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Mystery Deepens How Long Has XMRV and SAIC Been Involved?
Movement on New Retrovirus is Rapid!
Mystery Deepens on XMRV Now SAIC Shows Involvement
[Federal Register: August 27, 2010 (Volume 75, Number 166)]
[Notices]
[Page 52758-52760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au10-66]
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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, HHS.
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.
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 virus-
related 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
[[Page 52759]]
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 scale-up processes. The expression vectors were
generated utilizing the Gateway[supreg] cloning system and consist of
Gateway[supreg] 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[supreg] 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[supreg] 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.
Tempol: A Commercially Available Nitroxide as Cancer Therapeutics
Description of Invention: The invention is the discovery that a
commercially available stable nitroxide, namely TEMPOL can effectively
reduce the level of hypoxia-inducible transcription factor (HIF)-
2[alpha]. Elevated HIF-2[alpha] is associated with clear cell kidney
cancer characterized by mutation of the VHL tumor suppressor gene and
with many other cancers. Therefore, TEMPOL can potentially be developed
into a cancer drug to treat patients with elevated HIF-2[alpha],
whether due to compromised VHL function or not.
Applications: Known compound (TEMPOL) found to be effective in
treating several cancers.
Advantages: Animal data confirms effectiveness of TEMPOL against
cancer support.
Development Status: Pre-clinical, In vivo animal data available.
Target Market: The potential drug will target a population that
suffers from genetic diseases such as inherited von Hippel-Lindau (VHL)
disease, which is associated with elevated expression of HIF-2[alpha]
and patients with kidney and other cancers characterized by elevation
of HIF-2[alpha]. Inherited VHL disease is a cancer syndrome caused by
germ line mutations of the VHL tumor suppressor gene. VHL is
characterized by angiomas and hemangioblastomas of the brain, spinal
cord, and retina. These can lead to cysts and/or tumors of the kidney,
pancreas, and adrenal glands (e.g.,
[[Page 52760]]
pheochromocytoma and endolymphatic sac tumors).
Renal clear cell carcinoma (RCC) develops in approximately 75% of
VHL patients by age 60 and is a leading cause of death in this
population. Inactivation (mutation or methylation) of the VHL gene is
associated with greater than 90% of all clear cell RCC (including
sporadic cases) (Nickerson et al. Clin Cancer Res 2008;14:4726-34).
Thus, subjects with compromised VHL function represent a significant
population that has or is at risk for developing cancer, including RCC.
There is data that HIF-2[alpha] may be important in all or most cancers
(Franovic et al. Proc Natl Acad Sci U S A 2009;106:21306-11).
Inventors: W. Marston Linehan (NCI), Tracey A. Rouault (NICHD),
James B. Mitchell (NCI), Murali K. Cherukuri (NCI).
Patent Status: U.S. Provisional Application No. 61/265,194 filed 30
Nov 2009 (HHS Reference No. E-133-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Sabarni Chatterjee, Ph.D.; 301-435-5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Urologic Oncology Branch, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize the use of Tempol to target HIF-
2[alpha] in cancer. Please contact John Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Chimeric Anti-human ROR1 Monoclonal Antibodies
Description of Invention: Available for licensing are mouse anti-
human receptor tyrosine kinase-like orphan receptor 1 (ROR1) monoclonal
antibodies (mAbs). ROR1 is a signature cell surface antigen for B-cell
chronic lymphocytic leukemia (B-CLL) and mantle cell lymphoma (MCL)
cells, two incurable B-cell malignancies that are newly diagnosed in
approximately 15,000 and 3,500 patients per year, respectively, in the
United States. Currently, there are no therapeutic mAbs that
specifically target B-CLL or MCL cells. Anti-ROR1 mAbs may be linked to
chemical drugs or biological toxins thus providing cytotoxic delivery
to malignant B-cells and not normal cells. Additionally, these
antibodies can be fused to radioisotopes and can be used to diagnose B-
CLL and MCL malignancies.
Applications:
B-CLL and MCL antibody therapeutics.
Method to diagnose B-CLL and MCL.
Advantages: Selective targeting to malignant B-CLL and MCL cells.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market:
The monoclonal antibody market is one of the fastest
growing sectors of the pharmaceutical industry with a 48.1% growth
between 2003 and 2004 and the potential to reach $30.3 billion in 2010.
This growth rate is driven by the evolution of chimeric and humanized
to fully humanized antibody therapeutics.
Approximately 18,500 patients with ROR1-expressing B-cell
malignancies are newly diagnosed annually in the United States.
Inventors: Christoph Rader and Sivasubramanian Baskar (NCI).
Related Publications:
1. S Baskar et al. Unique cell surface expression of receptor
tyrosine kinase ROR1 in human B-cell chronic lymphocytic leukemia. Clin
Cancer Res. 2008 Jan 15;14(2):396-404. [PubMed: 18223214]
2. M Hudecek et al. The B-cell tumor associated antigen ROR1 can be
targeted with T-cells modified to express a ROR1-specific chimeric
antigen receptor. Blood. 2010 Aug 11; Epub ahead of print. [PubMed:
20702778]
Patent Status:
U.S. Provisional Application No. 61/172,099 filed 23 Apr
2009 (HHS Reference No. E-097-2009/0-US-01).
PCT Application No. PCT/US10/32208 filed 23 Apr 2010 (HHS
Reference No. E-097-2009/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Experimental Transplantation and Immunology Branch is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
anti-ROR1 mAbs, antibody-drug conjugates, radioimmunoconjugates,
bispecific antibodies, and other therapeutic or diagnostic modalities.
Please contact John D. Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Dated: August 23, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-21349 Filed 8-26-10; 8:45 am]
BILLING CODE 4140-01-P
Short URL: http://www.veteranstoday.com/?p=46616
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Posted by Denise Nichols on Aug 27 2010, With 0 Reads, Filed under Gulf War Illness (GWI), Health. You can follow any responses to this entry through the RSS 2.0. Both comments and pings are currently closed.
Posted by Denise Nichols on Aug 27 2010, With 0 Reads, Filed under Gulf War Illness (GWI), Health. You can follow any responses to this entry through the RSS 2.0. Both comments and pings are currently closed.
COMMENTS
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So, is this only in the research phase or can any of us get tested for it? Still fuzzy on that one. If we can get tested; how do we do it?
ask your primary care dr. to go to wriisc (war related illness and injury study center) there are only 3 in the US. I will be going to the one in Cal. in 3 weeks, after 4 years of asking to go. Dr. cannot refuse from what I understand.
but you can google WRIISC, to find out more.
Tony
Think that this is a shock? Go visit WIPO (World Intellectual Property Organization). You will find all kinds of familiar names like MRSA are actually owned by the US military, Dept. of Agriculture etc. Ask yourselves, why would our government consider controlling the population of this country and others their mission? Particularly when they have made it clear that this population control will take place by “force” if necessary?
That was the official position of the US military’s leadership in the ’70s. Ask yourselves if you want to be “defending” a hierarchy with those goals?
I would be very suspicious of testing by a government department…although it is free. Following the results of deliberate innoculations of biodiseases is one of the aims of the gov. The gov gives it to vets and then follows the results.
Read Donald Scott and his tracing of mycoplasmas, the linking pathogen in neurosystemic diseases. The gov has deliberately inooculated vets and it can usually be passed on to families, etc., etc., etc. Also read Dr. Garth Nicholson
It’s a shame but I would now never put anything past our own government and military to use the vets and US population as test subjects. And I do believe that this newly discovered “mouse virus family” (was XMRV but now MLVs) was a creation by the US Military that the CDC has done everything possible to keep as a psychiatric issue/disorder (can’t deal with stress, abused childhood, maladaptive personality, etc).
I expect shortly that this whole ugly situation will be out into the public for all to see. CFIDS has been going on for over 25 years and the CDC and NIH killed off research and funding for that Retrovirus (see http://www.oslersweb.com) back in the mid 1980′s and published/patented in the early 1990′s by Dr. Elaine Defreitas, Drs Bell/Cheney. And now CDC is trying to damage the findings of Whittemore-Peterson Institute and even the FDA/NIH studies on another Retrovirus “family”.
So “they” are hiding something terrible and “they” have used it against their own miliitary and their own population. I hate to write these things, but all fingers point in this ugly direction. Shame that my husband and I wasted so much time supporting DoD for so long only to become terribly sick and disabled because of “them” – it will come out, it always does.
FOR IMMEDIATE RELEASE
August 24, 2010
ME/CFS Worldwide Patient Alliance
Patient-driven Public Awareness Group
http://www.causes.com/causes/511536?m=f042604e (Join and Donate to a 1/2 page Advert in the Washington Post on the lack of attention, funding, research for ME/CFS/Gulf War – Neuroendocrine/immune disorders)
Tina Tidmore
205-680-6890
editor@claynews.net
Protect from Infectious Virus, Act Now
Clay, AL—No one would wish a debilitating neuroimmune disease on their worst enemy. Chronic fatigue syndrome patients are concerned that a recently-published study suggests a family of retroviruses, murine leukemia virus-related viruses, are in the nation’s blood supply at a rate of 7%. Reference Proceedings of the National Academy of Sciences, August 24, 2010.
The ME/CFS Worldwide Patient Alliance applauds the National Institutes of Health and FDA for their responsible study that confirms the strong association between a family of XMRV-related viruses and chronic fatigue syndrome, also known as myalgic encephalomyelitis, at a rate of 87%. This serves as a pivotal time that calls for a change from paltry research in the last twenty-five years of an illness that now disables millions worldwide.
“My H.I.V. patients for the most part are hale and hearty, thanks to three decades of intense and excellent research and billions of dollars invested. Many of my C.F.S. patients, on the other hand, are terribly ill and unable to work or participate in the care of their families.” Dr. Nancy Klimas, Director of Research for the Clinical AIDS/HIV Research at the Miami Veterans Affairs Medical Center, New York Times, October 15, 2009
As each day passes, more Americans with ME/CFS lose their jobs, their social activities and their health. A large majority of them will not recover based on the current lack of effective treatments.
We call for government-funded anti-retroviral treatment clinical trials now.
We call for aggressive scientific studies to protect the nation’s blood supply.
In the words of University of Alberta professor, Andrew Mason, “If the patients improve, after a certain point you stop debating whether it causes the disease and say, the treatment works and we’re going to use it.” Washington Post, August 24, 2010
The possible threat to the public health in this case is as real as the disability with the illness. This is the time to be proactive.
ME/CFS Worldwide Patient Alliance is a group of patients who have launched an ME/CFS public awareness campaign from the patient perspective.
# # #
For more information, contact Sharon Stapleton at luvpuggles@hotmail.com OR Tina Tidmore at editor@claynews.net. FOR IMMEDIATE RELEASE
August 24, 2010
ME/CFS Worldwide Patient Alliance
Patient-driven Public Awareness Group
http://www.causes.com/causes/511536?m=f042604e (Join and Donate to a 1/2 page Advert in the Washington Post on the lack of attention, funding, research for ME/CFS/Gulf War – Neuroendocrine/immune disorders)
Tina Tidmore
205-680-6890
editor@claynews.net
Protect from Infectious Virus, Act Now
Clay, AL—No one would wish a debilitating neuroimmune disease on their worst enemy. Chronic fatigue syndrome patients are concerned that a recently-published study suggests a family of retroviruses, murine leukemia virus-related viruses, are in the nation’s blood supply at a rate of 7%. Reference Proceedings of the National Academy of Sciences, August 24, 2010.
The ME/CFS Worldwide Patient Alliance applauds the National Institutes of Health and FDA for their responsible study that confirms the strong association between a family of XMRV-related viruses and chronic fatigue syndrome, also known as myalgic encephalomyelitis, at a rate of 87%. This serves as a pivotal time that calls for a change from paltry research in the last twenty-five years of an illness that now disables millions worldwide.
“My H.I.V. patients for the most part are hale and hearty, thanks to three decades of intense and excellent research and billions of dollars invested. Many of my C.F.S. patients, on the other hand, are terribly ill and unable to work or participate in the care of their families.” Dr. Nancy Klimas, Director of Research for the Clinical AIDS/HIV Research at the Miami Veterans Affairs Medical Center, New York Times, October 15, 2009
As each day passes, more Americans with ME/CFS lose their jobs, their social activities and their health. A large majority of them will not recover based on the current lack of effective treatments.
We call for government-funded anti-retroviral treatment clinical trials now.
We call for aggressive scientific studies to protect the nation’s blood supply.
In the words of University of Alberta professor, Andrew Mason, “If the patients improve, after a certain point you stop debating whether it causes the disease and say, the treatment works and we’re going to use it.” Washington Post, August 24, 2010
The possible threat to the public health in this case is as real as the disability with the illness. This is the time to be proactive.
ME/CFS Worldwide Patient Alliance is a group of patients who have launched an ME/CFS public awareness campaign from the patient perspective.
# # #
For more information, contact Sharon Stapleton at luvpuggles@hotmail.com OR Tina Tidmore at editor@claynews.net. Or simply go to this site and read all that is being done NOW. There are almost 900 members in the three weeks since this initiative was launched. The very sick KNOW that the senior policy makers in Washington DC MUST be made aware of these situations regarding our diseases, the newly discovered viral family (WPI/NCI/CC FDA/NIH)and the treatments that we are not getting. Go to: http://www.causes.com/causes/511536?m=f042604e
Thank you all. Sharon Stapleton
You all know this is being swept under the rug. My own research regarding gene splicing and the removal of sequences has already been performed for HIV patients and the sequence for XMRV is pretty close. The snipping of the sequence can be done by designer enzymes. It’s all about the $$$$ for WPI and Cleveland Clinic and others. They would rather treat with newly created Antivirals and make money with agreements with bio-med companies which would still leave the virus in tact. They would rather just give you another 20 years to live instead of removing the virus via gene manipulation/splicing. I am starting to get sick of this capitalistic society. This was written by an XMRV+ computer science geek forced to become a bio-med geek. 3+ years of reading every day. I have spent over 3,000 hours of reading and listening to lectures online and I know more than every infectious disease doctor that exists out there regarding this virus. Now that’s upsetting especially when I visit one and they say that they have never heard of it and want to copy my notes. What a joke. Go ahead all powerful United States of America…. let us die because you know its deadly. Grow up FDA, NIH and especially the CDC!!!!