Multiple-variable dose regimen for treating diabetes
OwnerPnina STRAUSS, Naveh TOVinventors
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Abstract
The present invention relates to the field of preservation of functional pancreatic islet (beta-cells) and treatment of diabetes, providing improved dosage regimen of AAT administration to Type 1 Diabetes Mellitus (T1DM) patients, particularly to newly diagnosed T1DM patients. The improved dose regiment is a multiple variable dosage regimen, comprising and induction phase and a treatment phase.
Claims36
A method of treating Type 1 Diabetes Mellitus (T1DM) in a subject in need thereof, comprising administering to the subject alpha-1 antitrypsin (AAT) in a multiple variable dosage regimen comprising an induction phase followed by a treatment phase, wherein the cumulative dose of AAT administered during the induction phase is higher than the cumulative dose of AAT administered during the treatment phase.
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The method of claim 52, wherein the induction phase comprises administering a cumulative AAT dose of 120-960 mg AAT/KgBW and the treatment phase comprises administering at least two AAT doses, each dose comprising 15-120 mg/KgBW.
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The method of claim 52, wherein:
- (a) the induction phase comprises administering 12 doses each of 60 or 120 mg AAT/KgBW at intervals of one week;
- and, (b) the treatment phase comprises (i) administering four doses each of 60 or 120 mg AAT/KgBW at intervals of two weeks;
- (ii) no AAT administration for 26 weeks;
- (ii) administering 4 doses each of 60 or 120 mg AAT/KgBW at intervals of two weeks;
- (iii) no AAT administration for 24 weeks;
- and, (iv) administering 6 doses each of 60 or 120 mg AAT/KgBW at intervals of one week;
- and, optionally, (v) administering 6 doses each of 60 or 120 mg AAT/KgBW at intervals of one week;
- wherein steps (a)-(b) and (i)-(v) are performed in a sequential order.
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A method of prolonging cellular implant survival in a subject in need thereof undergoing cellular implantation, comprising administering to the subject AAT in a multiple variable dosage regimen, thereby prolonging the cellular implant survival, the multiple variable dosage regimen comprising an induction phase followed by a treatment phase, wherein the cumulative dose of AAT administered during the induction phase is higher than the cumulative dose of AAT administered during the treatment phase.
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Dependencies are inferred from the claim text.