[Federal Register: December 20, 2004 (Volume 69, Number 243)]
[Notices]
[Page 75993-75994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de04-98]
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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 an agency 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.
The Use of Rabbits With Defined Immunoglobulin Light Chain Genes
(Ckappa b Allotypes) To Optimize Production of Chimeric and
Humanized Monoclonal Antibodies for Therapeutic, Imaging and Diagnostic
Applications
Rose G. Mage, Cornelius Alexander (NIAID).
DHHS Reference No. E-332-2004/0--Research Tool.
Licensing Contact: Pradeep Ghosh; (301) 435-5282; ghoshpr@mail.nih.gov.
Biological materials are important research tools that can be used
for diagnostic as well as therapeutic purposes. Antibodies have become
viable drugs in the market today and there is a general market need for
systems that may facilitate production of efficient and effective
antibodies. In recent years, monoclonal antibodies have gained
significant importance in their use, both as diagnostics and
therapeutics, to intervene and combat diseases such as cancer,
cardiovascular diseases, and infections. The present invention relates
to the discovery of rabbits, genetically defined as b9, as the
biological vehicle for the isolation of chimeric phage displaying Fab
with human constant regions and rabbit immunoglobulin heavy and light
chain variable regions for the development of diagnostic antibodies and
humanized monoclonal therapeutic antibodies of high affinity and
specificity (Popkov et al., J. Molec. Biol. 325: 325-335, 2003; Popkov
et al. J. Immunol. Methods 288: 149-164, 2004). Recently, many
effective antibodies have been developed as a result of the integration
of antibody libraries with phage display technology. The rabbit model
described in this invention may be used for production of antibodies
that may cross react with both human and mouse antigens. Rabbit
monoclonal antibodies that react with both human and mouse antigens are
of particular relevance for the preclinical evaluation of therapeutic
antibodies in mouse models of human diseases. Therefore, this invention
has a broad commercial potential in its use as a source for producing
monoclonal antibodies for therapeutic interventions in infectious,
autoimmune and neurological diseases, nerve damage and cancer.
Methods for Diagnosis of Atherosclerosis
Paul Hwang et al. (NHLBI).
U.S. Provisional Application No. 60/607,031 filed 03 Sep 2004 (DHHS
Reference No. E-276-2004/0-US-01).
Licensing Contact: Fatima Sayyid; 301/435-4521; sayyidf@mail.nih.gov.
In industrialized countries coronary heart disease and stroke due
to atherosclerosis are the leading causes of morbidity and mortality.
Coronary heart disease is the single largest cause of death in the
U.S.A. and will cost approximately $133.2 billion according to the 2004
American Heart Association statistics update.
The identification of more sensitive and specific markers of
atherosclerosis that are non-invasive and cost-effective may have
profound impacts on public health. One such strategy involves the
detection of marker genes or their products in blood or serum. Such
markers may help identify high-risk patients with subclinical
atherosclerosis who may benefit from intensive primary prevention or
they may help determine the activity of established disease for
monitoring response to treatment, resulting in more targeted secondary
prevention.
The present invention relates to methods for detecting
atherosclerosis using highly reactive biomarkers (FOS and/or DUSP1)
expressed in blood cells or released into serum. Because these markers
are also involved in pathogenesis, they may serve as potential targets
for drug discovery and for intervention to modify disease progression.
An Improved Method To Separate and Expand Antigen-Specific T Cells
Jonming Li and John Barrett (NHLBI).
U.S. Provisional Application No. 60/606,197 filed 31 Aug 2004 (DHHS
Reference No. E-246-2004/0-US-01).
Licensing Contact: Fatima Sayyid; (301) 435-4521; sayyidf@mail.nih.gov.
Stem cell transplants can be used to treat patients with leukemia
or other disorders. Transplanted donor T cells (lymphocytes) exert
strong alloimmune
[[Page 75994]]
graft versus leukemia and other anti-tumor effects however they can
also cause potentially lethal graft versus host disease (GVHD),
requiring post-transplant immunosuppression. Such immunosuppression may
place patients at a greater risk of contracting potentially fatal
cytomegalovirus infection further reducing their capacity to be cured
of their malignant disease.
The transfer of T lymphocytes specific for leukemia cells or micro-
organism antigens can be useful since therapeutic immune effects would
be enhanced while GVHD reactions would not be induced. Currently
available methods for isolating and expanding antigen-specific T cells
including selection using HLA tetramers, magnetic beads binding to
activation markers or laborious limiting dilution techniques are
unreliable, poorly reproducible, expensive and impede clinical
progress.
The present invention relates to methods for selecting and
expanding antigen specific T-cells that recognize a pre selected target
antigen, to purified populations of antigen-specific T cells that
recognize a pre selected target antigen and to therapeutic uses of
antigen-specific T cells that recognize a pre selected target antigen.
Potential applications include treatment of cytomegalovirus, Epstein-
Barr virus and adenovirus reactivation following stem cell
transplantation or organ transplantation, prevention and treatment of
leukemic relapse after transplantation or chemotherapy using autologous
expanded T cells, and selective depletion of alloreactive T cells from
transplants which may produce GVHD.
Novel Compounds for Selectively Inactivating Pain Pathways
Peter Blumberg, Jeewoo Lee (NCI).
U.S. Provisional Application No. 60/558,003 filed 26 Mar 2004 (DHHS
Reference No. E-141-2004/0-US-01).
Licensing Contact: Norbert Pontzer; 301/435-5502;
pontzern@mail.nih.gov.
Available for licensing are compositions and methods for the long-
term control of pain and other pathological conditions caused by the
over-activity of pain pathways. Neurons in the dorsal root, trigeminal
and nodose ganglia project unmyelinated C-fibers and A[delta]-fibers
that transmit pain and temperature sensation between the periphery and
spinal cord. Along with acute and chronic pain, over activation of
those pathways leads to neurogenic and neuropathic inflammation leading
to such conditions as post-herpetic neuralgia, diabetic neuropathy,
cystitis, and reflex sympathetic dystrophy among many others.
These neurons are activated both centrally and peripherally by a
relatively non-selective cation channel initially identified as site of
action of capsaicin, the pungent ingredient in chili peppers. That
channel is now called VR1 or TRPV1 and is found in high concentration
only on C and A[delta] neurons. These inventors previously discovered
and patented resiniferatoxin (RTX), an ultrapotent agonist of the VR1
receptor. RTX desensitizes C and A[delta]-fibers when applied
peripherally and may selectively ablate those neurons when applied
centrally without causing substantial pain from activation of the
neurons. RTX type compounds thus provide a method of controlling pain
other conditions caused by C and A[delta]-fiber activity. The present
invention provides new RTX analogues that may have an improved
therapeutic index and metabolic profile.
Dated: December 9, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 04-27783 Filed 12-17-04; 8:45 am]
BILLING CODE 4140-01-P