[Federal Register Volume 63, Number 34 (Friday, February 20, 1998)]
[Notices]
[Page 8652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4236]



[[Page 8652]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health.

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 infromaiton 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.

Aspirin Metabolites As Protectors Against Oxidative Stress And 
Chemotherapy Drug Toxicity

JB Mitchell, A Russo, CM Krishna, W DeGraff, AM DeLuca, L Myers, SM 
Hahn (NCI)
Serial No. 60/039,375 filed 20 Mar 97
Licensing Contact: Leopold J. Luberecki, Jr., 301/496-7735 ext. 223

    Although oxygen is required to sustain most life forms, a variety 
of toxic oxygen-related species, such as hydroxyl radicals, hydrogen 
peroxide, and superoxide, are produced, which could damage cells if 
left unchecked. Cells usually possess systems which rid themselves of 
these by-products, yet there is a small amount of these substances 
which escapes the biochemical defense network. It is not known whether 
chronic exposure to low levels of oxygen-derived free radical species 
is deleterious. It is postulated that the aging process may be a 
manifestation of the organism's inability to cope with sustained 
oxidative stress. In addition, some cancer treatment modalities exert 
their cytotoxicity via production of free radicals. This invention 
describes methods of using a composition made of a hydroxybenzoate 
metabolite, a hydroxybenzoate analogue, or a mixture thereof, in the 
preventative and therapeutic treatment for oxidative stress. The use of 
the compounds to treat oxidative stress is superior to aspirin itself 
for reasons including avoidance of gastric and duodenal ulcers and 
platelet function disorders, and the ability to realize high 
concentrations of specific metabolities or analogues, which cannot be 
achieved using aspirin. In addition, compositions may be used to 
protect biological material from the cytotoxic effects of cancer 
chemotherapeutic agents, including adriamycin, one of the most widely 
used chemotherapeutic agents. As an example, the effectiveness of 
adriamycin is limited by the resulting bone marrow suppression, 
gastorintestional damage, and cumulative cardiotoxicity caused by the 
treatment. The compositions of this invention could act as anti-
cytotoxic agents. The compositions also could be used to treat 
extravasation tissue injury. Extravasation occurs when a hypodermic 
injection, such as an injection of a chemotherapeutic agent, misses the 
vein, as frequently occurs in older persons, thereby causing release of 
a high localized concentration of the agent into the surrounding 
tissue, which results in cellular damage and a disfiguring ulceration. 
A composition as described in this invention could be rapidly injected 
at the site of the missed injection to alleviate or prevent this 
damage.

Trophic and Cell Differentiating Effects of Glucagon-Like Peptite (GLP-
1) and Exedin-4

J Egan, R Perfetti, A Passaniti, N Greg, H Holloway (NIA)
DHHS Reference No. E-251-97/0
Licensing Contact: Charles M. Maynard, 301/496-7735 ext. 243

    GLP-1 is a hormone produced and predominantly found in the 
mammalian gut. GLP-1 has been found to stimulate insulin production and 
suppress glucagon production in response to increases in serum glucose 
levels caused by a variety of events, such as ingestion of a mixed 
meal. Consequently, it has generated a considerable amount of 
investigation as a potentially useful therapeutic agent in the 
treatment of diabetes. Clinical trials of administration of synthetic 
GLP-1 have shown a reduction of the need for insulin injection in 
patients with diabetes, both type I and type II. GLP-1 also has the 
distinct advantage over traditional treatment of these conditions, in 
that the insulinotropic effect of GLP-1 is dependent on serum glucose 
concentration, resulting in the fact that in vivo administration of 
significant amounts of GLP-1 appears not to trigger hyperinsulinemia. 
Unfortunately, GLP-1 has an effective pharmaceutical half-life in the 
realm of five minutes, requiring repeated dosing.
    Exedin-4 is an abstract from the venom of the Gila monster, about 
50% structurally related to GLP-1, which was found to be a potent 
agonist of GLP-1, and which also was found to increase insulin 
production when administered by itself. Exedin-4 also has the advantage 
of a significantly longer effective duration, on the order of ten 
hours. Research, therefore, has focused on finding combinations of GLP-
1 and exedin-4 that are likely to provide the longest effect, as well 
as on the mechanisms through which they mediate insulin production.

Oncoimmunins

B Packard, A Komoriya (FDA)
U.S. Patent 5,364,619 issued 15 Nov 94 and U.S. Patent 5,635,356 
issued 3 Jun 97
Licensing Contact: Jaconda Wagner, 301/496-7735 ext. 284

    Two tumor-derived soluble proteins named oncoimmunin-L and 
oncoimmunin-M have been isolated and partially characterized. 
Oncoimmunin-L is a T-cell mitogen and oncoimmunin-M is a myeloid 
differentiation inducing agent. The partial characterization of these 
two factors has shown that they are similar to human leukocyte elastase 
inhibitor and human lactate dehyrodrogenase M, respectively. As cells 
of both lymphoid and myeloid origin are known to play roles in immune 
defense, factors which can modulate their number and/or function may be 
useful in the diagnosis and treatment of cancer. Since these factors 
are derived from tumors, their appearance in blood may signal the 
presence of tumor or of metastatic disease. The in vivo bioactivities 
of these factors suggests their utility as therapeutic agents for 
cancer and infectious diseases.
    This research has been published in Biochim Biophys Acta 1995 Oct 
19; 1269(1): 41-50.

    Dated: February 11, 1998.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 98-4236 Filed 2-19-98; 8:45 am]
BILLING CODE 4140-01-M