Federal Register / Vol. 73, No. 160 / Monday, August 18, 2008 / Notices 48215 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. 

Christine D. Berg, Chief, Early Detection 

Research Group, National Cancer 

Institute, NIH, EPN Building, Room 

3070, 6130 Executive Boulevard, 

Bethesda, MD 20892, or call non-tollfree number 301–496–8544 or e-mail 

your request, including your address to: 

Bergc@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 5, 2008. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison Office, 

National Institutes of Health. 

[FR Doc. E8–18981 Filed 8–19–08; 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. 

Extracellular Matrix Gene Chips To 

Detect Metastatic Tumors 

Description of Technology: Cancer 

mortality is primarily associated with 

metastatic disease and not the primary 

tumor. Recent evidence suggests that 

metastatic disease can be an early event 

and in the majority of patients 

metastasis starts by the time the disease 

is diagnosed. Currently however, 

approximately one third of patients 

without evidence of tumor 

dissemination at the time of surgical 

resection of the primary tumor 

subsequently develop distant metastases 

after the tumor is removed. Therefore 

there is a need for methods of 

characterizing the early metastatic 

process for better treatment of cancer. 

This invention provides arrays which 

can be used for detecting the metastatic 

capacity of a tumor. In particular, these 

gene chips or microarrays detect the 

over-expression of the cancer-related 

extracellular matrix (ECM) modifier 

proteins Anakin and Bromodomain 4 

(Brd4). It has been shown that ECM gene 

dysregulation is predictive of metastasis 

in breast cancer and recently Brd4 and 

Anakin have been identified as 

metastasis modifiers. 

Using the signature profiles of Anakin 

and Brd4, the inventors have 

demonstrated that these genes predict 

survival outcome in affymetrix and glass 

slide based microarray experiments. As 

a result, screening for Brd4 and/or 

Anakin status in tumors could be an 

important prognostic test and may 

enable physicians to better stratify 

patients based on risk of recurrence and 

progression to metastatic disease. 

Applications: 

• Detecting metastatic disease in 

patients diagnosed with cancer. 

• Method of characterizing a tumor or 

cancer by detecting the expression 

levels of Anakin or Brd4. 

• Diagnostic tool to aid clinicians in 

determining appropriate cancer 

treatment. 

Market: 

• Approximately 1,437,180 new 

cancer cases are expected to be 

diagnosed in 2008. 

• Almost 565,650 people in the U.S. 

are expected to die of cancer. This is 

more than 1,500 people a day. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Kent Hunter and Nigel 

Crawford (NCI). 

Patent Status: U.S. Provisional 

Application No. 60/970,400 filed 06 Sep 

2007 (HHS Reference No. E–093–2007/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Whitney A. 

Hastings; 301–451–7337; 

hastingw@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute Metastasis 

Susceptibility Section of the Laboratory 

of Cancer Biology and Genetics is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

Brd4 and/or RRP1B (Anakin) prognostic 

tests. Please contact John D. Hewes, 

Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

NUP98-HOXD13 Transgenic Mice 

Description of Technology: 

Myelodysplastic syndrome (MDS) is 

collection of closely related blood 

diseases that arise in the bone marrow 

characterized by anemia, neutropenia, 

and thrombocytopenia resulting from 

hematopoietic stem cell disorders. A 

variety of genetic aberrations have been 

associated with MDS, including 

chromosomal translocations of the 

NUP98 gene. The only current curative 

therapy for MDS is allogeneic bone 

marrow transplant. Without bone 

marrow transplant, patients either die of 

progressive pancytopenia or following 

transformation of MDS to acute myeloid 

leukemia. Progress in understanding 

and treating MDS has been hampered by 

a lack of an animal model that 

accurately recapitulates all of the 

features of human MDS. Utilizing a 

NUP98-HOXD13 (hereafter NHD13) 

fusion gene, a mouse model was 

developed to elucidate the biology of 

MDS. Genetically engineered mice that 

express an NHD13 transgene display all 

of the phenotypic features of MDS 

including peripheral blood cytopenia, 

bone marrow dysplasia, and 

transformation to acute leukemia. These 

mice provide an accurate preclinical 

model for MDS. 

Applications: Model to study MDS 

and evaluate MDS therapy. 

Market: 15,000–20,000 new cases of 

MDS are diagnosed in the U.S.; 80–90% 

of patients are older than 60 years old. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Peter D. Aplan et al. (NCI). 

Publications: 

1. YW Lin et al. Notch1 mutations are 

important for leukemic transformation 

in murine models of precursor-T 

leukemia/lymphoma. Blood. 2006 Mar 

15;107(6):2540–2543. 


sroberts on PROD1PC70 with NOTICES
48216 Federal Register / Vol. 73, No. 160 / Monday, August 18, 2008 / Notices 

2. YW Lin et al., NUP98-HOXD13 

transgenic mice develop a highly 

penetrant, severe myelodysplastic 

syndrome that progresses to acute 

leukemia. Blood. 2005 Jul 1;106(1):287–

295. 

Patent Status: HHS Reference No. E–

071–2007/0—Research Tool. 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Leukemia Biology Section, Genetics 

Branch, National Cancer Institute is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize the 

NHD13 mouse model. Please contact 

John D. Hewes, Ph.D. at 301–435–3121 

or hewesj@mail.nih.gov for more 

information. 

Conjugates of Ligand, Linker, and 

Cytotoxic Agent and Related 

Compositions and Methods of Use 

Description of Technology: Systemic 

toxicity of drugs is one of the most 

serious problems in cancer 

chemotherapy and frequently is dose 

limiting. Specific delivery of cytotoxic 

drugs to cancer cells remains among the 

most intractable problems of cancer 

therapy. Targeted delivery of antiproliferation drugs through the cell 

surface receptors that are over expressed 

on cancer cells can reduce systemic 

toxicity and increase effectiveness of a 

treatment. 

The present invention describes 

cytotoxic compounds with an 

intracellular target that can selectively 

enter tumor cells through specific 

receptors on the cell surface. The 

invention also describes a conjugate 

comprising a cytotoxic agent, a linker 

arm and a ligand capable of delivering 

a cytotoxic agent in a cell specific 

manner. Such conjugates of a cytotoxic 

agent and a ligand (delivery moiety) 

have increased selectivity for tumor 

cells. The toxic moiety and the ligand 

are joined by a linker arm that is stable 

in circulation, but is easily cleaved in 

lysosomes upon internalization of the 

conjugate. A panel of compounds 

comprised of a variety of cytotoxic 

warheads, against various intracellular 

targets linked to an assortment of 

ligands, has been developed and tested 

in a model system. Ligand moieties of 

these conjugates are capable of specific 

delivery of cytotoxic agents to receptors 

that are frequently over expressed in 

gastric, colon, lung, breast, ovarian and 

pancreatic tumors. These compounds 

have the potential to be highly effective 

anti-tumor agents with considerably 

little negative effect. This disclosed 

technology could provide new and 

exciting methodologies to treat cancer. 

Applications: Anti-tumor agent for 

gastric, colon, lung, breast, ovarian and 

pancreatic tumors. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Nadya I. Tarasova et al. 

(NCI). 

Patent Status: U.S. Patent Application 

No. 10/505,239 filed 19 Aug 2004, 

claiming priority to 27 Feb 2002 (HHS 

Reference No. E–057–2002/2-US–02). 

Licensing Contact: Adaku 

Nwachukwu, J.D.; 301/435–5560; 

madua@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute Structural 

Biophysics Laboratory is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize Conjugates of Ligand, 

Linker, and Cytotoxic Agent and Related 

Compositions and Methods of Use. 

Please contact John D. Hewes, Ph.D. at 

301–435–3121 or hewesj@mail.nih.gov 

for more information. 

SH2 Domain Binding Inhibitors 

Description of Technology: Signal 

transduction processes underlie the 

transfer of extracellular information to 

the interior of the cell and ultimately to 

the nucleus. A variety of signal 

transduction processes are critical for 

normal cellular homeostasis, with 

protein-tyrosine kinases (PTKs) playing 

central roles in many of these pathways. 

Examples of such PTKs include the 

PDGF receptor, the FGF receptor, the 

HGF receptor, members of the EGF 

receptor family, such as the EGF 

receptor, erb-B2, erb-B3 and erb-B4, the 

src kinase family, Fak kinase and the Jak 

kinase family. Protein-tyrosine 

phosphorylation that results from the 

action of PTKs can modulate the activity 

of certain target enzymes as well as 

facilitate the formation of specific multiprotein signaling complexes through the 

actions of homologous protein modules 

termed Src homology 2 (SH2) domains, 

which recognize specific 

phosphotyrosyl containing sequences. A 

malfunction in this system through 

tyrosine kinase overexpression and/or 

deregulation can be manifested by 

various oncogenic and 

hyperproliferative disorders, including 

cancers, inflammation, autoimmune 

disease, hyperproliferative skin 

disorders, psoriasis and allergy/asthma, 

etc. The disclosed compounds, e.g. 

peptides, preferably, macrocyclic 

peptides, are Grb2 SH2 domain 

signaling antagonists with enhanced 

binding affinity. The claims of the 

current application are directed to 

compositions of matter and methods of 

use which provide for the diagnosis, 

testing and treatment of the 

aforementioned disease states. 

Applications: For treatment of cancer, 

inflammation, autoimmune diseases, 

hyperproliferative skin disorders, 

psoriasis and asthma. 

Development Status: The technology 

is currently in an early pre-clinical stage 

of development. 

Inventors: Terrence R. Burke, Jr., et al. 

(NCI). 

Patent Status: 

• U.S. Patent No. 6,977,241 issued 20 

Dec 2005 (HHS Reference No. E–262–

2000/0–US–03). 

• U.S. Patent Application No. 10/ 

517,717 filed 17 Mar 2005, allowed 

(HHS Reference No. E–262–2000/1-US–

03). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Adaku 

Nwachukwu, J.D.; 301–435–5560; 

madua@mail.nih.gov. 

Dated: August 7, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–18982 Filed 8–19–08; 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/ 


sroberts on PROD1PC70 with NOTICES