Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices 67741 

An estimated 180,510 new cases of 

breast cancer and 40,060 deaths due to 

breast cancer in the United States in 

2007. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Nima Sharifi et al. (NCI). 

Patent Status: U.S. Provisional 

Application No. 60/958,351 filed 03 Jul 

2007 (HHS Reference No. E–163–2007/ 

0–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Medical Oncology Branch, National 

Cancer Institute is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize—treatments of resistant 

prostate cancer. Please contact John D. 

Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

A Clinically Proven Therapeutic 

Treatment and Diagnostic Tool for 

Mesothelin Expressing Cancers: A 

Novel Recombinant Immunotoxin SS1P 

(anti-mesothelin dsFv–PE38) 

Description of Technology: 

Mesothelin is a glycoprotein, whose 

expression has been largely restricted to 

mesothelial cells in normal tissues. 

Mesothelin has been shown to be 

expressed in several cancers including 

mesothelioma, lung cancer, pancreatic 

cancers, gastric cancers and ovarian 

cancers, and has the potential of being 

used as a novel target for the 

development of new treatments. 

The technology relates to the SSIP 

immunotoxin that can be used to kill 

cells expressing mesothelin on their 

surfaces, such as mesothelioma, ovarian 

cancer, lung cancer, ovarian cancer and 

stomach cancer. Additionally, it can be 

used for the detection of mesothelin 

expressing cells present in a biological 

sample. 

The SSIP immunotoxin is a 

recombinant immunotoxin generated by 

the fusion of a high affinity antimesothelin Fv (SS1) with a 38 kDa 

portion of Pseudomonas Exotoxin A 

(PE38). 

Applications: SS1P can be used as a 

therapy for mesothelin expressing 

cancers. 

The immunotoxin can be used as a 

stand alone treatment and in 

combination with standard 

chemotherapy. 

Advantage: SS1P immunotoxin is 

available for use and has been 

successfully tested clinically for the 

treatment of mesothelioma and ovarian 

cancer with low side effects. 

Development Status: Phase 1 studies 

have been completed for mesothelin 

expressing cancers such as 

mesothelioma, ovarian cancer and 

pancreatic cancer. 

Phase 2 studies to begin shortly for 

combination therapy using SS1P and 

standard chemotherapy. 

Inventors: Ira Pastan (NCI) et al. 

Relevant Publications: 1. R Hassan et 

al. Phase I study of SS1P, a recombinant 

anti-mesothelin immunotoxin given as a 

bolus I.V. infusion to patients with 

mesothelin-expressing mesothelioma, 

ovarian, and pancreatic cancers. Clin 

Cancer Res. 2007 Sep 1;13 (17):5144–

5149. 

2. Y Zhang et al. Synergistic 

antitumor activity of taxol and 

immunotoxin SS1P in tumor-bearing 

mice. Clin Cancer Res. 2006 Aug 

1;12(15):4695–4701. 

Patent Status: U.S. Patent No. 

7,081,518 issued 25 Jul 2006, entitled 

‘‘Anti-Mesothelin Antibodies Having 

High Binding Affinity’’ (HHS Reference 

No. E–139–1999/0–US–07) 

Related Intellectual Property: 1. U.S. 

Patent No. 4,892,827 entitled 

‘‘Recombinant Pseudomonas Exotoxin: 

Construction of an Active Immunotoxin 

with Low Side Effects’’ [HHS Ref. No. 

E–385–1986/0]; 

2. U.S. Patent Nos. 6,051,405, 

5,863,745, and 5,696,237 ‘‘Recombinant 

Antibody-Toxin Fusion Protein’’ [HHS 

Ref. No. E–135–1989/0]; 

3. U.S. Patents 5,747,654, 6,147,203, 

and 6,558,672 entitled ‘‘Recombinant 

Disulfide-Stabilized Polypeptide 

Fragments Having Binding Specificity’’

[HHS Ref. No. E–163–1993/0]; 

4. U.S. Patent No. 6,153,430, and U.S. 

Patent Application No. 09/684,599 

‘‘Nucleic Acid Encoding Mesothelin, a 

Differentiation Antigen Present on 

Mesothelium, Mesotheliomas and 

Ovarian Cancers’’ [HHS Ref. No. E–002–

1996/0]; 

5. U.S. Patent 6,083,502 entitled 

‘‘Mesothelium Antigen and Methods 

and Kits for Targeting It’’ [HHS Ref. No. 

E–002–1996/1]; 

6. U.S. Patent Application 09/581,345: 

‘‘Antibodies, Including Fv Molecules, 

and Immunoconjugates Having High 

Binding Affinity for Mesothelin and 

Methods for Their Use’’ [HHS Ref. No. 

E–021–1998/0]; 

7. PCT Application No. PCT/US01/ 

18503, ‘‘Pegylation of Linkers Improves 

Antitumor Activity and Reduces 

Toxicity of Immunoconjugates’’ [HHS 

Ref. No. E–216–2000/2]; 

8. PCT Application No. PCT/US2006/ 

018502 and U.S. Patent Application No. 

60/681,104, entitled ‘‘Anti-Mesothelin 

Antibodies Useful For Immunological 

Assays’’ [HHS Ref. No. E–015–2005/0–

US–01]; and 

9. Any related foreign filed national 

stage applications claiming priority to 

such patent applications and patents 

listed above. 

Licensing Status: Available for 

exclusive and non-exclusive licensing. 

Licensing Contact: David A. 

Lambertson, Ph.D.; 301–435–4632; 

lambertsond@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute 

Laboratory of Molecular Biology is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, immunotoxin SS1P. Please 

contact John D. Hewes, Ph.D. at 301–

435–3121 or hewesj@mail.nih.gov for 

more information. 

Dated: November 16, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–23194 Filed 11–29–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

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applications, the disclosure of which 

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Name of Committee: Center for Inherited 

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Date: January 10–11, 2008. 

Time: 7 a.m. to 3:45 p.m. 

Agenda: To review and evaluate grant 

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Place: Embassy Suites at the Chevy Chase 

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Contact Person: Jerry Roberts, PhD., 

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Branch, National Human Genome Research 

Institute, National Institutes of Health, 5635 


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67742 Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices 

Fishers Lane, Suite 4076, MSC 9305, 

Bethesda, MD 20892–9306, 301 402–0838, 

jr39m@nih.gov. 

Name of Committee: Center for Inherited 

Disease Research Access Committee, CIDR 

Access Committee B. 

Date: January 11, 2008. 

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Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

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Contact Person: Rudy Pozzatti, PhD., 

Scientific Review Officer, Scientific Review 

Branch, National Human Genome Research 

Institute, 5635 Fishers Lane, Suite 4076, MSC 

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pozzattr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

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Research, National Institutes of Health, HHS) 

Dated: November 26, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–5883 Filed 11–29–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 

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Name of Committee: National Institute on 

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START Review. 

Date: December 14, 2007. 

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Agenda: To review and evaluate grant 

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Place: National Institutes of Health, 6101 

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Contact Person: Mark Swieter, PhD, Chief, 

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ms80x@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel, B/ 

START Review. 

Date: December 14, 2007. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852 

(Virtual Meeting). 

Contact Person: Mark Swieter, PhD, Chief, 

Training and Special Projects Review Branch, 

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(Catalogue of Federal Domestic Assistance 

Program No. 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: November 19, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–5878 Filed 11–29–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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is hereby given of the following 

meeting. 

The meeting will be closed to the 

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provisions set forth in sections 

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as amended. The grant applications and 

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Date: December 6–7, 2007. 

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Agenda: To review and evaluate grant 

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Place: Hyatt Regency Bethesda, One 

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Contact Person: Meredith D. TempleO’Connor, PhD, Office of Scientific Review, 

National Institute of General Medical 

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20892, 301–594–2772, 

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This notice is being published less than 15 

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(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

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Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: November 19, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–5879 Filed 11–29–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

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National Institutes of Health 

National Institute of Allergy and 

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Meeting 

Pursuant to section 10(d) of the 

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The meeting will be closed to the 

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Contact Person: Peter R. Jackson, PhD, 

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(Catalogue of Federal Domestic Assistance 

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