53264 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

42 CFR Citation and purpose Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response Total hours 

Total ..................................................................... 1,621 ........................ 2,418 .......................... 2,186 

* Average. 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: October 8, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–24940 Filed 10–15–09; 8:45 am] 

BILLING CODE 4162–20–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. 

B-cell Surface Reactive Antibodies for 

the Treatment of B–Cell Chronic 

Lymphocytic Leukemia 

Description of Technology: B-cell 

chronic lymphocytic leukemia (B–CLL) 

is a cancer characterized by a 

progressive accumulation of 

functionally incompetent lymphocytes. 

Despite high morbidity and mortality, 

the only available potential cure is 

allogeneic hematopoietic stem cell 

transplantation (alloHSCST). However, 

there is less than a 50% chance of 

finding a matching bone marrow or 

blood donor for B–CLL patients. Other 

clinically tested targeted therapies such 

as rituximab and alemtuzumab target 

both malignant and normal B cells, 

resulting in immunosuppression. 

Available for licensing are fully 

human monoclonal antibodies that were 

selected from the first human postalloHSCT antibody library. The library 

was generated from a time point after 

transplantation at which antibodies to 

B–CLL cell surface antigens peaked, 

thus indicating its therapeutic value. 

Utilizing phage display, the 

investigators generated a panel of fully 

human monoclonal antibodies that 

strongly bind to the same epitope on a 

B–CLL cell surface antigen. Weaker 

binding to normal B cells, but not to 

other lymphocytes, was observed. These 

fully human monoclonal antibodies 

provide readily available treatment that 

selectively targets malignant B cells. 

Applications: 

• B-cell chronic lymphocytic 

leukemia therapeutics. 

• Method to inhibit the growth of 

malignant B-cells. 

• Method to detect B-cell tumors. 

Advantages: 

• Selective targeting of malignant Bcell surface antigens that are minimally 

non-damaging to non-diseased cells. 

• Readily available therapeutics 

without the need for bone marrow or 

blood transplantation. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Market: 

• Monoclonal antibody market has 

the potential to reach $30.3 billion in 

2010 largely driven by technological 

evolution from chimeric and humanized 

to fully human antibodies. 

• In the U.S., there is annual 

incidence of an estimated 15,000 newly 

diagnosed cases of B–CLL and the 

disease is responsible for an estimated 

4,500 deaths. 

Inventors: Christoph Rader et al. (NCI) 

Publication: S Baskar, JM Suschak, I 

Samija, R Srinivasan, RW Childs, SZ 

Pavletic, MR Bishop, C Rader. A human 

monoclonal antibody drug and target 

discovery platform for B-cell chronic 

lymphocytic leukemia based on 

allogeneic hematopoietic stem cell 

transplantation and phage display. 

Blood, in press. Epub ahead of print, 

2009 Aug 10. 

Patent Status: U.S. Provisional 

Application No. 61/178,688 filed 15 

May 2009 (HHS Reference No. E–163– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Experimental Transplantation and 

Immunology Branch, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize fully human monoclonal 

antibodies selected from post-alloHSCT 

antibody libraries. Please contact John 

D. Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

CXCR4 and CCR10 Expressing Cells: 

Useful for the Study of Cancer Cell 

Survival and Metastasis 

Description of Technology: The 

chemokine receptor CXCR4 functions in 

normal cells, but has been shown to be 

the most common chemokine receptor 

expressed on cancer cells, including 

melanoma, colon, breast, and lung 

cancers. It plays roles in angiogenesis 

and cancer cell survival as well as 

metastasis. CCR10 has also been shown 

to be expressed by melanoma cells. Like 

CXCR4, expression of CCR10 can 

enhance cancer cell survival and block 

immune recognition of cancer cells. 

Antagonists of CXCR4 and CCR10, 

under various conditions, have 

decreased metastasis or prevented 

tumor formation after implantation of 

cancer cells in mice. 

These cell lines are based on the 

widely used B16 murine melanoma cell 

line. The cell lines were transduced 

with retroviral vectors encoding cDNA 

for either CXCR4 or CCR10 under 

control of a TET-dependent promoter. 

Both lines achieve greater than 10 fold 

induction of the respective genes 

(proteins), which has been confirmed by 

surface antibody staining using flow 

cytometry. These cell lines are ideally 

suited for studying the effect of these 

chemokine receptors in tumor growth or 

metastasis. They are also useful for 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53265 

developing a mouse model for studying 

the effect of down-regulating these 

receptors specifically in melanoma 

cells. This would mimic the effect of 

antagonists without the confounding 

effects of systemically inhibiting CXCR4 

or CCR10. By either adding or removing 

dietary administered doxycycline, 

receptor expression can be regulated to 

assess the role of these two receptors in 

a variety of cancer-related assays. 

Applications: 

• Study the effect of chemokine 

receptors in tumor growth or metastasis. 

• Test CXCR4 and CCR10 antagonists 

in preclinical studies. 

• Develop B16 melanoma mouse 

model mimicking the effect of 

chemokine receptor antagonists. 

Advantages: 

• Ability to regulate in vitro and in 

vivo expression of the chemokine 

receptor. 

• Ability to investigate the in vivo 

role in cancer cells of doxycycline 

control of chemokine receptor 

expression. 

Development Status: The technology 

is currently in the preclinical stage of 

development. 

Market: Cancer is the second leading 

cause of death in the U.S. and it is 

estimated that more than 1 million 

Americans develop cancer in a year. 

Inventors: Sam T. Hwang (NCI). 

Publication: T Kakinuma, ST Hwang. 

Chemokines, chemokine receptors, and 

cancer metastasis. J Leukoc Biol. 2006 

Apr;79(4):639–651. 

Patent Status: HHS Reference No. E– 

345–2008/0—Research Material. Patent 

protection is not being sought for either 

technology. 

Licensing Status: Available for nonexclusive licensing under a Biological 

Materials License Agreement. 

Licensing Contact: Betty B. Tong, 

Ph.D.; 301–594–6565; 

tongb@mail.nih.gov. 

Identification of Persons Likely To 

Benefit From Statin Mediated Cancer 

Prevention by Pharmacogenetics 

Description of Technology: Inhibitors 

of 3-hydroxy-3-methylglutaryl (HMG) 

coenzyme A reductase (statins) are a 

class of well-tolerated compounds that 

are the most widely used cholesterollowering drugs in the United States. 

Reduced cancer risk among statin users 

has also been observed as a secondary 

outcome in randomized controlled 

clinical trials evaluating effects of 

statins on cardiovascular outcomes. 

However the observed cancer risk 

reduction varied with different clinical 

studies. Thus there is a need to identify 

individuals who would benefit from 

treatment with statins. 

The current invention describes a 

pharmacogenetic method to identify 

candidates who are most likely to 

benefit from treatment with statins to 

reduce cancer risk, and consequently 

minimizing any unnecessary cost and 

side effects in individuals who do not 

benefit. Specifically, we discovered that 

an HMGCR genetic variant rs12654264 

is associated with significantly lower 

colorectal cancer risk, with most of the 

benefit seen in HMGCoA reductase 

inhibitor (statin) users. We also 

discovered that this same HMGCR 

genetic variant is associated with 

significantly higher serum cholesterol 

levels in Israeli colorectal cancer 

patients. The same HMGCR genetic 

variant has also been associated with 

significantly higher serum cholesterol 

levels in two independent groups of 

individuals of mixed European descent 

[http://www.broad.mit.edu/diabetes/ 

scandinavs/index.html and N Engl J 

Med.2008 March 20;358(12):1240–1249 

(http://www.ncbi.nlm.nih.gov/pubmed/ 

18354102?dopt)]. These data suggest 

that the same genetic variant modifies 

cholesterol metabolism in a manner that 

affects both colorectal cancer risk and 

cardiovascular risk. 

Applications and Market: 

• Statins account for approximately 

80% of the cholesterol-lowering drugs 

prescribed in the United States, and six 

statins are currently available on the 

U.S. market. Reduced cancer risk is also 

associated with statin use. This 

invention provides a method to 

indentify individuals who are most 

likely to benefit from cancer 

chemopreventive treatment with statins. 

• Pharmacogenetic markers can be 

developed to identify patient population 

that can be benefit from statins, 

therefore expands the markets of stains. 

Development Status: The inventors 

have discovered several novel genetic 

variants of HMG coenzyme A reductase 

gene, and are further investigating the 

functional significance of the variants in 

vitro. 

Inventors: Levy Kopelovich (NCI) et 

al. 

Patent Status: PCT Application No. 

PCT/US2008/082359 filed 04 Nov 2008, 

which published as WO 2009/061734 

on 14 May 2009 (HHS Reference No. E– 

328–2007/0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Betty B. Tong, 

Ph.D.; 301–594–6565; 

tongb@mail.nih.gov. 

Dated: October 7, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–24877 Filed 10–15–09; 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. 

Biological/Research Material for H1N1 

Influenza Virus Vaccine Research 

Description of Technology: Offered for 

licensing is a recombinant attenuated 

vaccinia virus, MVA, that expresses the 

haemagglutinin (HA) and nucleoprotein 

(NP) of influenza virus A/PR/8/34 

(H1N1). The virus has been shown to 

stimulate protective immunity to 

influenza virus in mice. 

The materials can be used for research 

purposes and in particular in the area of 

influenza virus vaccines. 

The related publications listed below 

demonstrate the usefulness of this 

biological material in influenza virus 

vaccine research. 

Applications: Research reagents 

useful in research and development in 

the area of H1N1 Influenza virus 

vaccines. 

Development Status: Fully developed. 

The usefulness of the materials has been 

shown in Dr. Moss’ laboratory. 


jlentini on DSKJ8SOYB1PROD with NOTICES