Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 18561 

compliance with the Hill-Burton 

uncompensated services assurance and 

administers construction grant programs 

under section 1610(b) of the Public 

Health Service Act, under the Health 

Care and Other Facilities (HCOF) 

program, and under the Patient 

Protection and Affordable Care Act, 

Public Law 111–148. Specifically, the 

Division: (1) Administers the process for 

awarding new construction and 

equipment grants, under section 

1610(b), the HCOF, and the PPACA 

programs, including ensuring the 

delivery of comprehensive architectural 

and engineering services and ensuring 

compliance with historic preservation 

and other laws and regulations related 

to construction projects, maintains a 

computerized database of key project 

information, and provides technical 

assistance in application preparation to 

potential grantees under Division grant 

programs; (2) monitors grant projects 

during construction to assure 

compliance with the terms of the award, 

reviews requests for changes in scope to 

grant projects, and obtains information 

needed to close out completed grant 

projects; (3) establishes, develops, 

monitors, and enforces the 

implementation of Hill-Burton 

regulations, policies, procedures, and 

guidelines for use by staff and health 

care facilities; (4) maintains a system for 

receipt, analysis and disposition of 

audit appeals by Hill-Burton obligated 

facilities and for receiving and 

responding to patient complaints; (5) 

manages the recovery or waiver of 

recovery of Federal grant funds process 

for Titles VI and XVI; (6) manages the 

national Hill-Burton Hotline to ensure 

that consumers receive timely and 

accurate information on the program; 

and (7) provides architectural and 

engineering services to other Agencies 

such as the Administration for Children 

and Families and the Food and Drug 

Administration. 

Division of Vaccine Injury 

Compensation (RR4) 

This Division of Vaccine Injury 

Compensation (DVIC) administers all 

statutory authorities related to the 

operation of the National Vaccine Injury 

Compensation Program (VICP) by the: 

(1) Evaluation of petitions for 

compensation filed under the VICP 

through medical review and assessment 

of compensability for all complete 

claims; (2) processing of awards for 

compensation made under the VICP; (3) 

promulgation of regulations to revise the 

Vaccine Injury Table; (4) provision of 

professional and administrative support 

to the Advisory Commission on 

Childhood Vaccines (ACCV); (5) 

development and maintenance of all 

automated information systems 

necessary for program implementation; 

(6) provision and dissemination of 

program information; and (7) 

contributes to the understanding of 

vaccine-related adverse events through 

the analysis of VICP claims. The VICP 

maintains a working relationship with 

other relevant Federal and private sector 

partners in its administration and 

operation. 

Office of Pharmacy Affairs (RR7) 

The Office of Pharmacy Affairs (OPA) 

promotes access to clinical and cost 

effective pharmacy services to enable 

participating entities to stretch scarce 

Federal resources in order to serve more 

patients, expand their services or offer 

additional services. Specifically the 

office: (1) Manages the 340B 

involvement of pharmaceutical 

manufacturers that participate in the 

Medicaid program, through 

Pharmaceutical Pricing Agreements; (2) 

maintains a publicly accessible database 

of participating covered entities, sites, 

and contract pharmacies; (3) publishes 

guidelines/regulations to assist in the 

understanding and participation in the 

340B Program; (4) maintains a Prime 

Vendor Program to increase the value of 

the 340B Program; (5) maintains the 

Pharmacy Services Support Center to 

assist OPA and the diverse Program 

stakeholders to understand and make 

best use of the 340B Program; (6) fosters 

mutually productive relationships with 

Federal and private sector partners; (7) 

provides a national platform for the 

coordination and development of 

leading practices for pharmacy services; 

(8) promotes comprehensive and 

efficient pharmacy management 

application and systems use to ensure 

safe and effective medication use; and 

(9) manages quality improvement 

activities such as the Patient Safety and 

Clinical Pharmacy Services 

Collaborative. 

Section RR–30, Delegations of Authority 

All delegations of authority and redelegations of authority made to HRSA 

officials that were in effect immediately 

prior to this reorganization, and that are 

consistent with this reorganization, 

shall continue in effect pending further 

re-delegation. 

This reorganization is upon date of 

signature. 

Dated: March 28, 2011. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2011–7781 Filed 4–1–11; 8:45 am] 

BILLING CODE 4165–15–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. 

New Molecules for HIV Therapeutics: 

Fab, scFv, and Related Binding 

Molecules Specific for HIV–1 Rev 

Description of Invention: The 

invention offered for licensing and 

commercial development is in the field 

of HIV therapeutics. More specifically, 

the invention relates to methods and 

compositions for treating and/or 

inhibiting HIV infection or any other 

lentivirus. The invention describes the 

identification, though phage display, of 

a chimeric rabbit/human anti-Rev Fab 

(SJS–R1) that can inhibit polymerization 

of the HIV Rev protein and thus inhibit 

its normal function in virus replication. 

The Fab binds with very high affinity to 

a conformational epitope in the Nterminal half of HIV–1 Rev. The 

corresponding single chain antibody 

(scFv) was also prepared and 

characterized. Methods of making and 

using SJS–R1 Fab and SJS–R1 scFv, and 

antibodies and antibody fragments that 

share at least one CDR with SJS–R1 Fab, 

are provided. Specific described 

methods include methods of preventing 

or reversing polymerization of HIV Rev, 

methods of reducing infectivity of 

replication of a lentivirus, inhibiting 

Rev function in a cell infected with a 

lentivirus, and methods of treating a 


Emcdonald on DSK2BSOYB1PROD with NOTICES
18562 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 

disease or symptom associated with Rev 

expression in an animal. 

Applications: HIV therapeutics. 

Advantages 

• The invention utilizes a novel target 

and thus can be effective in conjunction 

with other HIV drugs. 

• The chimeric structure of the Fab 

makes it possible to produce it in rabbit 

in high yields while being readily 

applicable for human treatment. 

Development Status: The therapeutic 

molecules have been produced and their 

strong affinity to Rev and its inhibitory 

effect on HIV proliferation was 

demonstrated. 

Inventors: Stephen J. Stahl (NIAMS) et 

al. 

Patent Status: U.S. Provisional 

Application No. 61/439,307 filed 

February 3, 2011 (HHS Reference No. E– 

064–2011/0–US–01), entitled 

‘‘Generation and Use of Fab, scFv, and 

Related Binding Molecules Specific for 

HIV–1 Rev.’’ 

Related Publications 

1. Stahl SJ, Watts NR, Rader C, 

DiMattia MA, Mage RG, Palmer I, 

Kaufman JD, Grimes JM, Stuart DI, 

Steven AC, Wingfield PT. Generation 

and characterization of a chimeric 

rabbit/human Fab for co-crystallization 

of HIV–1 Rev. J Mol Biol. 2010 Apr 

2;397(3):697–708. [PubMed: 20138059] 

2. DiMattia MA, Watts NR, Stahl SJ, 

Rader C, Wingfield PT, Stuart DI, Steven 

AC, Grimes JM. Implications of the 

HIV–1 Rev dimer structure at 3.2 A 

resolution for binding to the Rev 

response element. Proc Natl Acad Sci U 

S A. 2010 Mar 30;107(13):5810–5814. 

[PubMed: 20231488] 

Licensing Status: Available for 

licensing and commercial development. 

Licensing Contacts 

• Uri Reichman, PhD, MBA; 301– 

435–4616; UR7a@nih.gov. 

• John Stansberry, PhD; 301–435– 

5236; js852e@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Arthritis and 

Musculoskeletal and Skin Diseases, 

Protein Expression Laboratory is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize the technology. Please 

contact Cecilia Pazman, PhD at 301– 

402–5579 for more information. 

Modulation of Leucine-Rich Repeats 

and Calponin Homology DomainContaining Protein 4 (Lrch4) Activity 

for Therapeutic Applications 

Description of Invention: NIH 

Inventors have recently discovered a 

novel Leucine-rich repeat and calponin 

homology domain-containing protein 4 

(Lrch4) in a proteomic screen of the 

plasma membrane of lipopolysaccharide 

(LPS)-exposed macrophages. Expression 

data by RT–PCR revealed that all Lrch 

family members (1–4) are expressed in 

macrophages, but only Lrch4 was 

recruited into lipid rafts (signaling 

microdomains of the plasma membrane) 

by LPS. Lrch4 is the most highly 

expressed Lrch family member in mouse 

tissues. It is a predicted single-spanning 

transmembrane protein that is encoded 

by the Lrch4 gene in humans. The Lrch4 

ectodomain is predicted to have a series 

of leucine-rich repeats, the motifs by 

which Toll like Receptors (TLR) are 

thought to bind microbial ligands. The 

human form of Lrch4 is 83% identical 

to murine Lrch4 and is predicted to 

have 680 amino acids and a molecular 

weight of 73 kDa. 

NIH inventors have shown that Lrch4 

is expressed on the plasma membrane of 

macrophages. They have determined 

that Lrch4 regulates pro-inflammatory 

signals (NF-kB activation, cytokine 

induction) emanating from all TLRs 

tested, and also regulates ligandindependent signals from MyD88. 

Further, LPS-induced p38, JNK, and 

NFkB activation are attenuated 

following Lrch4 knockdown, indicating 

that Lrch4 regulates upstream LPS 

signaling events. LPS-induced 

expression of the NF-kB-dependent 

cytokine TNFa was attenuated 

following Lrch4 knockdown at the level 

of both transcript and protein. Based on 

these and other findings, the inventors 

of this technology propose that Lrch4 

may be a novel component of TLR 

receptor complexes and that modulation 

of Lrch4 activity might open up new 

opportunities for developing novel 

therapeutics for inflammatory diseases. 

Applications: Identification and 

development of modulators of Lrch4 

activity to treat inflammatory disorders, 

cancer, and sepsis. 

Development Status: Early-stage. 

Inventors: Michael B. Fessler, et al. 

(NIEHS). 

Related Publication: Dhungana S et al. 

Quantitative proteomics analysis of 

macrophage rafts reveals 

compartmentalized activation of the 

proteasome and of proteasome-mediated 

ERK activation in response to 

lipopolysaccharide. Mol Cell Proteomics 

2009 Jan; 8(1):201–213. [PubMed: 

18815123] 

Patent Status: U.S. Provisional 

Application No. 61/433,491 filed 17 

January 2011 (HHS Reference No. E– 

012–2011/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Suryanarayana 

Vepa, PhD, J.D.; 301–435–5020; 

vepas@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Environmental 

Health Sciences (NIEHS) Laboratory of 

Respiratory Biology is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize Lrch4. Please contact Dr. 

Elizabeth M. Denholm at 

denholme@niehs.nih.gov for more 

information. 

Superparamagnetic Nanocomplexes 

and Their Use as Contrast Agents in 

MRI 

Description of Invention: The 

invention offered for licensing and 

commercial development relates to the 

fields of cell therapy and tracking of 

such therapy by magnetic resonance 

imaging. More specifically the 

technology describes novel 

superparamagnetic magnetic resonance 

contrast agents, methods of making the 

agents, and methods of labeling cells 

with the contrast agents and imaging the 

labeled cells using magnetic resonance. 

The self assembled agents are 

composed of three (3) components: 

Superparamagnetic iron oxide 

nanoparticle (e.g. F3O4), associated 

with a carbohydrate coating (e.g., a 

polycation (e.g., Protamine Sulfate); and 

a polycation (e.g., 

glycosaminoglycan:Heparin). Selfassembling superparamagnetic 

nanocomplexes made from simple 

commercially available chemicals such 

as Heparin sulfate (H), Protamine sulfate 

(P), and Ferumoxytol nanocomplexes 

(HPF nanocomplexes) can effectively 

label stem cells, immune cells, tumor 

cells, or any other therapeutically 

engineered cells for cellular MRI. 

Biological cells can be labeled with the 

nanocomplexes by contacting cells 

under conditions sufficient to produce 

the nanocomplexes, or by contacting the 

cells with pre-assembled 

nanocomplexes. The labeled biological 

cells can be transplanted into an 

individual, imaged by MRI and the 

migration pattern and/or cellular 

distribution pattern of the labeled 

biological cells in the subject can then 

be detected. This technique will readily 

facilitate the tracking of the therapeutic 

cells, and thus render cell-based therapy 

and/or tissue repair more precise, 

accurate and effective. 

Applications 

Clinical— 

• Cell-based therapy (e.g. stem cells, 

or immune cells therapy, genetic 

engineered cells); monitoring and 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 18563 

detecting cell trafficking and 

distribution. 

• Diagnostics. 

Research— 

• Cell-based therapy. 

• Tissue regeneration. 

Advantages 

• Avoid radioactive labeling. 

• More efficient cell incorporation 

than the use of noncomplexed 

paramagnetic or superparamagnetic 

particles. 

• Non toxic. 

• Easily prepared from three (3) 

commercially available FDA approved 

drugs off label. No synthesis is required 

(self assembled). 

• No FDA approved MRI contrast 

agent containing paramagnetic or 

superparamagnetic iron oxide 

nanoparticles. 

Development Status 

• The labeling complex has been 

repeatedly prepared. May require some 

further optimization for specific cell 

products and scale up. 

• Incorporation into mammal cells 

has been demonstrated. 

Market: The total U.S. market for 

imaging reagents was $2.8 billion in 

2003 and is expected to grow to $4.5 

billion by 2010 at an average annual 

growth rate of 6.9%. Sales of MRI 

reagents for cardiovascular applications 

were $770 million in 2003 and are 

expected to rise at an average annual 

growth rate of 7.0%. Reagents used in 

oncology and gastrointestinal tract are 

rising at average annual growth rates of 

7.0% and 5.1%, respectively. The 

subject technology maybe readily 

applied in both diagnostics and 

therapeutic fields. A commercial 

development of the subject technology 

may therefore be attractive for 

commercial organizations. 

Inventors: Joseph A. Frank et al. (CC). 

Patent Status: U.S. Provisional 

Application No. 61/439,106 filed 

February 3, 2011 (HHS Reference No. E– 

285–2010/0–US–01), entitled 

‘‘Superparamagnetic Nanocomplexes, 

Articles, and Methods of Use Thereof’’. 

Relevant Publications 

1. Frank JA, Anderson SA, Kalsih H, 

Lewis BK, Yocum GT, Arbab AS. 

Methods for magnetically labeling stem 

and other cells for detection by in vivo 

magnetic resonance imaging. 

Cytotherapy. 2004; 6(6):621–625. 

[PubMed: 15773025] 

2. Arbab AS, Liu W, Frank JA. 

Cellular magnetic resonance imaging: 

current status and future prospects. 

Expert Rev Med Devices. 2006 

Jul;3(4):427–439. [PubMed: 16866640] 

Licensing Status: Available for 

licensing and commercial development. 

Licensing Contacts 

• Uri Reichman, PhD, MBA; 301– 

435–4616; UR7a@nih.gov. 

• John Stansberry, PhD; 301–435– 

5236; js852e@nih.gov. 

Collaborative Research Opportunity: 

The Clinical Center, Frank Laboratory, 

Radiology and Imaging Sciences, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact Joseph A. 

Frank MS MD at 301–402–4314 or 

jafrank@helix.nih.gov for more 

information. 

Methods of Treating Age-Related 

Macular Degeneration 

Description of Invention: Available for 

licensing is a novel method of treating 

age related macular degeneration 

(AMD). AMD is the leading cause of 

irreversible blindness in elderly 

populations worldwide. Inflammation, 

among other factors, has been suggested 

to play an important role in AMD 

pathogenesis. Recent studies have 

demonstrated a link between the 

complement system, inflammation, and 

AMD pathogenesis. Notably, researchers 

at NEI have shown that certain members 

of the C5a pathway are increased in 

AMD patients, and in vitro experiments 

demonstrated that those same pathway 

members cause a decrease in retinal 

pigment epithelium (RPE) viability, a 

hallmark of AMD. Blocking the C5a 

pathway presents a promising approach 

to prevent and treat AMD. 

Application: Prevention and/or 

treatment of Age-related Macular 

Degeneration. 

Development Status: In vivo mouse 

studies are in progress to test the 

effectiveness of the treatment. 

Market: Age-related macular 

degeneration is a leading cause of 

severe, irreversible vision impairment in 

developed countries (http:// 

geteyesmart.org/eyesmart/diseases/ 

amd.cfm). It is estimated that 1.8 

million Americans 40 years and older 

are affected by AMD and an additional 

7.3 million with large drusen (yellow or 

white deposits under the retina) are at 

substantial risk of developing AMD. The 

number of people with AMD is 

estimated to reach 2.95 million in 2020. 

AMD is the leading cause of permanent 

impairment of reading and fine or closeup vision among people aged 65 years 

and older (http://www.cdc.gov/ 

visionhealth/basic_information/ 

eye_disorders.htm). 

Inventors: Robert B. Nussenblatt et al. 

(NEI). 

Patent Status: U.S. Provisional 

Application No. 61/429,580 filed 04 Jan 

2011 (HHS Reference No. E–099–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jaime M. Greene, 

M.S.; 301–435–5559; 

greenejaime@mail.nih.gov. 

Methods for Inhibiting 

Proinflammatory Cytokine Expression 

Using Ghrelin 

Description of Invention: Ghrelin, an 

endogenous ligand for growth hormone 

secretagogue receptors (GHS–R), is 

primarily produced by the stomach but 

also by many other organs systems in 

the body (including the immune system) 

serves as a potent circulating orexigen 

controlling energy expenditure, 

adiposity and GH secretion. We have 

discovered that ghrelin exerts antiinflammatory effects via inhibiting the 

secretion of both acute and chronic 

cytokines including IL–1, IL–6, TNFalpha, IFN-gamma, IL–12 p40, Il–17, 

various chemokines and CSFs in vitro in 

human and murine cells as well as in 

vivo in murine models of sepsis, 

inflammation and aging. We also found 

that ghrelin directly controls human 

growth hormone and insulin growth 

factor expression by human immune 

cells. 

Applications: This invention is useful 

for treatment of various inflammatory 

disorders including inflammatory bowel 

disease, Crohn’s disease, rheumatoid 

arthritis, multiple sclerosis, 

atherosclerosis, endotoxemia and graftversus-host disease. 

Inventors: Vishwa D. Dixit and Dennis 

D. Taub (NIA). 

Relevant Publications 

1. Dixit VD, Schaffer EM, Pyle RS, 

Collins GD, Sakthivel SK, Palaniappan 

R, Lillard JW Jr, Taub DD. Ghrelin 

inhibits leptin- and activation-induced 

proinflammatory cytokine expression by 

human monocytes and T cells. J Clin 

Invest. 2004 Jul; 114(1):57–66. [PubMed: 

15232612] Note: Article highlighted in 

this issue of JCI. This was also the 

subject of a Science SAGE KE News 

Focus article—M Leslie. Opposites 

Detract. Sci Aging Knowl Environ. 2004 

Jul 14; 28:nf65 [doi: 10.1126/ 

sageke.2004.28.nf65]. 

2. Dixit VD, Weeraratna AT, Yang H, 

Bertak D, Cooper-Jenkins A, Riggins GJ, 

Eberhart CG, Taub DD. Ghrelin and the 

growth hormone secretagogue receptor 

constitute a novel autocrine pathway in 

astrocytoma motility. J Biol Chem. 2006 


Emcdonald on DSK2BSOYB1PROD with NOTICES
18564 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices 

Jun 16; 281(24):16681–16690. [PubMed: 

16527811] 

3. Dixit VD, Yang H, Sun Y, 

Weeraratna AT, Smith RG, Taub DD. 

Ghrelin promotes thymopoiesis during 

aging. J Clin Invest. 2007 Oct; 

117(10):2778–2790. [PubMed: 

17823656] Note: Article highlighted in 

this issue of JCI. 

4. Yang H, Dixit VD, Patel K, 

Vandanmagsar B, Collins G, Sun Y, 

Smith RG, Taub DD. Reduction in 

hypophyseal growth hormone and 

prolactin expression due to deficiency 

in ghrelin receptor signaling is 

associated with Pit-1 suppression: 

relevance to the immune system. Blood 

Behav Immun. 2008 Nov; 22(8):1138– 

1145. [PubMed: 18602461] 

5. Dixit VD, Yang H, Cooper-Jenkins 

A, Giri BB, Patel K, Taub DD. Reduction 

of T cell-derived ghrelin enhances 

proinflammatory cytokine expression: 

implications for age-associated increases 

in inflammation. Blood. 2009 May 21; 

113(21):5202–5205. [PubMed: 

19324904] 

Relevant Reviews 

6. Dixit V and Taub DD. Ghrelin and 

immunity: a young player in an old 

field. Exp. Gerontol. 2005 Nov; 

40(11):900–910. [PubMed: 16233968] 

7. Taub DD. Novel connections 

between the neuroendocrine and 

immune systems: the ghrelin 

immunoregulatory network. Vitam 

Horm. 2008; 77:325–346. [PubMed: 

17983863] 

8. Taub DD. Neuroendocrine 

interactions in the immune system. Cell 

Immunol. 2008 Mar–Apr; 252(1–2):1–6. 

[PubMed: 18619587] Note: Image from 

article used on the cover of this issue. 

9. Redelman D, Welniak LA, Taub D, 

Murphy WJ. Neuroendocrine hormones 

such as growth hormone (GH) and 

prolactin (PRL) are integral members of 

the immunological cytokine network. 

Cell Immunol. 2008 Mar–Apr; 252(1– 

2):111–121. [PubMed: 18313040] 

10. Patel K and Taub DD. Role of 

neuropeptides, hormones, and growth 

factors in regulating thymopoiesis in 

middle to old age. F1000 Biol Rep. 2009 

May 28; 1. pii: 42. [PubMed: 20948643] 

11. Taub DD, Murphy WJ, Longo DL. 

Rejuvenation of the aging thymus: 

growth hormone-mediated and ghrelinmediated signaling pathways. Curr Opin 

Pharmacol. 2010 Aug; 10(4):408–424. 

[PubMed: 20595009] 

Patent Status: U.S. Patent Application 

No. 11/596,310 filed 06 Jun 2008 (HHS 

Reference No. E–016–2004/0–US–07) 

and related international applications. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sally H. Hu, PhD, 

M.B.A.; 301–435–5606; 

hus@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

Methods of Inhibiting Proinflammatory 

Cytokine Expression Using Ghrelin. 

Please contact Nikki Guyton at 301– 

435–3101 or guytonn@mail.nih.gov for 

more information. 

Dated: March 29, 2011. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2011–7925 Filed 4–1–11; 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. 

Diagnostic and Prognostic Serum 

Biomarkers for Cancer Patients Treated 

With Cancer Vaccines 

Description of Technology: Although 

antibodies are a critical element of the 

immune response, the role of antibody 

responses in cancer vaccines is still 

unknown. Carbohydrate antigens, which 

are directly or indirectly involved in 

most types of cancer vaccines, are a 

class of antigens that has been largely 

understudied but play a significant role 

in the immune response of cancer 

vaccines. 

This invention involves the 

identification of serum biomarkers for 

cancer that target carbohydrate antigens. 

The biomarkers are specific subpopulations of serum antibodies present 

in the serum of patients that bind to 

various glycan and/or glycoprotein 

antigens, such as the Forssman antigen. 

The biomarkers are useful for (a) 

predicting a patient’s immune responses 

to a cancer vaccine, (b) measuring the 

efficacy of a cancer vaccine, and (c) 

determining the prognosis and longterm survival of cancer patients. 

Applications: 

• Diagnostic and prognostic test to 

monitor the progression and long-term 

survival of cancer patients. 

• Predictive indicator of cancer 

patients’ immune response to a cancer 

vaccine. 

• Indicator to monitor the efficacy of 

a cancer vaccine. 

Advantages: The technology is backed 

by clinical data. 

Development Status: Preliminary 

clinical data; validation studies are 

ongoing (confirmed findings in two 

independent patient groups). 

Market: Cancer Vaccines are emerging 

as the forefront treatment regimens for 

several cancers. Provenge® was recently 

approved by the FDA for the treatment 

of prostate cancer. There are several 

other cancer vaccines in clinical trials. 

This technology can be developed 

into a pioneering test, as no such test to 

monitor prognosis and efficacy of cancer 

vaccines currently exists in the market. 

Inventors: Jeff Gildersleeve, et al. 

(NCI). 

Publications: No publications directly 

related to this technology. 

Patent Status: 

• U.S. Provisional Application No. 

61/371,537 filed August 6, 2010 (HHS 

Reference No. E–234–2010/0–US–01). 

• U.S. Provisional Application No. 

61/443,955 filed February 17, 2011 

(HHS Reference No. E–234–2010/1–US– 

01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sabarni Chatterjee, 

M.B.A., PhD; 301–435–5587; 

chatterjeesa@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Chemical Biology Laboratory, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize anti-glycan serum 

antibodies as biomarkers for cancer or 


Emcdonald on DSK2BSOYB1PROD with NOTICES