[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Notices]
[Pages 43201-43203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20456]
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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
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be required to receive copies of the patent applications.
Direct C-14 Oxidation of Opioids
A Coop and KC Rice (NIDDK)
Serial No. 60/132,628 filed 05 May 1999, Licensing Specialist: Leopold
J. Luberecki, Jr.; 301/496-7735 ext. 223; e-mail:
leo__luberecki@nih.gov.
This application describes a simple one-step method for the direct
oxidation of 14-H opioids into the desired 14-hydroxy opioid
derivatives, providing a quicker and less expensive means for the
manufacture of these compounds. For example, this process converts
codeinone into 14-hydroxycodeinone, eliminating the need for using
thebaine, the currently used common starting material, whose price is
increasing at 10% annually. The invention claims a process of employing
certain oxidizing agents, using much less reagent volume than the
present standard. The invention also circumvents diene intermediate
formation, thus eliminating the need for expensive chromatographic
isolation. The process takes much less time than the industry standard
and produces high yields between 50% and 80% at higher cost-
effectiveness than current methods. The 14-hydroxyl substituted opioid
antagonists are useful in a number of medicinal applications. For
instance, the antagonists naltrexone and naloxone are drugs used in the
treatment of opiate abuse, opiate overdose, and alcohol addiction. In
addition, certain derivatives of these compounds have been found useful
in the prevention of tolerance to morphine and as immunosuppressants.
Methods for Detecting Cancer Cells
Thomas Ried, Evelin Schrock, Bijan M. Ghadimi (NHGRI)
DHHS Reference No. E-211-98/0 filed 01 Apr 1999, Licensing Contact:
John Fahner-Vihtelic; 301/496-7735 ext. 270; e-mail: jf36z@nih.gov
The present application describes a highly sensitive assay for
distinguishing between cancer and non-cancer epithelial cells in the
blood. It provides an improved diagnostic technique for detecting
cancer and determining the organ-origin of the cancer. This assay can
be used to prove the neoplastic nature of cells and predict when shed
tumor cells have or will become metastatic. A major advantage of the
present invention is that tumor cells can also be recovered as viable
cells. Thus, the tumor cells can be kept alive in vitro for a
sufficient period of time to determine the effect of particular anti-
tumor pharmaceuticals on the cells. Furthermore, the assay provides an
early detector of treatment success or failure and thereby allows a
treatment regimen to be customized for an individual patient with
advanced primary cancer.
Replication-Defective Dengue Viruses that are Replication-Defective
in Mosquitoes for Use as Vaccines
L Zeng, L Markoff (FDA)
Serial No. 60/098,981 filed 01 Sep 1998, Licensing Contact: Carol
Salata; 301/496-7735 ext. 232; e-mail cs253n@nih.gov
Although flaviviruses cause a great deal of human suffering and
economic loss, there is a shortage of effective vaccines. The present
invention is directed toward vector stage replication-defective
flaviviruses that are replication-defective in mosquito vectors that
transmit them to humans. The replication-defective flaviviruses of the
present invention demonstrate a limited ability to replicate in the
vector organisms that transmit flaviviruses from one host to another.
More specifically, the present invention is directed toward the
construction and propagation of flaviviruses that possess 3'-noncoding
regions altered in such a way as to prevent or severely limit viral
reproduction in a vector organism. Such mutant flaviviruses may be
useful as vaccines.
Vaccine Against Eschericha coli 0157 Infection, Composed of
Detoxified LPS Conjugated to Proteins
Shousun C. Szu, Edward Konadu, and John B. Robbins (NICHD) DHHS
Reference No. E-158-98/0 filed 20 July 1998 (PCT/US98/14976)
Licensing Contact: Robert Benson; 301/496-7056 ext. 267; e-mail:
rb20m@nih.gov
This invention is a conjugate vaccine to prevent infection, in
particular in young children under 5 years of age, by E. coli 0157:H7,
an emerging human pathogen which causes a spectrum of illnesses with
high morbidity and mortality, ranging from diarrhea to hemorrhagic
colitis and hemolytic-uremic syndrome (HUS). Infection is due to the
consumption of water or meat contaminated by feces from infected
animals, such as cattle. The conjugate is composed of the O-specific
polysaccharide isolated from E. coli 0157, or other Shiga-toxin
producing bacteria, conjugated to carrier proteins, such as non-toxic
P. aeruginosa exotoxin A or Shiga toxin 1. A Phase I clinical trial,
involving adult humans, showed the vaccine is safe and highly
immunogenic. Adults, after one injection containing 25 (g of antigen,
responded with high titers of bactericidal antibodies. Thus the
conjugates of the invention are promising vaccines, especially for
children and the elderly, who are most likely to suffer serious
consequences from infection. The clinical study is described in J.
Infectious Diseases 177, 383-387, 1998.
Applicator System and Method of Use
Michael J. Lenardo, Galen Fisher (NIAID)
Serial No. 09/005,475 filed 12 Jan 1998, Licensing Contact: John
Fahner-Vihtelic, 301/496-7735 ext. 270
The present application describes a novel microcentrifuge tube and
tube cap and research method, which allows for dispensing the contents
of a microcentrifuge tube without pipetting. The design eliminates
pipetting volume error and prevents the cross-contamination which can
be experienced in conventional pipetting. This invention is
particularly useful for such applications as loading tube contents into
an electrophoresis gel after a reaction such as PCR. Using the
disclosed apparatus and methods increases the speed of a variety of
routine procedures and prevents contamination of samples due to soiled
lab apparatus.
Method To Reduce the Bias in the Mean and Variance of Indices of
Water Diffusion Anisotropy as Measured by Diffusion Tensor MRI
Carlo Pierpaoli (NINDS/NICHD), Peter J. Basser (NICHD)
Serial No. 08/824,706 filed 14 Apr 1997; Licensing Contact: John
Fahner-Vihtelic; 301/496-7735, ext. 270; e-mail: jf36z@nih.gov.
This invention describes several novel MRI ``stains'' to measure
and display water diffusion anisotropy data obtained by diffusion
tensor MRI (DT-MRI). One problem that this invention overcomes is that
it significantly reduces the statistical bias in the mean and variance
of the measured anisotropy of water diffusion caused by background
noise in the MR images. These benefits are achieved by exploiting the
idea that fiber tracts exhibiting diffusion anisotropy vary
continuously in most regions. Thus, the principal axes of the diffusion
tensor (or eigenvectors) can be used to improve the estimate of the
principal diffusivities (or eigenvalues) within a local region of
interest. These eigenvalues, in turn, are used to
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compute our improved local measures of diffusion anisotropy. Images or
maps of water diffusion anisotropy are increasingly being used to
gather structural information about fibrous tissue, such as white
matter fibers as well as cardiac and skeletal muscle fibers in vivo, in
health, disease, development, and aging. This invention results not
only in a more accurate measurement of diffusion anisotropy, but it
improves image quality and reduces scanning time in clinical and
biological applications of DT-MRI. Since the reduction in diffusion
anisotropy has been shown to be sensitive to nerve fiber degeneration,
this new data should be useful in studies to screen for and determine
the efficacy of neuroprotective agents, as well as streamline multi-
site and longitudinal clinical trials designed to assess their safety
and efficacy.
A New Class of Anti-Tumor Agents
Christopher J. Michejda (NCI), Richard H. Smith, Jr.
Serial No. 07/179,622 filed 29 Mar 1988; U.S. Patent 4,9023,970 issued
08 May 1990; Licensing Contact: Girish Barua; 301/496-7056, ext. 263;
e-mail: gb18t@nih.gov
Substituted triazenes are potentially useful anti-tumor agents.
Examples of substituted triazenes in clinical use include 5-
(dimethyltriazeno)imidazole-4-carboxamide (DTIC), which is used in the
treatment of metastatic melanoma and some soft tissue sarcomas, and the
recently approved temozolomide, which is used in brain cancer. The
National Institutes of Health has developed compounds which have many
advantages over known triazene anti-cancer compounds. Advantages
include a novel mechanism of action for at least one of them, namely,
1-(2-chloroethyl)-3-(N-methylcarbamoyl)-methyltriazene, which is a
highly selective, non-toxic anti-tumor compound, their well understood
chemistry, and ease of synthesis of new analogs.
The technology covers compounds of the series of 1-(2-chloroethyl)-
3-acyl-3-alkyltriazenes and a method for their synthesis. Some of the
subject acyl triazenes generate 2-chloroethyldiazonium ions at very
easily controlled rates, while others require metabolic activation to
release the electrophilic agent.
Several of the acyltriazenes have shown excellent in vivo activity
against human tumor xenografts in nude mice and low toxicity. These
compounds are good candidates for development as anti-tumor drugs.
Dated: August 3, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 99-20456 Filed 8-6-99; 8:45 am]
BILLING CODE 4140-01-P
