61142 Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 

Subject name Address Effective date 

Howard-Love, Kimberly ......................................................................................... Springfield, OH ......................................... 10/20/2005 

Marder, Charles .................................................................................................... Plano, TX .................................................. 10/20/2005 

Mikolinnas, Thomas .............................................................................................. Worcester, MA .......................................... 9/22/2005 

Slusher, Kevin ....................................................................................................... Shreveport, LA .......................................... 10/20/2005 

Zimmerman, Seth .................................................................................................. Port Washington, NY ................................ 10/20/2005 

Dated: October 6, 2005. 

Katherine B. Petrowski, 

Director, Exclusions Staff, Office of Inspector 

General. 

[FR Doc. 05–20963 Filed 10–19–05; 8:45 am] 

BILLING CODE 4152–01–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. 

N- and 2-Substituted Benztropine 

Compounds and Use Thereof for 

Treating Mental Disorders 

Amy H. Newman et al. (NIDA) 

U.S. Provisional Application filed 24 

Aug 2005 (HHS Reference No. E–234–

2005/0–US–01). 

Licensing Contact: Marlene Shinn-Astor; 

301/435–4426; shinnm@mail.nih.gov. 

Dopamine is a neurotransmitter that 

exerts important effects on locomotor 

activity, motivation and reward, and 

cognition. The dopamine transporter 

(DAT) is expressed on the plasma 

membrane of dopamine synthesizing 

neurons. It is responsible for clearing 

dopamine released into the extracellular 

space, thereby regulating 

neurotransmission. The dopamine 

transporter plays a significant role in 

neurotoxicity and human diseases, such 

as Parkinson’s disease, drug abuse 

(especially cocaine addiction), Attention 

Deficit Disorder/Attention Deficit 

Hyperactivity Disorder (ADD/ADHD), 

and a number of other CNS disorders. 

Therefore, the dopamine transporter is a 

strong target for research and the 

discovery of potential therapeutics for 

the treatment of these indications. 

Benztropine and its analogs bind with 

high affinity to the DAT and inhibit 

dopamine reuptake, but generally do not 

produce behavioral effects comparable 

to those produced by cocaine. Recent 

benztropine analogs have been shown to 

(1) reduce cocaine-induced stimulant 

effects, (2) retain long-lasting actions, 

and (3) lack significant abuse liability. 

These data suggest that this class of 

compounds may be useful medications 

for human diseases where dopaminerelated behavior is compromised, 

especially in situations in which an 

agonist treatment is indicated. 

Although the benztropines bind with 

high affinity to the DAT without 

substitution in the 2-position of the 

tropane ring, only a substituent in the Sconfiguration is tolerated at DAT, in 

direct contrast to cocaine and its analogs 

that must have the 2-position 

substituent in the R-configuration. In 

this invention, substitution at the S-2- 

position of 4′,4′′-difluoro-or 4′,4′′- 

dichlorobenztropines with various 

functional groups such as alkyl, aryl, 

akyl, alcohol, ether, etc., as well as 

substitution at the tropane nitrogen 

were achieved and have demonstrated 

high affinity and selectivity for the DAT 

over the other monoamine transporters 

as well as muscarinic receptors, without 

a significant cocaine-like behavioral 

profile. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Novobiocin Analogues as Anticancer 

Agents 

Leonard M. Neckers (NCI) et al. 

U.S. Provisional Application No. 60/ 

624,566 filed 03 Nov 2004 (HHS 

Reference No. E–065–2005/0–US–01). 

Licensing Contact: George Pipia; 301/ 

435–5560; pipiag@mail.nih.gov. 

Functional Hsp90 requires C-terminal 

homodimerization of two molecules of 

Hsp90. Novobiocin competes with ATP 

for binding to the C-terminus and 

studies demonstrated that this binding 

results in degradation of Hsp90 protein 

through ubiquitination and ultimately 

transportation to proteosome for 

proteolysis. Twenty three analogs of 

novobiocin were prepared and screened 

for their activity against Hsp90 and the 

most active derivatives were identified. 

Novobiocin was previously identified as 

an inhibitor of type II topoisomerases 

and has been used clinically for more 

than a decade for the treatment of 

cancer. However recent studies have 

shown that novobiocin selectively 

inhibits the maturation of Hsp90 

dependent proteins. In addition to its 

effect on Hsp90, novobiocin has been 

shown to reverse drug resistance and 

increase the intracellular concentration 

of topoisomerase II drugs such as 

Etoposide and tubulin binding drugs, 

such as Taxol, making cells more 

susceptible to chemotherapeutics and 

induction of apoptosis. 

This research is described, in part, in: 

Yu XM, Shen G, Neckers L, Blake H, 

Holzbeierlein J, Cronk B and Blagg BSJ. 

‘‘Hsp90 Inhibitors Identified from a 

Library of Novobiocin Analogues,’’ J. 

Am. Chem. Soc., in press. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Anticancer Effects of Novel Vitamin D 

Receptor Antagonists 

Julianna Barsony (NIDDK) 

U.S. Provisional Application No. 60/ 

300,409 filed 22 Jun 2001 (HHS 

Reference No. E–213–2001/1–US–01). 

PCT Patent Application No. PCT/US02/ 

19774 filed 20 Jun 2002 (HHS 

Reference No. E–213–2001/2–PCT–

01). 

Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 61143 

U.S. Patent Application No. 10/481,052 

filed 16 Dec 2003 (HHS Reference No. 

E–213–2001/2–US–02). 

Licensing Contact: Mojdeh Bahar; 301/ 

435–2950; baharm@mail.nih.gov. 

The present invention relates to 

cancer therapeutics. Specifically, this 

invention relates to novel selective 

vitamin D receptor modulators (SEDM), 

also known as vitamin D receptor 

antagonists. Methods of treatment 

resulting in inhibition of cell growth, 

inducement of cell differentiation, 

inhibition of breast cancer growth, and 

inhibition of parathyroid hormone 

secretion in mice are disclosed. 

Vitamin D does not have significant 

biological activity. Rather, it must be 

metabolized within the body to its 

hormonally active form, calcitriol. 

Calcitriol acts through the vitamin D 

receptor (VDR) to regulate important 

functions, such as calcium homeostasis, 

cell proliferation and differentiation, 

and immune functions. Many cancers 

contain VDR and, therefore respond to 

calcitriol. In such cancers, low 

concentrations of calcitriol stimulate 

growth and high concentrations inhibit 

growth. High doses of calcitriol and 

calcitriol analogues, however, cause 

hypercalcemia, limiting the use of this 

hormone for cancer treatment. 

The present invention relates to 

derivatives of calcitriol that have been 

synthesized in a manner similar to the 

principles developed to create estrogen 

receptor modulators (SERM). These 

vitamin D receptor modulators bind 

well to VDR, inhibit their ability to 

stimulate cancer cell growth and 

increase their ability to induce cell 

differentiation. In mice, SEDM inhibited 

human breast cancer growth without 

causing hypercalcemia. The technology 

disclosed herein may also be used for 

the prevention of breast cancer, 

treatment and/or prevention of other 

types of conditions or diseases, such as, 

but not limited to, prostate, colorectal, 

and lung cancers, leukemia, primary or 

metastatic melanoma, glyoma, and 

parathyroid diseases. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Zebularine, A Stable and Orally Active 

Inhibitor of Cytosine DNA 

Methyltransferase Capable of 

Reactivating Dormant Tumor 

Suppressor and Inhibiting Tumor 

Growth 

Victor E. Marquez (NCI) et al. 

U.S. Provisional Application No. 60/ 

309,242 filed 31 Jul 2001 (HHS Ref. 

No. E–081–2001/0–US–01). 

U.S. Provisional Application No. 60/ 

311,435 filed 10 Aug 2001 (HHS Ref. 

No. E–081–2001/1–US–01). 

PCT Application No. PCT/US02/24223 

filed 30 Jul 2002, which published as 

WO 03/012051 on 13 Feb 2003 (HHS 

Ref. No. E–081–2001/2–PCT–01). 

U.S. Patent Application No. 10/485,438 

filed 30 Jan 2004 (HHS Ref. No. E–

081–2001/2–US–06). 

Licensing Contact: John Stansberry; 301/ 

435–5239; stansbej@mail.nih.gov. 

DNA methyltransferases (also referred 

to as DNA methylases) transfer methyl 

groups from the universal methyl donor 

S-adenosyl methionine to specific sites 

on a DNA molecule. When gene 

sequences contain many methylated 

cytosines, they are less likely to be 

expressed. Several such ‘silenced’ genes 

are now known to be an important 

contributing factor in many cancers 

where expression of tumor suppressor 

genes has been suppressed. Preventing 

DNA methyltransferase production, or 

inhibiting the enzyme, may allow tumor 

suppressor genes that have been 

silenced by hypermethylation to be reactivated. Re-activation of tumor 

suppressor genes is intended to stop or 

slow tumor growth by restoring growth 

control mechanisms. Thus, there exists 

a need for an effective and stable 

inhibitor of DNA methylation. 

The inventors have discovered a 

potent inhibitor of DNA methylation 

(Zebularine) that can specifically 

reactivate silenced tumor suppressor 

genes. This agent can be used to inhibit 

methylation and thereby combat certain 

cancers that have been linked to 

hypermethylation. This agent has also 

been shown in initial animal testing to 

be active orally and is more stable than 

some other agents in this same area of 

therapy and is a suitable candidate for 

further pre-clinical and clinical 

development as an anti-cancer agent to 

be used as monotherapy and/or as an 

adjunct to existing anti-cancer 

therapeutics. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Compositions and Methods of 

Specifically Targeting Tumors 

Dr. Raj K. Puri (FDA) et al. 

U.S. Patent No. 6,428,788 issued 06 Aug 

2002 (HHS Reference No. E–266–

1994/1–US–01). 

Licensing Contact: Jesse S. Kindra; 301/ 

594–4697; kindraj@mail.nih.gov. 

A chimeric molecule that binds 

specifically to IL–13 receptors has been 

identified. The molecule, IL13- 

PE38QQR, targets tumor cells with less 

binding to healthy cells. The improved 

specific targeting of this molecule is 

premised upon the discovery that tumor 

cells overexpress IL–13 receptors at 

extremely high levels and that binding 

of IL–13–PE38QQR can be blocked to 

IL–4 receptors in normal cells. This 

phenomenon permits the use of lower 

dosages of chimeric molecules along 

with IL–4 receptor blocker to deliver 

effector molecules to targeted tumor 

cells. 

This invention may be useful in the 

treatment of cancer. The targeting 

method could be used in conjunction 

with current methods, e.g., 

chemotherapy to help maintain the 

healthy cells. To date, IL13–PE38QQR 

has been shown to be effective against 

a variety of solid tumor cancers in 

animal models including 

adenocarcinoma, brain cancer and AIDS 

associated Kaposi’s sarcoma. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

1,2-Dihydroellipticines with Activity 

Against CNS-Specific Cancer Cell Lines 

Rudiger D. Haugwitz (NCI) et al. 

U.S. Patent No. 5,272,146 issued 21 Dec 

1993 (HHS Reference No. E–110–

1992/0–US–01). 

U.S. Patent No. 5,441,941 issued 15 Aug 

1995 (HHS Reference No. E–110–

1992/0–US–02). 

Licensing Contact: George G. Pipia; 301/ 

435–5560; pipiag@mail.nih.gov. 

The present invention is directed, in 

general, to methods for treating human 

cancers and in particular to new 

compounds which cross the blood brain 

barrier and retain activity against CNS 

specific cancer cell lines, to 

pharmaceutical formulations containing 

such compounds, and to methods for 

the treatment of cancer. 

This research is described, in part, in 

Jurayj et al., ‘‘Design and Synthesis of 

Ellipticinium Salts and 1,2- 

Dihydroellipticines with High 

Selectivities against Human CNS 

61144 Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 

Cancers in vitro,’’ J. Med. Chem. 

37(4):2190–2197, 1994. 

Dated: October 10, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 05–21010 Filed 10–19–05; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting 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. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel 

Review of Conference Grants (R13s) 

Date: November 8–9, 2005. 

Time: 8 a.m. to 8 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call) 

Contact Person: Deborah P. Beebe, 

Director, Division of Extramural Affairs, 

National Heart, Lung, and Blood Institute, 

NIH, Two Rockledge Center, Room 1700, 

6701 Rockledge Drive, Bethesda, MD 20892, 

301/435–0260, beebed@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.937, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: October 11, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21020 Filed 10–19–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel 

Review of Research Project (Cooperative 

Agreement) Applications 

Date: November 15, 2005. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Shelley S. Sehnert, PhD, 

Scientific Review Administrator, Review 

Branch, NIH/NHLBI, 6701 Rockledge Drive, 

Room 7206, Bethesda, MD 20892–7924, 301/ 

435–0303, ssehnert@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel 

Review of Research Project Grant 

Applications (R01s) 

Date: November 17, 2005. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: YingYing Li-Smerin, PhD, 

MD, Scientific Review Administrator, 

Division of Extramural Affairs, Review 

Branch, National Heart, Lung, and Blood 

Institute, NIH, 6701 Rockledge Drive, Room 

7184, Bethesda, MD 20814, 301/435–0275, 

lismerin@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: October 11, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21022 Filed 10–19–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting 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. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group.Heart, Lung, and 

Blood Program Project Review Committee. 

Date: December 1, 2005. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Chevy Chase, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Jeffrey H. Hurst, PhD, 

Review Branch, Division of Extramural 

Affairs, National Heart, Lung, and Blood 

Institute/NIH, 6701 Rockledge Drive, RM 

7208, Bethesda, MD 20892, (301) 435–0303, 

hurstj@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: October 11, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21024 Filed 10–19–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings.