Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices 57637 

Biol., in press (available online 2008 

Sep 16, doi:10.1016/j.jmb.2008.09.008). 

Patent Status: U.S. Provisional 

Application No. 61/086,027 filed 04 

Aug 2008 (HHS Reference No. E–211– 

2008/0–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Experimental Transplantation and 

Immunology Branch, Center for Cancer 

Research, National Cancer Institute is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize the 

fully human anti-human NKG2D 

monoclonal antibody KYK–2.0 IgG1. 

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

301–435–3121 or hewesj@mail.nih.gov 

for more information. 

Methods for the Detection and 

Treatment of Lung Cancer 

Description of Technology: Lung 

cancer is the third most common 

malignant disease and the first leading 

cause of cancer death in the western 

world. Non-small cell lung cancer 

(NSCLC) is one of the leading causes of 

death accounting for nearly 30% of all 

cancer deaths. Despite considerable 

research, lung cancer remains difficult 

to diagnose and treat effectively. Current 

chemotherapeutic regimens provide 

poor survival benefits and the unmet 

clinical need among lung cancer 

patients is very high. The prognosis is 

very bleak since most patients are 

diagnosed with lung cancer at a late 

stage. 

The inventors have discovered that 

approximately 20% of common adult 

NSCLC have an aberrant activation of 

CRTC gene members with marked 

induction of CRTC regulated genes. 

CRTC activation is linked with the loss 

of LKB1/STK11 kinases which results in 

CRTC underphosphorylation and 

enhanced nuclear localization. As the 

LKB1/STK11 signaling pathways has 

been exploited in potential cancer 

therapeutic treatments, this novel 

unrecognized consequence the loss of 

LKB1/STK11 function associated with 

aberrant CRTC activation in cancer 

offers new candidate diagnostic and 

therapeutic targets for NSCLC. 

Applications: 

• Novel cancer diagnostics and 

therapeutic treatments. 

• Method to detect and treat lung 

cancer. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Market: 

• Lung cancer is the leading cause of 

cancer deaths among both men and 

women in the U.S. 

• The NSCLC market was estimated 

to be worth US$3.7 billion in 2006 and 

will increase by 17% by 2012. 

Inventors: Frederic Kaye and Amy 

Coxon (NCI). 

Patent Status: U.S. Provisional 

Application No.61/036,830 filed 13 Mar 

2008 (HHS Reference No. E–069–2008/ 

0–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Human Perilipin Proteins 

Description of Technology: Perilipins 

are important regulators of lipid storage 

in fat cells. These proteins stabilize fat 

droplets and control their breakdown by 

controlling access of lipid-degrading 

enzymes. Since these proteins are 

central to the storage and breakdown of 

body fat it very likely that they are 

crucial for the regulation of body 

weight. Perilipin expression is elevated 

in obese animals and humans. 

Mutations in the perilipin gene are 

associated with increased risk of obesity 

in women. Importantly, when the 

perilipin gene is inactivated the obesity 

of model mice is reversed. Therefore, 

perilipin could be a good candidate for 

therapeutic targeting to treat obesity in 

humans. 

This NIH invention claims DNA 

sequences of splice variants that code 

for human perilipin protein isoforms 

and methods of expressing the 

recombinant protein in bacteria or 

mammalian cells. It also claims 

substantially purified perilipin proteins 

and methods for detecting their 

presence in a biological sample. 

Applications: 

• Drug development for obesity. 

• Diagnostics for detection of 

perilipins. 

• Antigens for antibody production. 

• Markers for identifying true 

adipocytes. 

Advantages: 

• Cloned DNA sequences ready for 

protein expression. 

• Isoforms allow greater flexibility in 

designing therapeutics. 

Development Status: Pre-clinical. 

Inventors: Constantine Londos, 

Andrew S. Greenberg, Alan R. Kimmel, 

John J. Egan (NIDDK). 

Related Publication: AS Greenberg et 

al. Perilipin, a major hormonally 

regulated adipocyte-specific 

phosphoprotein associated with the 

periphery of lipid storage droplets. J 

Biol Chem. 1991 Jun 15;266(17):11341– 

11346. 

Patent Status: 

• U.S. Patent No. 6,074,842 issued 13 

Jun 2000 (HHS Reference No. E–111– 

1991/0–US–03). 

• U.S. Patent No. 5,585,462 issued 17 

Dec 1996 (HHS Reference No. E–111– 

1991/1–US–01). 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Surekha Vathyam, 

PhD; 301–435–4076; 

vathyams@mail.nih.gov. 

Dated: September 29, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–23436 Filed 10–2–08; 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. 

Murine Monoclonal Antibodies 

Effective To Treat Respiratory 

Syncytial Virus 

Description of Technology: Available 

for licensing through a Biological 

Materials License Agreement are the 

murine MAbs described in Beeler et al, 

‘‘Neutralization epitopes of the F 

glycoprotein of respiratory syncytial 

virus: effect of mutation upon fusion 

function,’’ J Virol. 1989 Jul;63(7):2941– 

mstockstill on PROD1PC66 with NOTICES

57638 Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices 

2950. The MAbs that are available for 

licensing are the following: 1129, 1153, 

1142, 1200, 1214, 1237, 1112, 1269, and 

1243. One of these MAbs, 1129, is the 

basis for a humanized murine MAb (see 

U.S. Patent 5,824,307 to humanized 

1129 owned by MedImmune, Inc.), 

recently approved for marketing in the 

United States. MAbs in the panel 

reported by Beeler et al. have been 

shown to be effective therapeutically 

when administered into the lungs of 

cotton rats by small-particle aerosol. 

Among these MAbs several exhibited a 

high affinity (approximately 109M-1) for 

the RSV F glycoprotein and are directed 

at epitopes encompassing amino acid 

262, 272, 275, 276 or 389. These 

epitopes are separate, nonoverlapping 

and distinct from the epitope recognized 

by the human Fab of U.S. Patent 

5,762,905 owned by The Scripps 

Research Institute. 

Applications: Research and drug 

development for treatment of respiratory 

syncytial virus. 

Inventors: Robert M. Chanock, Brian 

R. Murphy, Judith A. Beeler, and 

Kathleen L. van Wyke Coelingh (NIAID). 

Patent Status: HHS Reference No. B– 

056–1994/1—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for nonexclusive licensing under a Biological 

Materials License Agreement. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Neutralizing Monoclonal Antibodies to 

Respiratory Syncytial Virus 

Description of Technology: 

Respiratory syncytial virus (RSV) is the 

most common cause of bronchiolitis and 

pneumonia among infants and children 

under 1 year of age. Illness begins most 

frequently with fever, runny nose, 

cough, and sometimes wheezing. During 

their first RSV infection, between 25% 

and 40% of infants and young children 

have signs or symptoms of bronchiolitis 

or pneumonia, and 0.5% to 2% require 

hospitalization. Most children recover 

from illness in 8 to 15 days. The 

majority of children hospitalized for 

RSV infection are under 6 months of 

age. RSV also causes repeated infections 

throughout life, usually associated with 

moderate-to-severe cold-like symptoms; 

however, severe lower respiratory tract 

disease may occur at any age, especially 

among the elderly or among those with 

compromised cardiac, pulmonary, or 

immune systems. 

This invention is a human 

monoclonal antibody fragment (Fab) 

discovered utilizing phage display 

technology. The neutralizing 

monoclonal antibody was isolated and 

its binding site was identified. Fab F2– 

5 is a broadly reactive fusion (F) 

protein-specific recombinant Fab 

generated by antigen selection from a 

random combinatorial library displayed 

on the surface of filamentous phage. In 

an in vitro plaque-reduction test, the 

Fab RSVF2–5 neutralized the infectivity 

of a variety of field isolates representing 

viruses of both RSV subgroups A and B. 

The Fab recognized an antigenic 

determinant that differed from the only 

other human anti-F monoclonal 

antibody (RSV Fab 19) described thus 

far. A single dose of 4.0 mg of Fab 

RSVF2–5/kg of body weight 

administered by inhalation was 

sufficient to achieve a 2000-fold 

reduction in pulmonary virus titer in 

RSV-infected mice. The antigen-binding 

domain of Fab RSVF2–5 offers promise 

as part of a prophylactic regimen for 

RSV infection in humans. 

Application: Respiratory Syncytial 

Virus prophylaxis/therapeutic. 

Development Stage: The antibodies 

have been synthesized and preclinical 

studies have been performed. 

Inventors: Brian Murphy (NIAID), 

Robert Chanock (NIAID), James Crowe 

(NIAID), et al. 

Publication: JE Crowe et al. Isolation 

of a second recombinant human 

respiratory syncytial virus monoclonal 

antibody fragment (Fab RSVF2–5) that 

exhibits therapeutic efficacy in vivo. J 

Infect Dis. 1998 Apr;177(4):1073–1076. 

Patent Status: HHS Reference No. E– 

001–1996/0—U.S. and Foreign Rights 

Available. 

Licensing Status: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Human Neutralizing Monoclonal 

Antibodies to Respiratory Syncytial 

Virus and Human Neutralizing 

Antibodies to Respiratory Syncytial 

Virus 

Description of Technology: This 

invention is a human monoclonal 

antibody fragment (Fab) discovered 

utilizing phage display technology. It is 

described in Crowe et al. , Proc Natl 

Acad Sci USA. 1994 Feb 15;91(4):1386– 

1390 and Barbas et al. , Proc Natl Acad 

Sci USA. 1992 Nov 1;89(21):10164– 

10168. This MAb binds an epitope on 

the RSV F glycoprotein at amino acid 

266 with an affinity of approximately 

109M-1. This MAb neutralized each of 

10 subgroup A and 9 subgroup B RSV 

strains with high efficiency. It was 

effective in reducing the amount of RSV 

in lungs of RSV-infected cotton rats 24 

hours after treatment, and successive 

treatments caused an even greater 

reduction in the amount of RSV 

detected. 

Applications: Research and drug 

development for treatment of respiratory 

syncytial virus. 

Inventors: Robert M. Chanock 

(NIAID), Brian R. Murphy (NIAID), 

James E. Crowe Jr. (NIAID), et al. 

Patent Status: U.S. Patent 5,762,905 

issued 09 Jun 1998 (HHS Reference No. 

E–032–1993/1–US–01); U.S. Patent 

6,685,942 issued 03 Feb 2004 (HHS 

Reference No. E–032–1993/1–US–02); 

U.S. Patent Application No. 10/768,952 

filed 29 Jan 2004 (HHS Reference No. E– 

032–1993/1–US–03). 

Licensing Status: Available for nonexclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

Dated: September 26, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–23437 Filed 10–2–08; 8:45 am] 

BILLING CODE 4140–01–P 

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 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Early 

Diagnosis Using Nanotechnology-Based 

Imaging and Sensing. 

Date: October 23, 2008. 

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

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room 406, Rockville, 

MD 20852, (Telephone Conference Call). 

Contact Person: Joyce C. Pegues, PhD, 

Scientific Review Officer, Special Review 

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