10282 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

BODIPY®-FL Nilotinib (Tasigna®) for 

Use in Cancer Research 

Description of Invention: Investigators 

at the National Institutes of Health have 

produced a fluorescently labeled 

derivative of the clinically-approved, 

tyrosine kinase inhibitor (TKI) nilotinib 

(Tasigna®) for use in research. This was 

accomplished by conjugating the 

fluorescent dye BODIPY®-FL to 

nilotinib. 

The TKI imatinib (Gleevec®) is the 

first targeted therapeutic developed and 

is used as first line treatment of 

Philadelphia chromosome-positive 

(Ph+) cancers like chronic myeloid 

leukemia (CML). Although imatinib is 

highly effective, after continued use the 

cancer cells frequently become resistant 

to the drug. Nilotinib is a second 

generation TKI developed to overcome 

imatinib resistance, but eventually it 

can also result in drug resistance. 

The fluorescent nilotinib conjugate 

was developed to study the mechanism 

by which cancer cells become resistant 

to nilotinib and better understand its 

cytotoxic effects. 

Applications 

• Use in monitoring cellular 

accumulation of nilotinib using flow 

cytometry, fluorescent microscopy, or 

other fluorometric techniques 

• Use as an in vivo probe with 

experimental models and in clinical 

studies for analyzing drug efficacy, 

pharmacokinetic profile and drug 

localization 

• Use for the study of cytotoxic 

effects of nilotinib in important 

physiological locations such as the heart 

and brain 

• Use in identifying other potential 

targets of nilotinib in different types of 

cancer 

• Use in in vivo imaging to identify 

potential physiological barriers to drug 

penetration into tissues 

Advantages 

• Material is ready for use reducing 

time and effort to duplicate 

• BODIPY®-FL dye is compatible 

with commonly-used fluorescein dye 

optics and has superior can be used for 

both in vitro and in vivo studies. 

Development Status: 

• Ready for use. 

• Pre-clinical data available. 

Market: The size of the chronic 

myeloid leukemia (CML) market is 

expected fluorescent properties to 

fluorescein 

• BODIPY®-FL Nilotinib (Tasigna®) is 

compatible and to increase with an 

aging population. It was estimated that 

in 2009, there were 91,500 patients with 

CML in the U.S. and other major other 

developed countries, increasing by 9– 

11% per year. The fluorescently- labeled 

Nilotinib (Tasigna®) will be useful for 

researchers working to develop next 

generation tyrosine kinase inhibitors. 

Inventors: Suneet Shukla (NCI), 

Suresh V. Ambudkar (NCI), Craig J. 

Thomas (NHGRI/NCGC), Amanda P. 

Skoumbourdis (NHGRI/NCGC). 

Publications: None currently available 

for this technology. 

Patent Status: HHS Reference No. E– 

009–2010/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

biological materials licensing. 

Licensing Contact: Sabarni Chatterjee, 

Ph.D.; 301–435–5587; 

chatterjeesa@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, Transport 

Biochemistry Section, Laboratory of Cell 

Biology, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize bodipy conjugated 

tyrosine kinase inhibitors that are 

currently used in the clinic for the 

treatment of CML or gastric cancers. We 

are also interested in evaluating third 

generation tyrosine kinase inhibitor 

derivatives as modulators of ABC drug 

transporters to improve the efficiency of 

chemotherapy in animal (mouse) model 

system. In addition, we can identify 

possible pharmacokinetic interactions of 

the novel kinase inhibitors with ABC 

drug transporters. Please contact John 

Hewes, Ph.D. at 301–435–3131 or 

hewesj@mail.nih.gov for more 

information. 

Diagnosis and Treatment of Cancer 

Using Histone Deacetylase Inhibitors 

and Radiolabeled 

Metaiodobenzylguanidine 

Description of Invention: 

Pheochromocytoma is a neuroendocrine 

tumor of the adrenal glands. 

Pheochromocytoma patients display the 

signs and symptoms of those of 

sympathetic nervous system 

hyperactivity. Up to 36% of patients 

worldwide with pheochromocytoma 

develop metastatic disease and have a 5- 

year survival rate of approximately 50% 

after diagnosis. Patients with metastatic 

pheochromocytoma exhibit excessive 

levels of circulating catecholamines, 

which results in increased risk of 

strokes, cardiac arrhythmias, and 

hypertensive complications. Current 

treatments for malignant 

pheochromocytoma include targeted 

radiation using [131I]- 

metaiodobenzylguanidine ([131I]-MIBG), 

cytotoxic chemotherapy, octreotide, 

tumor hemoembolization, etc. The 

success of these treatments varies based 

on the sites and growth rate of 

metastatic lesions. 

The present invention provides a 

method for treating a mammalian tumor 

with a histone deacetylase inhibitor 

(HDACi), and followed by administering 

[131I]-MIBG. Methods of diagnosis and 

imaging of mammalian tumors are also 

disclosed. These findings suggest that 

HDACi could enhance the therapeutic 

efficacy of [131I]-MIBG treatment in 

patients with malignant 

pheochromocytoma. 

Applications and Market: 

• Diagnosis and therapeutic for 

treating cancer, such as 

pheochromocytoma. 

• Approximately 1000 cases of 

pheochromocytoma are diagnosed in 

United States yearly. 

Development Status: Pre-clinical stage 

of development. 

Inventors: Karel Pacak et al. (NICHD). 

Publications: Manuscript submitted. 

Patent Status: U.S. Provisional 

Application No. 61/260,991 filed 13 

Nov 2009 (HHS Reference No. E–299– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 10283 

Licensing Contact: Betty B. Tong, 

PhD; 301–594–6565; 

tongb@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Child Health 

and Human Development, Reproductive 

Biology and Adult Endocrinology 

Branch, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize [131I]-MIBG treatment of 

malignant/metastatic 

pheochromocytoma, paraganglioma, and 

neuroblastoma; also [123/131I]-MIBG 

scintigraphy—in all situations histone 

deacetylase to be used before MIBG is 

used. Please contact Joseph Conrad, PhD 

at 301–435–3107 or 

jmconrad@mail.nih.gov for more 

information. 

Specific Binding Agents for KSHV vIL– 

6 That Neutralize a Biological Activity 

Description of Invention: Kaposi’s 

sarcoma-associated herpes virus (KSHV) 

is an oncogenic herpes virus originally 

identified in AIDS associated Kaposi’s 

sarcoma (KS) lesions, the most common 

tumor associated with HIV infection. 

KSHV encodes various proteins that 

have characteristics associated with 

cellular growth and transformation, 

including viral (v) IL–6 (KSHV vIL–6). 

These viral proteins display structural 

homology to their cellular counterparts, 

and human and vIL–6 are 

multifunctional cytokines that have 

been shown to induce vascular 

endothelial growth factor and other 

factors. 

Available for licensing are binding 

agents that neutralize vIL–6 biological 

activities, methods of diagnosing and 

treating KSHV disorders, and methods 

to monitor KSHV patient response to 

treatment. Deregulation of cellular IL–6 

expression is known to contribute to 

tumor development, suggesting that 

KSHV-derived vIL–6 could be part of a 

viral strategy to promote malignant 

transformation. Neutralizing activity of 

anti-vIL–6 antibodies may provide a 

potential therapeutic for KSHV 

disorders such as HIV, Castleman’s 

disease, and primary effusion 

lymphoma. 

Applications: 

• Therapeutic compositions to treat 

KSHV disorders such as KS, 

Castleman’s disease, and primary 

effusion lymphoma. 

• Method to diagnose and treat KSHV 

disorders. 

• Method to monitor patient response 

to KSHV treatment. 

Market: 

• Approximately 476,095 persons 

currently living with HIV/AIDS in the 

United States. 

• Estimated annual incidence rate for 

KS is 5 cases per 100,000/year in the 

U.S. 

• KS contributes to approximately 

30% of AIDS related deaths. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Giovanna Tosato (NCI) et 

al. 

Publications: 

1. Y Aoki and G Tosato. Therapeutic 

options for human herpesvirus-8/ 

Kaposi’s sarcoma-associated 

herpesvirus-related disorders. Expert 

Rev Anti Ther. 2004 Apr;2(2):213–225. 

[PubMed: 15482187]. 

2. Y Aoki et al. Detection of viral 

interleukin-6 in Kaposi sarcomaassociated herpesvirus-linked disorders. 

Blood. 2001 Apr 1;97(7):2173–2176. 

[PubMed: 11264189]. 

3. Y Aoki et al. Kaposi’s sarcomaassociated herpesvirus-encoded 

interleukin-6. J Hemathother Stem Cell 

Res. 2000;9(2):137–145. [PubMed: 

10813527]. 

Patent Status: 

U.S. Patent No. 6,939,547 issued 06 

Sep 2005 (HHS Reference No. E–180– 

2000/0–US–03). 

U.S. Patent No. 7,108,981 issued 19 

Sep 2006 (HHS Reference No. E–180– 

2000/0–US–04). 

U.S. Patent No. 7,235,365 issued 26 

Jun 2007 (HHS Reference No. E–180– 

2000/0–US–05). 

U.S. Patent No. 7,374,756 issued 20 

May 2008 (HHS Reference No. E–180– 

2000/0–US–06). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301/435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute’s 

Laboratory of Cellular Oncology is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

therapeutics for Kaposi’s sarcomaassociated herpes virus (KSHV). Please 

contact John D. Hewes, PhD at 301–435– 

3121 or hewesj@mail.nih.gov for more 

information. 

Dated: March 1, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–4762 Filed 3–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Patient-Derived Gastrointestinal 

Stromal and Paraganglioma Tumor 

Samples Harboring Novel Stem Cell 

Factor FOXD3 Variants 

Description of Invention: The cancer 

market is forecast to reach $40 billion 

dollars by the year 2012. There is still 

a significant need to develop new 

therapies for treating sarcomas and 

malignant neoplasms. 

Researchers at the National Institute 

of Child Health and Human 

Development (NICHD), NIH, have made 

available samples of patient-derived 

gastrointestinal tumors (GIST) and 

paraganglioma tumors that harbor 

genetic mutations that have an effect on 

early stage embrogenesis which plays a 

role in the fate of stem cells. GISTs are 

one of the most common sarcomas of 

the gastrointestinal tract with an 

estimated 5,000–10,000 new cases in the 

U.S. reported each year. GISTs affect 

mainly pediatric and young adult 

patients, and respond poorly to current 

therapies. Paragangliomas are rare 

neuroendocrine neoplasms that develop 

primarily in the abdomen. 

The tumor samples made available 

herein contain deletions in the FOXD3 

gene and display down-regulated 

FOXD3 protein expression. While the 


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