A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
167/130, 167/202
A61K 39/00 (2006.01) A61K 37/10 (1990.01)
Patent
CA 1285481
ANTI-VIRAL AND IMMUNOSTIMULATORY POLYNUCLEOTIDE DUPLEX AND USE THEREOR ABSTRACT OF INVENTION A drug has been provided which is a mismatched analog of rIn.rCn,[rIn.r(C12,U)n]. It retains the ability to induce interferon but does not evidence cellular toxicity. In vitro, the drug treatment of HSV-2 infected human fibroblasts [0.25-2.5 mg/ml; 24 hrs. pre- to 1 hr. post infection (p.i.)] results in 80% reduction in virus titers. In vivo, antiviral activity was evaluated in a guinea pig model of recurrent HSV-2 infection. Guinea pigs were inoculated with HSV-2 (5x105 PFU in the footpad) and treated with 4 (2 day intervals) intraperitoneal injections of the [rIn.r(C12,U)n] (5 µg/g weight) or placebo (saline) beginning at 0- 24 hrs. p.i. They were followed for: (i) development and severity (lesion score) of primary disease and (ii) appearance and duration of recurrent episodes. Animals first treated at 8 hrs. p.i. evidenced a significant reduction in the severity of the primary disease (lesion scores 1.7 ? 0.6 and 3.3 ? 0.7 for rIn.rC12U and placebo treated respectively), and in the incidence of recurrent episodes (33% and 83% in drug and placebo treated respectively). Similar results were obtained in animals treated i.p. at 20 hrs. p.i. and in those given 5 (2 day intervals) antranasal doses (0.5 mg) starting at 6 hrs. p.i. Experiments designed to elucidate the mechanism of in vivo action of the drug indicated that it: (i) causes a 3-fold reduction in virus titers at the site of infection, (ii) reduces 2-5 fold the titers of ganglionic virus, (iii) does not modify virus specific lymphocyte blastogenesis and titers of neutralizing antibody and (iv) causes a 2-fold enhancement of in vitro natural killer cell activity. This data indicates that the drug rIn,rC12U may have both antiviral and immunomodulatory activities. In the other mice models, the inoculation of HSV-2 induced fatal events. Injection of rIn.r(C12U)n compound can protect infected animals from fatality. The aged animal is much more suspectible to the virally induced fatality than the younger animal. Injection of rIn.r(C12U)n compound affords the protection to the old animal against the virus as the aged animal now has the same resistance as the young animal. Immunological studies including NK cell activation indicated that rIn.r(C12U)n compound produced immunological protection for the aged animal so that it now becomes immune to the virally induced fatality. This study indicates the rIn.r(C12U)n compound can stimulate the immunal defense system of aged animal including humans against viral diseases.
523303
Aurelian Laure
Ts'o Paul O.p.
Gowling Lafleur Henderson Llp
The Johns Hopkins University
University Of Maryland
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