Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices 44753 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and the assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information collected; 

and (4) ways to minimize the burden of 

the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. George Nemo, 

Project Officer, NHLBI, Two Rockledge 

Center, Room 10142, 6701 Rockledge 

Drive, MSC 7950, Bethesda, MD 20892–

7950, or call 301–435–0075, or e-mail 

your request to nemog@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: July 23, 2008. 

George Nemo, 

Project Officer, NHLBI, National Institutes of 

Health. 

[FR Doc. E8–17528 Filed 7–30–08; 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. 

Protein-tyrosine Phosphotase Inhibitors 

as Inhibitors of Human Tyrosyl-DNA 

Phosphodiesterase (Tdp1) and Methods 

of Treating Disorders 

Description of Technology: TyrosylDNA phosphodiesterase (Tdp1) is an 

enzyme that repairs topoisomerase I 

(Top1)-mediated DNA damage induced 

by chemotherapeutic agents (such as 

camptothecins) and ubiquitous DNA 

lesions that interfere with transcription 

and replication. Tdp1 is a relevant target 

for anticancer therapies due to its role 

in repairing Top1-mediated DNA 

damage and DNA damage associated 

with DNA strand breaks. Tdp1 

inhibitors are expected to be effective in 

cancer treatment when used in 

combination with Top1 inhibitors. 

The current invention is Me-3,4 

dephostatin, and more generally 

protein-tyrosine phosphatase inhibitors, 

which is a Tdp1 inhibitor. Me-3,4 

dephostatin could potentiate the 

pharmacological action of Top1 

inhibitors. 

Applications and Modality 

• It is anticipated that Tdp1 

inhibitors in association with Top1 

inhibitors can have selective activity 

toward tumor tissues. 

• Tdp1 inhibitors may exhibit 

antitumor activity by themselves 

because tumors have excess free 

radicals. 

Market 

• An estimated 1,444,920 new cancer 

diagnoses in the U.S. in 2007. 

• 600,000 deaths caused by cancer in 

the U.S. in 2006. 

• Cancer is the second leading cause 

of death in the U.S. 

• Cancer drug market will likely 

double to $50 billion in 2010 from $25 

billion in 2006. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Yves Pommier (NCI) et al. 

Relevant Publication: S Antony et al. 

Novel high-throughput 

electrochemiluminescent assay for 

identification of human tyrosyl-DNA 

phosphodiesterase (Tdp1) inhibitors 

and characterization for furamidine 

(NSC 305831) as an inhibitor of Tdp1. 

Nucleic Acid Res. 2007;35(13):4474–

4484. 

Patent Status: U.S. Provisional 

Application No. 61/042,706 filed 04 Apr 

2008 (HHS Ref. No. E–121–2008/0–US–

01). 

Licensing Status: Available for 

exclusive and non-exclusive licensing. 

Licensing Contact: Adaku 

Nwachukwu, J.D.; 301–435–5560; 

madua@mail.nih.gov. 

Steroid Derivatives as Inhibitors of 

Human Tyrosyl-DNA 

Phosphodiesterase (Tdp1) 

Description of Technology: TyrosylDNA phosphodiesterase (Tdp1) is an 

enzyme that repairs topoisomerase I 

(Top1)-mediated DNA damage induced 

by chemotherapeutic agents and 

ubiquitous DNA lesions that interfere 

with transcription. The current 

technology are steroid derivatives that 

human inhibit Tdp1. 

Currently, there are various types of 

Top1 inhibitors used in chemotherapy, 

e.g., camptothecin. However, Tdp1 

inhibitors are expected to be effective in 

combination therapy with Top1 

inhibitors for the treatment of cancers. 

Combining Tdp1 inhibitors with Top1 

inhibitors would allow Tdp1 to 

potentiate the antiproliferative activity 

of Top1 inhibitors. In addition to Tdp1’s 

effect on Top1, Tdp1 inhibitors can also 

exhibit antitumor activity 

independently, as tumors are shown to 

have excess free radicals, and Tdp1 

repairs DNA damage by oxygen radicals. 

Applications and Modality: It is 

anticipated that Tdp1 inhibitors in 

association with Top1 inhibitors can 

have selective activity toward tumor 

tissues. Tdp1 inhibitors may exhibit 

antitumor activity by themselves 

because tumors have excess free 

radicals. 

Market: 600,000 deaths from cancer 

related diseases were estimated in 2006. 

In 2006, cancer drug sales were 

estimated to be $25 billion. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Yves Pommier et al. (NCI). 

Patent Status: 

• U.S. Provisional Application No. 

61/000,430 filed 24 Oct 2007 (HHS 

Reference No. E–130–2007/1–US–01). 

• PCT Application No. PCT/US2008/ 

004541 filed 05 Apr 2008, claiming 

priority to 05 Apr 2007 (HHS Reference 

No. E–130–2007/2–PCT–01). 

Licensing Status: Available for 

exclusive and non-exclusive licensing. 


jlentini on PROD1PC65 with NOTICES
44754 Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices 

Licensing Contact: Adaku 

Nwachukwu, J.D.; 301/435–5560; 

madua@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, Center for 

Cancer Research, Laboratory of 

Molecular Pharmacology, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize inhibitors of TyrosylDNA phosphodiesterase (Tdp1). Please 

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

3121 or hewesj@mail.nih.gov for more 

information. 

Dated: July 22, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–17506 Filed 7–30–08; 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. 

Methods for Promoting Stem Cell 

Proliferation and Survival 

Description of Technology: 

Regenerative medicine has the potential 

to treat numerous human diseases and 

afflictions including neurodegenerative 

disorders and spinal cord injury that are 

typically insidious and worsen over 

time. This technology consists of a 

promising treatment method that coaxes 

stem cells into a state that promotes 

survival and proliferation. Two critical 

elements of this approach involve 

identifying the target niche and 

determining the pharmacological agents 

that can be used to promote stem cell 

regeneration. 

Specifically, this technology consists 

of a method to activate the endogenous 

neural stem cells (NSCs) to promote 

their survival and yield using 

angiopoietin-2 and a cocktail of ligands 

and growth factors. This method has 

demonstrated that it can significantly 

improve the yield of stem cell cultures 

in vitro and stimulate behavioral 

recovery in a model of Parkinson’s 

disease in vivo. This method is 

applicable to a variety of stem cell types 

including embryonic stem cells, adult 

spinal cord cells, and pericyctes from 

blood vessels. 

Possible Applications: 

• Method for culturing stem cells for 

optimal regeneration. 

• Treatment of neurological diseases 

and disorders such as Parkinson’s 

disease, stroke, diabetes-related 

neuropathies, and spinal cord. 

• Diagnostic assays to determine 

proliferation or inhibition of stem cells. 

Development Status: Pre-clinical. 

Inventors: Andreas AndroutsellisTheotokis and Ronald D.G. McKay 

(NINDS). 

Relevant Publication: A 

Androutsellis-Theotokis, RR Leker, F 

Soldner, DJ Hoeppner, R Ravin, SW 

Poser, MA Rueger, SK Bae, R Kittappa, 

RD McKay. Notch signaling regulates 

stem cell numbers in vitro and in vivo. 

Nature. 2006 Aug 17;442(7104):823–

826. 

Patent Status: U.S. Provisional 

Application No. 60/965,094 filed 16 

Aug 2007 (HHS Reference No. E–182–

2007/0–US–01) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Fatima Sayyid, 

M.H.P.M.; 301–435–4521; 

Fatima.Sayyid@nih.hhs.gov 

Collaborative Research Opportunity: 

The National Institute of Neurological 

Disorders and Stroke is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize agents with activity on 

proliferation and/or differentiation of 

stem cells. Please contact Laurie Arrants 

at 301–435–3112 or 

ArrantsL@ninds.nih.gov or Martha 

Lubet at 301–435–3120 or 

lubetm@mail.nih.gov for more 

information. 

Treatment of Alcoholism by Inhibition 

of the Neuropeptide Y Receptor 

Description of Technology: Aversive 

or anticraving medications are currently 

used to supplement behavioral 

treatment of alcohol dependence. 

However, there is a need for developing 

more effective medications than those 

available. Neuropeptide Y (NPY) is a 

neurotransmitter known for increasing 

appetite and possibly having a role in 

alcohol preference and dependence. 

This is likely to be mediated by 

activation of the post-synaptic NPY–Y1 

receptor, but developing molecules 

suitable for human therapeutics that 

activate that receptor represents a major 

challenge. Researchers at the NIH have 

now shown that administering 

antagonists of the presynaptic Y2 

receptor of NPY decreases alcohol 

consumption and may be a valuable 

new treatment for alcoholism. 

Applications: Treatment of alcohol 

dependence. 

Market: In the United States, 17.6 

million people—about l in every 12 

adults—abuse alcohol or are alcohol 

dependent. It is estimated that on any 

given day, more than 700,000 people in 

the United States receive alcoholism 

treatment. Consequently, billions of 

dollars are spent in the treatment, 

prevention, and support of persons 

suffering from alcoholism. Moreover, 

the economic loss attributed to alcohol 

abuse and alcoholism is in the trillions. 

Development Status: Early stage. 

Inventors: Markus Heilig (NIAAA) et 

al. 

Publications: 

1. R Rimondini et al. Suppression of 

ethanol self-administration by the 

neuropeptide Y (NPY) Y2 receptor 

antagonist BIIE0246: Evidence for 

sensitization in rats with a history of 

dependence. Neurosci Lett. 2005 Feb 

28;375(2):129–133. 

2. A Thorsell et al. Blockade of central 

neuropeptide Y (NPY) Y2 receptors 

reduces ethanol self-administration in 

rats. Neurosci Lett. 2002 Oct 

25;332(1):1–4. 

Patent Status: U.S. Patent Application 

10/492,785 filed 17 May 2004 (HHS 

Reference No. E–101–2004/0–US–03); 

Swedish Patent Application 0103476–8 

filed 18 Oct 2001 (HHS Reference No. 

E–101–2004/0–SE–01) 

Licensing Status: Available for 

licensing. 

Licensing Contact: Norbert Pontzer, 

JD, PhD; 301–435–5502; 

pontzern@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Alcohol Abuse 

and Alcoholism, Laboratory of Clinical 

and Translational Studies is seeking 


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