Prospective Grant of Exclusive License: Treatment of Inflammatory Diseases Using Ghrelin, 44672-44673 [05-15343]

Download as PDF 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 Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices 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: July 19, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–15343 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 an Exclusive License: Therapeutics for the Treatment of Kidney Cancer and Thyroid Neoplasms National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in 1. E–199–2002/0–US–01, ‘‘Treatment Method and Therapeutic Agent of Kidney Cancer’’, by Susan Bates, and Yoshinori Naoe, Pat. Application No. 60/369,868 (filing date April 5, 2002); 2. E–199–2002/0–PCT–02, ‘‘Treatment Method and Therapeutic Agent of Kidney Cancer’’, by Susan Bates, and Yoshinori Naoe, Pat. Application No. PCT/US03/03823 (filing date March 27, 2003); 3. E–199–2002/0–US–04, ‘‘Depsipeptide for Therapy of Kidney Cancer’’, by Susan Bates, and Yoshinori Naoe, Pat. Application No. 10/508,958 (filing date October 5, 2004); 4. E–199–2002/0–JP–08, ‘‘Depsipeptide for Therapy of Kidney Cancer’’, by Susan Bates, and Yoshinori Naoe, Pat. Application No. 20003581847 (filing date October 5, 2004); 5. E–199–2002/0–EP–05, ‘‘Depsipeptide for Therapy of Kidney Cancer’’, by Susan Bates, and Yoshinori Naoe, Pat Application No.037155033– 2107 (filing date October 8, 2004); 6. E–286–2000/0–US–01, ‘‘Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms’’, by Tito Fojo and Susan Bates, Pat. Application No. 60/260,733 (filing date January 10, 2001); VerDate jul<14>2003 15:22 Aug 02, 2005 Jkt 205001 7. E–286–2000/0–US–02, ‘‘Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms’’, by Tito Fojo and Susan Bates, Pat. Application No. PCT/US02/0714 (filing date January 9, 2001); 8. E–286–2000/0–EP–03, ‘‘Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms’’, by Tito Fojo and Susan Bates, Pat. Application No. 02718823.4 (filing date January 9, 2001); 9. E–286–2000/0–AU–04, ‘‘Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms’’, by Tito Fojo and Susan Bates, Pat. Application No. 2002249938 (filing date January 9, 2001); 10. E–286–2000/0–CA–04, ‘‘Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms’’, by Tito Fojo and Susan Bates, Pat. Application No. 2434269 (filing date January 9, 2001); 11. E–286–2000/0–US–07, ‘‘Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms’’, by Tito Fojo and Susan Bates, Pat. Application No. 10/250,320 (filing date June 26, 2003); 12. E–286–2000/0–JP–05, ‘‘Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms’’, by Tito Fojo and Susan Bates, Pat. Application No. 2002–556736 (filing date July 10, 2003) to Gloucester Pharmaceticals, having a place of business in Cambridge, MA. 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 therapeutics for the treatment of Kidney Cancer and Thyroid Neoplasms. DATES: Only written comments and/or license applications which are received by the National Institutes of Health on or before October 3, 2005 will be considered. Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: John Stansberrry, 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. ADDRESSES: The inventions describe methods of treating kidney cancer and thyroid neoplasms SUPPLEMENTARY INFORMATION: PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 44673 with FK228, which is a histone deacetylase (HDAC) inhibitor. FK228 is currently in Phase II clinical trials, and has been shown to inhibit histone deacetylation, a process instrumental in the regulation of gene expression. FK228 modulates cell cycle arrest and can promote differentiation and apoptosis. To date, FK228 has been administered to more than 300 patients and has shown promising clinical activity in Phase II trials for patients with cutaneous T-cell lymphoma (CTCL). Clinical responses have also been observed in Phase II studies in peripheral T-cell lymphoma, renal cell carcinoma (RCC) and hormone refractory prostate cancer (HRPC). 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 establish 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. 05–15345 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 an Exclusive License: Anti-Cancer Vaccines National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Notices]
[Pages 44672-44673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15343]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of Inflammatory 
Diseases Using Ghrelin

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 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 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 pro-inflammatory 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-[alpha], IFN-[gamma], 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

[[Page 44673]]

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: July 19, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-15343 Filed 8-2-05; 8:45 am]
BILLING CODE 4140-01-P
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