Prospective Grant of Exclusive License: Adaphostin as a Novel Cancer Therapy, 44671-44672 [05-15349]

Download as PDF Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: July 26, 2005. Anthony M. Coelho, Jr., Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–15242 Filed 8–2–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings 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: Center for Scientific Review Special emphasis Panel, Member Conflict: Tumor Cell Biology and Microenvironment. Date: August 2, 2005. Time: 11 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone conference call). Contact Person: Sharon K. Gubanich, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6204, MSC 7804. Bethesda, MD 20892. (301) 435– 1767. gubanics@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Hyperaccelerated Award/Mechanisms in Immunomodulation Trials. Date: August 2, 2005. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive. Bethesda, MD 20892. (Telephone conference call). Contact Person: Samuel C. Edwards, PhD, Scientific Review Administrator, Center for VerDate jul<14>2003 15:22 Aug 02, 2005 Jkt 205001 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4200, MSC 7812, Bethesda, MD 20892. (301) 435– 1767. edwardss@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Dermatological Sciences Special Emphasis Panel. Date: August 8, 2005. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive. Bethesda, MD 20892. (Telephone conference call). Contact Person: Aftab A. Ansari, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4108, MSC 7814, Bethesda, MD 20892. (301) 594– 6376. ansaria@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Entamoeba Metabolism and Virulence. Date: August 16, 2005. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone conference call). Contact Person: Joseph D. Mosca, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158, MSC 7808, Bethesda, MD 20892. (301) 435– 2344, moscajos@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Coxiella Pathogenesis. Date: August 19, 2005. Time: 11 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone conference call). Contact Person: Melody Mills, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3204, MSC 7808, Bethesda, MD 20892. (301) 435– 0903, millsm@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–396, 93.837–93.844, 93.846– 93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: July 27, 2005. Anthony M. Coelho, Jr., Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–15246 Filed 8–2–05; 8:45 am] BILLING CODE 4140–01–M PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 44671 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Adaphostin as a Novel Cancer Therapy National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in: 1. E–013–1998/0–US–01, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 60/076,330 (filed February 27, 1998); 2. E–013–1998/0–PCT–02, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number PCT/US99/04002 (filed February 24, 1999); 3. E–013–1998/0–EP–03, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 99910987.9 (filed February 24, 1999); 4. E–013–1998/0–JP–04, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 2000–533395 (filed February 24, 1999); 5. E–013–1998/0–AU–05, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, patent number 760046 (filed February 24, 1999); 6. E–013–1998/0–CA–06, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 60/076,330 (filed February 24, 1999); E:\FR\FM\03AUN1.SGM 03AUN1 44672 Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices 7. E–013–1998/0–US–07, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 09/623,000 (filed February 24, 1999); 8. E–013–1998/0–EP–08, ‘‘Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs’’, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 03009396.7 (filed February 24, 1999); to Ascenta Therapeutics, Inc, which is located in San Diego, CA. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to human therapeutics for cancer. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 3, 2005 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: John Stansberry, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5236; Facsimile: (301) 402–0220; E-mail: stansbej@mail.nih.gov. SUPPLEMENTARY INFORMATION: The patent applications for this technology contain composition of matter claims and method claims for treating proliferative diseases. The technology describes tyrphostins, which are a class of small molecules that were designed to act as tyrosine kinase inhibitors. One of these compounds, adaphostin (NSC 680410), was originally identified as an inhibitor of p210Bcr/abl kinase and a potent inducer of myeloid cell death in p210Bcr⁄abl -positive K562 cells in vitro. Recent studies report that adaphostin can induce cell death in Bcr/ablnegative leukemia cells, including B-cell chronic lymphocytic leukemia. Additional studies have demonstrated that this agent might induce cell death through elevation of reactive oxygen species (ROS) or down-regulation of VEGF rather than inhibition of p210Bcr⁄abl. Moreover, adaphostin in combination with other anti-cancer agents induces apoptosis in CLL–B cells. VerDate jul<14>2003 15:22 Aug 02, 2005 Jkt 205001 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 sixty (60) 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 404.7. 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 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: July 26, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–15349 Filed 8–2–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Treatment of Inflammatory Diseases Using Ghrelin National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is 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, is contemplating the grant of an exclusive license to practice the invention embodied in U.S. provisional patent application, S/N 60/569,819 filed May 11, 2004, entitled ‘‘Methods for Inhibiting Proinflammatory Cytokine Expression Using Ghrelin’’ and converted to PCT on May 11, 2005 (E– 016–2004/0–PCT–02), [Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric Schaffer, and Dzung Nguyen (NIA)], to Gastrotech Pharma (hereafter Gastrotech), having a place of business in Copenhagen, Denmark. The patent rights in these inventions have been assigned to the United States of America. DATES: Only written comments and/or application for a license, which are received by the NIH Office of PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 Technology Transfer on or before October 3, 2005 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: Sally Hu, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Email: hus@mail.nih.gov; Telephone: (301) 435–5606; Facsimile: (301) 402– 0220. SUPPLEMENTARY INFORMATION: E–016– 2004/0–US–01 provides methods for treating inflammation by inhibiting proinflammatory cytokine expression using Ghrelin, or a fragment thereof. Inflammation could be caused by a variety of viral, bacterial, fungal, or parasitic infections. The invention also provides methods for treating loss of appetite, and sepsis. Ghrelin, a naturally occurring peptide hormone was shown to be the ligand for growth hormone secretagogue receptor (GHS–R), and is mainly produced by the epithelial cells in the stomach. Ghrelin exerts many important actions in the body, including stimulation of growth hormone secretion, induction of appetite, and regulation of energy expenditure. Ghrelin directly controls human growth hormone and insulin growth factor expression by human immune cells. The inventors showed that Ghrelin exerts anti-inflammatory effects by inhibiting the secretion of acute and chronic cytokines, including IL-1, IL-6, TNF-a, IFN-g, IL-12, chemokines, and CSF in vitro and in vivo mouse models of sepsis and inflammation. This invention can be useful for treatment of various inflammatory disorders, including inflammatory bowel disease, Crohn’s disease, rheumatoid arthritis, multiple sclerosis, atherosclerosis, endotoxemia, and graft-versus-host disease. It can also be used as a treatment for loss of appetite and sepsis. 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 60 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. The field of use may be limited to the use of Ghrelin as a novel drug to treat a range of inflammatory diseases. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Notices]
[Pages 44671-44672]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15349]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Adaphostin as a Novel 
Cancer Therapy

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

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR part 404.7(a)(1)(i), that the National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to practice the inventions embodied in:
    1. E-013-1998/0-US-01, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application 
number 60/076,330 (filed February 27, 1998);
    2. E-013-1998/0-PCT-02, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application 
number PCT/US99/04002 (filed February 24, 1999);

    3. E-013-1998/0-EP-03, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application 
number 99910987.9 (filed February 24, 1999);
    4. E-013-1998/0-JP-04, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application 
number 2000-533395 (filed February 24, 1999);
    5. E-013-1998/0-AU-05, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, patent number 
760046 (filed February 24, 1999);
    6. E-013-1998/0-CA-06, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application 
number 60/076,330 (filed February 24, 1999);

[[Page 44672]]

    7. E-013-1998/0-US-07, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application 
number 09/623,000 (filed February 24, 1999);
    8. E-013-1998/0-EP-08, ``Disubstituted Lavendustin A Analogs and 
Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala 
Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application 
number 03009396.7 (filed February 24, 1999);

to Ascenta Therapeutics, Inc, which is located in San Diego, CA. The 
patent rights in these inventions have been assigned to the United 
States of America.

    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to human therapeutics for cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 3, 2005 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: John Stansberry, Ph.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-5236; Facsimile: (301) 402-0220; E-
mail: stansbej@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The patent applications for this technology 
contain composition of matter claims and method claims for treating 
proliferative diseases. The technology describes tyrphostins, which are 
a class of small molecules that were designed to act as tyrosine kinase 
inhibitors. One of these compounds, adaphostin (NSC 680410), was 
originally identified as an inhibitor of p210Bcr/abl kinase and a 
potent inducer of myeloid cell death in p210B\cr/abl\ -positive K562 
cells in vitro. Recent studies report that adaphostin can induce cell 
death in Bcr/abl-negative leukemia cells, including B-cell chronic 
lymphocytic leukemia. Additional studies have demonstrated that this 
agent might induce cell death through elevation of reactive oxygen 
species (ROS) or down-regulation of VEGF rather than inhibition of 
p210B\cr/abl\. Moreover, adaphostin in combination with other anti-
cancer agents induces apoptosis in CLL-B cells.
    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 sixty 
(60) 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 404.7.
    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 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: July 26, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-15349 Filed 8-2-05; 8:45 am]
BILLING CODE 4140-01-P

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