8558 Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 

Time: 1 p.m. to 3 p.m. 

Agenda: Review and evaluate the final 

draft for the Environmental Factors in Cancer 

2008/2009 Annual Report. 

Place: National Cancer Institute, Office of 

the Director, National Institutes of Health, 

6116 Executive Blvd., Suite 220, Bethesda, 

MD 20892 (Teleconference). 

Contact Person: Abby Sandler, PhD., 

Executive Secretary, Chief, Institute Review 

Office, Office of the Director, National Cancer 

Institute, NIH, 6116 Executive Blvd., Suite 

220, MSC 8349, Bethesda, MD 20892–8349, 

301/451–9399, sandlera@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the comments to the Contact Person listed on 

this notice. The comments should include 

the name, address, telephone number and, 

when applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

deainfo.nci.nih.gov/advisory/pcp/pcp.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: February 19, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–4048 Filed 2–24–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Co-Exclusive 

License: Use Fully Human and/or 

Humanized Monoclonal Antibodies 

Against IGF-I and/or IGF-II for the 

Treatment of Human Cancers 

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, Department of 

Health and Human Services, is 

contemplating the grant of a coexclusive patent license to practice the 

inventions embodied in U.S. Patent 

Application No. 12/296,328 entitled, 

‘‘Human IGF-I-Specific and IGF-I and 

IGF-II Cross-Reactive Human 

Monoclonal Antibodies’’ and all foreign 

counterparts [HHS Ref. No. E–336– 

2005/0] to Trubion Pharmaceuticals, 

Inc., which is located in Seattle, 

Washington. The patent rights in this 

invention have been assigned to the 

United States of America. 

The prospective co-exclusive license 

territory may be worldwide and the 

field of use may be limited to the use 

of the antibodies and their method of 

use in the Licensed Patent Rights for the 

treatment of human cancers. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before April 

27, 2009 will be considered. This notice 

updates the Federal Register Notice 

published in 73 FR 32719, June 10, 

2008. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated co-exclusive license 

should be directed to: Whitney A. 

Hastings, M.S., Licensing and Patenting 

Manager, Office of Technology Transfer, 

National Institutes of Health, 6011 

Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804. Telephone: 

(301) 451–7337; Facsimile: (301) 402– 

0220; E-mail: hastingw@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The type 1 

insulin-like growth factor (IGF) receptor 

(IGF1R) is over-expressed by many 

tumors and mediates proliferation, 

motility, and protection from apoptosis. 

Agents that inhibit IGF1R expression or 

function can potentially block tumor 

growth and metastasis. Its major ligands, 

IGF-I and IGF-II, are over-expressed by 

multiple tumor types. Previous studies 

indicate that inhibition of IGF-I and/or 

IGF-II binding to its cognizant receptor 

negatively modulates signal 

transduction through the IGF pathway 

and concomitant cell growth. Therefore, 

use of humanized or fully human 

antibodies against IGFs represents a 

valid approach to inhibit tumor growth. 

The above identified patent 

applications discloses three (3) novel 

fully human monoclonal antibodies 

designated m705, m706, and m708, 

which are specific for insulin-like 

growth factor (IGF)-I. Two (2) of the 

three (3) antibodies, m705 and m706 are 

specific for IGF-I and do not cross react 

with IGF-II and insulin while, m708 

cross reacts with IGF-II. 

These antibodies can be used to 

prevent binding of IGF-I to its 

concomitant receptor IGFIR, 

consequently, modulating diseases such 

as cancer. Additional embodiments 

describe methods for treating various 

human diseases associated with 

aberrant cell growth and motility 

including breast, prostate, and leukemia 

carcinomas. Thus, these novel 

antibodies may provide a therapeutic 

intervention for multiple carcinomas 

without the negative side effects 

associated with insulin inhibition. 

The prospective co-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 co-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 co-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: February 17, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–4045 Filed 2–24–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Diagnostic Tests for 

Predicting the Emergence of Suicidal 

Ideation Subsequent to AntiDepressant Treatment 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This notice, in accordance 

with 35 U.S.C. 209(c)(l) and 37 CFR 

404.7(a)(l)(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 

U.S. Patent Application 60/854,978 

[HHS Ref. E–157–2006/0–US–01], PCT 

Patent Application PCT/US2007/082683 

[HHS Ref. E–157–2006/1–PCT–01], U.S. 

Patent Application 11/925,334 [HHS 

Ref. E–157–2006/1–US–02], all entitled 

‘‘Methods to Identify Patients at Risk of 

Developing Adverse Events During 

Treatment With Antidepressant 

Medication’’, and all continuing 


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