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>>>> 7 April 2011 <<<
Editorship : j.van.roijen@chello.nl
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CHRONIX BIOMEDICAL
Routine Laboratory Blood Tests for Cancer
News and Resources
Press Releases
CHRONIX BIOMEDICAL AND HEMISPHERX
BIOPHARMA JOINTLY FILE PATENT
APPLICATION FOR A BLOOD TEST FOR
CHRONIC FATIGUE SYNDROME (CFS)
—CHRONIX TECHNOLOGY FOCUSES ON
CHANGES TO CFS PATIENTS’ DNA—
— HEMISPHERX AND CHRONIX PLAN
STUDIES TO VALIDATE TECHNOLOGY
AS A POTENTIAL DIAGNOSTIC TEST
FOR CFS —
San Jose, CA March 3, 2011 – Chronix Biomedical
("Chronix") announced today that it filed a
provisional United States patent application jointly
with Hemispherx Biopharma, Inc. (NYSE Amex:HEB)
("Hemispherx") on a blood test for Chronic Fatigue
Syndrome (“CFS”).
Patients with CFS exhibit a wide range of disabling
symptoms including the inability to overcome fatigue
by rest, swollen lymph nodes and cognitive
deficiencies.
CFS is estimated to affect approximately 4 million
Americans, according to the Centers for Disease
Control and Prevention (CDC). The disorder has a
negative economic impact in the United States
estimated at more than $9 billion annually.
The Chronix experimental approach analyzes
fragments of DNA often released into the
bloodstream during the process of apoptosis or
programmed cell death.
Chronix is using its proprietary technology and
advanced DNA sequencing platforms to measure
alterations in specific regions of the chromosome,
which can be detected as distinctive “signatures” in
cell-free blood-borne DNA.
By focusing on these signatures, Chronix’s
technology can detect the presence of
disease-damaged cells in simple blood samples
without needing to biopsy diseased cells or tissues.
“Our technology - based on DNA released into the
bloodstream by dying and damaged cells - taps into
the dynamic information provided by the genomic
alterations unique to each diseased cell.
We capture what is happening to the DNA very early
in and throughout the disease process, in real time,
and patient by patient.
That’s how our approach differs from other tests that
focus on static genomic data or protein biomarkers,”
said Dr. Urnovitz.
The patient-unique signatures captured by the
Chronix technology may prove useful as a companion
diagnostic – a test that is used to help guide
treatment decisions – and to provide information
about the disease process to help pharmaceutical
companies select the most efficacious drug
candidates.
Use of the Chronix diagnostic technology in CFS will
be evaluated in a study being planned by Chronix
and Hemispherx, a leader in CFS pharmaceutical
research.
Dr. William Carter, Hemispherx CEO, commented:
“It is with great enthusiasm that we will be
conducting studies aimed at validating the utility of
the Chronix technology to identify how different
individuals can respond to Hemispherx’s
experimental drug Ampligen®.”
The Chronix Biomedical blood test for Chronic Fatigue
Syndrome is experimental in nature and has not been
evaluated by any regulatory agency. It is currently
limited to investigational use.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough
approach to the diagnosis, monitoring and
management of a broad range of cancers and other
conditions. It has developed proprietary technology
that measures and categorizes DNA sequences
circulating in the blood that are associated with
specific changes in disease and health status. Using
advanced genome analysis methodology, proprietary
data tools and disease-specific databases, Chronix
has demonstrated the utility of its diagnostic and
prognostic approach in a chronic neurologic disease,
in breast and prostate cancer and in multiple
myeloma. It is currently conducting studies in other
cancers. The company initially plans to offer an
Apoptotic Serum DNA testing service to cancer
clinical researchers “For Investigational Use Only” to
track disease recurrence and monitor treatment.
Chronix is headquartered in San Jose, California and
has research facilities in Germany.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty
pharmaceutical company engaged in the manufacture
and clinical development of new drug entities for
treatment of seriously debilitating disorders.
Hemispherx’s flagship products include Alferon N
Injection® (FDA approved for a category of sexually
transmitted diseases) and the experimental
therapeutics Ampligen® and Alferon® LDO.
Ampligen® is an experimental RNA nucleic acid being
developed for globally important debilitating
diseases and disorders of the immune system.
Hemispherx’s platform technology includes
components for potential treatment of various
severely debilitating and life threatening diseases.
Hemispherx has patents comprising its core
intellectual property estate and a fully
commercialized product (Alferon N Injection®). The
Company wholly owns and exclusively operates a
GMP certified manufacturing facility in the United
States for commercial products. For more
information please visit www.hemispherx.net.
Information contained in this news release, other
than historical information, should be considered
forward-looking and is subject to various risk factors
and uncertainties. For instance, the strategies and
operations of Hemispherx involve risk of competition,
changing market conditions, change in laws and
regulations affecting these industries and numerous
other factors discussed in this release and in
Hemispherx’s filings with the Securities and
Exchange Commission. Any referenced
investigational drugs and associated technologies of
Hemispherx or Chronix are experimental in nature
and as such are not designated safe and effective by
a regulatory authority for general use and are legally
available only for investigational use. The
forward-looking statements represent Hemispherx’s
and Chronix’s respective judgments as of the date of
this release. Both Companies disclaim, however, any
intent or obligation to update these forward-looking
statements. The planning, completion, results or
submission of investigations do not imply that any
study product or test will ever be approved or
permitted for commercial distribution for the studied
or other treatment uses.
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