hich is what FDA pays attention to, did NOT have to pay for the drug. Those=
of us in the "cost-recovery open-label study" - are paying what has been de=
emed a "fair price" for the drug. But we know we are getting it.
Mary Schweitzer
On Oct 11, 2011, at 1:36 PM, kelly <kellylatta66@gmail.com> wrote:
> Note: Just for clarification, the Nobel Prize was not awarded for
> Ampligen - one of the professors that won did research that involved
> the drug in addition to other research. This is public relations spin
> by a company trying to connect their product with a prestigious award.
> Nor does the release mention that the product, Ampligen, has been in
> clinical trials for decades, that it is unusual in that the company
> asks patients to pay to be included in the trials and that the payment
> far exceeds the cost of the actual drug.
>=20
>=20
> Oct. 11, 2011, 10:30 a.m. EDT
> 2011 Nobel Prize Awarded for Discovery of Innate Immunity Pathways --
> Research Included Studies on Experimental Drug in Hemispherx Biopharma
> Portfolio
>=20
> PHILADELPHIA, Oct 11, 2011 (GlobeNewswire via COMTEX) -- Hemispherx
> Biopharma, Inc. HEB +6.97% ("Hemispherx" or the "Company") offered
> congratulations and homage to Ralph M. Steinman (1943-2011) who shared
> the 2011 Nobel Prize in Physiology or Medicine with Drs. Bruce A.
> Beutler and Jules A. Hoffman.
>=20
> Innovative research conducted by this year's Nobel Prize winner has
> led to greater understanding and involvement of Innate Immunity
> Receptors such as Toll-Like Receptors (TLRs), dendritic cells, and
> their immune signaling pathways that control and drive the immune
> response.
>=20
> Professor Ralph Steinman, while director of the Center for Immunology
> and Immune Disease, at Rockefeller University, published in the
> Proceedings of the Academy of Natural Sciences ("PNAS")
> (105:2574-2579)(105:2008) data that demonstrated the unique action of
> Ampligen(R) (poly i:Poly C12U) as a specific TLR3 activator and
> dendritic cell maturation agent. Other TLR3 activators reported by the
> Steinman team had immune stimulating activities, which were
> "off-target", i.e., these compounds also acted outside of the specific
> TLR3 activation mechanism. Prof. Steinman's team supplemented these
> Ampligen(R) results in his subsequent publication in PLoS Pathogen
> (5(4):e1000373, 2009). These results were independently corroborated
> by researchers at Utah State University (the journal of immunology
> (178:5200-5208)(the journal of immunology (178:2007)).
>=20
> Ampligen(R), an experimental therapeutic, is a flagship product within
> the Hemispherx proprietary platform being investigated clinically in a
> variety of Phase I thru Phase III clinical trials as an
> immunomodulatory drug, both as monotherapy as well as part of various
> immunologic-based cocktails. Active U.S. based clinical trials include
> those at the University of Pennsylvania, the University of Washington,
> and the CFS (Chronic Fatigue Syndrome)/Ampligen(R) consortium group
> with active clinical sites in New York City, NY, Charlotte, NC, Miami,
> FL, Incline Village, Nevada, and Salt Lake City, UT, and a planned
> (FDA authorized) study at the University of Alabama on potential
> protection against seasonal and pandemic influenza.
>=20
> Prof. Steinman discovered, in 1973, a new type of cell, which he
> called the dendritic cell. He postulated that it could be important in
> the immune system. The remainder of his life was devoted to unraveling
> the complexities of this fundamental biological process. Ampligen(R),
> an experimental therapeutic, was discovered at about the same time at
> Johns Hopkins University. The Ampligen(R) co-discoverers speculated
> that it might induce the body to produce interferon which plays a key
> role in immunity; only several decades later was its activity as the
> first specific TLR3 activator reported by the Steinman team in the
> PNAS publication. New, ongoing, research suggests that genetic
> variants in TLRs, especially TLR3, may be associated with an increased
> risk for certain chronic diseases.
>=20
> In both commerce and basic research areas, many have benefited from
> the work of Prof. Steinman that resulted in his recognition as the
> 2011 Nobel laureate in Medicine. The vast potential enabled by his
> work for translational medicine remains to be discovered.
>=20
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Co-Cure's purpose is to provide information from across the spectrum of
opinion concerning medical, research and political aspects of ME/CFS and/or
FMS. We take no position on the validity of any specific scientific or
political opinion expressed in Co-Cure posts, and we urge readers to
research the various opinions available before assuming any one
interpretation is definitive. The Co-Cure website <www.co-cure.org> has a
link to our complete archive of posts as well as articles of central
importance to the issues of our community.
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