Prospective Grant of Exclusive License: The Use of HMG-CoA Inhibitors for the Treatment of Adenocarcinomas and Ewing's Sarcoma, 14231-14232 [E6-4074]

Download as PDF Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices provide contact information (name, affiliation, mailing address, phone, fax, email and sponsoring organization, if applicable) when registering to make oral comments. Summary minutes and a final report of the Panel will be available following the meeting at the ICCVAM/NICEATM Web site (https://iccvam.niehs.nih.gov). ICCVAM will consider the conclusions and recommendations from the Panel and any public comments received in finalizing test method recommendations and performance standards for these test methods. sroberts on PROD1PC70 with NOTICES Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 U.S. Federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products while refining (less pain and distress), reducing, and replacing animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106–545, available at https:// iccvam.niehs.nih.gov/about/ PL106545.htm) establishes ICCVAM as a permanent interagency committee of the NIEHS under the NICEATM. NICEATM administers the ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of U.S. Federal agencies. Additional information about ICCVAM and NICEATM can be found at the ICCVAM/ NICEATM Web site: https:// iccvam.niehs.nih.gov. References EPA. 2002a. Health Effects Test Guidelines OPPTS 870.1100 Acute Oral Toxicity. EPA 712–C–02–190. Washington, DC: U.S. Environmental Protection Agency. ICCVAM. 2001a. Report of the international workshop on in vitro methods for assessing acute systemic toxicity. NIH Publication 01–4499. Research Triangle Park, NC: National Institute for Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/. ICCVAM. 2001b. Guidance document on using in vitro data to estimate in vivo starting doses for acute toxicity. NIH Publication 01–4500. Research Triangle Park, NC: National Institute for Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/. OECD. 2001a. VerDate Aug<31>2005 19:30 Mar 20, 2006 Jkt 208001 Guideline for Testing of Chemicals, 425, Acute Oral Toxicity—Up-and-Down Procedure. Paris France: OECD. Available at: https://www.oecd.org [accessed June 2, 2004]. OECD. 2001b. Guideline For Testing of Chemicals, 423, Acute Oral Toxicity—Acute Toxic Class Method. Paris France: OECD. Dated: March 9, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6–4075 Filed 3–20–06; 8:45 am] BILLING CODE 4140–01–P 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, Skeletal Biology. Date: March 27, 2006. Time: 1 p.m. to 2:30 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: Priscilla B. Chen, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4104, MSC 7814, Bethesda, MD 20892. (301) 594– 1787. chenp@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, Computational Modeling and Development. Date: April 5, 2006. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 14231 Contact Person: Sherry L. Dupere, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5136, MSC 7843, Bethesda, MD 20892. (301) 435– 1021. duperes@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Musculoskeletal Rehabilitation Sciences. Date: April 7, 2006. Time: 1 p.m. to 3:30 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: John P. Holden, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4016J, MSC 7814, Bethesda, MD 20892. (301) 596– 8551. holdenjo@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: March 13, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–2739 Filed 3–20–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Use of HMG-CoA Inhibitors for the Treatment of Adenocarcinomas and Ewing’s Sarcoma 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 (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 6,040,334 issued March 21, 2000, entitled ‘‘Use of Inhibitors of 3-Hydroxy-3Methylglutaryl Coenzyme A reductase as a Modality in Cancer Therapy’’ [HHS Reference E–146–1992/0–US–23] and related foreign applications to Nascent Oncology, Inc., which has offices in Chapel Hill, North Carolina. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. E:\FR\FM\21MRN1.SGM 21MRN1 sroberts on PROD1PC70 with NOTICES 14232 Federal Register / Vol. 71, No. 54 / Tuesday, March 21, 2006 / Notices The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of adenocarcinoma and Ewing’s sarcoma with HMG-CoA inhibitors. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 22, 2006 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, PhD, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 4632; Facsimile: (301) 402–0220; E-mail: lambertsond@od.nih.gov. SUPPLEMENTARY INFORMATION: The technology relates to the treatment of adenocarcinomas and Ewing’s sarcoma with HMG-CoA inhibitors. Adenocarcinoma affects the inner lining or inner surface of a number of organs, and is responsible for approximately 95% of prostate cancers, over 75% of pancreatic cancers, and is the most common form of lung cancer. Ewing’s sarcoma is a bone tumor typically attacking the long bones. Current methods of treating these cancers include surgery, chemotherapy, radiation therapy or a combination thereof. The current technology involves the use of HMG-CoA inhibitors (such as lovastatin or simvastatin) to treat adenocarcinomas and Ewing’s sarcoma. HMG-CoA inhibitors have been approved for use in the treatment of high cholesterol in humans, with typical doses of 10mg, 20mg or 40mg. This technology recommends using higher doses (based on the weight of the patient) for the treatment of cancer. 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 VerDate Aug<31>2005 19:30 Mar 20, 2006 Jkt 208001 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: March 13, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–4074 Filed 3–20–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Use of IL13–PE38 for the Treatment of Asthma and Pulmonary Fibrosis 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 (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/337,179 filed December 4, 2001, entitled ‘‘IL–13 Receptor-Targeted Immunotoxins Ameliorates Symptoms of Asthma and of Allergy’’ [HHS Reference No. E–296–2001/0–US–01], PCT Application No. PCT/US02/00616 filed February 28, 2002, entitled ‘‘Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL–13 Receptor-Expressing Cells in the Respiratory Tract’’ [HHS Reference No. E–296–2001/0–PCT–02], U.S. Patent Application No. 10/497,804 filed June 4, 2004, entitled ‘‘Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL–13 Receptor-Expressing Cells in the Respiratory Tract’’ [HHS Reference No. E–296–2001/0-US–03], Australian Patent Application No. 2002258011 filed June 8, 2004, entitled ‘‘Alleviating Symptoms of TH2-Like Cytokine Mediated Disorders by Reducing IL–13 Receptor-Expressing Cells in the Respiratory Tract’’ [HHS Reference No. E–296–2001/0–AU–04], Canadian Patent Application No. 2469082 filed February 28, 2002, entitled ‘‘Chimeric Molecule for the Treatment of TH2-Like Cytokine Mediated Disorders’’ [HHS Reference No. E–296–2001/0-CA–05], and European Patent Application No. 02727815.9 filed June 29, 2004 entitled ‘‘Alleviating Symptoms of TH2-Like PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Cytokine Mediated Disorders by Reducing IL–13 Receptor-Expressing Cells in the Respiratory Tract’’ [HHS Reference No. E–296–2001/0–EP–06], including background patent rights to U.S. Patent No. 4,892,827, issued on January 9, 1990, entitled ‘‘Recombinant Pseudomonas Exotoxins: Construction of an Active Immunotoxin with Low Side Effects’’ [HHS Reference No. E– 385–1986/0–US–01], U.S. Patent No. 5,919,456, issued on July 6, 1999, entitled ‘‘IL–13 Receptor Specific Chimeric Proteins’’ [HHS Reference No. E–266–1994/0–US–07], U.S. Patent 6,518,061, issued on February 11, 2003, entitled ‘‘IL–13 Receptor Specific Chimeric Proteins and Uses Thereof’’ [HHS Reference No. E–266–1994/0-US– 08], to NeoPharm, Inc., which has offices in Waukegan, Illinois. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of asthma and pulmonary fibrosis with IL13–PE38. This notice replaces the Prospective Grant notice published in the Federal Register on Monday, March 6, 2006 (71 FR 11213). DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 22, 2006 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, 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– 4632; Facsimile: (301) 402–0220; E-mail: lambertsond@od.nih.gov. SUPPLEMENTARY INFORMATION: The technology relates to the treatment of asthma and pulmonary fibrosis. When airway inflammation occurs (e.g., during an asthmatic attack or a response to an allergen), the number of cells that produce the receptor for IL–13 increases in the lungs. When IL–13 interacts with the receptor, an inflammatory response is induced; when this occurs in the lungs, it leads to the symptom of constricted breathing. Blocking the interaction between IL–13 and its receptors on the cells has been shown to reduce the inflammatory response. A chimeric molecule was developed that comprised both an IL–13 domain E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 71, Number 54 (Tuesday, March 21, 2006)]
[Notices]
[Pages 14231-14232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4074]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Use of HMG-CoA 
Inhibitors for the Treatment of Adenocarcinomas and Ewing's Sarcoma

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 (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of an exclusive patent license to practice the inventions 
embodied in U.S. Patent No. 6,040,334 issued March 21, 2000, entitled 
``Use of Inhibitors of 3-Hydroxy-3-Methylglutaryl Coenzyme A reductase 
as a Modality in Cancer Therapy'' [HHS Reference E-146-1992/0-US-23] 
and related foreign applications to Nascent Oncology, Inc., which has 
offices in Chapel Hill, North Carolina. The patent rights in these 
inventions have been assigned and/or exclusively licensed to the 
Government of the United States of America.

[[Page 14232]]

    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the treatment of adenocarcinoma and 
Ewing's sarcoma with HMG-CoA inhibitors.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before May 
22, 2006 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: David A. Lambertson, PhD, Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; E-
mail: lambertsond@od.nih.gov.

SUPPLEMENTARY INFORMATION: The technology relates to the treatment of 
adenocarcinomas and Ewing's sarcoma with HMG-CoA inhibitors. 
Adenocarcinoma affects the inner lining or inner surface of a number of 
organs, and is responsible for approximately 95% of prostate cancers, 
over 75% of pancreatic cancers, and is the most common form of lung 
cancer. Ewing's sarcoma is a bone tumor typically attacking the long 
bones. Current methods of treating these cancers include surgery, 
chemotherapy, radiation therapy or a combination thereof.
    The current technology involves the use of HMG-CoA inhibitors (such 
as lovastatin or simvastatin) to treat adenocarcinomas and Ewing's 
sarcoma. HMG-CoA inhibitors have been approved for use in the treatment 
of high cholesterol in humans, with typical doses of 10mg, 20mg or 
40mg. This technology recommends using higher doses (based on the 
weight of the patient) for the treatment of cancer.
    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: March 13, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E6-4074 Filed 3-20-06; 8:45 am]
BILLING CODE 4140-01-P
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