Wednesday, December 23, 2009

Hemispherx comments on Ampligen

 
It should be noted that the term enigmatic means hard to understand or
explain - CFS is actually neither. "We know in part" pretty much describes
all of medicine, but it doesn't automatically make it enigmatic.

Although the research water is muddied by the partially successful
career-long attempts by psychiatric liasons Simon Wessely and Peter Denton
White to use CFS and other similar organic diseases to illustrate the
principles of psychiatrist George Engel's biopsychosocial theory, the
biomedical evidence is no more enigmatic than that of other organic
diseases.

Biomedical researchers have no biomarkers and/or objective tests for
Alzheimer's Disease, Huntington's Disease, diabetes or Parkinson's Disease for example, but no one uses the term enigmatic or enigma to describe them. 
Nor is the etiology of many organic diseases known including that of most of
the diseases listed above, but once again, no one uses the term enigma or
enigmatic to describe any of them.


PHILADELPHIA, Dec. 16, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.
(NYSE Amex:HEB) (the "Company"), stated that on December 11, 2009, the
Company, via its manufacturing subcontractor, in Spokane, WA, submitted
comprehensive new data to the regional office of the Food and Drug
Administration ("FDA"), Seattle, WA, which Hemispherx management believes
demonstrate that certain manufacturing issues noted in earlier pre-approval
inspections at the facility have been fully addressed. The referenced
reports on Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic
being developed for potential treatment of Chronic Fatigue Syndrome ("CFS"),
are the combined work-product of the staffs at Hemispherx and its
subcontractor. These are the same manufacturing issues sited in previous
10-Q's and the recent 10-K. These manufacturing issues were also part of a
Complete Response Letter from the FDA described in a December 1, 2009 press
release.

About Hemispherx Biopharma

Chronic Fatigue Syndrome is an enigmatic, profoundly debilitating and
potentially life-threatening disease with which a new retrovirus was
recently associated. Researchers are investigating the possible role of this
virus in the symptomatology of the disease using Ampligen(R) as an
investigational therapeutic.

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(R) (FDA approved for a category of
sexually transmitted diseases) and the experimental therapeutics Ampligen(R)
Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent
experimental RNA nucleic acids being developed for globally important
debilitating diseases and disorders of the immune system. Hemispherx's
platform technology includes large and small agent components for potential
treatment of various severely debilitating and life threatening diseases.
Hemispherx has in excess of 50 patents comprising its core intellectual
property estate and a fully commercialized product (Alferon N Injection(R)).
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
 http://www.globenewswire.com/newsroom/ctr?d=180474&l=4&a=www.hemispherx.net&u=http%3A%2F%2Fwww.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 completion of the NDA
filing process with Ampligen(R) and the receipt of a Complete Response
Letter from the FDA do not imply that the Company will be able to
successfully comply with any or all of the requirements requested in that
Letter or that the product will ever be approved for commercial sale. In
addition, 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 Ampligen(R), Alferon(R) LDO and
Oragens(R)) 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. Clinical trials for other potential
indications of the approved biologic Alferon N Injection(R) do not imply
that the product will ever be specifically approved commercially for these
other treatment indications; Similarly, the completion of NDA filing process
with Ampligen(R) does not imply that the product will ever be approved
commercially.


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