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Drug delivery systems and methods for treatment of bladder cancer with gemcitabine

Inactive Publication Date: 2015-09-10
TARIS BIOMEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent describes a medicament and a drug delivery device for treating bladder cancer by locally administering gemcitabine into the bladder of a patient. The medicament can be in the form of a solution or a solid form that can be dissolved in water. The drug delivery device can be a flexible catheter that releases the medicament continuously or intermittently over a period of time. The treatment involves achieving a therapeutic concentration of gemcitabine in the bladder tissues to produce a therapeutic effect. The method can also include administering a second therapeutic agent or a solubility altering agent to enhance the solubilization of gemcitabine. The technical effect of this patent is to provide a more effective and targeted treatment for bladder cancer with reduced systemic toxicity and improved efficacy.

Problems solved by technology

Bladder cancer is a significant medical problem, and currently available treatment options are unsatisfactory for a number of reasons.
However, there is a high rate of recurrence after surgery and the cancer may progress to muscle-invasive disease.
However, many patients do not respond to BCG, and BCG treatment can also induce a range of adverse effects leading to discontinuation of treatment.
However, intravesical administration of high doses of gemcitabine can lead to significant systemic absorption and cause gastrointestinal, bladder and bone marrow toxicity further limiting the clinical utility in addition to local tolerability issues.

Method used

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  • Drug delivery systems and methods for treatment of bladder cancer with gemcitabine
  • Drug delivery systems and methods for treatment of bladder cancer with gemcitabine
  • Drug delivery systems and methods for treatment of bladder cancer with gemcitabine

Examples

Experimental program
Comparison scheme
Effect test

example 1

Gemcitabine Prostate Uptake from Bladder

[0064]A study was conducted on male Sprague Dawley rats administering 14C gemcitabine by intra-urinary bladder cannula, over a 6- or 24-hour continuous perfusion, or by a single IV bolus. The 6- and 24-hour continuous perfusions perfused 6.9 and 26.6 mg, respectively, of gemcitabine into the bladder. The single IV bolus included 5.0 mg of gemcitabine.

[0065]Blood (FIG. 8), urine, and tissue samples (e.g., bladder, prostate)(FIGS. 7 and 9) were collected and analyzed for gemcitabine content. The results are illustrated in FIGS. 7-9. The results show that sustained gemcitabine urine concentrations have been found to produce significant gemcitabine levels in bladder tissue, which are at or exceed therapeutic concentrations based on in vitro bladder cancer cell experiments. The gemcitabine levels in the bladder are shown in FIG. 9, which also depicts a significantly lower concentration of gemcitabine in the bladder 24 hours after a clinically relev...

example 2

Gemcitabine Study in Large Mixed Breed Hounds

[0066]Two gemcitabine release systems (devices as shown in FIGS. 1A-1B) designed to release therapeutic levels (4 mg / day and 40 mg / day) into the urine were screened. The devices used either laser-drilled orifices or punched orifices for release of the gemcitabine. The systems tested were compared to intravesical instillations which were designed to mimic the standard intravesical doses used clinically. The test animals were large mixed breed hounds, with N=3 for each group.

[0067]Each system in vitro exhibited different release rates of gemcitabine. In vivo, one system yielded very low urine and tissue concentrations but was well tolerated by the test animal. The other system produced target urine concentration levels but was poorly tolerated by the test animal. Urine profiles were also variable and the duration of drug release was unacceptably short. It was also observed that intravesical administration produced significant urothelial les...

example 3

Gemcitabine Bladder Perfusion Study in Minipigs

[0069]Varying concentrations of gemcitabine were perfused into pigs for 7 days, N=5 (2 males and 3 females per treatment group). The perfusion animals were dosed at concentrations selected to bracket the target doses for bladder cancer in humans. For comparison, a gemcitabine releasing device (as shown in FIGS. 1A-1B) with large bore end caps (restraining plugs with a large aperture therethrough for drug release) with an intermediate in vitro release rate was deployed in a separate group of animals. All perfusion groups tolerated gemcitabine well, including the highest perfusion dose. In contrast, the gemcitabine-releasing devices produced intermediate urine concentrations but were not well tolerated.

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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).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Patent Application No. 61 / 949,215, filed Mar. 6, 2014, which are incorporated herein by reference.FIELD OF INVENTION[0002]The present invention relates generation to the treatment of cancer, and more particularly relates to compositions, devices, and methods for the treatment of urinary bladder cancers.BACKGROUND[0003]Bladder cancer is a significant medical problem, and currently available treatment options are unsatisfactory for a number of reasons.[0004]In general, bladder cancers are classified as muscle invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC). The pathological classification and staging of bladder cancer is as follows: pTa (urothelial involvement); pTis (high risk urothelial confined); pT1 (lamina propria invasion); pT2 (muscularis invasion); pT3 (perivesical fat invasion); and pT4 (pelvic organ extension). Bladder cancers can also be classifi...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K47/18A61K31/7068
CPCA61K9/0034A61K47/18A61K31/7068A61K9/0004A61K9/0024A61K45/06A61P13/10A61P35/00A61P43/00A61K2300/00A61K9/0092C07H19/06A61M31/002
Inventor GIESING, DENNISLEE, HEEJINDANIEL, KAREN DANIELLE
Owner TARIS BIOMEDICAL
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