[Federal Register Volume 67, Number 105 (Friday, May 31, 2002)]
[Notices]
[Page 38133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13731]


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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, DHHS.

ACTION: Notice.

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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.

Enhanced Distribution of Therapeutic Agents After Local Delivery

Krys Bankiewicz et al. (NINDS)
    U.S.P.A. Nos. 60/250,286 filed 30 Nov 2000 and 60/286,308 filed 25 
Apr 2001
    Licensing Contact: Norbert Pontzer; 301/496-7736 ext. 284; e-mail: 
[email protected]
    Many experimental therapies will rely on the local parenchymal 
delivery of macromolecules or nucleic acids for their success. However, 
the volume of distribution of many of these potential therapeutic 
agents is restricted by their interactions with the extracellular 
matrix and cellular receptors. Heparin-sulfate proteoglycans are a cell 
surface component which bind to many different types of molecules such 
as growth factors, cytokines and chemokines and viruses such as 
cytomegalovirus, herpes simplex virus and HIV.
    These inventions provide a method of dramatically increasing the 
volume of distribution and effectiveness of certain therapeutic agents 
after local delivery by the use of facilitating agents as described in 
Neuroreport. 2001 Jul 3;12(9):1961-4 entitled ``Convection-enhanced 
delivery of AAV-2 combined with heparin increases TK gene transfer in 
the rat brain'' and in Exp Neurol. 2001 Mar;168(1):155-61 entitled 
``Heparin coinfusion during convection-enhanced delivery (CED) 
increases the distribution of the glial-derived neurotrophic factor 
(GDNF) ligand family in rat striatum and enhances the pharmacological 
activity of neurturin.'' These methods are especially useful when used 
in conjunction with technology described and claimed in U.S. Patent 
5,720,720 entitled ``Convection-enhanced drug delivery.'' Licenses for 
methods to enhance the distribution of all claimed therapeutics except 
adeno-associated viral vectors are available.

Sol Fusin: Use of GP64-6HIS to Catalyze Membrane Fusion

D. H. Kingsley and J. J. Zimmerberg (NICHD)
    DHHS Reference Nos. E-113-99/0 filed 18 Feb 1999 and E-113-99/1 
filed 15 Nov 2001
    Licensing Contact: Pradeep Ghosh; 301/496-7736 ext. 211; e-mail 
[email protected]
    An efficient drug delivery system is a necessity for a wide range 
of therapeutic interventions. This technology pertains to a process 
related to the solubilizing of insoluble membrane proteins, thus 
generating soluble and functional version (sol-proteins) of previously 
insoluble proteins. Specifically, the invention relates to the addition 
of histidine amino acids to the cytoplasmic domains of membrane and 
viral envelope proteins for the purpose of solubilizing, purifying and/
or reconstituting functional viral envelope proteins in lipid-
containing vesicles. The modified protein mediates fusion of the 
resulting vesicular membrane with other lipid membranes, thus creating 
an efficient delivery system. The proteins in this form have been 
referred to as ``sol-fusin'' and the resultant sol-fusin/liposome 
complex is potentially able to catalyze delivery of therapeutic, 
genetic, or antigenic compounds both in vivo and in vitro. Thus, 
pharmaceutical and vaccine manufacturers may use these proteoliposomes 
as tools to deliver active therapeutic, genetic or antigenic agents 
without destruction by lysosomes. In addition to being useful as a 
delivery tool, the sol-fusin/ liposomes can be used to mimic viral 
infections. The triggering of sol-fusin is low pH-dependent, and thus 
may perhaps facilitate oral ingestion and gastrointestinal absorption 
of the bioactive agents because of their direct membrane fusion 
mediating activity.

    Dated: May 23, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 02-13731 Filed 5-30-02; 8:45 am]
BILLING CODE 4140-01-P