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
53266 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

Inventors: Bernard Moss and Linda S. 

Wyatt (NIAID). 

Publications: 

1. G Sutter, LS Wyatt, PL Foley, JR 

Bennink, B Moss. A recombinant vector 

derived from the host range-restricted 

and highly attenuated MVA strain of 

vaccinia virus stimulates protective 

immunity in mice to influenza virus. 

Vaccine 1994 Aug;12(11):1032–1040. 

2. B Bender, CA Rowe, SF Taylor, LS 

Wyatt, B Moss, PA Small Jr. Oral 

immunization with a replicationdeficient recombinant vaccinia virus 

protects mice against influenza. J Virol. 

1996 Sep;70(9): 6418–6424. 

Patent Status: HHS Reference No. E– 

260–2009/0—Research Material. Patent 

protection is not being sought for this 

technology. 

Related Technologies: HHS Reference 

No. E–552–1982/2— 

1. U.S. Patent No. 6,998,252 issued 14 

Feb 2006, ‘‘Recombinant Poxviruses 

Having Foreign DNA Expressed Under 

the Control of Poxvirus Regulatory 

Sequences’’ 

2. U.S. Patent No. 7,015,024 issued 21 

Mar 2006, ‘‘Compositions Containing 

Poxviruses Having Foreign DNA 

Expressed Under the Control of 

Poxvirus Sequences’’ 

3. U.S. Patent No. 7,045,313 issued 16 

May 2006, ‘‘Recombinant Vaccinia 

Virus Containing Chimeric Gene Having 

Foreign DNA Flanked by Vaccinia 

Regulatory DNA’’ 

4. U.S. Patent No. 7,045,136 issued 16 

May 2006, ‘‘Methods of Immunization 

Using Recombinant Poxviruses Having 

Foreign DNA Expressed Under the 

Control of Poxvirus Regulatory 

Sequences’’ 

An abstract describing these 

technologies may be viewed at http:// 

www.ott.nih.gov/Technologies/ 

abstractDetails.aspx?RefNo=2000. 

Licensing Status: Available for 

licensing. 

Licensing Contacts: Uri Reichman, 

Ph.D., MBA; 301–435–4616; 

UR7a@nih.gov; RC Tang, JD, LLM; 301– 

435–5031; tangrc@mail.nih.gov. 

Biological/Research Material for HIV 

Vaccine Research 

Description of Technology: Offered for 

licensing is a recombinant attenuated 

vaccinia virus, MVA, that expresses SIV 

239gagpol. The materials can be used 

for research purposes and in particular 

in the area of HIV/AIDS vaccines. 

Plasmid insertion vector pJH–4, 

containing the foreign gene SIV 239 

GagPol controlled by vaccinia early/late 

promoter, inserts into del III of 

attenuated vaccinia MVA virus to make 

recombinant MVA virus. The resulting 

recombinant virus made from pJH4, 

MVA/SIV239gagpol, expresses the SIV 

239gagpol gene and thus can be used to 

conduct vaccine studies in animal 

models such as Rhesus macaques. 

The list of publications shown below 

demonstrates the usefulness of this 

biological material in HIV vaccine 

research. 

Applications: Research reagents 

useful in research and development in 

the area of HIV/AIDS vaccines. 

Development Status: Fully developed. 

Material has been used extensively in 

research. 

Inventors: Bernard Moss and Linda S. 

Wyatt (NIAID). 

Publications: 

1. RR Amara, F Villinger, JD Altman, 

SL Lydy, SP O’Neil, SI Staprans, DC 

Montefiori, Y Xu, JG Herndon, LS 

Wyatt, MA Candido, NL Kozyr, PL Earl, 

JM Smith, HL Ma, BD Grimm, ML 

Hulsey, J Miller, HM McClure, JM 

McNicholl, B Moss, HL Robinson. 

Control of a mucosal challenge and 

prevention of AIDS by a multiprotein 

DNA/MVA vaccine. Science 2001 Apr 

6;292(5514):69–74. 

2. PL Earl, LS Wyatt, DC Montefiori, 

M Bilska, R Woodward, PD Markbam, 

JD Malley, TU Vogel, TM Allen, DI 

Watkins, N Miller, B Moss. Comparison 

of vaccine strategies using recombinant 

env-gag-pol MVA with or without an 

oligomeric Env protein boost in the 

SHIV rhesus macaque model. Virology 

2002 Mar 15;294(2):270–281. 

3. RR Amara, JM Smith, SI Staprans, 

DC Montefiori, F Villinger, JD Altman, 

SP O’Neil, NL Kozyr, Y Xu, LS Wyatt, 

PL Earl, JG Herndon, JM McNicholl, HM 

McClure, B Moss, HL Robinson. Critical 

role for Env as well as Gag-Pol in 

control of a simian-human 

immunodeficiency virus 89.6P 

challenge by a DNA prime/recombinant 

modified vaccinia virus Ankara vaccine. 

J Virol. 2002 Jun;76(12):6138–6146. 

4. RR Amara, F Villinger, SI Staprans, 

JD Ahman, DC Montefiori, NL Kozyr, Y 

Xu, LS Wyatt, PL Earl, JG Herndon, HM 

McClure, B Moss, HL Robinson. 

Different patterns of immune responses 

but similar control of simian human 

immunodeficiency virus 89.6P mucosal 

challenge by modified vaccinia virus 

Ankara (MVA) and DNA/MVA vaccines. 

J Virol. 2002 Aug;76(15):7625–7631. 

5. S Sadagopal, RR Amara, DC 

Montefiori, LS Wyatt, SI Staprans, NL 

Kozyr, HM McClure, B Moss, HL 

Robinson. Signature for long-term 

vaccine-mediated control of a Simian 

and human immunodeficiency virus 

89.6P challenge: stable low-breath and 

low-frequency T-cell response capable 

of coproducing gamma interferon and 

interleukin-2. J Virol. 2005 

Mar;79(6):3243–3253. 

Patent Status: HHS Reference No. E– 

258–2009/0—Research Material. Patent 

protection is not being pursued for this 

technology. 

Related Technologies: HHS Reference 

No. E–552–1982/2— 

1. U.S. Patent No. 6,998,252 issued 14 

Feb 2006, ‘‘Recombinant Poxviruses 

Having Foreign DNA Expressed Under 

the Control of Poxvirus Regulatory 

Sequences’’ 

2. U.S. Patent No. 7,015,024 issued 21 

Mar 2006, ‘‘Compositions Containing 

Poxviruses Having Foreign DNA 

Expressed Under the Control of 

Poxvirus Sequences’’ 

3. U.S. Patent No. 7,045,313 issued 16 

May 2006, ‘‘Recombinant Vaccinia 

Virus Containing Chimeric Gene Having 

Foreign DNA Flanked by Vaccinia 

Regulatory DNA’’ 

4. U.S. Patent No. 7,045,136 issued 16 

May 2006, ‘‘Methods of Immunization 

Using Recombinant Poxviruses Having 

Foreign DNA Expressed Under the 

Control of Poxvirus Regulatory 

Sequences’’ 

An abstract describing these 

technologies may be viewed at http:// 

www.ott.nih.gov/Technologies/ 

abstractDetails.aspx?RefNo=2000. 

Licensing Status: Available for 

licensing. 

Licensing Contacts: Uri Reichman, 

Ph.D., MBA; 301–435–4616; 

UR7a@nih.gov; RC Tang, JD, LLM; 301– 

435–5031; tangrc@mail.nih.gov. 

A Target for the Development of 

Diagnostics and Therapeutics for 

Abnormal Hematopoiesis 

Description of Technology: The zinc 

finger protein ZFP36L2 has been shown 

by the inventors to play an essential role 

in hematopoiesis, a process that is 

dysregulated in hematological cancers, 

anemia, and other conditions. Thus, 

ZFP36L2 has promise for use in a 

diagnostic test to detect abnormal 

hematopoiesis, or as a target for the 

development of therapeutics to treat 

abnormal hematopoiesis. 

Hematopoiesis is the formation of 

blood cellular components, through the 

differentiation of hematopoietic stem 

cells into lineages with a variety of 

roles, such as carrying oxygen, immune 

function, and blood clotting. 

Abnormally high hematopoiesis can be 

caused by hematological cancers such as 

leukemia or lymphoma, or by other 

myeloproliferative disorders. 

Abnormally low hematopoiesis can be 

caused by diseases such as anemia, 

thrombocytopenia, or myelodysplastic 

syndrome, and is often a secondary 

symptom of other conditions, such as 

cancer, infection, or dialysis. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53267 

The inventors have discovered that 

Zinc finger protein 36 like type-2 

(ZFP36L2) plays an essential role in 

hematopoiesis, possibly by affecting the 

stability of mRNAs involved in this 

process. ZFP36L2 is a member of the 

tristetraprolin (TTP) family, which are 

mRNA-binding proteins involved in 

mRNA processing and degradation. The 

invention discloses methods of 

detecting abnormal hematopoiesis by 

detecting abnormal ZFP36L2 expression 

or a mutation in the ZFP36L2 gene, and 

methods of controlling abnormal 

hematopoiesis by modulating levels of 

ZFP36L2 protein. 

Applications: 

• Diagnostic test to detect abnormal 

hematopoiesis. 

• Therapy for abnormal 

hematopoiesis. 

Development Status: Discovery stage. 

Market: 

• Over 3.5 million people in the 

United States suffer from anemia, 

according to NHLBI, and more than half 

of all chemotherapy treatment for cancer 

results in anemia. 

• The American Cancer Society 

estimates that approximately 4300 cases 

of chronic myelogenous leukemia are 

diagnosed in the United States every 

year. 

Inventors: Perry J. Blackshear and 

Deborah J. Stumpo (NIEHS). 

Related Publication: DJ Stumpo, HE 

Broxmeyer, T Ward, S Cooper, G 

Hangoc, YJ Chung, WC Shelley, EK 

Richfield, MK Ray, MC Yoder, PD 

Aplan, PJ Blackshear. Targeted 

disruption of Zfp36l2, encoding a CCCH 

tandem zinc finger RNA-binding 

protein, results in defective 

hematopoiesis. Blood 2009 Sep 

17;114(12):2401–2410. 

Patent Status: PCT Application Serial 

No. PCT/US08/68900 filed on 01 Jul 

2008 (HHS Reference No. E–255–2007/ 

0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Tara Kirby, Ph.D.; 

301–435–4426; tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIEHS Laboratory of Signal 

Transduction, Polypeptide Hormone 

Action Group, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact Elizabeth M. Denholm, Ph.D., 

Director, Office of Technology Transfer, 

NIEHS, at denholme@niehs.nih.gov for 

more information. 

Susceptibility-Matched Multiwell Plates 

for High-Throughput Screening by 

Magnetic Resonance Imaging and 

Nuclear Magnetic Resonance 

Spectroscopy 

Description of Technology: Available 

for licensing and commercial 

development is a patent estate that 

covers multi-well assay plates for highthroughput screening by magnetic 

resonance imaging (MRI) and nuclear 

magnetic resonance (NMR) 

spectroscopy. Multi-well plates are used 

in a wide variety of high-throughput 

measurements in clinical chemistry and 

immunology, as well as in drug 

discovery and other research 

applications. Magnetic resonance 

imaging (MRI) of multi-well plates offers 

the possibility of performing new kinds 

of high-throughput assays, including the 

detection of magnetic nanoparticles 

attached to or within cells. Moreover, 

MRI-guided localized nuclear magnetic 

resonance (NMR) spectroscopy could be 

used to perform detailed chemical 

analysis of complex mixtures of 

metabolites not possible by any other 

common analytical technique. Best of 

all, conventional MRI techniques exist 

which would permit all samples in one 

or more multi-well plate(s) to be 

analyzed simultaneously. 

Unfortunately, conventional multi-well 

plates typically give poor performance 

for MRI-based assays since they provide 

inadequate matching of magnetic 

susceptibility between the plate, the 

sample and their surroundings. This 

results in distortion of the magnetic 

field within the scanner and thus 

reduces the sensitivity for detecting 

magnetic particles and the resolution of 

NMR spectra. 

This invention relates to a new multiwell plate design incorporating onepiece polyetherimide plastic 

construction for improved magnetic 

susceptibility matching for aqueous 

samples. This design can easily be 

extended to non-aqueous samples by the 

selection of an appropriate, 

commercially available plastic resin or 

resin blend. Further enhancement in 

susceptibility matching can be 

accomplished by combining the new 

plate design with plugs for each well 

constructed from the same plastic as the 

plate. These plugs would allow the 

entire thickness of each sample to be 

scanned in chemical analyses, 

improving signal-to-noise ratio and 

sensitivity. These plugs can optionally 

be integrated into a single ‘‘cap mat’’ so 

that the entire assembly can be filled 

and manipulated by standard robotic 

laboratory equipment already in wide 

use in the pharmaceutical industry. 

Alternatively, spherical wells, accessed 

by narrow fill holes, may be molded 

into a solid plate, eliminating the need 

for individual plugs to seal each well. 

The new multi-well plate/plug design 

reduces magnetic field distortions and 

should dramatically improve spectral 

resolution and sensitivity for NMR and 

MRI-based high-throughput screening. 

Applications: 

• NMR Spectroscopy, 

• MRI Imaging of magnetic 

nanoparticles, 

• Clinical Chemistry, 

• Immunology, 

• Drug Discovery, 

• Combinatorial Chemistry, and 

• Quality Control in the 

pharmaceutical, chemical and 

agricultural industries. 

Advantages: 

• Increased signal-to-noise ratio and 

sensitivity relative to conventional 

multi- well plates 

• Portability 

• Compatible with existing highthroughput robots. 

Development Status: Used actively in 

inventor’s lab. 

Inventor: Kenneth W Fishbein (NIA). 

Patent Status: U.S. Patent Application 

No. 12/083,501 filed 30 Dec 2008 (HHS 

Reference No. E–243–2005/0–US–03). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Michael 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Magnetic Resonance Imaging & 

Spectroscopy Section, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact Nicole Darack, Ph.D. at 301– 

435–3101 or darackn@mail.nih.gov for 

more information. 

Dated: October 5, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–24871 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. 


jlentini on DSKJ8SOYB1PROD with NOTICES