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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10284 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 

majority of GISTs result from activating 

mutations in the oncogene receptor 

tyrosine kinases c-KIT and PDGFRA, 

these tumor samples do not harbor 

mutations in c-KIT or PDGFRA (‘‘nonKIT/ PDGFRA-GISTs’’) and respond 

poorly to receptor tyrosine kinase 

inhibitors. 

Applications: 

• Useful in the investigation of 

inactivating genetic changes in FOXD3 

in non-KIT/PDGFRA-GISTs. 

• Useful in the study of new 

molecules and/or pathways that may 

serve as an appropriate therapeutic 

target. 

Inventors: Constantine Stratakis et al. 

(NICHD). 

Patent Status: HHS Reference No. E– 

058–2010/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing under a biological material 

license. 

Licensing Contact: Patrick P. McCue, 

PhD; 301–435–5560; 

mccuepat@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Child Health 

and Human Development 

Endocrinology & Genetics Section is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact Joseph 

Conrad, PhD at 301–435–3107 or 

jmconrad@mail.nih.gov for more 

information. 

Novel Kinase Inhibitors Targeting the 

PH Domain of AKT for Preventing and 

Treating Cancer 

Description of Invention: Activation of 

the PI3K/Akt signaling pathway has 

been implicated in the development of 

cancer. Akt, a kinase that is central to 

this pathway, is found at elevated levels 

in many tumors and is associated with 

a poor disease prognosis. Many research 

studies have validated Akt as a 

therapeutic target for the development 

of anti-cancer drugs. Most efforts of drug 

development targeting Akt have focused 

on inhibitors of the ATP-binding 

domain which tend to interfere with 

other physiologically important kinases. 

An alternative strategy that has been 

proposed to improve drug specificity is 

the targeting of the unique pleckstrin 

homology (PH) domain of Akt. 

Investigators at the National Institutes 

of Health have screened a library of 

small chemical compounds with druglike characteristics that likely bound to 

the PH domain and have identified 

several candidates previously unknown 

to interact with Akt. These compounds 

were tested and found to inhibit Akt 

activity specifically through the PH 

domain. Some of these compounds 

demonstrated broad cytotoxicity to a 

wide variety of tumor cells. These novel 

Akt-inhibiting compositions target the 

PH domain and help in the prevention 

and treatment of cancer. Since it has 

been shown that reducing the activity of 

the PI3K–Akt pathway sensitizes 

malignant cells to chemotherapy or 

radiotherapy, these novel Akt inhibitors 

have potential either as single anticancer agents or in combination with 

conventional cancer therapies. 

One of the candidate compounds 

inhibited Colony Stimulating Factor-1 

Receptor (CSF1R) from binding to ATP 

but had no activity for other kinases. 

CSF1R has been implicated in 

development of cancers like chronic 

myelomonocytic leukemia, but also in 

Alzheimer’s disease so this specific 

compound may have use in treating 

other diseases in addition to cancer. 

Applications: 

• Treating or preventing development 

of cancer or preventing progression of 

premalignant lesions to cancer. 

• Used as a single agent or in 

combination with other anti-cancer 

treatments like chemotherapy, 

biological therapy, or radiation. 

• Inhibiting the activity of CSF1R 

receptor to treat diseases like chronic 

myelomonocytic leukemia and 

Alzheimer’s disease or an adverse 

condition, such as brain injury. 

Advantages: Targeting the PH domain 

improves specificity against Akt kinase 

in comparison to inhibitors of the ATP 

domain which typically are unspecific. 

Inventors: Phillip A. Dennis (NCI) et 

al. 

Patent Status: U.S. Provisional 

Application No. 61/226,328 filed 17 Jul 

2009 (HHS Reference No. E–212–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Surekha Vathyam, 

PhD; 301–435–4076; 

vathyams@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Medical Oncology Branch and 

Affiliates, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

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

3121 or hewesj@mail.nih.gov for more 

information. 

Diagnostic Biomarker of Metastasis for 

Improved Clinical Management of Head 

and Neck Cancer 

Description of Invention: Squamous 

Cell Carcinoma of the Head and Neck 

(HNSCC) is associated with poor 

prognosis due to the advanced stage of 

disease (metastasis) typically found at 

the time of diagnosis. Investigators at 

the NIH have developed a sensitive 

method using a protein biomarker for 

detecting even just a few HNSCC tumor 

cells in lymph nodes with occult 

disease. Combination of this staging 

technique with intraoperative sentinel 

lymph node mapping would improve 

the management of HNSCC by 

identifying patients for which radical 

lymph node dissection is most 

appropriate, sparing those for which it 

is not, and informing decisions for 

adjuvant cancer therapy during a single 

surgery. 

This technology arose from the 

discovery that the Desmoglein-3 (DSG3) 

protein which is highly expressed in 

tumors of squamous epithelial origin, 

like HNSCC, is also expressed in 

invaded lymph nodes but it is not found 

in normal lymph nodes. Therefore, 

DSG3 can serve as a biomarker for 

detecting metastastatic spread of 

squamous cell carcinoma tumors. This 

is achieved by performing protein 

detection immunoassays to samples 

(biopsy, aspirate, or isolated cells) of 

suspect lymph nodes. 

Applications: Use with sentinel 

lymph node mapping for rapid, 

intraoperational diagnosis of metastatic 

HNSCC for guiding proper therapeutic 

approach. 

Advantages: 

• Rapid diagnosis during surgery 

increases effectiveness of intervention 

thereby reducing need for subsequent 

surgery. 

• Improved accuracy of direct 

measurement of protein levels over RNA 

assays. 

• More robust assay as protein is 

more stable than RNA. 

Development Status: 

• Early stage. 

• Clinical data available. 

Market: HNSCC is the sixth most 

prevalent cancer among men worldwide 

and is associated with poor prognosis, 

which has improved only marginally 

over the past three decades. This is 

reflected by HNSCC being the eighth 

leading cause of cancer death 

worldwide. 

Inventors: J. Silvio Gutkind et al. 

(NIDCR). 

Related Publication: Patel V, Hood 

BL, Molinolo AA, Lee NH, Conrads TP, 

Braisted JC, Krizman DB, Veenstra TD, 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices 10285 

Gutkind JS. Proteomic analysis of lasercaptured paraffin-embedded tissues: a 

molecular portrait of head and neck 

cancer progression. Clin Cancer Res. 

2008 Feb 15;14(4)1002–1014. [PubMed: 

18281532]. 

Patent Status: U.S. Provisional 

Application No. 61/186,582 filed June 6, 

2009 (HHS Reference No. E–300–2008/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Whitney Hastings, 

PhD; 301–451–7337; 

hastingw@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIDCR, OPCB, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize the use of DSG3 as a 

biomarker for detecting metastastatic 

spread of squamous cell carcinoma 

tumors. Please contact David W. 

Bradley, PhD at 

bradleyda@nidcr.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. 2010–4761 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. 

Long Acting Ophthalmic Analgesic Eye 

Drops 

Description of Invention: This 

invention is directed to the discovery 

that resiniferatoxin (RTX) produces a 

three to four day analgesic effect when 

topically applied to the cornea. Efficacy 

for RTX as an effective analgesic has 

been demonstrated in vivo in rats. 

Importantly, unlike currently available 

analgesics, RTX left the blink reflex 

intact and did not impact mechanical 

sensitivity. RTX also did not impair 

epithelial wound healing and 

functioned without detectable damage 

to the cornea. 

RTX is a potent agonist of the 

transient receptor potential channel, 

subfamily V, member 1 (TRPV1). TRPV1 

is involved in pain sensation and is 

expressed only in select neurons. Unlike 

other local analgesics that target a wide 

breadth of neurons, RTX targets only 

those neurons that express TRPV1, 

leaving the important blink reflex and 

mechanical sensitivity of the eye 

unaffected. 

Applications: 

• An ophthalmic analgesic for postoperative eye pain. 

• An ophthalmic analgesic for acute 

or chronic eye injury. 

• Applicable to both human and 

veterinary patients. 

Advantages: 

• Both long lasting and reversible. 

• Does not impair epithelial wound 

healing, leaves the blink reflex intact, 

and functions without detectable 

damage to the cornea. 

Development Status: 

• Early stage. 

• Demonstrated efficacy in vivo in 

rats. 

Market: Twenty-six million people 

worldwide experience neuropathic 

pain, resulting in healthcare costs of 

over three billion dollars per year. 

Inventors: Michael J. Iadarola, 

Andrew J. Mannes, Jason M. Keller, 

Kendall Mitchell, Brian D. Bates 

(NIDCR). 

Publication: In preparation. 

Patent Status: U.S. Provisional 

Application No. 61/247,881 filed 01 Oct 

2009 (HHS Reference No. E–117–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Charlene Sydnor, 

PhD; 301–435–4689; 

sydnorc@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Dental and 

Craniofacial Research, Laboratory of 

Sensory Biology, Neurobiology and Pain 

Therapeutics Section, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact David W. Bradley, PhD at 301– 

402–0540 or bradleyda@nidcr.nih.gov 

for more information. 

Novel Compositions for Use as Bone 

Scaffolds and Enhancers of Bone 

Regeneration 

Description of Invention: This 

invention is directed to the discovery 

that a mixture of an organic polymer 

and inorganic particles may hold 

therapeutic utility as a biomaterial for 

artificial bone scaffolds, injectable bonefilling materials, and enhancement of 

new bone generation. This composition 

has demonstrated utility in vivo in 

mice. 

The inventors have discovered a 

means of producing a stably 

homogenous mixture of the organic 

polymer and inorganic particles by 

crosslinking the two components. In 

contrast to current technologies, this 

invention not only imparts sufficient 

mechanical and load-bearing strength 

but also provides a suitable 

environment for new bone formation. 

Importantly, since the chemical reaction 

applied to make this biomaterial does 

not produce any harmful molecules or 

heat, it can be used in an injectable 

form. Bone formation or replacement is 

often a desired therapy for bone loss or 

defects due to fractures or bone 

degenerative diseases. 

Applications: 

• Injectable bone-filling materials. 

• Artificial bone sponge for bone 

defect. 

• Artificial bone sponge for bone cell 

culture in bone and mineralization 

research. 

Advantages: 

• Combines bone-like strength and a 

suitable environment for new bone 

formation 

• Injectable. 

Development Status: 

• Early stage. 

• Tested in vivo in mice. 

Market: According to 

Freedoniagroup.com, the US orthopedic 

implant market was $14.3 billion in 

2007 and is expected to grow 8.9 

percent annually through 2012. (http:// 

www.freedoniagroup.com/OrthopedicImplants.html, accessed December 2, 

2009.) 

Inventors: EunAh Lee and Pamela 

Robey (NIDCR) et al. 

Publication: In preparation. 

Patent Status: 


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