13344 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

information and experience on the 

application of the draft guidance in 

order to inform the final guidance 

document. 

FDA began accepting nominations for 

the pilot program on December 12, 

2011. In the Federal Register notice 

announcing the pilot program, FDA 

stated its intention to limit the pilot 

program to nine candidates. After 

review of the nominations received in 

response to the pilot program notice, 

FDA accepted nine appropriate 

candidates for the pilot program. 

In the pilot program notice, FDA 

stated its intention to accept 

nominations to participate in the pilot 

program until May 8, 2012. Because 

FDA has already accepted nine sponsors 

to participate in the program, FDA will 

no longer accept nominations to 

participate in the program and will 

conduct the pilot program for the nine 

sponsors that have already been 

accepted. 

In the pilot program notice, FDA also 

stated that the pilot program will 

terminate on May 8, 2012. Instead, the 

pilot program will be extended for the 

nine accepted sponsors until May 8, 

2013. 

Dated: February 28, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5311 Filed 3–5–12; 8:45 am] 

BILLING CODE 4160–01–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. 

Device for Simulating Explosive Blast 

Trauma 

Description of Technology: NIH 

scientists have developed a novel device 

to simulate the effects of pressure waves 

resulting from explosions or blasts on 

biological tissue. This methodology 

allows real-time monitoring of tissue 

damage while it is occurring and can 

track the secondary effects of pressure 

damage after tissue insult. This tool is 

well-adapted for investigating traumatic 

brain injury and organ damage resulting 

from explosion pressure waves, such as 

in military combat. 

Potential Commercial Applications: 

• Real-time monitoring of tissue 

damage from primary blast pressure 

• Real-time monitoring of tissue 

damage from secondary effects of blast 

pressure, such as tissue shearing against 

surfaces 

• Can monitor tissue through both 

live imaging and assaying cell viability 

• Can measure pressure effects on 

various tissues 

Competitive Advantages: 

• Allows differentiation of primary 

and secondary blast pressure effects on 

tissue damage 

• Employs multiple methods to assess 

cell viability 

• Possesses high temporal resolution 

Development Stage: Prototype. 

Inventors: Rea Ravin, Paul Blank, 

Alex Steinkamp, Joshua Zimmerberg, 

Sergey Bezrukov, and Kim Lee Mcafee 

(all of NICHD). 

Intellectual Property: HHS Reference 

No E–068–2012/0—U.S. Provisional 

Application No. 61/590,209 filed 24 Jan 

2012. 

Licensing Contact: Michael A. 

Shmilovich, Esq.; 301–435–5019; mish@

codon.nih.gov. 

Small-Molecule Inhibitors of Human 

Galactokinase for the Treatment of 

Galactosemia and Cancers 

Description of Technology: Lactose, 

found in dairy products and other foods, 

is comprised of two simple sugars, 

glucose and galactose. In galactosemia, 


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Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13345 

where galactose is not properly 

metabolized, build-up of toxic 

compounds, such as galactose-1- 

phosphate, can lead to liver disease, 

renal failure, cataracts, brain damage, 

and even death if this disorder is left 

untreated. Currently, the only treatment 

for galactosemia is elimination of 

lactose and galactose from the diet, but 

in some cases this is not sufficient to 

avoid long-term complications from the 

disorder. 

This technology describes selective 

small-molecule inhibitors of human 

galactokinase, which inhibit the first 

step in galactose metabolism. These 

compounds could be used to treat 

galactosemia by eliminating the buildup of toxic metabolites in brain, liver 

and other tissues, and could form the 

basis for the first effective treatment for 

this disorder. 

These inhibitors are also promising 

candidates for the treatment of certain 

cancers, such as PTEN/AKT 

misregulated cancers. The inventors 

have already shown that the inhibitors 

are cytotoxic for several cancer cell 

lines. 

Potential Commercial Applications: 

• Treatment of galactosemia 

• Treatment of certain cancers, such 

as PTEN/AKT misregulated cancers 

Competitive Advantages: 

• There is currently no effective 

treatment for classic galactosemia, 

where dietary restriction cannot prevent 

long-term complications in some cases. 

• Cancer therapeutics based on these 

inhibitors are predicted to have minimal 

side-effects. 

Development Stage: 

• Early-stage 

• In vitro data available 

Inventors: Matthew Boxer et al. 

(NCATS). 

Intellectual Property: HHS Reference 

No. E–240–2011/0 — PCT Application 

No. PCT/US2011/053021 filed 23 Sep 

2011. 

Licensing Contact: Tara L. Kirby, 

Ph.D.; 301–435–4426; 

tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Center for Advancing 

Translational Sciences is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate or 

commercialize Small-Molecule 

Inhibitors of Human Galactokinase for 

the Treatment of Galactosemia and 

Cancers. For collaboration 

opportunities, please contact Lili M. 

Portilla, MPA at portilll@mail.nih.gov. 

The Cancer Stem Cell Finder: A Novel 

Reporter Construct Which Uses 

Transposition and Green Fluorescent 

Protein Expression To Identify Cancer 

Stem Cells 

Description of Technology: Scientists 

at the National Institutes of Health (NIH) 

have designed a novel reporter construct 

which can be used to identify, monitor, 

and allow for the manipulation of 

cancer stem cells (CSCs). CSCs are a 

subset of poorly differentiated tumor 

cells expressed at low frequency within 

a tumor and are resistant to 

conventional chemotherapies. CSCs 

have high metastatic potential and give 

rise to new tumors that spread cancer 

throughout the body. These 

characteristics make CSCs prime targets 

for developing new therapeutic agents 

to eradicate cancer. 

The reporter construct is a novel 

expression vector composed of the 

Sleeping Beauty transposon plasmid 

and a Nanog promoter linked to green 

fluorescent protein (GFP). Nanog is a 

transcription factor that is 

overexpressed in embryonic stem (ES) 

cells and tumors that resemble ES cells. 

When introduced into a population of 

tumor cells, the Nanog-GFP-Sleeping 

Beauty transposon construct is able to 

integrate into tumor cell DNA via 

transposition. If the transposed cell is a 

CSC, the Nanog transcription factor 

overexpressed in that CSC will bind to 

the Nanog-promoter in the reporter 

construct to drive GFP expression 

within the cell. Thus, CSCs can be 

isolated based on their selective 

expression of the GFP label. The NIH 

scientists have utilized their reporter 

construct to identify small populations 

of CSCs in mouse and human breast 

cancer cell models. 

Potential Commercial Applications: 

• Identify CSCs with high metastatic 

potential in patients to target with 

therapeutic intervention 

• Screen therapeutic drug candidates 

to identify their effectiveness against 

CSCs in comparison to more highly 

differentiated tumor cells 

• Investigate genes, surface proteins, 

and other markers responsible for CSC 

‘‘stem-ness’’ to develop CSC diagnostics 

and identify therapeutic candidates to 

stop or reverse the properties 

contributing to the high metastatic 

potential of these cells 

•Identify transcription factors/genes 

activated in the tumor 

microenvironment that trigger 

metastasis 

Competitive Advantages: 

• The reporter construct is validated 

to identify CSCs in both human and 

mouse tumor cell populations 

• Researchers and clinicians can 

monitor the ‘‘stem-ness’’ of a tumor cell 

population to predict the metastatic 

potential of a tumor 

• CSCs are identified in vivo in 

somatic cells via GFP labeling without 

utilizing a virus for transfection 

• CSCs can be isolated, monitored, 

and traced via their GFP label in both 

in vitro and in vivo experimentation 

• Facilitates the generation of a large 

quantity of CSCs for further study 

Development Stage: 

• Early-stage 

• Pre-clinical 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Rachel L. de Kluyver 

(formerly NCI), Jimmy K. Stauffer (NCI), 

Thomas J. Sayers (SAIC–Frederick). 

Intellectual Property: HHS Reference 

No. E–215–2011/0 — Research Tool. 

Patent protection is not being pursued 

for this technology. 

Licensing Contact: Samuel E. Bish, 

Ph.D.; 301–435–5282; 

bishse@mail.nih.gov 

Collaborative Research Opportunity: 

The Cancer and Inflammation Program, 

NCI, is seeking statements of capability 

or interest from parties interested in 

collaborative research to further 

develop, evaluate or commercialize 

Nanog promoter driven GFP constructs 

for the easy identification and isolation 

of cancer stem cells. For collaboration 

opportunities, please contact John 

Hewes, Ph.D. at hewesj@mail.nih.gov. 

Genes and Autoantibodies To Diagnose 

and Treat Sjo ̈gren’s Syndrome 

Description of Technology: Sjo ̈gren’s 

syndrome (SS) is a chronic autoimmune 

disease of unknown etiology that targets 

salivary and lacrimal glands and may be 

accompanied by multi-organ systemic 

manifestations. To date, no specific 

diagnostic test has been developed for 

SS and, as a result, SS is often 

underdiagnosed and undertreated. 

In order to further understand the 

immunopathology of SS and uncover 

both therapeutic and diagnostic targets, 

researchers at NIH compared gene 

expression profiles of salivary glands 

with severe inflammation to those with 

mild or no disease. Results from these 

studies identified target genes that were 

further characterized in tissues, serum 

and in cultured cell populations by real 

time PCR and protein analyses. Among 

the most highly expressed SS genes 

were genes associated with myeloid 

cells, including members of the 

mammalian chitinase family. In 

addition to genes, the researchers have 

also identified autoantibodies that have 

increase levels in SS patients. The gene 

expression levels and autoantibodies 


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13346 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

identified in the research represent both 

promising means for diagnosing SS 

earlier in disease progression as well as 

therapeutic targets to treat SS. 

Potential Commercial Applications: 

• Diagnosis of Sjo ̈gren’s syndrome 

• Treatment of Sjo ̈gren’s syndrome 

Competitive Advantages: The genes 

and autoantibodies identified in this 

technology may lead to one of the first 

diagnostic tests for Sjo ̈gren’s syndrome. 

Development Stage: 

• Early-stage 

• In vitro data available 

Inventors: Sharon M. Wahl (NIDCR), 

et al. 

Publications: 

1. Greenwell-Wild T, et al. Chitinases in 

the salivary glands and circulation of patients 

with Sjo ̈gren’s syndrome: macrophage 

harbingers of disease severity. Arthritis 

Rheum. 2011 Oct;63(10):3103–3115, doi: 

10.1002/art.30465. [PMID 21618203] 

2. Katsifis GE, et al. Systemic and local 

interleukin-17 and linked cytokines 

associated with Sjo ̈gren’s syndrome 

immunopathogenesis. Am J Pathol. 2009 

Sep;175(3):1167–1177. [PMID 19700754] 

3. Moutsopoulos NM, et al. Lack of efficacy 

of etanercept in Sjo ̈gren syndrome correlates 

with failed suppression of tumour necrosis 

factor alpha and systemic immune activation. 

Ann Rheum Dis. 2008 Oct;67(10):1437–1443. 

[PMID 18198195] 

4. Mavragani CP, et al. Augmented 

interferon-alpha pathway activation in 

patients with Sjo ̈gren’s syndrome treated 

with etanercept. Arthritis Rheum. 2007 

Dec;56(12):3995–4004. [PMID 18050196] 

5. Katsifis GE, et al. T lymphocytes in 

Sjo ̈gren’s syndrome: contributors to and 

regulators of pathophysiology. Clin Rev 

Allergy Immunol. 2007 Jun;32(3):252–264. 

[PMID 17992592] 

Intellectual Property: 

• HHS Reference No. E–140–2011/0 

— U.S. Provisional Application No. 61/ 

476,192 filed 15 April 2011 

• HHS Reference No. E–140–2011/1 

— U.S. Provisional Application No. 61/ 

556,729 filed 07 November 2011 

Licensing Contact: Jaime M. Greene, 

M.S.; 301–435–5559; 

greenejaime@mail.nih.gov. 

Bacterially Expressed Influenza Virus 

Recombinant HA Proteins for Vaccine 

and Diagnostic Applications 

Description of Technology: Pandemic 

H1N1 influenza virus is a recently 

emergent strain of influenza virus that 

the World Health Organization (WHO) 

estimates has killed at least 14,711 

people worldwide. Avian influenza 

viruses are emerging health threats with 

pandemic potential. Due to their global 

health implications, there has been a 

massive international effort to produce 

protective vaccines against these 

influenza virus strains. Currently, 

influenza virus vaccines are produced 

in chicken eggs, a production method 

that is disadvantaged by lengthy vaccine 

production times and by inability to 

meet large-scale, global demands. 

The subject technologies are specific 

recombinant HA proteins from H1N1, 

H5N1, and other strains of influenza 

virus produced in bacteria. The HA 

proteins properly fold, form oligomers, 

bind fetuin, agglutinate red blood cells 

and induce strong neutralizing antibody 

titers in several in vivo animal models. 

The key advantages of this technology 

are that expression of these proteins in 

bacteria reduces the vaccine production 

time and offers the ease of scalability for 

global usage, an issue with current 

production methods. The recombinant 

HA proteins can also be used for 

diagnostic applications. 

Potential Commercial Applications: 

• Vaccines for the prevention of 

influenza infection 

• Diagnostics for influenza virus 

specific antibodies 

Competitive Advantages: 

• Novel vaccine candidates 

• Rapid production time 

• Ease of scalability 

Development Stage: 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Hana Golding and Surender 

Khurana (FDA). 

Publication: Khurana S, et al. 

Recombinant HA1 produced in E. coli 

forms functional oligomers and 

generates strain-specific SRID potency 

antibodies for pandemic influenza 

vaccines. Vaccine. 2011 Aug 

5;29(34):5657–5665. [PMID 21704111]. 

Intellectual Property: HHS Reference 

No. E–032–2010/1—PCT Application 

No. PCT/US2010/055166 filed 02 Nov 

2010. 

Licensing Contact: Kevin W. Chang, 

Ph.D.; 301–435–5018; 

changke@mail.nih.gov. 

Potent, Easy To Use Targeted Toxins as 

Anti-Tumor Agents 

Description of Technology: The 

invention discloses synthesis and use of 

novel derivatives of 2-[2’-(2- 

aminoethyl)-2-methyl-ethyl]-l,2- 

dihydro-6-methoxy-3H-dibenz- 

[de,h]isoquinoline-l,3-dione as targeted 

anti-tumor agents. The use of targeted 

toxin conjugates with anti-cancer 

antibodies, such as herceptin, is 

increasing. Based on a comparison with 

the structurally complex toxins, such as 

DM1, available in the market, these 

novel toxins are more stable in 

circulation, thus making the toxinconjugates more tumor-selective and 

less toxic. As such, these compounds 

are superior alternatives to the existing 

toxins. 

The invention describes a potent and 

easy to synthesize toxin that can be used 

for generating a variety of prodrugs. 

These compounds can be attached to a 

ligand that recognizes a receptor on 

cancer cells, or to a peptide that is 

cleaved by tumor-specific proteases. 

The compounds are topoisomerase 

inhibitors and are mechanistically 

different from DM1 that targets tubulin. 

The structure of the toxin allows it to 

be modified with a peptide linker that 

is stable, but rapidly cleaved in 

lysosomes after the compound is 

specifically taken up by cancer cells. 

Potential Commercial Applications: 

The compounds can be used for 

preparation of a variety of potent anticancer agents with low systemic 

toxicity. 

Competitive Advantages: 

• Easy to prepare 

• Structural features make these 

compounds more stable in circulation 

• Toxin conjugates are more tumorselective and less toxic 

Development Status: 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Nadya Tarasova, et al. 

(NCI). 

Intellectual Property: HHS Reference 

No. E–160–2006/0—U.S. Patent No. 

8,008,316 issued 30 Aug 2011. 

Licensing Contact: Jennifer Wong; 

301–465–4633; wongje@mail.nih.gov. 

Dated: February 29, 2012. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2012–5356 Filed 3–5–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 


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