53428 Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 10, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–21574 Filed 9–15–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0484] 

Preparation for International 

Conference on Harmonization 

Meetings in Brussels, Belgium; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH meetings in Brussels, Belgium’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Brussels, Belgium. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in 

Brussels, Belgium, November 10 to 13, 

2008, at which discussion of the topics 

underway and the future of ICH will 

continue. 

Date and Time: The meeting will be 

held on Tuesday, October 21, 2008, 

from 3 p.m. to 5:30 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, Conference 

Rooms D and E, Rockville, MD 20857. 

For security reasons, all attendees are 

asked to arrive no later than 2:45 p.m., 

as you will be escorted from the front 

entrance of 5600 Fishers Lane to 

Conference Rooms D and E. 

Contact Person: All participants must 

register with Tammie Jo Bell, Office of 

the Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by email: 

tammie.bell@fda.hhs.gov or fax: 301– 

827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material and requests 

to make oral presentation, to the contact 

person by October 14, 2008. 

If you need special accommodations 

due to a disability, please contact 

Tammie Jo Bell at least 7 days in 

advance. 

Transcripts: Transcripts of the 

meeting may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–66, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

Background: The ICH was established 

in 1990 as a joint regulatory/industry 

project to improve, through 

harmonization, the efficiency of the 

process for developing and registering 

new medicinal products in Europe, 

Japan, and the United States, without 

compromising the regulatory obligations 

of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufactures 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. 

Dated: September 9, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21573 Filed 9–15–08; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

Use of Razoxane for the Treatment of 

Alzheimer’s Disease 

Description of Technology: 

Abnormalities in the metabolism of the 

transition metals, iron and copper, have 

been demonstrated to play a crucial role 

in the pathogenesis of various 

neurodegenerative diseases, including 

Alzheimer’s disease (AD) and 

Parkinson’s disease (PD). Excessive iron 

accumulation in the brain occurs in 

both AD and PD. High levels of reactive 

iron can increase oxidative stressinduced neuronal vulnerability, 

increase the toxicity of environmental or 

endogenous toxins, and accelerate 

hallmark pathologies of these diseases. 

As an example among many, the 

expression level of amyloid-b precursor 

protein (APP) that generates the AD 

neurotoxic peptide, amyloid-b (Ab), is 


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Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices 53429 

regulated in large part by iron levels. 

APP mRNA has an iron response 

element (IRE) in its 5′-untranslated 

region, and cleavage of APP to release 

different amyloidogenic and nonamyloidogenic peptide forms involves 

metalloproteases. 

Elevated Ab levels as well as plaques 

formed by aggregation of Ab involve 

iron, and play a significant role in 

degeneration of the brain seen in AD. 

Chelators can reduce both the 

generation and aggregation of Ab. 

Razoxane, a bisdioxopiperazine, is an 

orally active metal chelator approved for 

the treatment of cancer, where it and 

dexrazoxane have been effectively used 

for decades. In neuronal cell culture 

models, razoxane induced dosedependent reductions in APP and Ab 

levels without toxicity. In animal 

experiments (transgenic mice expressing 

human Ab), razoxane substantially 

reduced Ab 1–40 and 1–42 in brain by 

up to 46% without toxicity following 

once daily, 21 day administration. 

The claimed invention is the novel 

use of razoxane and other 

bisdioxopiperazines to reduce amyloidbeta peptide levels, reduce aggregation 

of alpha-synuclein and tau protein, and 

reduce abnormal protein folding or 

aggregation for the treatment of AD and 

related diseases with protein 

aggregation pathology. Since razoxane 

has been approved for humans use, it 

could be more quickly developed as a 

treatment for AD, PD and other diseases. 

Market: 

• Up to 4.5 million Americans are 

estimated to suffer from AD, which 

usually strikes after the age of 60. 

• Population longevity is increasing 

so AD is expected to be a growing health 

problem. 

• Currently marketed drugs only 

delay the severity of AD so better 

solutions are needed. 

Development Status: Clinical safety 

data and pre-clinical efficacy data for 

treatment of Alzheimer’s disease. 

Inventors: Nigel H. Greig (NIA). 

Patent Status: 

• U.S. Provisional Application No. 

60/811,836 filed 08 Jun 2006 (HHS 

Reference No. E–216–2007/0–US–01). 

• PCT Application No. PCT/US2007/ 

013607 filed 08 Jun 2007, which 

published as WO 2007/146178 on 21 

Dec 2007 (HHS Reference No. E–216– 

2007/0–PCT–02). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Norbert Pontzer, 

J.D., PhD; 301–435–5502; 

pontzern@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Laboratory of Neurosciences, Section on 

Drug Design & Development, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize razoxane and analogues 

for the treatment of neurodegenerative 

disorders, such as Alzheimer’s and 

Parkinson’s diseases. Please contact 

Nigel H. Greig (Greign@grc.nia.nih.gov) 

for more information. 

Prevention and Treatment of Multiple 

Sclerosis (MS) by Administering 

E–Selectin 

Description of Technology: The 

invention is a method and composition 

for inhibiting or treating symptoms of 

inflammatory demyelination or 

inflammation associated with 

autoimmune disorders. This is 

accomplished by administering 

recombinant E-selectin protein 

intranasally and resulting in E selectinspecific regulatory T-cells. These 

regulatory T-cells suppress activation of 

blood vessels where E-selectin is 

normally expressed by the localized 

production of immunosuppressive 

cytokines, modulating the actions of 

otherwise pro-inflammatory T-cells that 

can aberrantly cause demyelination of 

neurons, which leads to diseases like 

MS. 

Applications: In addition to MS, 

potentially effective in treating other 

autoimmune disorders such as 

rheumatoid arthritis, type 1 diabetes, 

psoriasis, and those that affect blood 

vessels. 

Market: MS may affect more than 2.5 

million people worldwide. Currently, it 

is estimated that approximately 400,000 

Americans are afflicted with MS and 

200 more are diagnosed weekly. 

Development Status: In vitro and in 

vivo data are available. 

Inventors: Jacqueline ShukaliakQuandt et al. (NINDS). 

Patent Status: 

• U.S. Provisional Application No. 

60/828,735 filed 09 Oct 2006 (HHS 

Reference No. E–153–2005/0–US–01). 

• PCT Application No. PCT/2007/ 

021682 filed 09 Oct 2007 (HHS 

Reference No. E–153–2005/2–PCT–02). 

Licensing Status: Available for nonexclusive or exclusive licensing. 

Licensing Contact: Norbert Pontzer, 

J.D., PhD; 301–435–5502; 

pontzern@mail.nih.gov. 

Use of Pentosan Polysulfate To Treat 

Certain Conditions of the Prostate 

Description of Technology: Benign 

prostatic hyperplasia (BPH), involving a 

proliferation of smooth muscle cells and 

increased deposition of extracellular 

matrix, is a common development: 50% 

of men over age 60 (about 12.5 million 

men), and as much as 80% of all men 

over age 80 (about 3.2 million men), 

have some enlargement of the prostate 

gland. 

This technology is a method for 

treating BHP using the oral medication, 

pentosan polysulfate. Pentosan 

polysulfate is a well known semisynthetic polysaccharide extracted from 

beech wood cellulose that is FDA 

approved for the treatment of interstitial 

fibrosis. The current technology builds 

on the surprising discovery that 

pentosan polysulfate can cause 

regression of scarring and lesions in 

prostatic tissue. Pentosan polysulfate 

reduces or eliminates both smooth 

muscle cell proliferation and 

extracellular matrix deposition, and 

thus reduces the size of the prostate 

gland and associated obstructive 

symptoms. 

Applications and Advantages: 

• A method of treating benign 

prostatic hyperplasia using pentosan 

polysulfate. 

• The method treats the underlying 

pathology of BHP non-invasively. 

• The method addresses associated 

conditions, such as chronic prostatitis, 

prostadynia, and irritative bladder 

conditions (other than interstitial 

cystitis). 

• Pentosan polysulfate has been FDA 

approved for another use. 

Development Status: In vitro studies 

on BPH biopsy samples that 

demonstrate the drug slows the growth 

of prostate cells and extracellular matrix 

have been completed. 

Patent Status: U.S. Patent No. 

6,828,309 issued 07 Dec 2004 (HHS 

Reference No. E–104–1997/0–US–03). 

Inventor: Gary E. Striker (NIDDK). 

Publication: SJ Elliot et al. Pentosan 

polysulfate decreases prostate smooth 

muscle proliferation and extracellular 

matrix turnover. Prostate Cancer 

Prostatic Dis. 2003;6(2):138–142. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Fatima Sayyid, 

M.H.P.M.; 301–435–4521; 

Fatima.Sayyid@nih.hhs.gov. 

Dated: September 9, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–21504 Filed 9–15–08; 8:45 am] 

BILLING CODE 4140–01–P 


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