[Federal Register Volume 71, Number 84 (Tuesday, May 2, 2006)]
[Notices]
[Pages 25852-25853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6549]


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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.

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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.

Tetracyclines and Derivatives as Inhibitors of Human Tyrosyl-DNA-
phosphodiesterase (Tdp1)

    Description of Technology: The invention describes tetracycline 
compounds and their derivatives as having anticancer activity, as well 
as methods of treating cancer. Tetracyclines are commonly used as 
antibiotics, however testing of these compounds in a high throughput 
screening system for Tdp1 inhibitors revealed them to be potent Tdp1 
inhibitors. Tdp1 is known to be important for mutation avoidance under 
normal growth conditions. Tetracyclines derivatives are expected to 
increase the selectivity of chemotherapeutic agents (e.g. 
camptothecin), for tumors, thereby increasing the antitumor activity 
while reducing their side effects.
    Inventors: Yves Pommier, Christophe Marchand, Laurent Thibaut 
(NCI).
    Patent Status: U.S. Provisional Application filed March 27, 2006 
(HHS Reference No. E-097-2006/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Richard Rodriguez; 301/435-4013; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Molecular 
Pharmacology at the National Cancer Institute is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize tetracycline 
derivatives, particularly optimizing them for therapeutic use. Please 
contact Lisa Finkelstein at 301-451-7458 for more information.

Insect Cell Production of Recombinant Adeno-Associated Virus That 
Produce Cytotoxic Gene Products and Applications for Solid Tumor 
Therapy

    Description of Technology: Cancer is the second leading cause of 
death in United States and it is estimated that there will be 
approximately 600,000 deaths caused by cancer in 2006. Due to the high 
incidence of death from cancer despite the use of current therapies, 
there is a strong need for targeted therapeutic approaches such as gene 
therapy.
    This technology describes a new method for targeting solid tumors 
using gene therapy. More specifically, mammalian HEC-1 has a critical 
role in chromosome segregation and thus cell division. This technology 
involves targeted depletion of HEC-1 using shRNA against the HEC-1 mRNA 
inhibiting cancer cell growth in cell culture models (in vitro) as well 
as regressed tumor size in mouse model (in vivo). Additionally, this is 
the sole technology using an insect cell based recombinant adeno-
associated virus (rAAV) gene transfer vehicle with high titer 
containing the shRNA of interest thus enabling high dosing during 
therapeutic intervention if necessary. This technology platform has the 
potential to treat a broad spectrum of cancers and related diseases.
    Applications: A new anti-cancer adjuvant therapy for non-resectable 
tumors targeting HEC-1 protein; a new method involving insect cell 
based production of recombinant adeno-associated virus (rAAV) gene 
transfer vehicle.
    Market: 600,000 deaths from cancer related diseases estimated in 
2006. The technology platform involving new cancer therapy and gene 
therapy technology has a potential market of more than 50 billion 
dollars.
    Development Status: The technology is currently in pre-clinical 
stage of development.
    Inventors: Robert M. Kotin and Lina Li (NHLBI).
    Publications:
    1. EN Gurzov et al., ``RNA Interference against Hec 1 inhibits 
tumor growth in vivo,'' Gene Ther. 2006 Jan; 13 (1):1-7.
    2. JG DeLuca et al., ``Hec1 and nuf2 are core components of the 
kinetochore outer plate essential for organizing microtubule attachment 
sites,'' Mol Biol Cell. 2005 Feb; 16 (2):519-531.
    3. S Martin-Lluesma et al., ``Role of Hec1 in spindle checkpoint 
signaling and kinetochore recruitment of Mad1/Mad2,'' Science 2002 Sep 
27; 297 (5590):2267-2270.

[[Page 25853]]

    4. T Hori et al., ``Dynamic behavior of Nuf2-Hec1 complex that 
localizes to the centrosome and centromere and is essential for mitotic 
progression in vertebrate cells,'' J Cell Sci. 2003 Aug 15; 116 (Pt 
16):3347-3362.
    5. Y Chen et al., ``Phosphorylation of the mitotic regulator 
protein Hec1 by Nek2 kinase is essential for faithful chromosome 
segregation,'' J Biol Chem. 2002 Dec 20; 277 (51):49408-49416.
    Patent Status: U.S. Provisional Application No. 60/782,277 filed 15 
Mar 2006 (HHS Reference No. E-200-2005/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Jesse S. Kindra, J.D.; 301/435-5559; 
[email protected].
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute, Laboratory of Biochemical Genetics, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop therapeutics using rAAV-shRNA 
to induce selective cytotoxicity in primary and metastatic solid 
tumors. Partners are sought for conducting translational research from 
preclinical trials to clinical trials. Please contact Dr. Vincent 
Kolesnitchenko, Office of Technology Transfer and Development, NHLBI at 
301-594-4115 or by e-mail ([email protected]) for more information.

Identification of a Novel Folliculin Interacting Protein, FNIP-1

    Description of Technology: Renal cell carcinoma is an important 
health problem in the United States, affecting 32,000 individuals each 
year and resulting in 12,000 deaths annually. Several familial cancer 
disorders with a renal epithelial tumor phenotype have been well 
characterized and the causative genes have been identified including 
the Birt-Hogg-Dube (BHD) gene. The BHD gene encodes a protein called 
folliculin. Mutations in BHD lead to the development of Birt-Hogg Dube 
syndrome, a dermatologic disorder associated with an increased risk for 
developing renal cancer, spontaneous pneumothorax and lung cysts.
    This invention describes the cloning and characterization of the 
first folliculin interacting protein FNIP-1 and purified antibodies 
that selectively bind to an epitope of FNIP-1. FNIP-1 interacts with 
subunits of AMP-dependent protein kinase (AMPK). The FNIP-1/AMPK 
interaction places FNIP-1 and folliculin as potential interactors in 
cellular pathways essential for regulating cell growth and cell size. 
FNIP-1 may play an important role in folliculin's function. 
Identification of the FNIP-1 cDNA sequence will enable evaluation of 
sporadic renal tumors, enable the development of cancer diagnostics and 
aid in the treatment of BHD skin lesions.
    Inventors: Laura S. Schmidt et al. (NCI).
    Patent Status: U.S. Provisional Application No. 60/689,749 filed 
June 9, 2005 (HHS Reference No. E-139-2005/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: John Stansberry, Ph.D.; 301/435-5236; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize folliculin interacting protein 
FNIP-1 and purified antibodies. Please contact Kathy Higinbotham at 
301-846-5465 or [email protected] for more information.

Bone Morphogenetic Variants, Compositions and Methods of Treatment

    Description of Technology: The invention identifies proteins 
belonging to TGF-Beta superfamily that promote repair of menisci, 
cruciate and collateral ligaments of the knee, and rotator cuff 
tendons. The application claims nucleic acids encoding human Cartilage-
Derived Morphogenetic Protein-1 (hCDMP-1) variant polypeptides. 
Morphogenetic proteins are able to induce the proliferation and 
differentiation of progenitor cells into functional bone, cartilage, 
tendon, or ligament tissue.
    Inventors: Malcolm C. Moos et al. (FDA).
    Patent Status: U.S. Provisional Application No. 60/689,346 filed 
June 9, 2005 (HHS Reference No. E-196-2004/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076; 
[email protected].

    Dated: April 25, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-6549 Filed 5-1-06; 8:45 am]
BILLING CODE 4140-01-P