[Federal Register Volume 71, Number 16 (Wednesday, January 25, 2006)]
[Notices]
[Pages 4152-4153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-877]


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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.

Intraperitoneal Injection of Pseudovirions Carrying a Toxin Leads to 
Significantly Reduced Tumor Size

Michael M. Gottesman et al. (NCI)
U.S. Provisional Application filed 01 Dec 2005 (HHS Reference No. E-
163-2005/0-US-01)
Licensing Contact: Michelle A. Booden; 301/451-7337; 
[email protected]

    SV40-based pseudovirions show great promise in the cancer gene 
therapy field. SV40 vectors very efficiently deliver genes such as 
anti-viral agents, DNA vaccine, genes for chemoprotection, suicide 
genes, and antiangiogenic genes. The immediate application for this 
technology is to target plasmid DNA to cancerous cells as a gene 
therapy treatment for various human carcinomas. In previous studies, 
NCI investigators Chava Kimchi-Sarfaty and Michael Gottesman have

[[Page 4153]]

demonstrated that SV40 infectious particles delivering DNA encoding a 
toxin to tumors can be used as a novel cancer treatment.
    This invention discloses a method for delivering a toxin such as 
Pseudomonas extotoxin (PE38) to tumor cells. Administration of the SV40 
infectious particle can be by parenteral administration, which includes 
intraperitoneal, intravenous, intramuscular, subcutaneous, 
intraorbital, intracapsular, intraspinal, or intrasternal. This 
disclosure also provides a combined method of use of SV40 infectious 
particle/PE38 with a chemotherapeutic agent, such as doxorubicin. 
Interestingly, this combination is very effective at reducing tumor 
size while eliminating many of the side effects of conventional 
chemotherapy. This delivery system has a commercial advantage as a new 
method to increase efficacy and reduce side effects of standard 
chemotherapies.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Transcytosis of Adeno-Associated Viruses

John A. Chiorini and Giovanni Di Pasquale (NIDCR)
PCT Application No. PCT/US2005/03183 filed 08 Sep 2005 (HHS Reference 
No. E-298-2004/0-PCT-02)
Licensing Contact: Jesse Kindra; 301/435-5559; [email protected].

    The invention relates to a method for delivering nucleic acids to a 
variety of cells including those of the gut, kidney, lung and central 
nervous system. The underlying cells of such organs are covered by a 
barrier of endothelial or epithelial cells which can limit the transfer 
of nucleic acids, or other potentially therapeutic agents, to the 
underlying target cells. To overcome this limitation, the method 
employs certain members of the parvovirus family to transcytose the 
barrier cells. During transcytosis, the virus passes through these 
barrier cells and can infect cells of the underlying layer. Therefore, 
this method could facilitate the transfer of nucleic acids to cells 
that currently available viral vectors are unable to reach.
    The method could be applied to the treatment of neurodegenerative 
diseases such as Parkinson's, Alzheimer's, Huntington's, lysosomal 
storage diseases, the dominant spinal cerebellar ataxias, and Krabbe's 
disease without the need for stereotactic injection. The method could 
potentially also be used in the treatment of genetic muscle disorders 
such as muscular dystrophy. Several of the viruses described in the 
invention are serologically distinct and could be used in patients who 
have developed an immune response to other vectors. This work is part 
of an ongoing effort to development AAV vectors for gene transfer. 
Other key technology related to this invention, such as several vector 
platforms, production, purification methods, and target cell tropism is 
available for licensing.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Treatment of Hyperproliferative Epithelial Skin Diseases by Topical 
Application of Hydroxylated Aromatic Protein Cross-Linking Compounds

Caroline Stanwell et al. (NCI)
U.S. Patent No. 5,610,185 issued 11 Mar 1997 (HHS Reference No. E-067-
1995/0-US-01)
Licensing Contact: George Pipia; 301/435-5560; [email protected]

    In recent years there has been a dramatic increase in the incidence 
of skin disease. Increase in exposure to UV light has contributed to 
the increase in premalignant skin lesions such as actinic keratoses. In 
the U.S. over 700,000 individuals suffer from superficial squamous and 
basal cell carcinoma. In addition, other skin diseases such as plantar 
and genital warts are extremely common. Currently, the treatment for 
these types of skin diseases include surgical resection or freezing the 
tissue to destroy the desired cells. Topical treatments, for example 
acidic compounds or cytotoxic agents, are also employed. However, none 
of the above treatments are without drawbacks. Surgical methods may be 
painful and the current topical treatments are not selective for 
hyperproliferative cells, not always curative, and may be toxic. This 
invention embodies a series of compounds, hydroxylated aromatic protein 
cross-linking agents, that can be applied topically and are useful for 
premalignant and malignant superficial neoplasias of the skin and for 
the treatment of basal and squamous cell carcinomas.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Pharmaceutical Compositions and Methods for Preventing Skin Tumor 
Formation and Causing Regression of Existing Tumors

Stuart R. Yuspa et al. (NCI)
U.S. Patent Application No. 10/445,251 filed 27 May 2003, claiming 
priority to 29 Mar 1991 (HHS Reference No. E-014-1991/0-US-08)
Licensing Contact: George Pipia; 301/435-5560; [email protected].

    Toxic drugs used to treat epithelial cancers often kill both normal 
and tumorous cells whereas retinoids used to prevent tumor formation 
appear to have a suppressive rather than a curative effect. The 
compositions and methods of administration described in this invention 
are based on indole carbazole, which causes terminal differentiation of 
tumor cells by exploiting a normal physiologic pathway. They can be 
used to regress as well as prevent skin tumors.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: January 17, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-877 Filed 1-24-06; 8:45 am]
BILLING CODE 4167-01-P