66108 Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 

commercialize this technology. Please 

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

3121 or hewesj@mail.nih.gov for more 

information. 

Dated: October 21, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–27181 Filed 10–26–10; 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. 

Photosensitizing Antibody-Fluorophore 

Conjugate for Photo-Immunotherapy 

Description of Invention: A major goal 

of targeted cancer therapy is to improve 

the sensitivity and specificity of the 

therapy so that cancer cells can be 

detected and targeted for elimination, 

while normal cells in the surrounding 

area remain largely intact. 

Photodynamic therapy (PDT) is a 

treatment for cancer and non-cancerous 

lesions involving light and a 

photosensitizer. The photosensitizer can 

be targeted to a specific cell using 

antibodies specific for proteins 

expressed on the target cell surface, the 

target cells will then be destroyed after 

being exposed to light at appropriate 

wavelength. 

The NIH technology describes a 

method of photosensitizing cancerous 

cells by irradiating an antibody 

fluorophore conjugate. The NIH 

investigators have conducted in vitro 

studies using a proprietary IRDye 

700DX NHS Ester. The IR700 dye was 

conjugated to a proprietary humanized 

anti-HER1 or anti-HER2 or anti-PSMA 

antibody, Panitumumab or Trastuzumab 

or huJ591. Subsequent irradiation of 

non-ionizing near infrared light showed 

rapid cell death of tumor cells, while 

normal cells were not noticeably killed. 

The studies were repeated in mice with 

similar results. 

Applications and Market: 

• Photodynamic therapy for cancer by 

selective targeting and killing of cells 

without suffering normal tissue side 

effects. 

• Cancer was responsible for about 

13% of all human deaths in 2007. There 

remains a need for therapies that 

effectively kill the tumor cells while not 

harming non-cancerous cells. 

Development Status: Both in vitro and 

in vivo data available. 

Inventors: Hisataka Kobayashi, Peter 

L. Choyke, Makoto Mitsunaga (NCI) 

Publications: Manuscript in 

submission. 

Patent Status: U.S. Provisional Patent 

Application No. 61/363,079, filed July 9, 

2010 (HHS Reference No. E–205–2010/ 

0–US–01) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Betty B. Tong, 

PhD; 301–594–6565; 

tongb@mail.nih.gov. 

Soluble Glypican-3 Protein for 

Treatment of Cancer 

Description of Technology: 

Hepatocellular carcinoma (HCC) is a 

form of liver cancer that is among the 

more deadly cancers in the world. HCC 

is typically only detected at the later 

stages of cancer development, which is 

always associated with poor prognosis. 

Because HCC is often associated with 

liver disease, traditional chemotherapy 

is not an option, making surgery the 

most common form of treatment. As a 

result, there is a need for new 

treatments. 

Glypican-3 (GPC3) is a cell surface 

protein that is normally involved in cell 

growth and differentiation. GPC3 has 

been shown to act through the Wntsignaling pathway, a pathway that is 

often activated in a number of different 

cancer cell types. Significantly, the 

ability of GPC3 to activate signaling 

through Wnt requires that GPC3 be 

bound to the cell membrane. GPC3 is 

also preferentially expressed on HCC 

cells, suggesting it could play a 

particularly important role in 

tumorigenesis in HCC. 

This invention concerns a soluble 

form of GPC3 that lacks its cell 

membrane anchoring domain. This 

soluble form of GPC3 maintains its 

ability to interact with the Wnt signaling 

pathway, but cannot induce the 

activation of the pathway because it is 

not bound to the cell membrane. By 

competing with fully functional GPC3, 

the soluble GPC3 is able to inhibit the 

growth of HCC cells, thereby decreasing 

the ability of tumors to grow and 

metastasize. This suggests that soluble 

GPC3 represents a possible therapeutic 

for HCC. 

Applications: 

• Soluble GPC3 represents a potential 

therapeutic for patients with cancer 

with hyperactivated Wnt-signaling 

pathways. 

• Specific cancers include 

hepatocellular cancer (HCC), melanoma, 

thyroid cancer, lung squamous cell 

carcinoma, Wilms’ tumor, 

neuroblastoma, hepatoblastoma, and 

testicular germ-cell tumors. 

Advantages: 

• Removal of the glycosylphosphatidylinositol (GPI) anchor 

results in a soluble form of GPC3 that 

can interrupt Wnt-signaling. 

• Soluble GPC3 maintains the ability 

to compete with fully functional GPC3 

despite its inability to activate signaling. 

• For treatment of HCC, offers a noninvasive, potentially non-liver toxic 

alternative to current strategies. 

Development Status: Preclinical stage 

of development; cell culture data with 

HCC cells 

Inventors: Ho (NCI) et al. 

For more information, see: 

• ‘‘Recombinant soluble glypican 3 

protein inhibits the growth of 

hepatocellular carcinoma in vitro’’ Feng 

et al. Int. J. Cancer: E-pub (8 July 2010). 

• ‘‘Soluble Glypican 3 inhibits the 

growth of Hepatocellular Carcinoma in 

vitro and in vivo’’ Zitterman et al. Int. 

J. Cancer: 126, 1291–1301 (2010). 

Patent Status: U.S. provisional 

applications 61/334,135 (E–176–2010/ 

0–US–01) and 61/350,722 (E–176–2010/ 

1–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: David A. 

Lambertson, PhD; 301–435–4632; 

lambertsond@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, 

Laboratory of Molecular Biology, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact John Hewes, 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 66109 

PhD, at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Drug Combination of DNA 

Topoisomerase I (TOP1) Inhibitors and 

Extracellular ATP Produces a 

Significant Increase in Beneficial AntiCarcinoma Cytotoxicity 

Description of Invention: DNA 

Topoisomerase inhibitors are a category 

of drugs used for cancer therapy. DNA 

topoisomerase 1 (TOP1) inhibitors, such 

as Camptothecin (CPT) and its 

structurally related analogues, bind to 

the TOP1 complex and prevent the 

religation of the single strand DNA 

molecules, ultimately leading to cell 

death. CPT and close analogues show 

anticancer activity in clinical trials 

treating ovarian, small-cell lung, and 

colorectal cancers, but also adverse drug 

reaction. By reducing the cytotoxic dose 

in the thousands of folds, the NIH 

scientists are able to target the tumor 

and reduce the cytotoxicity to normal 

cells. The instant invention discloses 

that the drug combination of DNA 

topoisomerase 1 (TOP1) inhibitors, such 

as the anti-cancer drug Camptothecin 

(CPT), and extracellular ATP produces a 

significant increase in beneficial anticarcinoma cytotoxicity. 

Applications and Market: 

• This invention may provide a new 

combination of drug with extracellular 

ATP to target various cancers for 

treatment. 

• Cancer is the second leading cause 

of death in the U.S. The National Cancer 

Institute estimate the overall annual 

costs for cancer in the U.S. at $107 

billion; development of more effective 

therapies with less adverse drug 

reaction is always in high demand. 

Development Status: Pre-clinical stage 

of development. 

Inventors: Joseph Riss, Glenn Merlino, 

J. Carl Barrett (NCI). 

Publications: Manuscript in 

preparation. 

Patent Status: U.S. Provisional 

Application No. 61/350,660 filed 02 Jun 

2010 (HHS Reference No. E–098–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Betty B. Tong, 

PhD; 301–594–6565; 

tongb@mail.nih.gov. 

Novel Prognostic and Therapeutic 

Biomarker for Cancer and 

Inflammatory Diseases 

Description of Invention: There 

remains a significant unmet need for 

diagnostics, prognostics, and 

therapeutics for conditions that involve 

inflammation and the formation of 

blood clots such as bleeding disorders, 

trauma, and diseases such as sepsis, 

cardiovascular disease, stroke, and 

cancer. The global market for such 

products is varied and competitive, and 

is forecast to be over $40 billion by 

2010. 

Researchers at the National Cancer 

Institute (NCI) have identified that 

levels of a novel soluble protein 

involved in the repair mechanism for 

damaged blood vessels correlate with 

outcome in sepsis and with the 

diagnosis of disseminated intravascular 

coagulation, a contributing factor to the 

morbidity and mortality associated with 

sepsis. 

Further, the NCI researchers have 

demonstrated that a recombinant 

version of this novel protein facilitates 

the clotting of blood, suggesting a 

potentially significant therapeutic 

benefit for the treatment of bleeding 

disorders or trauma. 

Applications: 

• Diagnostic and prognostic 

biomarker for diseases that involve 

inflammation and blood clot formation 

(i.e., sepsis, cardiovascular disease, 

stroke, cancer). 

• Treatment of bleeding disorders or 

trauma. 

• Treatment of cerebral bleeding 

associated with aneurism or stroke. 

• Therapy for patients with low 

platelet counts. 

• Therapy for women suffering from 

preeclampsia or thrombotic episodes. 

Advantages: 

• High specificity. 

• Protein levels correlate with disease 

state/outcome. 

• Administration of recombinant 

protein accelerates the formation of 

blood clots. 

Development Status: Pre-clinical. 

Inventors: Daniel McVicar et al. (NCI). 

Relevant Publications: 

1. Washington AV et al. TREM-like 

transcript-1 protects against 

inflammation-associated hemorrhage by 

facilitating platelet aggregation in mice 

and humans. J Clin Invest. 2009 

Jun;119(6):1489–1501. [PubMed: 

19436112]. 

2. Ford JW, McVicar DW. TREM and 

TREM-like receptors in inflammation 

and disease. Curr Opin Immunol. 2009 

Feb;21(1):38–46. [PubMed: 19230638]. 

Patent Status: 

• U.S. Provisional Application No. 

61/177,242 filed 11 May 2009 (HHS 

Reference No. E–197–2009/0–US–01). 

• PCT Application No. PCT/US10/ 

34263 filed 10 May 2010 (HHS 

Reference No. E–197–2009/0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Patrick P. McCue, 

PhD; 301–435–5560; 

mccuepat@mail.nih.gov. 

Treatment and Prevention of 

Inflammatory Bowel Disease (IBD) 

Using Mutant and Chimeric IL–13 

Molecules 

Description of Invention: Ulcerative 

colitis (UC) is a chronic inflammatory 

disease of the colorectum and affects 

approximately 400,000 people in the 

United States. The cause of UC is not 

known, although an abnormal 

immunological response to bacterial 

antigens in the gut microflora is thought 

to be involved. Present treatments for 

UC include anti-inflammatory therapy 

using aminosalicylates or 

corticosteroids, as well as 

immunomodulators and diet. However, 

25–40% of ulcerative colitis patients 

must eventually have their colons 

removed due to massive bleeding, 

severe illness, rupture of the colon, risk 

of cancer or due to side effects of 

corticosteroids and novel treatments are 

still actively being sought. NIH 

scientists and their collaborators have 

used a mouse model of experimental 

colitis (oxazolone colitis, OC) to show 

that IL–13, a Th2 cytokine, is a 

significant pathologic factor in OC and 

that neutralizing IL–13 in these animals 

effectively prevents colitis. 

OC is a colitis induced by intrarectal 

administration of a relatively low dose 

of the haptenating agent oxazolone 

subsequent to skin sensitization with 

oxazolone. A highly reproducible and 

chronic colonic inflammation is 

obtained that is histologically similar to 

human ulcerative colitis. Studies show 

that Natural Killer T (NKT) cells, rather 

than conventional CD4+T cells, mediate 

oxazolone colitis and are the source of 

IL–13 as well as being activated by CD1- 

expressing intestinal epithelial cells. 

Tissue removed from ulcerative colitis 

patients were also shown to contain 

increased numbers of nonclassical NKT 

cells that produce markedly increased 

amounts of IL–13 and that in keeping 

with epithelial damage being a key 

factor in UC, these NKT cells are 

cytotoxic for epithelial cells. Building 

on their previous work, scientists at 

NIAID and FDA have shown that an Il13 chimeric fusion protein linked to an 

effector molecule was able to prevent 

colitis in a mouse model of ulcerative 

colitis. 

Available for licensing are methods 

for treating or preventing the 

inflammatory response of IBD by 

inhibiting the binding of IL–13 to IL–13 

receptors on NKT cells. Additionally, 

these mutant and chimeric Il-13 

molecules are able to block the chronic 


srobinson on DSKHWCL6B1PROD with NOTICES
66110 Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 

inflammatory response that results in 

fibrosis as seen in Crohn’s disease. 

Preventing the inflammatory response of 

colitis by either modulating or blocking 

IL–13 and NKT cell activity continues to 

be an effective therapeutic approach in 

animal models of colitis with 

implications for the treatment of human 

ulcerative colitis and for the treatment 

of fibrosis associated with Crohn’s 

disease. 

Inventors: Warren Strober (NIAID), 

Ivan J. Fuss (NIAID), Peter Mannon 

(NIAID), Jan Preiss (NIAID), Raj Puri 

(FDA), Koji Kawakami (FDA), Stefan 

Fichtner-Feigl (NIAID), Atsushi Kitani 

(NIAID). 

Related Publications: 

1. F Heller, IJ Fuss, EW Nieuwenhuis, 

RS Blumberg, W Strober. Oxazolone 

colitis, a Th2 colitis model resembling 

ulcerative colitis, is mediated by IL–13- 

producing NK–T cells. Immunity 2002 

Nov;17(5):629–628. [PubMed: 

12433369]. 

2. IJ Fuss, F Heller, M Boirivant, F 

Leon, M Yoshida, S Fichtner-Feigl, Z 

Yang, M Exley, A Kitani, RS Blumberg, 

P Mannon, W Strober. Nonclassical 

CD1d-restricted NK T cells that produce 

IL–13 characterize an atypical Th2 

response in ulcerative colitis. J Clin 

Invest. 2004 May 15;113(10):1490–1497. 

[PubMed: 15146247]. 

Patent Status: U.S. Patent Application 

No. 11/918,711 filed 14 Apr 2006 (HHS 

Reference No. E–003–2005/0–US–03) 

and related international filings. 

Related Technologies: 

• IL–13 modulators and inhibitors— 

U.S. Patent No. 7,666,411 issued 23 Feb 

2010 (HHS Reference No. 131–2002/0– 

US–02), U.S. Patent Application No. 12/ 

709,029 filed 19 Feb 2010 (HHS 

Reference No. E–131–2002/0–US–10), 

and related international filings. 

• NF-kappa B decoy 

oligonucleotides—U.S. Patent 

Application No. 11/920,214 filed 09 

Nov 2007 (HHS Reference No. E–108– 

2005/0–US–03). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Betty B. Tong, 

Ph.D.; 301–594–6565; 

tongb@mail.nih.gov. 

Dated: October 21, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–27177 Filed 10–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Guidelines for Use of Stored 

Specimens and Access to Ancillary 

Data and Proposed Cost Schedule: 

Stored Biologic Specimens and 

Ancillary Data From the Collaborative 

Perinatal Project (CPP) 

ACTION: Notice and request for 

comments. 

SUMMARY: The Division of 

Epidemiology, Statistics and Prevention 

Research (hereafter, Division) of the 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development (NICHD) maintains an 

extensive repository of datasets from 

completed studies, biospecimens, and 

ancillary data. The Division intends to 

make datasets and biospecimens more 

widely available to the research 

community for use by qualified 

researchers and to establish procedures 

for access consistent with the National 

Institutes of Health (NIH) Data Sharing 

Policy. The Division has established an 

internal committee, the Biospecimen 

Repository Access and Data Sharing 

Committee (BRADSC), to oversee the 

repository access and data sharing 

program. The purpose of this notice is 

to request comments on this program 

and present the initial proposed cost 

schedule. After full consideration of 

comments submitted in response to this 

notice, the BRADSC will finalize 

proposal guidelines and procedures, 

publish the cost schedule to the 

Division Web site, and begin to accept 

proposals for use of the stored biologic 

samples and for access to ancillary data 

that may not be available electronically. 

The first specimens and ancillary data 

that will be made available under this 

program are those from the national 

Collaborative Perinatal Project (CPP). 

The CPP is a large, prospective cohort 

study, conducted by the National 

Institute of Neurological Diseases and 

Stroke (NINDS) of the National 

Institutes of Health (NIH), which 

recruited and enrolled 48,197 women 

who contributed 54,390 pregnancies 

that were prospectively followed from 

1959–1966 at twelve academic medical 

centers across the United States. 

Custody for disposition of the CPP 

serum specimens was transferred to the 

Division from the NINDS in 1993 and 

for the microfiche archives in 1999. 

However, under the Federal Privacy Act 

of 1974 the samples and archive still 

belong to NINDS. Since 1992, the 

specimens have had limited public 

availability through Division 

investigators. Going forward, the 

Biospecimen Repository Access and 

Data Sharing Committee (BRADSC) will 

oversee the repository access and data 

sharing program. Access to other 

Division resources will be announced 

on the Division Web site. The BRADSC 

reserves the right to amend the 

procedures and costs schedules as 

necessary to maintain the integrity of 

the program and to suit the conditions 

under which other specimens were 

collected. Announcements and current 

proposal guidelines will be available 

under the Research link at http:// 

despr.nichd.nih.gov, and interested 

researchers should consult the Division 

Web site for resources available, the 

most recent guidelines for proposal 

submission and evaluation, and cost 

schedules. Procedures may vary 

depending on the age and nature of the 

samples and original institutional 

review board (IRB) approval, although 

the general outline of the procedures 

should remain the same. Cost schedules 

may vary depending on the nature and 

complexity of the request. 

No funding is provided as part of this 

notice nor will any be available as part 

of the program either to support 

laboratory analyses or data management. 

Samples will only be provided to 

approved projects upon receipt of 

evidence of necessary IRB approval(s), 

funding and payment of repository costs 

and shipping. Approved projects that do 

not obtain funding will be canceled 

within one year of their approval date. 

A more complete description of this 

program follows. Comments or requests 

for clarification on all aspects of the 

program are welcome. 

DATES: 

• Comment Receipt Date: December 

15, 2010. 

• Invitation to Submit Proposal: 

Proposals can be submitted on an 

ongoing basis. 

• Scientific Review Dates: Technical 

Panels for reviews will be assembled 

beginning on January 1, May 1, or 

September 1 of the calendar year so that 

proposals can be evaluated well in 

advance of Federal funding deadlines. 

• Anticipated Distribution of 

Samples: Within one month of 

demonstrable proof of applicant IRB 

approval and receipt of payment to 

cover repository costs and shipping. 

ADDRESSES: To send comments and to 

request information, contact: Dr. Mary 

L. Hediger, Division of Epidemiology, 

Statistics and Prevention Research, 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, 6100 Executive Blvd, 


srobinson on DSKHWCL6B1PROD with NOTICES