Government-Owned Inventions; Availability for Licensing, 20710-20711 [E9-10300]

Download as PDF 20710 Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Notices Dated: April 28, 2009. Daniel G. Wheeland, Director, Office of Research Facilities Development and Operations, National Institutes of Health. [FR Doc. E9–10290 Filed 5–4–09; 8:45 am] certain cancers, such as extrahepatic cholangiocarcinoma (EHCC). This technology describes compositions, methods and kits for identifying, characterizing biomolecules expressed in a sample that are associated with the presence, the development, or progression of cancer. Utilizing multiplex tissue immunoblotting, the inventors have demonstrated that PTEN expression, PTEN/p-AKT ratios, and PTEN/p-mTOR ratios can predict the survival of cancer patients. These biomarkers may provide useful diagnostic information for cancer patients as well as identify patients appropriate for mTOR analog-based chemotherapy or agents directed against AKT. BILLING CODE 4140–01–P Applications the long-range physical Master Plan for Rocky Mountain Laboratories in Hamilton, Montana. The decision accounts for potential growth in RML personnel, possible land acquisitions, and consequent construction of new administrative and research space over the 20-year planning period. The decision was based upon review and careful consideration of the impacts identified in the FEIS and public comments received throughout the NEPA process. 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. Ratio Based Biomarkers for the Prediction of Cancer Survival Description of Technology: The AKT pathway plays a key role in the regulation of cellular survival, apoptosis, and protein translation and has been shown to have prognostic significance in a number of cancers. Recently, the inventors have identified several functions of the AKT pathway in VerDate Nov<24>2008 23:12 May 04, 2009 Jkt 217001 • Diagnostic and Prognostic tool to detect the presence of cancer and predict the relative cancer survival rate for a subject with cancer. • Method of identifying patients appropriate for therapies targeted to the AKT pathway. • A kit for detecting cancer associated proteins in a sample. Development Status: Pre-clinical stage of development. Market: Extrahepatic cholangiocarcinoma (EHCC) is a malignant neoplasm of biliary tract epithelia, and constitutes approximately 80–90% of all cholangiocarcinomas. Surgical resection is the mainstay of treatment, but results in only an approximately 20% 5-year survival rate. Neoadjuvant therapies, including chemotherapy, radiation therapy, and photodynamic therapy have also failed to show significant survival benefit, thus emphasizing the need for prognostic and predictive biomarkers. Inventors: Stephen M. Hewitt and Joon-Yong Chung (NCI). Publications 1. JY Chung et al. The expression of phospho-AKT, phospho-mTOR, and PTEN in extrahepatic cholangiocarcinoma. Clin Cancer Res. 2009 Jan 15;15(2):660–667. 2. JY Chung et al. Transfer and multiplex immunoblotting of a paraffin embedded tissue. Proteomics 2006 Feb;6(3):767–774. 3. JY Chung et al. A multiplex tissue immunoblotting assay for proteomic profiling: a pilot study of the normal to tumor transition of esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 2006 Jul;15(7):1403–1408. Patent Status: U.S. Provisional Application No. 61/114,501 filed PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 January 14, 2009 (HHS Reference No. E– 025–2009/0–US–01). Licensing Status: Available for licensing. Licensing Contact: Whitney A. Hastings; 301–451–7337; hastingw@mail.nih.gov. Modulating Expression of the Metastasis Suppressor MxA Description of Technology: The invention discloses compounds that could be used to inhibit metastases. The compounds of the current invention were discovered by high-throughput screening of a novel cell line engineered with a MxA reporter. The compounds could be used to treat metastatic cancers including prostate and melanomas by increasing MxA expression. MxA expression reduces cell motility and metastases in a mouse model. Cells expressing MxA produced smaller tumors in engrafted mice compared to controls. When injected into mouse spleens, cells expressing MxA showed a significantly delayed metastasis, and the mice survived significantly longer than controls. Expression of MxA reduced cellular motility of prostate cancer cell lines in vitro and reduced cellular motility and invasiveness of the highly metastatic melanoma cell line LOX. In addition to the use of the instant MxA compounds as antimetastatic agents, MxA is a known effective anti-viral agent and the MxA-inducing compounds could be used to treat infections sensitive to the antiviral activity of MxA, which potentially include myxovirus-associated disease. Applications • Treatment or prevention of cancers using MxA-targeted small molecule therapeutics. • MxA diagnostic to identify metastatic potential in tumor biopsies. • Treatment or prevention of a myxovirus-associated infection, including seasonal and avian flu, using MxA-inducing small molecule therapeutics. Development Status: Identifying lead compounds for clinical development using structure-activity relationship (SAR) analysis. Inventors: Jane B. Trepel et al. (NCI). Publications 1. JF Mushinski, P Nguyen, LM Stevens, C Khanna, S Lee, EJ Chung, MJ Lee, YS Kim, WM Linehan, MA Horisberger, JB Trepel. Inhibition of tumor cell motility by the interferoninducible GTPase MxA. J Biol Chem. 2009 Mar 18; online publication ahead of print. E:\FR\FM\05MYN1.SGM 05MYN1 Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Notices 2. G Athauda, A Giubellino, JA Coleman, C Horak, PS Steeg, MJ Lee, J Trepel, J Wimberly, J Sun, A Coxon, TL Burgess, DP Bottaro. c-Met ectodomain shedding rate correlates with malignant potential. Clin Cancer Res. 2006 Jul 15;12(14 Pt 1):4154–4162. Patent Status: U.S. Patent Application No. 11/663,936 filed March 27, 2007 (HHS Reference No. E–257–2004/0–US– 06) and foreign counterparts. Licensing Status: Available for licensing. Licensing Contact: Whitney A. Hastings; 301–451–7337; hastingw@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute, Medical Oncology Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John D. Hewes, Ph.D. at 301– 435–3121 or hewesj@mail.nih.gov for more information. Targeted Recombinant Adenoviral Vectors Description of Technology: The current invention embodies recombinant adenoviral vectors for use in targeted gene transfer. The method by which these vectors are generated involves no molecular modifications to the adenovirus genome, and allows for the production of vectors targeted specifically to virtually any cell line of choice. Specifically, the vectors are generated by directly linking biotin to the capsid of adenovirus particles. The particles are then treated with streptavidin and subsequently incubated with a biotinylated targeting moiety which is capable of recognizing a specific marker which is expressed on the surface of selected cells. The resulting adenoviral vectors are useful for gene transfer, and can be targeted to virtually any cell type of interest via incubation with a specific targeting moiety. To date, the inventors have demonstrated that these vectors can be specifically directed to target and infect hematopoietic cell lines which display the c-kit receptor, and are capable of achieving high levels of gene expression in these cell lines. Also, these vectors can be specifically directed to cell surface markers such as CD34, CD44 and others through antibodies directly attached to the biotynilated adenoviral vectors. Such gene transfer represents a gene therapy approach upon which the development of specific therapies against a broad range of diseases may be based, including immunodeficiency VerDate Nov<24>2008 23:12 May 04, 2009 Jkt 217001 20711 diseases, blood cell disorders, and various cancers. DEPARTMENT OF HEALTH AND HUMAN SERVICES Applications Centers for Disease Control and Prevention • Adenovirus with gene plus Biotinylation kit with strepavidin with ligand or antibody for gene of interest • Biotin linking kits with methods for use Development Status: Delivery of the biotinylated recombinant adenoviral vector in vitro for use in targeted gene transfer. Inventors: Jonathan Keller et al. (NCI). Publications 1. JS Smith, JR Keller, NC Lohrey, CS McCauslin, M Ortiz, K Cowan, SE Spence. Redirected infection of directly biotinylated recombinant adenovirus vectors through cell surface receptors and antigens. Proc Natl Acad Sci U S A. 1999 Aug 3;96(16):8855–8860. 2. S Ponnazhagan, G Mahendra, S Kumar, JA Thompson, M Castillas Jr. Conjugate-based targeting of recombinant adeno-associated virus type 2 vectors by using avidin-linked ligands. J Virol. 2002 Dec;76(24):12900– 12907. 3. M Brandon Parrott, KE Adams, GT Mercier, H Mok, SK Campos, MA Barry. Metabolically biotinylated adenovirus for cell targeting, ligand screening, and vector purification. Mol Ther. 2003 Oct;8(4):688–700. Patent Status • U.S. Patent 6,555,367 issued April 29, 2003 (HHS Reference No. E–193– 1997/0–US–03). • U.S. Patent Application Publication No. US2003/0175973, published September 18, 2003 (HHS Reference No. E–193–1997/0–US–04). Licensing Status: Available for licensing. Licensing Contact: Whitney A. Hastings; 301–451–7337; hastingw@mail.nih.gov. Dated: April 27, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E9–10300 Filed 5–4–09; 8:45 am] BILLING CODE 4140–01–P PO 00000 National Center for Injury Prevention and Control, Initial Review Group, (NCIPC, IRG) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned review group: Times and Date: 12:30 p.m.–1 p.m., May 20, 2009 (Open). 1 p.m.–3 p.m., May 20, 2009 (Closed). Place: Teleconference, Toll Free: 888–793– 2154. Participant Passcode: 4424802. Status: Portions of the meetings will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Section 10(d) of Public Law 92–463. Purpose: This group is charged with providing advice and guidance to the Secretary, Department of Health and Human Services, and the Director, CDC, concerning the scientific and technical merit of grant and cooperative agreement applications received from academic institutions and other public and private profit and nonprofit organizations, including State and local government agencies, to conduct specific injury research that focuses on prevention and control. Matters to be Discussed: The meeting will include the review, discussion, and evaluation of individual research cooperative agreement applications submitted in response to Fiscal Year 2009 Requests for Applications related to the following individual research announcement: RFA– EH–09–002 ‘‘Program to Expand State Public Health Laboratory Capacity for Newborn Bloodspot Screening (U01)’’. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Jane Suen, Dr.P.H., M.S., NCIPC, CDC, 4770 Buford Highway, NE., Mailstop F–62, Atlanta, Georgia 30341, Telephone: (770) 488–4281. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 24, 2009. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E9–10292 Filed 5–4–09; 8:45 am] BILLING CODE 4163–18–P Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\05MYN1.SGM 05MYN1

Agencies

[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Notices]
[Pages 20710-20711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10300]


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

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.

Ratio Based Biomarkers for the Prediction of Cancer Survival

    Description of Technology: The AKT pathway plays a key role in the 
regulation of cellular survival, apoptosis, and protein translation and 
has been shown to have prognostic significance in a number of cancers. 
Recently, the inventors have identified several functions of the AKT 
pathway in certain cancers, such as extrahepatic cholangiocarcinoma 
(EHCC).
    This technology describes compositions, methods and kits for 
identifying, characterizing biomolecules expressed in a sample that are 
associated with the presence, the development, or progression of 
cancer. Utilizing multiplex tissue immunoblotting, the inventors have 
demonstrated that PTEN expression, PTEN/p-AKT ratios, and PTEN/p-mTOR 
ratios can predict the survival of cancer patients. These biomarkers 
may provide useful diagnostic information for cancer patients as well 
as identify patients appropriate for mTOR analog-based chemotherapy or 
agents directed against AKT.

Applications

     Diagnostic and Prognostic tool to detect the presence of 
cancer and predict the relative cancer survival rate for a subject with 
cancer.
     Method of identifying patients appropriate for therapies 
targeted to the AKT pathway.
     A kit for detecting cancer associated proteins in a 
sample.
    Development Status: Pre-clinical stage of development.
    Market: Extrahepatic cholangiocarcinoma (EHCC) is a malignant 
neoplasm of biliary tract epithelia, and constitutes approximately 80-
90% of all cholangiocarcinomas. Surgical resection is the mainstay of 
treatment, but results in only an approximately 20% 5-year survival 
rate. Neoadjuvant therapies, including chemotherapy, radiation therapy, 
and photodynamic therapy have also failed to show significant survival 
benefit, thus emphasizing the need for prognostic and predictive 
biomarkers.
    Inventors: Stephen M. Hewitt and Joon-Yong Chung (NCI).

Publications

    1. JY Chung et al. The expression of phospho-AKT, phospho-mTOR, and 
PTEN in extrahepatic cholangiocarcinoma. Clin Cancer Res. 2009 Jan 
15;15(2):660-667.
    2. JY Chung et al. Transfer and multiplex immunoblotting of a 
paraffin embedded tissue. Proteomics 2006 Feb;6(3):767-774.
    3. JY Chung et al. A multiplex tissue immunoblotting assay for 
proteomic profiling: a pilot study of the normal to tumor transition of 
esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 
2006 Jul;15(7):1403-1408.
    Patent Status: U.S. Provisional Application No. 61/114,501 filed 
January 14, 2009 (HHS Reference No. E-025-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
hastingw@mail.nih.gov.

Modulating Expression of the Metastasis Suppressor MxA

    Description of Technology: The invention discloses compounds that 
could be used to inhibit metastases. The compounds of the current 
invention were discovered by high-throughput screening of a novel cell 
line engineered with a MxA reporter. The compounds could be used to 
treat metastatic cancers including prostate and melanomas by increasing 
MxA expression.
    MxA expression reduces cell motility and metastases in a mouse 
model. Cells expressing MxA produced smaller tumors in engrafted mice 
compared to controls. When injected into mouse spleens, cells 
expressing MxA showed a significantly delayed metastasis, and the mice 
survived significantly longer than controls. Expression of MxA reduced 
cellular motility of prostate cancer cell lines in vitro and reduced 
cellular motility and invasiveness of the highly metastatic melanoma 
cell line LOX. In addition to the use of the instant MxA compounds as 
antimetastatic agents, MxA is a known effective anti-viral agent and 
the MxA-inducing compounds could be used to treat infections sensitive 
to the antiviral activity of MxA, which potentially include myxovirus-
associated disease.

Applications

     Treatment or prevention of cancers using MxA-targeted 
small molecule therapeutics.
     MxA diagnostic to identify metastatic potential in tumor 
biopsies.
     Treatment or prevention of a myxovirus-associated 
infection, including seasonal and avian flu, using MxA-inducing small 
molecule therapeutics.
    Development Status: Identifying lead compounds for clinical 
development using structure-activity relationship (SAR) analysis.
    Inventors: Jane B. Trepel et al. (NCI).

Publications

    1. JF Mushinski, P Nguyen, LM Stevens, C Khanna, S Lee, EJ Chung, 
MJ Lee, YS Kim, WM Linehan, MA Horisberger, JB Trepel. Inhibition of 
tumor cell motility by the interferon-inducible GTPase MxA. J Biol 
Chem. 2009 Mar 18; online publication ahead of print.

[[Page 20711]]

    2. G Athauda, A Giubellino, JA Coleman, C Horak, PS Steeg, MJ Lee, 
J Trepel, J Wimberly, J Sun, A Coxon, TL Burgess, DP Bottaro. c-Met 
ectodomain shedding rate correlates with malignant potential. Clin 
Cancer Res. 2006 Jul 15;12(14 Pt 1):4154-4162.
    Patent Status: U.S. Patent Application No. 11/663,936 filed March 
27, 2007 (HHS Reference No. E-257-2004/0-US-06) and foreign 
counterparts.
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
hastingw@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute, 
Medical Oncology Branch, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize this technology. Please contact 
John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more 
information.

Targeted Recombinant Adenoviral Vectors

    Description of Technology: The current invention embodies 
recombinant adenoviral vectors for use in targeted gene transfer. The 
method by which these vectors are generated involves no molecular 
modifications to the adenovirus genome, and allows for the production 
of vectors targeted specifically to virtually any cell line of choice. 
Specifically, the vectors are generated by directly linking biotin to 
the capsid of adenovirus particles. The particles are then treated with 
streptavidin and subsequently incubated with a biotinylated targeting 
moiety which is capable of recognizing a specific marker which is 
expressed on the surface of selected cells. The resulting adenoviral 
vectors are useful for gene transfer, and can be targeted to virtually 
any cell type of interest via incubation with a specific targeting 
moiety.
    To date, the inventors have demonstrated that these vectors can be 
specifically directed to target and infect hematopoietic cell lines 
which display the c-kit receptor, and are capable of achieving high 
levels of gene expression in these cell lines. Also, these vectors can 
be specifically directed to cell surface markers such as CD34, CD44 and 
others through antibodies directly attached to the biotynilated 
adenoviral vectors. Such gene transfer represents a gene therapy 
approach upon which the development of specific therapies against a 
broad range of diseases may be based, including immunodeficiency 
diseases, blood cell disorders, and various cancers.

Applications

     Adenovirus with gene plus Biotinylation kit with 
strepavidin with ligand or antibody for gene of interest
     Biotin linking kits with methods for use
    Development Status: Delivery of the biotinylated recombinant 
adenoviral vector in vitro for use in targeted gene transfer.
    Inventors: Jonathan Keller et al. (NCI).

Publications

    1. JS Smith, JR Keller, NC Lohrey, CS McCauslin, M Ortiz, K Cowan, 
SE Spence. Redirected infection of directly biotinylated recombinant 
adenovirus vectors through cell surface receptors and antigens. Proc 
Natl Acad Sci U S A. 1999 Aug 3;96(16):8855-8860.
    2. S Ponnazhagan, G Mahendra, S Kumar, JA Thompson, M Castillas Jr. 
Conjugate-based targeting of recombinant adeno-associated virus type 2 
vectors by using avidin-linked ligands. J Virol. 2002 Dec;76(24):12900-
12907.
    3. M Brandon Parrott, KE Adams, GT Mercier, H Mok, SK Campos, MA 
Barry. Metabolically biotinylated adenovirus for cell targeting, ligand 
screening, and vector purification. Mol Ther. 2003 Oct;8(4):688-700.

Patent Status

     U.S. Patent 6,555,367 issued April 29, 2003 (HHS Reference 
No. E-193-1997/0-US-03).
     U.S. Patent Application Publication No. US2003/0175973, 
published September 18, 2003 (HHS Reference No. E-193-1997/0-US-04).
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
hastingw@mail.nih.gov.

    Dated: April 27, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-10300 Filed 5-4-09; 8:45 am]
BILLING CODE 4140-01-P

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