Prospective Grant of Exclusive License: Use of Agents Targeting Thrombospondin-1 and CD47 To Treat Radiation-Induced Damage and Enhance the Effectiveness of Radiotherapy in Cancer Patients, 76744-76745 [2011-31556]

Download as PDF 76744 Federal Register / Vol. 76, No. 236 / Thursday, December 8, 2011 / Notices Developmental Status: Proof of concept and pre-clinical development ongoing. • Anti-Tumor Immunity Elicited by Defensin Tumor Antigen Fusion Proteins (E–196–2000). Patent Status: US Patent No. 7,754,676 issued 13 Jul 2010; US Patent No. 7,915,040 issued 29 Mar 2011; US Patent Application No. 13/019,160 filed 01 Feb 2011. Developmental Status: Clinical Trials Pending. • Vaccine for the Treatment of Malignancies Expressing Immature Laminin Receptor Protein (OFA–iLRP) (E–271–2006). Patent Status: US Patent Application No. 11/899,165 filed 03 Sep 2007; US Provisional Application No. 60/841,927 filed 01 Sep 2006. Developmental Status: Pre-clinical with ongoing clinical tests in patients with NSCLC. • Tumor Associated Antigen SPANX– B for Cancer Immunotherapy (E–089– 2009). Patent Status: US Provisional Application No. 61/156,435 filed 27 Feb 2009. Developmental Status: Ongoing In vitro pre-clinical studies on human tumor cells. References mstockstill on DSK4VPTVN1PROD with NOTICES 1. A Biragyn et al. Genetic fusion of chemokines to a self tumor antigen induces protective, T-cell dependent antitumor immunity. Nat Biotechnol. 1999 Mar;17(3):253–258. [PMID 10096292] 2. A Biragyn et al. Mediators of innate immunity that target immature, but not mature, dendritic cells induce antitumor immunity when genetically fused with nonimmunogenic tumor antigens. J Immunol. 2001 Dec 1;167(11):6644– 6653. [PMID 11714836] 3. G Almanzar et al. Sperm-derived SPANX– B is a clinically relevant tumor antigen that is expressed in human tumors and readily recognized by human CD4+ and CD8+ T cells. Clin Cancer Res. 2009 Mar 15;15(6):1954–1963. [PMID 19276289] For information on the Immunotherapeutics Unit, Laboratory of Molecular Biology and Immunology of the National Institute on Aging (NIA), please visit: https://www.grc.nia.nih.gov/ branches/lmbi/cis_itu.htm. Dated: December 2, 2011. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–31554 Filed 12–7–11; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 15:59 Dec 07, 2011 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; 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 Biomedical Imaging and Bioengineering Special Emphasis Panel. Date: January 30–31, 2012. Time: 6 p.m. to 7 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New Hampshire Avenue, NW., Washington, DC 20037. Contact Person: Manana Sukhareva, PhD, Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Boulevard, Suite 959, Bethesda, MD 20892, (301) 451–3397, sukharem@mail.nih.gov. Dated: December 2, 2011. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–31551 Filed 12–7–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Use of Agents Targeting Thrombospondin-1 and CD47 To Treat Radiation-Induced Damage and Enhance the Effectiveness of Radiotherapy in Cancer Patients National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: This is a notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/850,132, filed October 6, 2006, now abandoned (HHS Ref. No. E–227–2006/0–US–01); U.S. Provisional Patent Application No. 60/ 864,153, filed November 02, 2006, now abandoned (HHS Ref. No. E–227–2006/ 1–US–01); U.S. Provisional Patent Application No. 60/888,754, filed February 07, 2007, now abandoned (HHS Ref. No. E–227–2006/2–US–01); U.S. Provisional Patent Application No. 60/910,549, filed April 06, 2007, now abandoned (HHS Ref. No. E–227–2006/ 3–US–01); U.S. Provisional Patent Application No. 60/956,375, filed August 16, 2007, now abandoned (HHS Ref. No. E–227–2006/4–US–01); PCT Patent Application No. PCT/2007/ 080647, filed October 5, 2007, now abandoned (HHS Ref. No. E–227–2006/ 5–PCT–01); U.S. Patent Application No. 12/444,364, filed April 3, 2009 (HHS Ref. No. E–227–2006/5–US–02); Canadian Patent Application No. 2,665,287, filed October 5, 2007 (HHS Ref. No. E–227–2006/5–CA–03); Australian Patent Application No. 2007319576, filed October 5, 2007 (HHS Ref. No. E–227–2006/5–AU–04); European Patent Application No. 07868382.8, filed October 5, 2007 (HHS Ref. No. E–227–2006/5–EP–05); U.S. Provisional Patent Application No. 61/ 086,991, filed August 7, 2008, now abandoned (HHS Ref. No. E–153–2008/ 0–US–01); PCT Patent Application No. PCT/2009/052902, filed August 5, 2009, now abandoned (HHS Ref. No. E–153– 2008/0–PCT–02); U.S. Patent Application No. 13/057,447, filed February 3, 2011 (HHS Ref. No. E–153– 2008/0–US–06); Canadian Patent Application No. 2732102 filed August 5, 2009 (HHS Ref. No. E–153–2008/0–CA– 043); Australian Patent Application No. 2009279676, filed August 5, 2009 (HHS Ref. No. E–153–2008/0–AU–03); and European Patent Application No. 09791202.6, filed August 5, 2009 (HHS Ref. No. E–153–2008/0–EP–08), entitled ‘‘Prevention of Tissue Ischemia, Related Methods and Compositions,’’ and ‘‘Radioprotectants Targeting Thrombospondin-1 and CD47,’’ to Radiation Control Technologies, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive license territory may be ‘‘worldwide,’’ E:\FR\FM\08DEN1.SGM 08DEN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 236 / Thursday, December 8, 2011 / Notices and the field of use may be limited to: (1) The use of morpholino oligonucleotides that reduce expression of CD47 in combination with radiotherapy, to treat or prevent cancers in humans; and (2) the use of morpholino oligonucleotides that reduce expression of CD47 to treat or prevent radiation exposure damage in humans. DATES: Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before January 9, 2012 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Suryanarayana (Sury) Vepa, Ph.D., J.D., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5020; Facsimile: (301) 402– 0220; Email: vepas@mail.nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published or issued by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: The present inventions provide for compositions and methods for preventing and/or reducing tissue ischemia and/or tissue damage due to ischemia, increasing blood vessel diameter, blood flow and tissue perfusion in the presence of vascular disease, by suppressing CD47 and/or blocking TSP1 and/or CD47 activity or interaction. The present inventions also provide for the use of morpholinos, peptides and antibodies that block the TSP1/CD47 signaling pathway as radioprotectants for normal tissue, radioenhancers for tumor tissue, and as protectants of normal tissue from damage caused by radiation exposure. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published notice, 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 404.7. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to VerDate Mar<15>2010 15:59 Dec 07, 2011 Jkt 226001 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: December 2, 2011. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–31556 Filed 12–7–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS–R3–R–2011–N209; 30136–1265–0000– S3] DeSoto National Wildlife Refuge, Harrison and Pottawattamie Counties, IA; and Washington County, NE; Comprehensive Conservation Plan and Environmental Assessment Fish and Wildlife Service, Interior. ACTION: Notice of intent; request for comments. AGENCY: We, the U.S. Fish and Wildlife Service, intend to prepare a comprehensive conservation plan (CCP) and environmental assessment (EA) for the DeSoto National Wildlife Refuge (Refuge, NWR). We provide this notice in compliance with our CCP policy to advise other Federal and State agencies, Tribes, and the public of our intentions, and to obtain suggestions and information on the scope of issues to consider in the planning process. In addition, we will use special mailings, newspaper articles, Internet postings, and other media announcements to inform people of opportunities for input. SUMMARY: Send your comments or requests for more information by any one of the following methods: • Email: tom_cox@fws.gov. Include ‘‘DeSoto CCP’’ in the subject line of the message. • Fax: Attn: Tom Cox, (712) 642– 2877. • U.S. Mail: Attention: Refuge Manager, DeSoto National Wildlife Refuge, 1434 316th Lane, Missouri Valley, IA 51555–7033. • In-Person Drop-off: You may drop off comments during regular business hours at the above address. You may also find information about the CCP planning process on the planning web site: https://www.fws.gov/ midwest/planning and submit comments to r3planning@fws.gov. ADDRESSES: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 76745 Include ‘‘DeSoto CCP’’ in the subject line of the message. FOR FURTHER INFORMATION CONTACT: Tom Cox, (712) 642–4121. SUPPLEMENTARY INFORMATION: Introduction With this notice, we initiate our process for developing a revised CCP for the DeSoto NWR, with headquarters in Missouri Valley, IA. This notice complies with our CCP policy to (1) advise other Federal and State agencies, Tribes, and the public of our intention to conduct detailed planning on this refuge and (2) obtain suggestions and information on the scope of issues to consider in the environmental document and during development of the CCP. This planning effort will be coordinated with the preparation of a CCP and EA for Boyer Chute National Wildlife Refuge, announced in the Federal Register on February 18, 2010 (FWS–R3–R–2009–N243). These refuges are located less than a half mile apart, share management resources, and have similar habitats, wildlife, and publics. Review and revision of refuge management and planning direction were prompted by major impacts to the refuges as a result of flooding on the Missouri River in 2011. Background The National Wildlife Refuge System Administration Act of 1966 (16 U.S.C. 668dd-668ee) (Administration Act), as amended by the National Wildlife Refuge System Improvement Act of 1997, requires us to develop a CCP for each national wildlife refuge. The purpose in developing a CCP is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System (NWRS), consistent with sound principles of fish and wildlife management, conservation, legal mandates, and our policies. In addition to outlining broad management direction on conserving wildlife and their habitats, CCPs identify wildlifedependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation and photography, and environmental education and interpretation. We will review and update the CCP at least every 15 years in accordance with the Administration Act. Each unit of the NWRS, including DeSoto NWR, was established for specific purposes. We use these purposes as the foundation for E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76744-76745]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Agents Targeting 
Thrombospondin-1 and CD47 To Treat Radiation-Induced Damage and Enhance 
the Effectiveness of Radiotherapy in Cancer Patients

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

ACTION: Notice.

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

SUMMARY: This is a notice, in accordance with 35 U.S.C. 209(c)(1) and 
37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of a worldwide exclusive license, to practice the inventions 
embodied in U.S. Provisional Patent Application No. 60/850,132, filed 
October 6, 2006, now abandoned (HHS Ref. No. E-227-2006/0-US-01); U.S. 
Provisional Patent Application No. 60/864,153, filed November 02, 2006, 
now abandoned (HHS Ref. No. E-227-2006/1-US-01); U.S. Provisional 
Patent Application No. 60/888,754, filed February 07, 2007, now 
abandoned (HHS Ref. No. E-227-2006/2-US-01); U.S. Provisional Patent 
Application No. 60/910,549, filed April 06, 2007, now abandoned (HHS 
Ref. No. E-227-2006/3-US-01); U.S. Provisional Patent Application No. 
60/956,375, filed August 16, 2007, now abandoned (HHS Ref. No. E-227-
2006/4-US-01); PCT Patent Application No. PCT/2007/080647, filed 
October 5, 2007, now abandoned (HHS Ref. No. E-227-2006/5-PCT-01); U.S. 
Patent Application No. 12/444,364, filed April 3, 2009 (HHS Ref. No. E-
227-2006/5-US-02); Canadian Patent Application No. 2,665,287, filed 
October 5, 2007 (HHS Ref. No. E-227-2006/5-CA-03); Australian Patent 
Application No. 2007319576, filed October 5, 2007 (HHS Ref. No. E-227-
2006/5-AU-04); European Patent Application No. 07868382.8, filed 
October 5, 2007 (HHS Ref. No. E-227-2006/5-EP-05); U.S. Provisional 
Patent Application No. 61/086,991, filed August 7, 2008, now abandoned 
(HHS Ref. No. E-153-2008/0-US-01); PCT Patent Application No. PCT/2009/
052902, filed August 5, 2009, now abandoned (HHS Ref. No. E-153-2008/0-
PCT-02); U.S. Patent Application No. 13/057,447, filed February 3, 2011 
(HHS Ref. No. E-153-2008/0-US-06); Canadian Patent Application No. 
2732102 filed August 5, 2009 (HHS Ref. No. E-153-2008/0-CA-043); 
Australian Patent Application No. 2009279676, filed August 5, 2009 (HHS 
Ref. No. E-153-2008/0-AU-03); and European Patent Application No. 
09791202.6, filed August 5, 2009 (HHS Ref. No. E-153-2008/0-EP-08), 
entitled ``Prevention of Tissue Ischemia, Related Methods and 
Compositions,'' and ``Radioprotectants Targeting Thrombospondin-1 and 
CD47,'' to Radiation Control Technologies, Inc., a company incorporated 
under the laws of the State of Delaware having its headquarters in 
Rockville, Maryland. The United States of America is the assignee of 
the rights of the above inventions. The prospective exclusive license 
territory may be ``worldwide,''

[[Page 76745]]

and the field of use may be limited to: (1) The use of morpholino 
oligonucleotides that reduce expression of CD47 in combination with 
radiotherapy, to treat or prevent cancers in humans; and (2) the use of 
morpholino oligonucleotides that reduce expression of CD47 to treat or 
prevent radiation exposure damage in humans.

DATES: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before January 9, 2012 
will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Suryanarayana (Sury) Vepa, Ph.D., J.D., Office 
of Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
5020; Facsimile: (301) 402-0220; Email: vepas@mail.nih.gov. A signed 
confidentiality nondisclosure agreement will be required to receive 
copies of any patent applications that have not been published or 
issued by the United States Patent and Trademark Office or the World 
Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: The present inventions provide for 
compositions and methods for preventing and/or reducing tissue ischemia 
and/or tissue damage due to ischemia, increasing blood vessel diameter, 
blood flow and tissue perfusion in the presence of vascular disease, by 
suppressing CD47 and/or blocking TSP1 and/or CD47 activity or 
interaction. The present inventions also provide for the use of 
morpholinos, peptides and antibodies that block the TSP1/CD47 signaling 
pathway as radioprotectants for normal tissue, radioenhancers for tumor 
tissue, and as protectants of normal tissue from damage caused by 
radiation exposure.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within thirty 
(30) days from the date of this published notice, 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 404.7.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: December 2, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-31556 Filed 12-7-11; 8:45 am]
BILLING CODE 4140-01-P
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