Ampligen
Potential health benefits and research finds   2007
In 1985, Carter WA and co-authors pointed out that double-stranded (ds) RNAs have been largely over-looked as
potentially valuable anticancer/antiviral drugs, primarily because of the many clinical toxicities and lack of
efficacy associated with the first clinically tested dsRNA--polyinosinic-polycytidylic acid (rIn X rCn). They
suggested that purposeful mispairing of bases could enhance the therapeutic ratio of dsRNAs significantly. [1]
Ampligen (rIn X r(C12,U)n) showed strong antitumor activity in different basic studies with limited toxicities.
In 1985, Carter WA and co-authors pointed out that double-stranded (ds) RNAs have
been largely over-looked as potentially valuable anticancer/antiviral drugs, primarily
because of the many clinical toxicities and lack of efficacy associated with the first
clinically tested dsRNA--polyinosinic-polycytidylic acid (rIn X rCn). They suggested that
purposeful mispairing of bases could enhance the therapeutic ratio of dsRNAs
significantly. [1] Ampligen (rIn X r(C12,U)n) showed strong antitumor activity in different
basic studies with limited toxicities.

Ampligen may benefit patients with cancers.
Ampligen showed strong antiproliferative activities against human carcinoid tumor cells
in a clonogenic assay when natural alpha- and beta-IFNs were inactive. [2]

In a study, 50% of untreated and IFN-treated athymic mice engrafted with human renal
cancer cells die within 20-22 weeks, mice treated with Ampligen survive a minimum of
32 weeks. [1] Antitumor action of Ampligen was also demonstrated on certain human
lung tumor cells but not shared by polyinosinic. [2]

In a pilot study of patients with hematologic malignancies, intravenous infusion of
Ampligen (10-80 mg/infusion, twice weekly) was well tolerated with limited side effects.
Side effects mainly were occasional mild fatigue, flu-like symptoms, low grade, transient
fever. The treatment did not induce specific antibodies directly against Ampligen. The
administration of Ampligen activated natural killer (NK) cells and a lymphocyte,
interferon-associated, intracellular enzyme. In doses of 10-40 mg, 3/9 patients showed
stable disease for up to 1 year. At the 80-mg dose level, 2/5 patients showed tumor
regressions. [3]

Ampligen may benefit HIV patients
Carter WA and co-workers also found that combined therapy with ampligen and
zidovudine (azidothymidine, AZT) reduced the concentration of zidovudine required for
inhibitory activity against human immunodeficiency virus (HIV) in vitro, i.e. a synergistic
effect. [4]

In a study of 10 patients with the acquired immunodeficiency syndrome (AIDS),
AIDS-related complex (ARC), or lymphadenopathy syndrome (LAS), the levels of HIV
RNA in peripheral blood mononuclear cells (in 9 patients) became undetectable
between days 10 and 40 of the start of 200-administration of 250 mg ampligen twice a
week for up to 18 weeks. Ampligen therapy also led to an increase in or maintenance of
numbers of helper-inducer T lymphocytes, improvements in HIV-related symptoms, rises
in titre of neutralising antibodies against HIV, and restoration of proper functioning of the
natural lymphocyte antiviral dsRNA-dependent (2'-5'-oligoadenylate/RNA-ase L)
pathway in the study. [5]

Ampligen may have benefits on chronic fatigue syndrome.
Hemispherx announced that it has finished its clinical trials on ampligen
(double-stranded (ds) RNA) in treating chronic fatigue syndrome on December 12,
2007. TL3 receptors are known to recognize viral double-stranded (ds) RNA, a
molecular pattern associated with increasing host defenses against disease. Ampligen
activates the TLR3 receptors on respiratory epithelium. They will summarize the phase 3
clinical trials of total 757 subjects at the upcoming 8th International IACFS Conference
on Chronic Fatigue Syndrome in January 2007. In their news release, they claimed that
they achieved the primary endpoints with statistical significance in all Ampligen® clinical
trials. [6]

Patients receiving Ampligen® for 40 weeks improved exercise treadmill performance
14.8% in the placebo group. And, the Ampligen group improved oxygen utilization by
6.1% v 0.58% in the placebo group. They also observed improvement in exercise
tolerance in the Ampligen group. [6]
.

[1] Carter WA, et al, Preclinical studies with Ampligen (mismatched double-stranded
RNA). J Biol Response Mod. 1985 Oct;4(5):495-502. [2] Carter WA, Comparative
studies of ampligen (mismatched double-stranded RNA) and interferons. J Biol
Response Mod. 1985 Dec;4(6):613-20. [3] Brodsky I, et al, Clinical studies with
ampligen (mismatched double-stranded RNA). J Biol Response Mod. 1985
Dec;4(6):669-75. [4] Mitchell WM, et al, Mismatched double-stranded RNA (ampligen)
reduces concentration of zidovudine (azidothymidine) required for in-vitro inhibition of
human immunodeficiency virus. Lancet. 1987 Apr 18;1(8538):890-2. [5] Carter WA,
Clinical, immunological, and virological effects of ampligen, a mismatched
double-stranded RNA, in patients with AIDS or AIDS-related complex. Lancet. 1987 Jun
6;1(8545):1286-92. [6] Hemispherx Comments on Chronic Fatigue Syndrome Initiatives
by the Centers for Disease Control Tuesday December 12, 8:30 am Hemispherx, Inc ET
2006
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