Alanosine formulations and methods of use
First Claim
1. A composition comprising alanosine and a solvent, wherein the pH of the composition is at least about 7.5 and the alanosine is stable for at least about one month when stored as a liquid.
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Accused Products
Abstract
Stable liquid formulations of the anti-tumor agent L-alanosine are described. These formulations preferably comprise L-alanosine in an aqueous environment having a basic pH, preferably in the range of about pH 8-9. The alanosine formulations and compositions disclosed herein can be used for various purposes, including the treatment of various cancers, particularly those that are deficient in methylthioadenosine phophorylase (MTAP) enzymatic activity. Also described are methods for the treatment of diseases susceptible to treatment with alanosine, e.g., certain cancers, particularly those characterized by tumor cells that are MTAP deficient, wherein a patient is administered L-alanosine, alone or as part of a combination therapy with a second chemotherapeutic agent.
14 Citations
20 Claims
- 1. A composition comprising alanosine and a solvent, wherein the pH of the composition is at least about 7.5 and the alanosine is stable for at least about one month when stored as a liquid.
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11. A composition comprising L-alanosine, water for injection, and a pH of about 8.5, wherein the L-alanosine is stable for at least about one year when stored as a liquid in a pH-insensitive container.
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12. A method of making a stable aqueous formulation of alanosine, comprising:
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a. dissolving or dispersing alanosine molecules in water to make an alanosine solution or suspension, wherein the alanosine molecules are selected from the group consisting of an alanosine acid salt and an alanosine base salt;
b. adjusting the pH of the solution or suspension to at least about 7.5; and
c. after adjusting the pH, storing the resulting solution in a pharmaceutically acceptable container. - View Dependent Claims (13)
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20. A method of treating a patient having a disease susceptible to treatment with alanosine, comprising administering to the patient a first composition comprising a therapeutically effective amount of L-alanosine and a second composition comprising a therapeutically effective amount of a second chemotherapeutic agent.
Specification