Method for preparation of large volume batches of poly-ICLC with increased biological potency; therapeutic, clinical and veterinary uses thereof
AssigneeOncovir, Inc.
InventorAndres Salazar
Life of this patent
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Abstract
Method for producing large lots of final sterile Poly-ICLC suitable for clinical use with reduced toxicity at effective dose levels, and method for using Poly-ICLC to regulate genes, and method for using Poly-ICLC to treat certain human and veterinary infectious, neoplastic and autoimmune disorders.
Claims10
1) An improved, modified method for the production-scale manufacture of large, clinical grade, sterile batches of poly-ICLC, a complex of high molecular weight polyriboinosinic-polyribocytidylic acid;
- low molecular weight poly-L-lysine;
- and carboxymethylcellulose, having greater accuracy of drug delivery in clinical applications, and increased biological potency and interferon induction activity in primates, comprising the steps of adding poly-L-lysine component solution very slowly to a carboxymethylcellulose component solution over a period of at least 4 days, and mixing for the entire blending time vigorously enough to form a vortex and minimize precipitate buildup.
5) A method of treatment of disease selected from among the group consisting of malignant brain tumors, melanoma, breast and lung cancer, colon cancer, sarcomas, renal cell cancer, leukemias, lymphomas, microbial infections including influenza, flavivirus infections, West Nile virus, Japanese encephalitis, dengue, yellow fever, coronaviruses such as SARS, filoviruses such as ebola virus, influenza, poxviruses such as vaccinia and smallpox, adenovirus, hepatitis, herpesviruses infections HIV, AIDS, equine encephalitis, foot & mouth virus, bovine respiratory complex, porcine reproductive respiratory syndrome virus, multiple sclerosis, Guillain Barre syndrome, immune neuropathies, vasculitides, and ionizing radiation injury, comprising the steps of:
- administering Poly-ICLC intranasally, orally, sublingually, intramuscularly, intravenously, transsdermally or topically in at least two doses spaced 4-72 hours apart, where the first dose is in a moderate range (20 to 100 mcg/kg in humans) sufficient to induce measurable but not excessive levels of serum interferon;
- and the second, lower dose is in the maximally effective range (10 to 50 mcg/kg in humans) for unblocking and stimulation of certain interferon and dsRNA inducible enzyme systems, including the PKR and 2′5′OAS.
7) A method for enhancing the action and decreasing the toxicity of a vaccine, comprising the steps of administering Poly-ICLC to a subject, and administering the desired vaccine to said subject
Dependencies are inferred from the claim text.