Compositions comprising IMPDH inhibitors and uses thereof...

Details Compositions comprising IMPDH inhibitors and uses thereof... Compositions comprising IMPDH inhibitors and uses thereof...

2008-05-13

2008-05-13

Saoud, Christine J (Department: 1647)

Drug, bio-affecting and body treating compositions

Lymphokine

Interferon

C424S085400, C514S002600, C514S588000, C514S894000

Reexamination Certificate

active

07371372

ABSTRACT:
The present invention relates to optimal compositions useful in treating HCV infections in humans. These compositions comprise alpha-interferon or pegylated alpha-interferon and an IMPDH inhibitor selected from VX-148 or VX-944, wherein the IMPDH inhibitor is present in an amount such that a ratio of Cavg/Cmin is between 1 to 10, wherein:Cavg is average plasma concentration produced by said IMPDH inhibitor in said human; andCmin is estimated trough concentration produced by said IMPDH inhibitor in said human.The present invention also relates to methods of producing and using the optimal compositions to treat HCV infections in humans.

REFERENCES:
patent: 6824769 (2004-11-01), Chaturvedi et al.
Jain et al. Characterization of Pharmacological Efficacy of VX-148, a New, Potent Immunosuppressive Inosine 5′-Monophosphate Dehydrogenase inhibitor (2002), The J. of Pharmacology and Experimental Therapeutics, vol. 302, No. 3, pp. 1272-1277.
Wright, et al., “Dose-Ranging Study of VX-497, A Novel Oral IMPDH Inhibitor, In Patients With Hepatitis C”, Hepatology, vol. 30, No. 4, p. 408A, Part 2, 1999.
Markland, et al., “Broad-Spectrum Antiviral Activity of the IMP Dehydrogenase Inhibitor VX-497: a Comparison with Ribavirin and Demonstration of Antiviral Additivity with Alpha Interferon”, Antimicrobial Agents and Chemotherapy, vol. 44, No. 4, pp. 859-866, 2000.
Khakoo et al., “Ribavirin and Interferon alfa-2b in Chronic Hepatitis C: Assessment of Possible Pharmacokinetic and Pharmacodynamic Interactions”, Br. J. Clin. Pharmacol, vol. 46, pp. 563-570, 1998.
McHutchinson et al., “Combination Therapy with Interferon Plus Ribavirin for the Initial Treatment of Chronic Hepatitis C”, Seminars in Liver Disease, vol. 19, Suppl. 1, pp. 57-65, 1999.
Glue et al., The Clinical Pharmacology of Ribavirin. Seminars in Liver Disease. vol. 19, Suppl. 1, pp. 17-24, 1999.
Brunet, et al., “Pharmacokinetics and Pharmacodynamics of Mycophenolic Acid in Stable Renal Transplant Recipients Treated with Low Doses of Mycophenolate Mofetil”, Transpl. Int., pp. S301-S305, 2000.

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