An XMRV Tool Box in the Federal Regustry August 27,2010

illsince1977

A shadow of my former self
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I couldn't find this posted previously. Hope it's not a duplicate. Remember Alan Dove picking the Federal Registry as his research pick of the week because it is now searchable? It sounds to me like the link to CFS is being taken seriously now. SAIC is a private defense contractor from what I understand.

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2010_register&docid=fr27au10-66.pdf

VerDate Mar<15>2010 15:33 Aug 26, 2010 Jkt 220001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\27AUN1.SGM 27AUN1 WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Federal Register /Vol. 75, No. 166 / Friday, August 27, 2010 /Notices 52759

An XMRV Tool Box: Expression
Plasmids, Genes, and Proteins for All
Components of the Xenotropic Murine
Leukemia Virus-Related Virus (XMRV)
Description of Invention: The
xenotropic murine leukemia virusrelated
virus (XMRV) has been
implicated as a possible causative agent
of prostate cancer and chronic fatigue
syndrome (CFS). Scientists at the
National Institutes of Health (NIH) and
Science Applications International
Corporation in Frederick, MD (SAIC–
Frederick) have developed sixty four
(64) protein expression plasmids for
components of XMRV. One or more
XMRV proteins made available through
these expression plasmids could have
clinical relevance to diagnosing or
treating human disease. The work to
develop this technology was performed
in the Protein Expression Laboratory at
SAIC–Frederick in collaboration with
expert retrovirologists from the National
Cancer Institute’s Frederick, MD
campus, a site well-positioned to
develop these expression plasmids from
initial cloning to final validations. The
development of these XMRV tools is
expected to save researchers months in
laboratory production time and
thousands of dollars in labor costs.
The XMRV strain utilized to generate
these expression plasmids is a reference
strain isolated from a human patient.
Each expression plasmid encodes one of
the ten proteins that comprise the
XMRV retrovirus (matrix, p12, capsid,
nucleocapsid, protease, reverse
transcriptase, integrase, surface,
transmembrane, and envelope). Nine of
the ten XMRV proteins expressed by
these clones have been successfully
purified in large quantities using scaleup
processes. The expression vectors
were generated utilizing the Gateway
cloning system and consist of Gateway
entry clones, bacterial (Escherichia coli)
expression clones, baculovirus
expression clones, and mammalian
expression clones. Expression of the
appropriate XMRV protein from its
corresponding expression clone has
been confirmed. The entry clones have
been validated for Gatewaysubcloning
and the baculovirus clones have been
validated for baculovirus production
and can be transposed into baculoviral
genomes. The plasmids have been fully
mapped and sequenced and contain one
or more elements to facilitate laboratory
use, such as antibiotic resistance genes,
specialized promoter sequences,
maltose-binding protein and His tags,
TEV protease sites, Kozak-ATG
sequences, signal peptides, and other
elements.
Applications:
Research tool whose large-scale
production capability can be utilized to
develop serological assays for detecting
XMRV and other retroviruses to
possibly establish these viruses as
causative agents for CFS, prostate
cancer, and other diseases with
unknown origins.
Collection of research tools that
could be utilized to develop a complete
set of diagnostic assays for detecting
each of these XMRV proteins in patient
samples.
Research tool to serve as a platform
for developing therapeutic moieties,
such as neutralizing antibodies and
other biologics, for treating prostate
cancer, chronic fatigue syndrome, and
any other disease where XMRV is later
identified as the causative agent.
A logical starting point for
generating clinical-grade XMRV
constructs for use in clinical vaccine,
immunotherapy, and gene therapy
studies.
Advantages:
First complete set of plasmids
available for the expression of each
XMRV protein individually: Researchers
looking to study XMRV can save months
of time and thousands of dollars by
using this set of XMRV tools. The
plasmids have been fully-mapped and
validated for protein expression. This
plasmid portfolio offers a variety of
vectors for expressing these XMRV
proteins including Gatewayentry
clones, bacterial vectors, baculoviral
vectors, and mammalian expression
systems.
Clones were developed from an
XMRV isolate taken from a patient with
a confirmed XMRV infection: The
proteins produced by these expression
plasmids are anticipated to have direct
clinical applicability to human XMRV
diseases.
Launching pad for any commercial
entity desiring to develop diagnostics or
therapeutics for XMRV: This technology
is likely to give companies in the
prostate cancer arena or the emerging
chronic fatigue syndrome market a
competitive advantage for developing
anti-XMRV products faster than
competitors. The molecular targets
needed as a starting point for
therapeutic development are provided
by this technology.
Market: Apart from cancers of the
skin, prostate cancer is the most
common form of cancer found in men,
especially in men over the age of 65. In
the United States, an estimated 200,000
men are diagnosed with prostate cancer
each year and around 100 men die of
the disease daily. About $5 billion
dollars is spent annually on treatments
for prostate cancer.
The Center for Disease Control (CDC)
estimates that over 1 million Americans
are living with chronic fatigue
syndrome and approximately 80% of
these individuals are undiagnosed. This
debilitating disease likely affects over 17
million people worldwide and the cause
of CFS is currently unknown. Those
individuals diagnosed with CFS are a
vocal patient group desiring expanded
research into the cause of CFS and
possible treatments and/or cures. In the
United States alone, an estimated $9
billion dollars is lost annually due to
CFS-induced decreases in worker
productivity.
Inventors: Dominic Esposito (SAIC),
Alan Rein (NCI), Stuart Le Grice (NCI),
James Hartley (SAIC), William Gillette
(SAIC), Ralph Hopkins III (SAIC), Troy
Taylor (SAIC).
Selected Publications:
1. VC Lombardi, et al. Detection of an
infectious retrovirus, XMRV, in blood
cells of patients with chronic fatigue
syndrome. Science 2009 Oct
23;326(5952):585–589. [PubMed:
19815723]
2. A Urisman, et al. Identification of
a novel Gammaretrovirus in prostate
tumors of patients homozygous for
R462Q RNASEL variant. PLoS Pathog.
2006 Mar;2(3):e25. [PubMed: 16609730]
Patent Status: HHS Reference No. E–
155–2010/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing under a Biological Materials
License Agreement.
Licensing Contact: Samuel E. Bish,
Ph.D.; 301–435–5282; bishse@
mail.nih.gov.
 

pictureofhealth

XMRV - L'Agent du Jour
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Hi illsince1977,

I think there is a thread up and running for this.

If you scan the forums I think it was started by BeesKnees and is entitled something like:
"SAIC and NCI to Develop XMRV Toolkit".

Good luck!