[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Notices]
[Pages 10282-10283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4762]
[[Page 10282]]
-----------------------------------------------------------------------
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.
BODIPY[supreg]-FL Nilotinib (Tasigna[supreg]) for Use in Cancer
Research
Description of Invention: Investigators at the National Institutes
of Health have produced a fluorescently labeled derivative of the
clinically-approved, tyrosine kinase inhibitor (TKI) nilotinib
(Tasigna[supreg]) for use in research. This was accomplished by
conjugating the fluorescent dye BODIPY[supreg]-FL to nilotinib.
The TKI imatinib (Gleevec[supreg]) is the first targeted
therapeutic developed and is used as first line treatment of
Philadelphia chromosome-positive (Ph+) cancers like chronic myeloid
leukemia (CML). Although imatinib is highly effective, after continued
use the cancer cells frequently become resistant to the drug. Nilotinib
is a second generation TKI developed to overcome imatinib resistance,
but eventually it can also result in drug resistance.
The fluorescent nilotinib conjugate was developed to study the
mechanism by which cancer cells become resistant to nilotinib and
better understand its cytotoxic effects.
Applications
Use in monitoring cellular accumulation of nilotinib using
flow cytometry, fluorescent microscopy, or other fluorometric
techniques
Use as an in vivo probe with experimental models and in
clinical studies for analyzing drug efficacy, pharmacokinetic profile
and drug localization
Use for the study of cytotoxic effects of nilotinib in
important physiological locations such as the heart and brain
Use in identifying other potential targets of nilotinib in
different types of cancer
Use in in vivo imaging to identify potential physiological
barriers to drug penetration into tissues
Advantages
Material is ready for use reducing time and effort to
duplicate
BODIPY[supreg]-FL dye is compatible with commonly-used
fluorescein dye optics and has superior can be used for both in vitro
and in vivo studies.
Development Status:
Ready for use.
Pre-clinical data available.
Market: The size of the chronic myeloid leukemia (CML) market is
expected fluorescent properties to fluorescein
BODIPY[supreg]-FL Nilotinib (Tasigna[supreg]) is
compatible and to increase with an aging population. It was estimated
that in 2009, there were 91,500 patients with CML in the U.S. and other
major other developed countries, increasing by 9-11% per year. The
fluorescently- labeled Nilotinib (Tasigna[supreg]) will be useful for
researchers working to develop next generation tyrosine kinase
inhibitors.
Inventors: Suneet Shukla (NCI), Suresh V. Ambudkar (NCI), Craig J.
Thomas (NHGRI/NCGC), Amanda P. Skoumbourdis (NHGRI/NCGC).
Publications: None currently available for this technology.
Patent Status: HHS Reference No. E-009-2010/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for biological materials licensing.
Licensing Contact: Sabarni Chatterjee, Ph.D.; 301-435-5587;
[email protected].
Collaborative Research Opportunity: The National Cancer Institute,
Transport Biochemistry Section, Laboratory of Cell Biology, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
bodipy conjugated tyrosine kinase inhibitors that are currently used in
the clinic for the treatment of CML or gastric cancers. We are also
interested in evaluating third generation tyrosine kinase inhibitor
derivatives as modulators of ABC drug transporters to improve the
efficiency of chemotherapy in animal (mouse) model system. In addition,
we can identify possible pharmacokinetic interactions of the novel
kinase inhibitors with ABC drug transporters. Please contact John
Hewes, Ph.D. at 301-435-3131 or [email protected] for more
information.
Diagnosis and Treatment of Cancer Using Histone Deacetylase Inhibitors
and Radiolabeled Metaiodobenzylguanidine
Description of Invention: Pheochromocytoma is a neuroendocrine
tumor of the adrenal glands. Pheochromocytoma patients display the
signs and symptoms of those of sympathetic nervous system
hyperactivity. Up to 36% of patients worldwide with pheochromocytoma
develop metastatic disease and have a 5-year survival rate of
approximately 50% after diagnosis. Patients with metastatic
pheochromocytoma exhibit excessive levels of circulating
catecholamines, which results in increased risk of strokes, cardiac
arrhythmias, and hypertensive complications. Current treatments for
malignant pheochromocytoma include targeted radiation using [\131\I]-
metaiodobenzylguanidine ([\131\I]-MIBG), cytotoxic chemotherapy,
octreotide, tumor hemoembolization, etc. The success of these
treatments varies based on the sites and growth rate of metastatic
lesions.
The present invention provides a method for treating a mammalian
tumor with a histone deacetylase inhibitor (HDACi), and followed by
administering [\131\I]-MIBG. Methods of diagnosis and imaging of
mammalian tumors are also disclosed. These findings suggest that HDACi
could enhance the therapeutic efficacy of [\131\I]-MIBG treatment in
patients with malignant pheochromocytoma.
Applications and Market:
Diagnosis and therapeutic for treating cancer, such as
pheochromocytoma.
Approximately 1000 cases of pheochromocytoma are diagnosed
in United States yearly.
Development Status: Pre-clinical stage of development.
Inventors: Karel Pacak et al. (NICHD).
Publications: Manuscript submitted.
Patent Status: U.S. Provisional Application No. 61/260,991 filed 13
Nov 2009 (HHS Reference No. E-299-2009/0-US-01).
Licensing Status: Available for licensing.
[[Page 10283]]
Licensing Contact: Betty B. Tong, PhD; 301-594-6565;
[email protected].
Collaborative Research Opportunity: The National Institute of Child
Health and Human Development, Reproductive Biology and Adult
Endocrinology Branch, is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize [\131\I]-MIBG treatment of malignant/
metastatic pheochromocytoma, paraganglioma, and neuroblastoma; also
[123/131I]-MIBG scintigraphy--in all situations histone
deacetylase to be used before MIBG is used. Please contact Joseph
Conrad, PhD at 301-435-3107 or [email protected] for more
information.
Specific Binding Agents for KSHV vIL-6 That Neutralize a Biological
Activity
Description of Invention: Kaposi's sarcoma-associated herpes virus
(KSHV) is an oncogenic herpes virus originally identified in AIDS
associated Kaposi's sarcoma (KS) lesions, the most common tumor
associated with HIV infection. KSHV encodes various proteins that have
characteristics associated with cellular growth and transformation,
including viral (v) IL-6 (KSHV vIL-6). These viral proteins display
structural homology to their cellular counterparts, and human and vIL-6
are multifunctional cytokines that have been shown to induce vascular
endothelial growth factor and other factors.
Available for licensing are binding agents that neutralize vIL-6
biological activities, methods of diagnosing and treating KSHV
disorders, and methods to monitor KSHV patient response to treatment.
Deregulation of cellular IL-6 expression is known to contribute to
tumor development, suggesting that KSHV-derived vIL-6 could be part of
a viral strategy to promote malignant transformation. Neutralizing
activity of anti-vIL-6 antibodies may provide a potential therapeutic
for KSHV disorders such as HIV, Castleman's disease, and primary
effusion lymphoma.
Applications:
Therapeutic compositions to treat KSHV disorders such as
KS, Castleman's disease, and primary effusion lymphoma.
Method to diagnose and treat KSHV disorders.
Method to monitor patient response to KSHV treatment.
Market:
Approximately 476,095 persons currently living with HIV/
AIDS in the United States.
Estimated annual incidence rate for KS is 5 cases per
100,000/year in the U.S.
KS contributes to approximately 30% of AIDS related
deaths.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Giovanna Tosato (NCI) et al.
Publications:
1. Y Aoki and G Tosato. Therapeutic options for human herpesvirus-
8/Kaposi's sarcoma-associated herpesvirus-related disorders. Expert Rev
Anti Ther. 2004 Apr;2(2):213-225. [PubMed: 15482187].
2. Y Aoki et al. Detection of viral interleukin-6 in Kaposi
sarcoma-associated herpesvirus-linked disorders. Blood. 2001 Apr
1;97(7):2173-2176. [PubMed: 11264189].
3. Y Aoki et al. Kaposi's sarcoma-associated herpesvirus-encoded
interleukin-6. J Hemathother Stem Cell Res. 2000;9(2):137-145. [PubMed:
10813527].
Patent Status:
U.S. Patent No. 6,939,547 issued 06 Sep 2005 (HHS Reference No. E-
180-2000/0-US-03).
U.S. Patent No. 7,108,981 issued 19 Sep 2006 (HHS Reference No. E-
180-2000/0-US-04).
U.S. Patent No. 7,235,365 issued 26 Jun 2007 (HHS Reference No. E-
180-2000/0-US-05).
U.S. Patent No. 7,374,756 issued 20 May 2008 (HHS Reference No. E-
180-2000/0-US-06).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301/435-4633;
[email protected].
Collaborative Research Opportunity: The National Cancer Institute's
Laboratory of Cellular Oncology is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize therapeutics for Kaposi's sarcoma-
associated herpes virus (KSHV). Please contact John D. Hewes, PhD at
301-435-3121 or [email protected] for more information.
Dated: March 1, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-4762 Filed 3-4-10; 8:45 am]
BILLING CODE 4140-01-P