[Federal Register Volume 72, Number 83 (Tuesday, May 1, 2007)]
[Notices]
[Pages 23835-23837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8288]


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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.

New High-Throughput and Bioinformatic Tools To Identify and Use Genomic 
DNA Sequence Dimorphisms (Indels)

    Description of Technology: This invention describes new methods to 
identify genomic DNA sequence dimorphisms called indels and to 
determine their biological consequences. ``Indels'' refers to large 
insertions and deletions, a form of variation in DNA sequences, that 
can cause genotypic and phenotypic differences between cells, tissues, 
individuals, populations or species. The technology describes new 
bioinformatic tools and high-throughput methods to identify such 
dimorphisms. Additionally, the technology provides new assays to 
distinguish genomic sequences by genotyping, understand the role of 
such indels in altering gene expression, for example in disease 
pathogenesis, develop new models for variation in genomes and in gene 
expression, and improve methods for the molecular diagnosis and 
treatment of disease.
    Applications:
    1. A new bioinformatics software tool that can easily identify 
dimorphisms and can help create a searchable database and graphical 
interface containing sites of dimorphisms and information regarding 
functional effects of dimorphisms.
    2. Low cost, high-throughput PCR based methods to identify 
dimorphic repetitive elements from any eukaryotic genome including 
individual tissue specimens.
    3. Methods to determine functional consequences of dimorphisms 
(indels).
    Development Status:
    1. Bioinformatics software tools are ready for use.
    2. High-throughput PCR methods have been validated.
    3. Annotated mouse genes whose expression is altered by dimorphic 
indels have been identified.
    Inventors: David E. Symer et al. (NCI).
    Relevant Publications:
    1. Manuscripts relating to this invention are under preparation and 
will be available once accepted for publication.
    2. RE Mills et al. An initial map of insertion and deletion (INDEL) 
variation in the human genome. Genome Res. 2006 Sep;16(9):1182-1190.
    Patent Status: U.S. Provisional Application No. 60/841,089 filed 29 
Aug 2006 (HHS Reference No. E-301-2006/0-US-01)
    Licensing Status: This technology is available for licensing under 
an

[[Page 23836]]

exclusive or non-exclusive patent license.
    Licensing Contact: Michelle Booden, PhD; 301/451-7337; 
[email protected]
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Mouse Cancer Genetics Program is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
identification and use of such genomic DNA sequence insertion/deletion 
dimorphisms (indels). Please contact John D. Hewes, PhD at 301/435-3121 
or [email protected] for more information.

Self-Assembling Nanoparticles Composed of Transmembrane Peptides and 
Their Application for Specific Intra-Tumor Delivery of Anti-Cancer 
Drugs

    Description of Technology: The current invention discloses peptide 
based nanoparticles as an alternative to liposomes. The nanoparticles 
have a diameter of 8-10 nm and are much smaller than a liposome thus 
providing better tumor penetration. Peptides corresponding to 
transmembrane domains of a number of integral membrane proteins have 
been discovered that spontaneously self-assemble in aqueous solutions 
into stable and remarkably uniform nanoparticles. The nanoparticles of 
the current invention are fully synthetic, and their surfaces can be 
functionalized with ligands that provide specific binding to cell 
surface receptors overexpressed on tumor cells. Thus, they are even 
more specific for tumor targeting.
    Nanoparticles constructed from transmembrane domains of certain 
receptors and transporters have biological activity of their own and 
inhibit metastasis or drug resistance thus sensitizing tumors to 
therapy. Hydrophobic drugs can be easily entrapped inside the 
nanoparticles, which not only solve the problem of drug insolubility 
under physiological conditions, but also generate a form of a drug that 
concentrates in tumors due to enhanced permeability and retention (EPR) 
effects.
    Applications and Modality:
    1. Self-assembling nano-particles as an alternative to liposomes, 
inorganic, dendrimeric or polymeric nanoparticles.
    2. Nanoparticles have biological activity of their own and can 
inhibit metastasis (CXCR4 receptor antagonists) or drug resistance 
(inhibitors of ABCG2 transporter and p-glycoprotein) thus sensitizing 
tumors to therapy.
    Advantages:
    1. The nanoparticles are superior in stability, uniformity, ease 
and reproducibility of preparation compared to conventional liposomes, 
are much more uniform and less toxic than inorganic, polymeric or 
dendrimeric nanoparticles.
    2. The nanoparticles are much smaller than a liposome thus 
providing better tumor penetration.
    3. Synthetic nanoparticles can be easily coated with receptor 
ligands and loaded with hydrophobic drugs for more specific tumor 
targeting.
    Market: Drug delivery remains one of the biggest challenges for the 
pharmaceutical industry. Nearly all therapeutics currently on the 
market are delivered in a non-specific manner to the whole body, and 
this results in unintentional side effects. The Food and Drug 
Administration (FDA) has created a new class of therapeutic products 
using nanoparticulate drug delivery system. In 2005, the first 
nanoparticulate drug delivery product, Abraxane, for the treatment of 
breast cancer, was launched. The worldwide R&D investment in 
nanotechnology research and development in 2004 from both public and 
private sectors was an estimated $US8.4 billion, 15% of which will be 
focused on nanobiotechnology.
    Development Status: The technology is in the pre-clinical stage of 
development.
    Inventors: Nadya I. Tarasova et al. (NCI).
    Related Publication: NI Tarasova et al. Transmembrane inhibitors of 
P-glycoprotein, an ABC transporter. J Med Chem. 2005 Jun 2;48(11):3768-
3775.
    Patent Status: U.S. Provisional Application No. 60/864,665 filed 07 
Nov 2006, entitled ``Self-Assembling Nanoparticles Composed of 
Transmembrane Peptides and Their Application for Specific Intra-Tumor 
Delivery of Anti-Cancer Drugs'' (HHS Reference No. E-256-2006/0-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The NCI Center for Cancer 
Research is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize self-assembling nanoparticles with intrinsic anti-tumor 
activity. Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

Sipa-Gene and Sipa-1 Inhibitor for the Diagnosis and Treatment of 
Metastatic Cancer

    Market Opportunity: No screening markers are currently available in 
the market that can diagnose early metastasis, which causes majority of 
cancer related deaths. Opportunity for new diagnostic and therapeutic 
technologies exists as personalized medicine is taking a major role in 
the clinical management of cancer. This invention can provide the much 
needed new diagnostic marker for predicting early metastasis as well as 
a new therapy targeting metastasis causing factors.
    Description of Technology: This technology relates to methods and 
compositions of a new gene Sipa-1 that can identify and treat 
metastatic cancer. The inventors have identified the Sipa-1 gene as a 
possible metastasis modifying gene. Further analyses revealed that 
Sipa-1 expression levels correlate with metastasis. Inhibitors that 
modulate the Sipa-1 expression and reduce metastasis in animal models 
have been identified. Additionally, single nucleotide polymorphisms 
(SNPs) present in the mouse Sipa-1 gene have been identified that, if 
also present in humans, could serve as the basis for diagnosing cancer 
and metastasis.
    Applications and Modality: Method for diagnosing early onset of 
metastasis with Sipa-1; Sipa-1 as a new therapeutic target for 
treatment of metastatic cancer.
    Advantages: Simple PCR based assay for detecting single nucleotide 
polymorphisms (SNPs) within the Sipa-1 gene; Inhibitors of Sipa-1 are 
known in the art, they can be easily screened from existing small 
molecule libraries.
    Current Development Status:
    1. The technology is currently in the pre-clinical stage of 
development.
    2. Proof of concept results show that inhibition of Sipa-1 reduces 
metastasis in mouse models.
    3. Laboratory data shows single nucleotide polymorphisms (SNPs) 
within the Sipa-1 gene linked to metastatic disease.
    Inventors: Kent Hunter et al. (NCI).
    Publications:
    1. PCT Publication No. WO 2006084027, published October 8, 2006.
    2. YG Park et al. Sipa1 is a candidate for underlying the 
metastasis efficiency modifier locus Mtes1. Nat Genet. 2005 
Oct;37(10):1055-1062. Epub 2005 Sep 4.
    3. NP Crawford et al. Germline polymorphisms in SIPA-1 are 
associated with metastasis and other indicators of poor prognosis in 
breast cancer. Breast Cancer Res. 2006;8(2):R16. Epub 2006 Mar 21.

[[Page 23837]]

    Patent Status: U.S. Provisional Application No. 60/649,365 filed 02 
Feb 2005 (HHS Reference No. E-082-2005/0-US-01); PCT Application No. 
PCT/US2006/003672 filed February 2, 2006 (HHS Reference No. E-082-2005/
2-PCT-01).
    Related Technology: U.S. Provisional Application No. 60/695,024 
filed 29 Jun 2005 (HHS Reference No. E-216-2005/0-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Mojdeh Bahar, J.D.; 301/435-2950; 
[email protected].

     Dated: April 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-8288 Filed 4-30-07; 8:45 am]
BILLING CODE 4140-01-P