Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 10769 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Mr. 

Richard M. Taffet, Director, Client 

Services Division; Office of Human 

Resources, Office of the Director, 

National Institutes of Health, Room 2–

D234, East Jefferson Street, Bethesda, 

MD 20892–8503, or call the non-toll-free 

number 301–402–6627, or e-mail your 

comments or request, including your 

address, to: Taffetr@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 this 

publication. 

Dated: February 26, 2007. 

Richard M. Taffet, 

Director, Client Services Division, OHR, OD, 

National Institutes of Health. 

[FR Doc. 07–1087 Filed 3–8–07; 8:45 am] 

BILLING CODE 4140–10–M 

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 of Treating Conditions 

Characterized by Unwanted or 

Excessive Presynaptic Neuronal 

Activity or Secretion 

Description of Technology: Botulinum 

toxins are highly potent neurotoxins 

produced by the spore-forming 

bacterium, Clostridium botulinum. 

Poisoning by any of the seven known 

botulinum toxin serotypes, designated A 

to G, results in impaired communication 

between nerve and muscle that causes 

paralysis in patients and possible death 

by respiratory failure. Injections of 

botulinum toxins A and B have been 

approved for treating disorders 

associated with uncontrollable muscle 

contractions. However, the use of 

approved botulinum toxins is limited by 

their temporary duration of action, the 

development of neutralizing antibodies 

after repeated injections, and crossreactivity with autonomic neurons. 

Thus, an interest exists in finding new 

ways to achieve longer-lasting effects 

using botulinum toxins. 

This technology describes a novel 

method for treating diseases by 

combining two botulinum toxins, 

botulinum toxin A and B. Researchers at 

the FDA have shown that the 

combination of the A and B toxins is 

synergistic, improves muscle paralysis 

characteristics compared to individually 

administered serotypes, and produces a 

longer duration of action and a faster 

onset of paralysis. The synergistic effect 

allows lower doses compared to single 

use of either toxin and should help 

reduce resistance after repeated use. 

This technology is beneficial for the 

treatment of diseases already known to 

be treatable with botulinum toxins, such 

as facial wrinkles, headaches, muscle 

spasms, and cervical dystonia. This 

technology is also suitable to treat other 

diseases, such as strabismus, hemifacial 

spasms, facial nerve damage, and 

hyperhidrosis (excessive sweating). 

Available for licensing are methods 

and pharmaceutical compositions for 

administering a combination of 

botulinum toxin A and B to treat 

unwanted or excessive presynaptic 

neuronal activity or secretion. 

Application: Alternative therapy for 

diseases treatable with individual 

botulinum toxins; such therapies 

include Botox, Botox Cosmetic, and 

Myobloc. 

Market: Patients who are currently 

prescribed individual toxins for 

treatment of diseases such as 

strabismus, blepharospasm, cervical 

dystonia, and cosmetic wrinkle 

reduction. 

Development Status: Pre-clinical data 

is available. 

Inventors: James E. Keller (CBER/ 

FDA). 

Publications: JE Keller. Recovery from 

botulinum neurotoxin poisoning in 

vivo. Neuroscience 2006 May 

12;139(2):629–637. 

Patent Status: U.S. Provisional 

Application No. 60/773,412 filed 15 Feb 

2006 (HHS Reference No. E–172–2005/ 

0–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Norbert Pontzer, 

PhD, J.D.; 301/435–5502; 

pontzern@mail.nih.gov. 

Collaborative Research Opportunity: 

The FDA Center for Biologics 

Evaluation and Research, Laboratory of 

Respiratory and Special Pathogens, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact James E. 

Keller, PhD, at 301/ for more 

information. 

Synergistic Effect of TGF-Beta Blockade 

and Immunogenic Agents on Tumors 

Description of Technology: 

Overcoming immune suppression in 

cancer patients is a major challenge for 

the success of cancer immunotherapy. 

TGF–b and its receptors are expressed 

in essentially all tissues, and they have 

been found to be important in many 

cellular processes including cell growth 

inhibition. The inhibition of TGF–b 

signaling has been shown to have an 

inhibitory effect on tumor growth. 

However, TGF–b also has 

immunosuppressive properties. 

Cancer vaccines are one of many 

therapies available for treatment and 

prevention. In particular, vaccines that 

elicit immune responses have been used 

to treat or control tumor growth that has 

evaded immunosurveillance. However, 

these vaccines have demonstrated 

limited success. 

Available for licensing is a method for 

synergistically affecting tumor growth 

involving the administration of an agent 

that blocks the TGF–b signaling 

pathway, in combination with an 

immunogenic agent. The agent that 

blocks the TGF–b signaling pathway 

may inhibit the immunosuppressive 

effects of TGF–b, while the 

immunogenic agent is believed to 

enhance an immune response. 

Surprisingly, the combination of such 

elements produces a synergistic effect. 

The administration of the 1D11.16 antiTGF–b antibody in combination with 

the human papilloma virus E7(49–57) 

peptide enhances tumor regression in an 

animal model. The administration of the 

1D11.16 anti-TGF–b antibody in 


jlentini on PROD1PC65 with NOTICES
10770 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 

combination with irradiated CT26 cells 

enhances tumor regression in another 

mouse model. The investigators found 

that administering the combination of 

agents is more effective than the sum of 

their individual effects. 

Applications: A method of cancer 

combination therapy based on 

immunotherapeutics. 

Development Status: The invention is 

in the clinical stages of development. 

Inventors: Masaki Terabe (NCI) et al. 

Publications: 

1. PCT patent publication WO 2006/ 

089251, August 24, 2006. 

2. M Terabe et al. Transforming 

growth factor-beta production and 

myeloid cells are an effector mechanism 

through which CD1d-restricted T cells 

block cytotoxic T lymphocyte-mediated 

tumor immunosurveillance: abrogation 

prevents tumor recurrence. J Exp Med. 

2003 Dec 1;198(11):1741–1752. 

Patent Status: U.S. Provisional 

Application No. 60/654,329 filed 17 Feb 

2005 (HHS Reference No. E–019–2005/ 

0–US–01); PCT Application No. PCT/ 

US2006/005888 filed 16 Feb 2006 (HHS 

Reference No. E–019–2005/0–PCT–02). 

Licensing Availability: Available for 

exclusive and non-exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301/435–4633; wongje@mail.nih.gov 

Arylthioindole Tubulin Polymerization 

Inhibitors and Methods of Treating or 

Preventing Cancer Using Same 

Description of Technology: 

Microtubules are involved in a variety 

of cellular functions including motility, 

division, shape maintenance, and 

intracellular transport. Tubulin is the 

major protein component in 

microtubules, and interference with 

microtubule assembly leads to an 

increase of cells in metaphase arrest. 

Inhibition of microtubule function using 

tubulin targeted agents are widely used 

in the treatment of cancer. 

This invention describes novel 

arylthioindole derivatives, 3- 

arylthioindole-2-carboxylic acid esters 

derivatives, having excellent affinity for 

tubulin and excellent efficacy as 

inhibitors of the growth of MCF–7 breast 

cancer cells. These new chemical 

compounds have the potential to result 

in more effective therapeutics for the 

treatment of neoplastic diseases. 

Applications: Therapeutic for 

proliferative diseases such as cancer. 

Market: 600,000 deaths from cancer 

related diseases estimated in 2006. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Ernest Hamel (NCI) et al. 

Publications: 

1. G De Martino, MC Edler, G La 

Regina, A Coluccia, MC Barbera, D 

Barrow, RI Nicholson, G Chiosis, A 

Brancale, E Hamel, M Artico, R 

Silvestri. New arylthioindoles: potent 

inhibitors of tubulin polymerization. 2. 

Structure-activity relationship and 

molecular modeling studies. J Med 

Chem. 2006 Feb 9;49(3):947–954. 

2. G De Martino, G La Regina, A 

Coluccia, MC Edler, MC Barbera, A 

Brancale, E Wilcox, E Hamel, M Artico, 

R Silvestri. Arylthioindoles, potent 

inhibitors of tubulin polymerization. J 

Med Chem. 2004 Dec 2;47(25):6120–

6123. 

Patent Status: PCT Application No. 

PCT/US2005/035896 filed 05 Oct 2005 

(HHS Reference No. E–323–2004/0–

PCT–02). 

Licensing Availability: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301/435–4633; wongje@mail.nih.gov. 

Dated: March 2, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–4182 Filed 3–8–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

is hereby given of a meeting of the NIH 

Advisory Board for Clinical Research. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: NIH Advisory Board 

for Clinical Research. 

Date: March 23, 2007. 

Time: 10 a.m. to 2 p.m. 

Agenda: To discuss progress of activities 

related to research opportunities, training, 

planning and funding in the NIH intramural 

clinical research program. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, CRC Medical 

Board Room 4–2551, Bethesda, MD 20892. 

Contact Person: Maureen E. Gormley, 

Executive Secretary, Mark O. Hatfield 

Clinical Research Center, National Institutes 

of Health, Building 10, Room 6–2551, 

Bethesda, MD 20892, 301/496–2897. 

This notice is being published less than 15 

days prior to the meeting due to the urgent 

need to meet timing limitations imposed by 

the intramural research review cycle. 

Any interested person may file written 

comments with the committee by forwarding 

the statements to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Dated: March 2, 2007. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1099 Filed 3–8–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the President’s Cancer 

Panel, February 12, 2007, 8 a.m. to 

February 12, 2007, 6 p.m., University of 

Mississippi, Medical Center, 2500 North 

State Street, Jackson, MS 39216 which 

was published in the Federal Register 

on January 11, 2007, 72 FR 1335. 

Due to inclement weather, this 

meeting is amended to reschedule the 

closed session on February 12, 2007, 4 

p.m.–6 p.m. to March 8, 2007, 11 a.m.–

1 p.m. as a telephone conference. The 

meeting is closed to the public. 

Dated: March 5, 2007. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1109 Filed 3–8–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer 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 


jlentini on PROD1PC65 with NOTICES