Methods for treatment of bladder cancer with gemcitabine
AssigneeTARIS Biomedical LLC
InventorsDennis GIESING, Heejin LEE, Karen DANIEL
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Abstract
Drug delivery devices and methods are provided for administering gemcitabine to a patient in need of treatment of bladder cancer by intravesically administering gemcitabine into the bladder of the patient to achieve a sustained concentration of the gemcitabine in urine in the bladder sufficient to produce a therapeutically effective concentration of the gemcitabine in the tissues of the bladder. In embodiments, the local administration into the patient's bladder is at a mean average amount of from 1 mg/day to about 300 mg/day of the gemcitabine (FBE).
Claims8
A method for treating non-muscle invasive bladder cancer (NMIBC) in a human patient, comprising:
- deploying into the human patient's bladder an intravesical drug delivery device which comprises gemcitabine and urea for a treatment period of 21 days;
- releasing from 10 mg/day to 50 mg/day of gemcitabine free base equivalent (FBE) continuously into the bladder of the human patient from the intravesical drug delivery device over a period of from 7 to 21 days,
- wherein the intravesical drug delivery device comprises a housing that is elastically deformable between a retention shape configured to retain the intravesical drug delivery device in the bladder and a deployment shape for passage of the intravesical drug delivery device through a urethra,
- wherein the housing comprises a predefined release aperture and a drug reservoir, the drug reservoir having a first region and a second region that is a distinct space from the first region,
- wherein the gemcitabine is located in the first region in the form of one or more gemcitabine minitablets, and wherein the urea is located in the second region in the form of one or more urea minitablets,
- wherein the gemcitabine is released from the predefined release aperture into urine in the human patient's bladder by osmotic pressure generated by the urea minitablets, and
- wherein the treatment does not comprise administering an active ingredient other than gemcitabine from the intravesical drug delivery device for the treatment of NMIBC.
Dependencies are inferred from the claim text.