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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