filed 24 May 2012. Related Technologies: • HHS Reference No. E–301–2003/ 0—U.S. Application No. 13/243,480 filed 06 Aug 2004, claiming priority to 06 Aug 2003 • HHS Reference No. E–085–2005/ 0—U.S. Patent 8,173,135 issued 08 May 2012; U.S. Application No. 13/440,856 filed 05 Apr 2012, claiming priority to 17 Mar 2006 Licensing Contact: Peter A. Soukas; 301–435–4646; ps193c@nih.gov Collaborative Research Opportunity: The FDA/CBER is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Multivalent Meningiococcal Conjugates and Methods for Preparing Conjugates. For collaboration opportunities, please contact Che-Hung Robert Lee at robert.lee@fda.hhs.gov or 301–451– 5934. Enhanced Cancer Therapy Using Photoimmunotherapy (PIT) in Combination With Anti-Cancer Agents Description of Technology: The invention is in the field of VerDate Mar<15>2010 17:13 Jan 25, 2013 Jkt 229001 Photoimmunotherapy (PIT). More specifically, the invention relates to antibody-fluorophore conjugates where the antibody is specific for cancer cells and the fluorophore is IR700 dye. Binding of such conjugates to targeted cancer cells followed by irradiation with near infrared light (NIR) was shown to kill cancer cells in a highly specific manner. Furthermore, the invention discloses that the therapeutic effect of the PIT conjugate is significantly enhanced by the administration of one or more anti-cancer agents following the irradiation step. This is achieved by the markedly rapid accumulation of the therapeutic agent in the PIT-treated tissue. Also provided in the invention are wearable devices that incorporate NIR light emitting diodes (LEDs) and can be used to activate the PIT conjugates. Potential Commercial Applications: Anti-cancer therapy. Competitive Advantages: • Highly specific to cancer cells • Do not affect surrounding normal cells • Negligible toxicity • Enhancement of therapeutic effects when administered in combination with one or more other therapeutic agents • Possible to follow the cell killing process in real time, using fluorescence lifetime imaging Development Stage: In vivo data available (animal). Inventors: Hisataka Kobayashi and Peter L. Choyke (NCI). Publications: 1. Mitsunaga M, et al. Immediate in vivo target-specific cancer cell death after near infrared photoimmunotherapy. BMC Cancer 2012 Aug 8;12: 345. [PMID 22873679] 2. Mitsunaga M, et al. Near-infrared theranostic photoimmunotherapy (PIT): Repeated exposure of light enhances the effect of immunoconjugate. Bioconjug Chem. 2012 Mar 21;23(3):604–9. [PMID 22369484] 3. Mitsunaga M, et al. Cancer cellselective in vivo near infrared photoimmunotherapy targeting specific membrane molecules. Nat Med. 2011 Nov6;17(12):1685–91. [PMID 22057348] Intellectual Property: • HHS Reference No. E–205–2010/ 2—PCT Application No. PCT/US2012/ 044421 filed 27 Jun 2012 • HHS Reference No. E–250–2010/ 1—U.S. Application No. 13/180,111 filed 11 Jul 2011 • HHS Reference No. E–205–2010/ 0—U.S. Provisional Application No. 61/ 636,079 filed 09 Jul 2010 Licensing Contact: Uri Reichman, Ph.D., MBA; 301–435–4616; reichmau@mail.nih.gov. PO 00000 Frm 00049 Fmt 4703 Sfmt 9990 5819 Dated: January 18, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–01620 Filed 1–25–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Time-Sensitive Obesity Applications. Date: February 15, 2013. Time: 10:00 p.m. to 11:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 753, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898, barnardm@extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: January 18, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–01621 Filed 1–25–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\28JAN1.SGM 28JAN1

Agencies

[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5818-5819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01620]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

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. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

SIRT2 Inhibitors as Novel Therapeutics for Myocardial Infarction and 
Ischemic Stroke and to Prevent Necrosis

    Description of Technology: Sirtuin 2 (SIRT2) inhibitors to reduce 
necrosis and, thereby, as novel therapeutics to treat ischemic stroke 
and myocardial infarction. Accumulating evidence indicates that 
programmed necrosis plays a critical role in cell death during 
ischemia-reperfusion. NIH investigators have shown that the NAD-
dependent deacetylase SIRT2 binds constitutively to receptor-
interacting protein 3 (RIP3) and that deletion or knockdown of SIRT2 
prevents formation of the RIP1-RIP3 complex in mice. These 
investigators also found that genetic or pharmacological inhibition of 
SIRT2 blocks cellular necrosis induced by TNF-alpha and RIP1 is a 
critical target of SIRT2-dependent deacetylation. Further studies also 
showed that the hearts of Sirt2	/	 mice, or wild-type mice treated with 
a specific pharmacological inhibitor of SIRT2, show marked protection 
from ischemic injury. These results implicate SIRT2 as an important 
regulator of programmed necrosis and indicate that SIRT2 inhibitors may 
constitute a novel approach to protect against necrotic injuries, 
including ischemic stroke and myocardial infarction.
    Potential Commercial Applications:
     Novel therapeutics to protect against necrotic injuries.
     Novel therapeutics to treat ischemic stroke and myocardial 
infarction.
     Novel therapeutics to treat diseases in which necrosis is 
involved.
    Competitive Advantages:
     None of the currently available drugs address the necrotic 
damage caused due to ischemia and reperfusion.
     Using a SIRT2 inhibitor could limit the damage caused by 
necrosis and contribute to accelerated recovery in patients suffering 
from these conditions.
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Drs. Nisha Narayan and Toren Finkel (NHLBI)
    Publication: Narayan N, et al. The NAD-dependent deacetylase SIRT2 
is required for programmed necrosis. Nature. 2012 Dec 13;492(7428):199-
204. [PMID 23201684]
    Intellectual Property: HHS Reference No. E-003-2013/0--U.S. 
Application No. 61/723,496 filed 17 Nov 2012
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov
    Collaborative Research Opportunity: The NHLBI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize retinoid-related 
orphan receptors (RORs) function in chronic diseases. For collaboration 
opportunities, please contact Ms. Peg Koelble at koelblep@mail.nih.gov 
or 301-594-4095.

Multivalent Meningiococcal Conjugates and Methods for Preparing 
Conjugates

    Description of Technology: Among 13 isolated meningococcal 
serogroups, A, B, C, W-135 and Y are the most prevalent. There are 
three FDA-approved capsular polysaccharide (PS)-based vaccines, one 
tetravalent PS vaccine, and two tetravalent conjugate vaccines for 
protection against

[[Page 5819]]

meningococcal disease caused by groups A, C, W-135 and Y Neisseria 
meningitidis. Group B capsular PS is similar to the PS structure 
expressed in certain human tissues, thus making it a poor immunogen. 
Furthermore, if used as a vaccine, the possibility exists of it 
inducing an autoimmune response. Thus, a need remains to develop 
additional meningococcal vaccines, particularly for group B and group X 
meningococcal serogroups.
    This application claims immunogenic conjugates including at least 
one polysaccharide conjugated to a group B factor H binding protein 
(fHbp). Also claimed are immunogenic conjugates including at least one 
polysaccharide conjugated to a Neisserial surface protein A (NspA). 
Additionally, improved methods for preparing conjugates are claimed.
    Potential Commercial Applications:
     Multivalent meningitis vaccine
     Research tool
    Competitive Advantages:
     Higher vaccine yield
     More efficient conjugation method
     Lower cost vaccines
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Che-Hung Robert Lee (FDA/CBER), Vavlerian Pinto (EM), 
Elizabeth Moran (EM), Robert Burden (EM)
    Intellectual Property: HHS Reference No. E-082-2012/0--U.S. 
Application No. 61/651,382 filed 24 May 2012.
    Related Technologies:
     HHS Reference No. E-301-2003/0--U.S. Application No. 13/
243,480 filed 06 Aug 2004, claiming priority to 06 Aug 2003
     HHS Reference No. E-085-2005/0--U.S. Patent 8,173,135 
issued 08 May 2012; U.S. Application No. 13/440,856 filed 05 Apr 2012, 
claiming priority to 17 Mar 2006
    Licensing Contact: Peter A. Soukas; 301-435-4646; ps193c@nih.gov
    Collaborative Research Opportunity: The FDA/CBER is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
Multivalent Meningiococcal Conjugates and Methods for Preparing 
Conjugates. For collaboration opportunities, please contact Che-Hung 
Robert Lee at robert.lee@fda.hhs.gov or 301-451-5934.

Enhanced Cancer Therapy Using Photoimmunotherapy (PIT) in Combination 
With Anti-Cancer Agents

    Description of Technology: The invention is in the field of 
Photoimmunotherapy (PIT). More specifically, the invention relates to 
antibody-fluorophore conjugates where the antibody is specific for 
cancer cells and the fluorophore is IR700 dye. Binding of such 
conjugates to targeted cancer cells followed by irradiation with near 
infrared light (NIR) was shown to kill cancer cells in a highly 
specific manner. Furthermore, the invention discloses that the 
therapeutic effect of the PIT conjugate is significantly enhanced by 
the administration of one or more anti-cancer agents following the 
irradiation step. This is achieved by the markedly rapid accumulation 
of the therapeutic agent in the PIT-treated tissue. Also provided in 
the invention are wearable devices that incorporate NIR light emitting 
diodes (LEDs) and can be used to activate the PIT conjugates.
    Potential Commercial Applications: Anti-cancer therapy.
    Competitive Advantages:
     Highly specific to cancer cells
     Do not affect surrounding normal cells
     Negligible toxicity
     Enhancement of therapeutic effects when administered in 
combination with one or more other therapeutic agents
     Possible to follow the cell killing process in real time, 
using fluorescence lifetime imaging
    Development Stage: In vivo data available (animal).
    Inventors: Hisataka Kobayashi and Peter L. Choyke (NCI).
    Publications:
    1. Mitsunaga M, et al. Immediate in vivo target-specific cancer 
cell death after near infrared photoimmunotherapy. BMC Cancer 2012 Aug 
8;12: 345. [PMID 22873679]
    2. Mitsunaga M, et al. Near-infrared theranostic photoimmunotherapy 
(PIT): Repeated exposure of light enhances the effect of 
immunoconjugate. Bioconjug Chem. 2012 Mar 21;23(3):604-9. [PMID 
22369484]
    3. Mitsunaga M, et al. Cancer cell-selective in vivo near infrared 
photoimmunotherapy targeting specific membrane molecules. Nat Med. 2011 
Nov6;17(12):1685-91. [PMID 22057348]
    Intellectual Property:
     HHS Reference No. E-205-2010/2--PCT Application No. PCT/
US2012/044421 filed 27 Jun 2012
     HHS Reference No. E-250-2010/1--U.S. Application No. 13/
180,111 filed 11 Jul 2011
     HHS Reference No. E-205-2010/0--U.S. Provisional 
Application No. 61/636,079 filed 09 Jul 2010
    Licensing Contact: Uri Reichman, Ph.D., MBA; 301-435-4616; 
reichmau@mail.nih.gov.

    Dated: January 18, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-01620 Filed 1-25-13; 8:45 am]
BILLING CODE 4140-01-P