Methods for intradermal delivery of therapeutics agents
First Claim
1. A method for treating a cancer in a human subject in need thereof, comprising delivering at least one therapeutic agent to an intradermal compartment of the human subject'"'"'s skin, wherein the therapeutic agent results in a greater reduction in the growth of the tumor as compared to when the agent is delivered by a route other than intradermal delivery.
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Abstract
The present invention relates to methods and devices for delivering one or more biologically active agents, particularly therapeutic agents, to the intradermal compartment of a subject'"'"'s skin. The present invention provides an improved method of delivery of biologically active agents, such as therapeutic agents, through lymphatic vasculature accessed by intradermal delivery. Therapeutic agents to be delivered in accordance with the present invention include, but are not limited to, antineoplastic agents, chemotherapeutic agents, antibodies, antibiotics, anti-angiogenesis agents, anti-inflammatory agents, and immunotherapeutic agents. Therapeutic agents delivered in accordance with the present invention have improved bioavailability, including improved systemic distribution and improved delivery to particular tissues. Therapeutic agents delivered in accordance with the methods of the invention have an improved clinical utility and therapeutic efficacy relative to other drug delivery methods, including intraperitoneal, intramuscular and subcutaneous delivery. The methods of the present invention provide benefits and improvements over conventional drug delivery methods including dose sparing, increased drug efficacy, reduced side effects, reduced metastatic potential and prolonged survival.
80 Citations
33 Claims
- 1. A method for treating a cancer in a human subject in need thereof, comprising delivering at least one therapeutic agent to an intradermal compartment of the human subject'"'"'s skin, wherein the therapeutic agent results in a greater reduction in the growth of the tumor as compared to when the agent is delivered by a route other than intradermal delivery.
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2. A method for treating a cancer in a human subject comprising delivering at least one therapeutic agent to an intradermal compartment of a human subject'"'"'s skin, wherein the agent results in an increase in the median life span of the human subject as compared to when the agent is delivered by a route other than intradermal delivery.
- 8. A method for administration of at least one therapeutic agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a higher tissue bioavailability in a particular tissue as compared to when the agent is delivered by a route other than intradermal delivery.
- 10. A method for administration of at least one therapeutic agent to a human subject for the prevention of a disease, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a higher tissue bioavailability in a particular tissue as compared to when the agent is delivered by a route other than intradermal delivery.
- 12. A method for administration of at least one therapeutic agent to a human subject for the delay of the onset or the progression of a disease state, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a higher tissue bioavailability in a particular tissue as compared to when the agent is delivered by a route other than intradermal delivery.
- 30. A method for treating a cancer in a human subject in need thereof, comprising delivering at least one therapeutic agent to an intradermal compartment of the human subject'"'"'s skin at a pre-selected dose, wherein the pre-selected dose is reduced by at least one half a fold as compared to the dose delivered by a route other than intradermal delivery.
- 32. A method for treating a cancer in a human subject in need thereof, comprising delivering at least one therapeutic agent to an intradermal compartment of the human subject'"'"'s skin so that the agent has a faster onset compared to when the same agent is delivered by a route other than intradermal delivery.
Specification