[Federal Register Volume 66, Number 182 (Wednesday, September 19, 2001)]
[Notices]
[Pages 48264-48265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23295]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: 301/496-7057; fax: 301/402-0220. 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: 
[email protected].

    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

[[Page 48265]]

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: 
[email protected].

    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: 
[email protected].

    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: 
[email protected].

    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.
[FR Doc. 01-23295 Filed 9-18-01; 8:45 am]
BILLING CODE 4140-01-P