E6-877. 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: [phone]; fax: [phone]. 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; [e-mail]

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 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; [e-mail].

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; [e-mail]

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; [e-mail].

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.