Government-Owned Inventions; Availability for Licensing, 30952-30954 [E8-11919]

Download as PDF 30952 Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices the viral subtypes currently transmitted within the screened population and hence most likely to ‘‘break-through’’ routine screening measures (i.e., periseroconversion window period donations). Molecular surveillance of incident HIV infections in blood donors not only characterizes genotypes of recently infected donors for purposes of blood safety, but also enables documentation of the rates of primary transmission of anti-viral drug resistant strains in the community, serving a public health role in identifying new HIV infections for anti-retroviral treatment. Both a prospective surveillance and a case-control design are proposed to enroll all eligible HIV seropositives detected at three blood ˜ centers in Brazil (Sao Paulo, Belo ´ Horizante, and Recıfe) plus a satellite center in Rio de Janeiro. A comparison of epidemiological risk profiles will be made between the seropositive donors and a group of randomly selected seronegative donors. There are three study aims. Laboratory studies (LS–EIA testing and sequencing of pol region) on linked specimens from all enrolled HIV cases, will allow for estimation of HIV prevalence and incidence relative to genotype and putative route of infection. Data derived from molecular genotyping, including drug resistant genotypes, will be provided, along with counseling, to all enrolled HIV positive donors to facilitate their clinical care via referral to the Brazilian national HIV treatment system. Our findings will be compared to trends in prevalence, incidence and molecular variants from studies of the general population and high risk populations in Brazil, thus allowing for broad monitoring of the HIV epidemic in Brazil and assessment of the impact of donor selection criteria on these parameters. Finally, HIV cases and a group of controls, through responses to a questionnaire, will provide data on HIV risk behaviors among prospective blood donors. This HIV risk behavior data will be used as covariates in the molecular surveillance analyses described above, as well as aid in assessing whether modifications may be needed to Brazil’s routine blood center operational donor screening questionnaire. The study participants will return to their local blood center for the administration of an informed consent form, explaining the confidential nature of the research study as well as the risks and benefits to their participation. Once enrolled, they will be asked to complete the self-administered risk factor questionnaire. In addition, a small blood sample will be collected from each HIV seropositive participant to be used for the genotyping and drug resistance testing. The results of the drug resistance testing will be communicated back to the seropositive participants during an in-person counseling session at the blood center. Defining prevalence and incidence in blood donors and residual risk of HIV transmission by Estimated number of responses per respondent Estimated number of respondents jlentini on PROD1PC65 with NOTICES 2,000 ................................................................................................................................ Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and the assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological VerDate Aug<31>2005 17:45 May 28, 2008 Jkt 214001 transfusions may lead to new regulations and blood safety initiatives in Brazil. The data can be used to project the yield, safety impact and cost effectiveness of implementing enhanced testing strategies such as combination antigen-antibody assays and/or NAT. Determination of HIV risk factors in donors (first time versus repeat donor status; volunteer versus replacement status; demographics and risk behaviors) will support policy discussions over strategies to recruit the safest possible donors in Brazil. The findings from this project will also complement similar monitoring of HIV prevalence, incidence, transfusion risk and molecular variants in the U.S. and other funded international REDS-II sites, thus allowing direct comparisons of these parameters on a global level. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 2,000; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.40 (including administration of the informed consent form and questionnaire completion instructions); and Estimated Total Annual Burden Hours Requested: 800. The annualized cost to respondents is estimated at: $5,200 (based on $6.50 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. collection techniques or other forms of information technology. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two Rockledge Center, Room 9144, 6701 Rockledge Drive, MSC 7950, Bethesda, MD 20892– 7950, or call 301–435–0065, orE-mail your request to nemog@nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: PO 00000 Average burden hours per response 1 Estimated total annual burden hours requested 0.40 800 Dated: May 20, 2008. George Nemo, Project Officer, NHLBI, National Institutes of Health. [FR Doc. E8–11921 Filed 5–28–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: The inventions listed below are owned by an agency of the U.S. Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\29MYN1.SGM 29MYN1 Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices 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. jlentini on PROD1PC65 with NOTICES Telomerase Suppressor Compositions and Methods for Diagnosis and Treatment of Cancer Description of Technology: Lung cancer is responsible for one-third of all cancer related deaths. Although tobacco smoking is a major cause of lung cancer, epidemiological studies have provided evidence for the involvement of genetic factors in the disease onset. For now there are no reliable markers for the early lung cancer diagnostics and no effective treatment except resection of the tumor on early stages. As a result, it is difficult to diagnose lung cancer without invasive methods and before significant progression of the disease has occurred. NIH inventors have recently discovered that a gene called CCDC36 (LELA1) is frequently inactivated in patients with non-small cell lung cancer (NSCLC). In many instances of lung cancer, particularly early onset NSCLC, one copy of CCDC36 will be lost due to the chromosomal deletion while the other will be inactivated by promoter methylation. This results in reduction or loss of CCDC36 gene expression. In addition, several single nucleotide polymorphisms (SNPs) found in the gene appeared to be associated with the early onset NSCLC. CCDC36 gene replacement could be utilized as a potential therapeutic strategy. Applications Detection of SNPs associated with early onset NSCLC can be potentially used to diagnose predisposition. Detection of chromosomal loss of CCDC36 and/or its methylation status in lung cancer can be used to diagnose NSCLC. Treatment of NSCLC using CCDC36based therapeutics. VerDate Aug<31>2005 17:45 May 28, 2008 Jkt 214001 Advantages Early detection of NSCLC has the potential to improve prognosis of lung cancer patient. Non-invasive nature of the test is beneficial to patient comfort. Benefits There is no current genetic test for early onset NSCLC, providing an excellent market opportunity. Developing a diagnostic test for lung cancer will have significant social benefits, allowing the early detection and treatment of lung cancer patients. Inventors: Tatiana Dracheva et al. (NCI). Patent Status: PCT Application No. PCT/US2008/059800 filed 09 Apr 2008 (HHS Reference No. E–265–2007/0– PCT–01). Licensing Status: Available for licensing. Licensing Contact: David A. Lambertson, Ph.D.; 301–435–4632; lambertsond@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute, Center for Cancer Research, Laboratory of Human Carcinogenesis is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize ‘‘Unique Genetic Changes in CCDC36 Gene That Are Associated with Early Onset Lung Cancer.’’ Please contact John D. Hewes, Ph.D., at 301–435–3121 or hewesj@mail.nih.gov for more information. Muramyl Dipeptide as a Therapeutic Agent for Inflammation Description of Technology: The nucleotide-binding oligomerization domain 2 (NOD2) protein plays a key role in innate immunity as a sensor of muramyl dipeptide (MDP), a breakdown product of bacterial peptidoglycan. Bacterial peptidoglycan promotes the innate immune response through the activation of Toll-like receptor 2 (TLR2), which ultimately provokes inflammation. Activation of NOD2 by MDP negatively regulates the activity of TLR2, and thus reduces inflammation. The inventors have demonstrated that administration of MDP prevents the development of experimental colitis in mice. They have also determined that MDP reduces pro-inflammatory cytokine production from multiple Tolllike receptors, and that this reduction arises from the induction of IFN regulatory factor 4 (IRF4). The technology includes methods of treating or preventing inflammation associated with an autoimmune disorder, PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 30953 particularly inflammatory bowel disease, via administration of muramyl peptide; also included are methods of reducing symptoms characteristic of inflammation via administration of muramyl peptide. Applications: This technology has potential as an anti-inflammatory therapy for autoimmune or other inflammation-associated diseases, particularly inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. Market: Approximately 1.8 million people suffer from inflammatory bowel disease in the major pharmaceutical markets. In the United States alone, there are approximately 300,000 to 500,000 people with inflammatory bowel disease, as estimated by the National Institute of Diabetes and Digestive and Kidney Diseases, NIH. Development Status: In vivo data are available in an experimental colitis mouse model, and in vitro data supporting mechanism of action also are available. Inventors: Warren Strober et al. (NIAID). Relevant Publication: T. Watanabe et al. Muramyl dipeptide activation of nucleotide-binding oligomerization domain 2 protects mice from experimental colitis. J Clin Invest. 2008 Feb;118(2):545–559. Patent Status: PCT Application No. PCT/US2007/086117 filed 30 Nov 2007 (HHS Reference No. E–110–2006/0– PCT–02). Licensing Status: This technology is available for exclusive or non-exclusive licensing. Licensing Contact: Tara Kirby, Ph.D.; 301–435–4426; tarak@mail.nih.gov. Collaborative Research Opportunity: The NIAID Laboratory of Host Defenses, Mucosal Immunity Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact either Rosemary Walsh or Charles Rainwater at 301–496–2644 for more information. Treatment and Diagnosis of Cancer, Diabetes and Other Disorders Using Adrenomedullin Peptides and Antibodies Description of Technology: Adrenomedullin (AM), a 52-amino acid regulatory peptide, is expressed in a wide range of tissues, and has a variety of biological roles. AM was initially identified as a vasodilator, and the effects of AM and its fragments in the cardiovascular system have been widely studied. AM also has important effects on renal function, cell growth, glucose E:\FR\FM\29MYN1.SGM 29MYN1 30954 Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices metabolism, and regulation of hormone secretion, and has antimicrobial activity. This technology claims AM peptides and antibodies, which would be useful in the development of a therapeutic or for diagnostics use. Also claimed are methods of inhibiting tumor cell growth using AM peptides, in particular in a patient suffering from a lung tumor. Claims are also directed to methods of treating a subject with AM-associated conditions, including diabetes, pregnancy, neurological disease, inflammation, or bone development. Finally, methods are claimed for diagnosing or monitoring a disease where AM levels are altered. Also available is a murine monoclonal antibody, MoAb-G6, which was raised against an AM peptide. This antibody neutralizes AM bioactivity, and reacts with the processed form of AM, but not the preprohormone. This antibody would be useful not only for research use, but also as part of a diagnostic assay for measurement or detection of AM. Applications Peptide- or antibody-based therapeutics for cancer, diabetes, inflammation or other AM-associated disease. Diagnostic tools for the detection of AM-positive tumors or other AMassociated conditions. Research use of AM peptides and antibodies. Development Status: This technology is currently in the pre-clinical stage of development. Inventors: Frank Cuttitta et al. (NCI). Related Publications ´ 1. A Martınez et al. Regulation of insulin secretion and blood glucose metabolism by adrenomedullin. Endocrinology. 1996 Jun;137(6):2626– 2632. 2. E Zudaire et al. The central role of adrenomedullin in host defense. J Leukoc Biol. 2006 Aug;80(2):237–244. 3. E Zudaire et al. Adrenomedullin is a cross-talk molecule that regulates tumor and mast cell function during human carcinogenesis. Am J Pathol. 2006 Jan;168(1):280–291. jlentini on PROD1PC65 with NOTICES Patent Status: U.S. Patent Serial No. 6,320,022 issued 20 Nov 2001 (HHS Reference No. E–206–1995/3–US–04). U.S. Patent Serial No. 7,101,548 issued 05 Sept 2006 (HHS Reference No. E–206–1995/3–US–10). U.S. Patent Application No. 11/ 517,599 filed 05 Sept 2006 (HHS Reference No. E–206–1995/3–US–11). VerDate Aug<31>2005 17:45 May 28, 2008 Jkt 214001 Foreign counterparts in Australia, Canada, France, Germany, Great Britain, and Japan. Related Technologies HHS Reference No. E–256–1999/0— Determination of AdrenomedullinBinding Proteins. HHS Reference No. E–294–2002/0—A New Target for Angiogenesis and AntiAngiogenesis Therapy. Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Tara Kirby, Ph.D.; 301–435–4426; tarak@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute Angiogenesis Core Facility is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Use of Adrenomedullin Peptides and Antibodies in the Treatment and Diagnosis of Cancer, Diabetes and other Disorders. Please contact John D. Hewes, Ph.D. at 301– 435–3121 or hewesj@mail.nih.gov for more information. Dated: May 21, 2008. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–11919 Filed 5–28–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, June 26, 2008, 1 p.m. to June 26, 2008, 3 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on May 16, 2008, 73 FR 28489– 28490. The meeting will be held June 24, 2008, 2 p.m. to 3 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: May 20, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–11785 Filed 5–28–08; 8:45 am] BILLING CODE 4140–01–M PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, June 23, 2008, 8 a.m. to June 24, 2008, 5 p.m., Sir Francis Drake Hotel, 450 Powell Street, San Francisco, CA 94102 which was published in the Federal Register on May 16, 2008, 73 FR 28489–28490. The meeting will be held one day only June 23, 2008, from 8 a.m. to 7 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: May 20, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–11787 Filed 5–28–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, June 17, 2008, 1 p.m. to June 17, 2008, 3 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on May 15, 2008, 73 FR 28121– 28122. The meeting will be held June 20, 2008, 11 a.m. to 2 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: May 20, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–11788 Filed 5–28–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Cancellation of Meeting Notice is hereby given of the cancellation of the Neurotechnology Study Section, June 3, 2008, 8 a.m. to June 4, 2008, 5 p.m., Grand Hyatt, 345 Stockton Street, San Francisco, CA E:\FR\FM\29MYN1.SGM 29MYN1

Agencies

[Federal Register Volume 73, Number 104 (Thursday, May 29, 2008)]
[Notices]
[Pages 30952-30954]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11919]


-----------------------------------------------------------------------

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.

[[Page 30953]]

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.

Telomerase Suppressor Compositions and Methods for Diagnosis and 
Treatment of Cancer

    Description of Technology: Lung cancer is responsible for one-third 
of all cancer related deaths. Although tobacco smoking is a major cause 
of lung cancer, epidemiological studies have provided evidence for the 
involvement of genetic factors in the disease onset. For now there are 
no reliable markers for the early lung cancer diagnostics and no 
effective treatment except resection of the tumor on early stages. As a 
result, it is difficult to diagnose lung cancer without invasive 
methods and before significant progression of the disease has occurred.
    NIH inventors have recently discovered that a gene called CCDC36 
(LELA1) is frequently inactivated in patients with non-small cell lung 
cancer (NSCLC). In many instances of lung cancer, particularly early 
onset NSCLC, one copy of CCDC36 will be lost due to the chromosomal 
deletion while the other will be inactivated by promoter methylation. 
This results in reduction or loss of CCDC36 gene expression. In 
addition, several single nucleotide polymorphisms (SNPs) found in the 
gene appeared to be associated with the early onset NSCLC. CCDC36 gene 
replacement could be utilized as a potential therapeutic strategy.

Applications

    Detection of SNPs associated with early onset NSCLC can be 
potentially used to diagnose predisposition.
    Detection of chromosomal loss of CCDC36 and/or its methylation 
status in lung cancer can be used to diagnose NSCLC.
    Treatment of NSCLC using CCDC36-based therapeutics.

Advantages

    Early detection of NSCLC has the potential to improve prognosis of 
lung cancer patient.
    Non-invasive nature of the test is beneficial to patient comfort.

Benefits

    There is no current genetic test for early onset NSCLC, providing 
an excellent market opportunity.
    Developing a diagnostic test for lung cancer will have significant 
social benefits, allowing the early detection and treatment of lung 
cancer patients.
    Inventors: Tatiana Dracheva et al. (NCI).
    Patent Status: PCT Application No. PCT/US2008/059800 filed 09 Apr 
2008 (HHS Reference No. E-265-2007/0-PCT-01).
    Licensing Status: Available for licensing.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Laboratory of Human Carcinogenesis is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
``Unique Genetic Changes in CCDC36 Gene That Are Associated with Early 
Onset Lung Cancer.'' Please contact John D. Hewes, Ph.D., at 301-435-
3121 or hewesj@mail.nih.gov for more information.

Muramyl Dipeptide as a Therapeutic Agent for Inflammation

    Description of Technology: The nucleotide-binding oligomerization 
domain 2 (NOD2) protein plays a key role in innate immunity as a sensor 
of muramyl dipeptide (MDP), a breakdown product of bacterial 
peptidoglycan. Bacterial peptidoglycan promotes the innate immune 
response through the activation of Toll-like receptor 2 (TLR2), which 
ultimately provokes inflammation. Activation of NOD2 by MDP negatively 
regulates the activity of TLR2, and thus reduces inflammation.
    The inventors have demonstrated that administration of MDP prevents 
the development of experimental colitis in mice. They have also 
determined that MDP reduces pro-inflammatory cytokine production from 
multiple Toll-like receptors, and that this reduction arises from the 
induction of IFN regulatory factor 4 (IRF4). The technology includes 
methods of treating or preventing inflammation associated with an 
autoimmune disorder, particularly inflammatory bowel disease, via 
administration of muramyl peptide; also included are methods of 
reducing symptoms characteristic of inflammation via administration of 
muramyl peptide.
    Applications: This technology has potential as an anti-inflammatory 
therapy for autoimmune or other inflammation-associated diseases, 
particularly inflammatory bowel diseases such as Crohn's disease and 
ulcerative colitis.
    Market: Approximately 1.8 million people suffer from inflammatory 
bowel disease in the major pharmaceutical markets. In the United States 
alone, there are approximately 300,000 to 500,000 people with 
inflammatory bowel disease, as estimated by the National Institute of 
Diabetes and Digestive and Kidney Diseases, NIH.
    Development Status: In vivo data are available in an experimental 
colitis mouse model, and in vitro data supporting mechanism of action 
also are available.
    Inventors: Warren Strober et al. (NIAID).
    Relevant Publication: T. Watanabe et al. Muramyl dipeptide 
activation of nucleotide-binding oligomerization domain 2 protects mice 
from experimental colitis. J Clin Invest. 2008 Feb;118(2):545-559.
    Patent Status: PCT Application No. PCT/US2007/086117 filed 30 Nov 
2007 (HHS Reference No. E-110-2006/0-PCT-02).
    Licensing Status: This technology is available for exclusive or 
non-exclusive licensing.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
tarak@mail.nih.gov.
    Collaborative Research Opportunity: The NIAID Laboratory of Host 
Defenses, Mucosal Immunity Section, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize this technology. Please 
contact either Rosemary Walsh or Charles Rainwater at 301-496-2644 for 
more information.

Treatment and Diagnosis of Cancer, Diabetes and Other Disorders Using 
Adrenomedullin Peptides and Antibodies

    Description of Technology: Adrenomedullin (AM), a 52-amino acid 
regulatory peptide, is expressed in a wide range of tissues, and has a 
variety of biological roles. AM was initially identified as a 
vasodilator, and the effects of AM and its fragments in the 
cardiovascular system have been widely studied. AM also has important 
effects on renal function, cell growth, glucose

[[Page 30954]]

metabolism, and regulation of hormone secretion, and has antimicrobial 
activity.
    This technology claims AM peptides and antibodies, which would be 
useful in the development of a therapeutic or for diagnostics use. Also 
claimed are methods of inhibiting tumor cell growth using AM peptides, 
in particular in a patient suffering from a lung tumor. Claims are also 
directed to methods of treating a subject with AM-associated 
conditions, including diabetes, pregnancy, neurological disease, 
inflammation, or bone development. Finally, methods are claimed for 
diagnosing or monitoring a disease where AM levels are altered.
    Also available is a murine monoclonal antibody, MoAb-G6, which was 
raised against an AM peptide. This antibody neutralizes AM bioactivity, 
and reacts with the processed form of AM, but not the preprohormone. 
This antibody would be useful not only for research use, but also as 
part of a diagnostic assay for measurement or detection of AM.

Applications

    Peptide- or antibody-based therapeutics for cancer, diabetes, 
inflammation or other AM-associated disease.
    Diagnostic tools for the detection of AM-positive tumors or other 
AM-associated conditions.
    Research use of AM peptides and antibodies.
    Development Status: This technology is currently in the pre-
clinical stage of development.
    Inventors: Frank Cuttitta et al. (NCI).

Related Publications

    1. A Martinez et al. Regulation of insulin secretion and blood 
glucose metabolism by adrenomedullin. Endocrinology. 1996 
Jun;137(6):2626-2632.
    2. E Zudaire et al. The central role of adrenomedullin in host 
defense. J Leukoc Biol. 2006 Aug;80(2):237-244.
    3. E Zudaire et al. Adrenomedullin is a cross-talk molecule that 
regulates tumor and mast cell function during human carcinogenesis. Am 
J Pathol. 2006 Jan;168(1):280-291.

Patent Status:

    U.S. Patent Serial No. 6,320,022 issued 20 Nov 2001 (HHS Reference 
No. E-206-1995/3-US-04).
    U.S. Patent Serial No. 7,101,548 issued 05 Sept 2006 (HHS Reference 
No. E-206-1995/3-US-10).
    U.S. Patent Application No. 11/517,599 filed 05 Sept 2006 (HHS 
Reference No. E-206-1995/3-US-11).
    Foreign counterparts in Australia, Canada, France, Germany, Great 
Britain, and Japan.

Related Technologies

    HHS Reference No. E-256-1999/0--Determination of Adrenomedullin-
Binding Proteins.
    HHS Reference No. E-294-2002/0--A New Target for Angiogenesis and 
Anti-Angiogenesis Therapy.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
tarak@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute 
Angiogenesis Core Facility is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize Use of Adrenomedullin Peptides and 
Antibodies in the Treatment and Diagnosis of Cancer, Diabetes and other 
Disorders. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
hewesj@mail.nih.gov for more information.

    Dated: May 21, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-11919 Filed 5-28-08; 8:45 am]
BILLING CODE 4140-01-P