What is Ampligen? It is an antiviral and immune modulatory drug under the nucleic acid class of drugs (NAs). Nucleic acid drugs are designed to mimic the body's own digitalized informational molecules (called DNA and RNA) which, in some laboratory and animal studies, reprogram certain diseased cells to enhance their intrinsic disease capabilities.
To date, HEMISPHERx and its subsidiaries have received over 200 patents internationally to protect its proprietary position in NA and related drug technologies.
What is the generic name of Ampligen? Ampligen is the drug poly I: poly C12U, which is a specific form of mismatched double-stranded ribonucleic acid (dsRNA) where uridylic acid (U) substitutions in the polycytidylic acid chain create periodic regions of non-hydrogen bonding in the helical configuration. These changes, developed by HEMISPHERx, have resulted in unique double-stranded RNA s, termed mismatched double-stranded RNA s. Double-stranded RNA s act as modulators or molecules that mediate cellular immune and antiviral activities.
How does Ampligen work? Ampligen inhibits viruses and tumor-cell growth through pleiotropic, or multiple interrelated, mechanisms. Ampligen up-regulates or down-regulates, as needed, two important enzyme systems; (1) the 2 ,5 oligoadenylate synthetase/RNase L (2-5A synthetase/RNase L) pathway; and (2) the P68 protein kinase pathway. Ampligen can induce the production of 2-5A synthetase independent of interferon induction. It also can activate both 2-5A and p68 protein kinase, while IFNs can only induce production, but not activate, these enzymes, an important biological distinction. Ampligen can also inhibit 2-phosphodiesterase, an enzyme which destroys the product of 2-5A synthetase, biactive 2-5A. These differences in mechanisms between IFNs and Ampligen result in clinical and biological activities in interferon intolerant or resistant states and synergistic interactions between Ampligen and interferon. (Once these pathways are stimulated correctly, the cell responds with the production of cytokines and lymphokines, the chemical messengers immune cells used to communicate the memory response of antigen specific CD8+ cells, the type of white blood cells thought to play the major role in cell-mediated immunity.)
2-5A Synthetase/RNase L Pathway: Once 2-5A mRNA has been transcribed by the genes in the nucleus (which earlier had been stimulated by messages from the cAMP signal transition pathway), latent 2-5A synthetase is created. Ampligen then activates this latent 2-5A synthetase and activated 2-5A is created. Activated 2-5A, in turn, activates an enzyme called RNase-L, which destroys viral RNA. (Oragen compounds directly stimulate the production of active 2-5A.) 2-5A itself also can control the growth of certain human tumor cells and inhibits reverse transcriptase, the enzyme both HIV and HBV use for reproduction.
The RNase-L pathway is one of the immune system s standard response to viral infection (termed intracellular immunity ). Some viruses, however, such as HIV, herpes, and HBV overcome intracellular immunity by producing substances that deactivate RNase-L, thereby releasing the virus to multiply largely unchecked within the intracellular environment and clinical deterioration occurs.
Protein Kinase (p68) Pathway: The protein kinase (p68) pathway is also affected in a similar manner. Once p68 kinase mRNA is transcribed from DNA templates in the nucleus of the cell, p68 kinase is formed by translation of the RNA message. Ampligen then induces the autophosphorylation of p68 kinase (essentially an activation of p68 kinase) that leads through two other steps, elF2a and elf25-P to the inhibition of viral protein syntheses.
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