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Medical compositions for intravesical treatment of bladder cancer

a technology of medicine compositions and bladder cancer, applied in the field of medicine compositions for intravesical treatment of bladder cancer, can solve the problems of finding e09 in the clinic, particularly disappointing, etc., and achieve the effects of improving the physical characteristics of the solution such as solubility, lyophilization, and easy reconstitution of the lyophilized solution

Inactive Publication Date: 2005-09-29
SPECTRUM PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about a new treatment for bladder cancer. The treatment involves using a pharmaceutical product called 3-hydroxymethyl-5-aziridinyl-1-methyl-2-[1H-indole-4,7-dione]propenol (E09) and a special formulation vehicle. The formulation vehicle improves the physical characteristics of the solution. The composition can be instilled into the bladder and can also be delivered through liposomes or microspheres. The treatment has been found to be effective in treating bladder cancer.

Problems solved by technology

These findings are particularly disappointing in view of the preclinical studies (Hendriks et al, 1993) together with reports that several tumor types have elevated NQ01 levels (Malkinson et al, 1992, Smitkamp-Wilms et al, 1995, Siegel et al, 1998).
Recent studies have demonstrated that the failure of E09 in the clinic may not be due to poor pharmacodynamic interactions but may be the result of poor drug delivery to tumors (Phillips et al, 1998).

Method used

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Embodiment Construction

[0008] The embodiments of the present invention are directed to compositions for treating bladder cancer via intravesical instillation. According to one embodiment, the composition of the present invention comprises 3-hydroxymethyl-5-aziridinyl-1-1-methyl-2-[1H-indole-4,7-dione]propenol (EO9) and a formulation vehicle. The formulation vehicles of the present invention are solvents that improves the solubility and stability of EO9. In a broad aspect of the present invention, the formulation vehicles of the present invention can be a mixture of an alcohol and water. According to the various embodiments of the present invention, EO9 dissolves in the formulation vehicles without physical manipulation such as grinding. Because the compositions of the present invention are capable of dissolving greater amounts of EO9, additional flexibility with respect to dosage units is achieved. According to one embodiment, a content of 8.0 mg of EO9 per dosage unit is contemplated. In other embodiment...

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PUM

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Abstract

Anti-cancer coating compositions comprising 3-hydroxymethyl-5-aziridinyl-1-1-methyl-2-[1 H-indole-4,7-dione]propenol (E09) are disclosed. More specifically, the coating compositions comprise EO9 and a formulation vehicle. The formulation vehicle improves the solubility and stability of EO9. Additionally, the coating compositions can include coating agents that provide better adhesion of the coating composition to the bladder wall during intravesical delivery of the coating composition.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of U.S. patent application Ser. No. 10 / 285,783 filed Nov. 1, 2002 which claims the benefit of U.S. Provisional Application No. 60 / 344,446, filed Nov. 1, 2001, the entire contents of which are hereby incorporated by reference.BACKGROUND OF THE INVENTION [0002] Bladder cancer accounts for approximately 2% of all malignant cancers and is the fifth and tenth most common cancer in men and women, respectively. The American Cancer Society estimated that 54,500 new cases and 11,700 deaths would have occurred in 1997. Superficial bladder cancers (pTa, pT1 and CIS) account for 70-80% of cancers at first presentation. Management of superficial bladder cancer may be achieved by endoscopic surgical resection often followed by a course of adjuvant intravesical chemotherapy or immunotherapy with the aim of both eradicating remaining tumor cells and preventing tumor recurrence (Herr H W (1987) Intravesical therapy-a cri...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/20A61K9/08A61K31/404A61K47/10A61K47/26A61K47/32A61K47/36A61K47/38A61K47/40A61K47/42A61P13/10A61P35/00
CPCA61K9/0034A61K9/127A61K9/19Y10S514/952Y10S514/908Y10S514/97A61K31/404A61P13/10A61P35/00A61P35/04
Inventor NUIJEN, BASTIAANPFADENHAUER, ERNIEBEIJNEN, JOS H.
Owner SPECTRUM PHARMA INC
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