Wednesday, September 29, 2010

XMRV and Ampligen

This is the basic info:
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"The XMRV antibody positive cohort had a greater relative percentage of
subjects showing a >25% increase in ETT with Ampligen(R) treatment compared
to placebo than the XMRV antibody negative cohort. The results also suggest
that the XMRV antibody negative subjects with CFS have a lower activity
level and a reduced ability to complete normal daily activities at
baseline."
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http://www.globenewswire.com/newsroom/news.html?d=200987

Source: Hemispherx Biopharma, Inc. 

Hemispherx Biopharma to Present New Retrovirus (XMRV) Data at 1st
International Workshop on XMRV and Chronic Fatigue Syndrome (CFS)

Retrovirus Positive CFS Patients Show Enhanced Response to Ampligen(R), an
Experimental Therapeutic, Relative to XMRV Negative Group

BETHESDA, Md., Sept. 8, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.
(AMEX:HEB) will present new clinical data on the possible
inter-relationships of XMRV positivity/chronic fatigue syndrome/AmpligenR
responsiveness at the 1st International Workshop on XMRV being held at the
National Institutes of Health in Bethesda, MD, on September 7 and 8, 2010.

CFS is a severe disorder consisting of profound fatigue and a variety of
other debilitating symptoms that affects up to 4 million Americans.
Recently, DNA was identified from a human gamma retrovirus (XMRV) in 67% of
CFS subjects. Evidence also suggested that approximately 50% of the CFS
subjects mounted a specific antibody response against XMRV (Science 326,
585-589 (2009)). The objective of this study was to compare demographic
parameters and health/performance status of XMRV antibody positive vs.
negative CFS subjects enrolled in a Phase III clinical trial evaluating the
safety and efficacy of a toll-like receptor 3 agonist, rintatolimod
(PolyI:PolyC12U, AmpligenR). The response to AmpligenR with regard to the
primary endpoint, treadmill exercise tolerance testing (ETT), in this
population was also evaluated.

Two-hundred-eight (208) evaluable subjects, who met the original (1988) and
revised (1994) Centers for Disease Control criteria for CFS, participated in
this randomized, placebo-controlled, double-blinded, multicenter study. Only
severely debilitated patients with a Karnofsky Performance Scale between
40-60 were selected for this study. The primary endpoint was exercise
treadmill duration. Subjects received AmpligenR (200-400 mg) or an
equivalent volume of placebo (saline) twice weekly by intravenous infusion
for 40 weeks. Baseline (or earliest available specimen) serum samples from
all 208 subjects were analyzed for antibodies directed against XMRV.

The XMRV antibody positive cohort had a greater relative percentage of
subjects showing a >25% increase in ETT with AmpligenR treatment compared to
placebo than the XMRV antibody negative cohort. The results also suggest
that the XMRV antibody negative subjects with CFS have a lower activity
level and a reduced ability to complete normal daily activities at baseline.
If validated as a relevant basis for targeting the XMRV positive CFS patient
sub-population, the observed response advantage of the XMRV may translate
into needing a smaller sample size for future research using a
placebo-controlled parallel design to obtain 80% power (รก=0.05): 216 XMRV
antibody positive subjects vs. 330 XMRV antibody negative subjects.
Additional studies to further evaluate XMRV in this CFS population are
currently underway.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company
engaged in the clinical development of new drug entities for treatment of
seriously debilitating disorders. Hemispherx's flagship products include
Alferon N InjectionT (FDA approved for a category of sexually transmitted
diseases) and the experimental therapeutics AmpligenR and Alferon LDOT.
AmpligenR represents experimental nucleic acids being developed for globally
important debilitating diseases and disorders of the immune system.
Hemispherx's platform technology includes agents for potential treatment of
various severely debilitating and life threatening diseases. Hemispherx has
an extensive number of patents comprising its core intellectual property
estate and a fully commercialized product (Alferon N InjectionT).  The
Company wholly owns and exclusively operates a GMP certified manufacturing
facility in the United States.  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 the Company's filings with the
Securities and Exchange Commission. Any specifically referenced
investigational drugs and associated technologies of the Company (including
AmpligenR and AlferonR LDO) 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 through clinical trials with the referenced
disorders. The forward-looking statements represent the Company's judgment
as of the date of this release. The Company disclaims, however, any intent
or obligation to update these forward-looking statements. The planning,
completion, results or submission of clinical trials do not imply that any
study product will ever be approved commercially for the studied or other
treatment indications.

CONTACT:  Hemispherx Biopharma, Inc.
          Company/Investor Contact:
          Dianne Will
          518-398-6222 begin_of_the_skype_highlighting
518-398-6222      end_of_the_skype_highlighting
          ir@hemispherx.net

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