01-23295. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by agencies 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.

Batrachotoxins as Unique Activators of Sodium Channels

John W. Daly (NIDDK)

DHHS Reference No. E-237-01/0

Licensing Contact: Pradeep Ghosh; 301-496-7736 ext. 211; e-mail: [e-mail].

Natural products provide a wide range of biologically active agents, many of which have unique pharmacological activity and therapeutic potential. The present invention relates to the identification and characterization of two alkaloids, namely, “batrachotoxin” and “homobatrachotoxin,” isolated from extracts of amphibian skin. Biologically, both these agents are potent activators of sodium channels. The sodium channels are primarily expressed in peripheral nerve cells in pain pathways, where they regulate cellular excitability. Thus, these channels are drug targets for the treatment of pain and/or peripheral neuropathies. The use of batrachotoxin or homobatrachotoxin as research tools is applicable to sodium channel studies related to the effects of local anesthetics, analgesics, antiarrythmics and anticonvulsants. Further, advancement of these studies and target validation present commercial opportunities to expand ion channel drug discovery into new therapeutic areas.

Identification of a Cell-Surface Receptor for Papillomaviruses

Douglas R. Lowy, Patricia Day and John T. Schiller (NCI)

DHHS Reference No. E-179-01/0, filed 1 May 2001

Licensing Contact: Sally Hu; 301/496-7056 ext. 265; e-mail: [e-mail].

Human papillomavirus (HPV) are the central cause of genital warts and most cervical cancers, which kills about 200,000 women globally each year. 20 million Americans acquire genital HPV infections annually. Prophylactic and therapeutic vaccines under development will likely afford strain-specific protection, precluding comprehensive immunity. In contrast, the instant invention identifies the cellular receptor that may be broadly utilized by papillomaviruses to gain entry into the cells. It further teaches developing molecular decoys for the virus to bind to, thereby preventing infection. The cell surface exposed domain of the receptor is soluble, biologically stable and is therefore suited for different delivery strategies including topical application. It may also be used for screening potential anti-HPV compounds. It can be produced by genetic engineering methods and may therefore lend itself to production in large amounts at a reasonable cost.

Secretion of Native Recombinant Lysosomal Enzymes by Liver

Dr. Nina Raben et al. (NIAMS)

DHHS Reference No. E-067-01/0 filed 09 Apr 2001

Licensing Contact: Marlene Shinn; 301-496-7056 ext. 285; e-mail: [e-mail].

Glycogen storage disease type II (GSDII) is an autosomal recessive disorder caused by the deficiency of acid alpha-glucosidase (GAA), a glycogen-degrading lysosomal enzyme. This deficiency results in generalized deposition of lysosomal glycogen in almost all tissues of the body and can ultimately lead to cardiac failure before the age of two years. Current treatment for the disease includes repairing the deficiency by injecting recombinant protein into the patient made from either cultured Chinese Hamster Ovary (CHO) cells or secreted in the milk from rabbits that bear the transgene for the protein under a milk-specific promoter. Both recombinant proteins produced are extremely inefficient in their uptake into and function in targeted tissues.

The NIH announces a new technology that relates to the use of hepatocytes whether in culture or in vivo for the production of human GAA. The hepatocytes produce appropriate post-translational modification of the enzyme in liver cells by proper glycosylation, thereby producing a superior enzyme capable of being easily taken up and localized intracellularly in the target tissue. Once there, the enzyme digests glycogen present in lysosomes.

High-Volume On-Line Spectroscopic Composition Testing of Manufactured Pharmaceutical Dosage Units

E. Neil Lewis, David J. Strachen, Linda H. Kidder (NIDDK)

DHHS Reference No. E-249-99/1 filed 14 Jul 1999

Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: [e-mail].

The invention is a pharmaceutical dosage unit manufacturing process control system that uses continuous spectral imaging to test the actual composition of pharmaceutical dosages even in packaged drugs. The system can screen for errors in coloring of ingredients, for contamination or breakdown that occurs independent of coloring and for other types of errors that might not otherwise be detected. The system can perform composition measurements through the end-user package walls to detect contamination or damage that occurs during packaging. The invention performs composition analysis by comparing spectral information with libraries of known spectral signatures, allowing small concentrations of potentially dangerous contaminants to be detected. Relative quantities of ingredients can be directly measured, such that a change in the ratio of these ingredients can be detected.

Dated: September 7, 2001.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.