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Methods of using (+)-1,4-dihydro-7-[(3s,4s)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid for treatment of antecedent hematologic disorders

a technology of hematologic disorders and pyrrolidinyl, which is applied in the field of using (+)1, 4dihydro7(3s, 4s)3methoxy4(methylamino)1pyrrolidinyl4oxo1(2thiazolyl)1, 8naphthyridine3carboxylic acid for treatment of antecedent hematologic disorders, can solve the problems of limited efficacy of hematop

Inactive Publication Date: 2013-04-25
SUNESIS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, hematopoietic growth factors have not proven effective in many clinical settings.
Clinical trials of MDS patients treated with recombinant human GM-CSF and G-CSF have shown that while these cytokines can restore granulocytopoiesis in treated patients, their efficacy is restricted to the granulocyte or monocyte lineage with little or no improvement in hemoglobin or platelet counts.

Method used

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  • Methods of using (+)-1,4-dihydro-7-[(3s,4s)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid for treatment of antecedent hematologic disorders

Examples

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example 1

Pharmaceutical Composition Suitable for Injection or Intravenous Infusion

[0155]Acidic compositions (<pH 4) provided the appropriate balance of increased solubility of SNS-595 and desirable pharmaceutical properties (e.g., increased patient comfort by causing less irritation at the delivery site). An illustrative example of a suitable composition comprises: 10 mg SNS-595 per mL of aqueous solution of 4.5% sorbitol that is adjusted to pH 2.5 with methanesulfonic acid. One protocol for making such a solution includes the following for making a 100 mg / 10 mL presentation: 100 mg of SNS-595 and 450 mg D-sorbitol are added to distilled water; the volume is brought up to a volume of 10 mL; and the pH of the resulting solution is adjusted to 2.5 with methanesulfonic acid. The resulting composition is also suitable for lyophilization. The lyophilized form is then reconstituted with sterile water to the appropriate concentration prior to use.

example 2

Clinical Study: Treatment with SNS-595

[0156]A caucasian female patient (81 years old) with MDS that had transformed to refractory CMML was enrolled in this study. The patient was diagnosed about 26 months prior to the study and was given 8 cycles of azacitadine (Vidaza®) about 10 months prior to the study. She was then treated with mitoxantrone+VP16 for 1 cycle, about 4 months prior to the study. The disease had progressed to AML prior to treatment with SNS-595.

[0157]The treatment with SNS-595 was started at 72 mg / m2 (once per week for three weeks, as slow IV push).

[0158]The patient had initial marrow blast count of 39%. The following observations were noted on days 15 and 35.

Peripheral White blood cellAbsolute neutrophilBlasts(WBC) countcount (ANC)Day 15No blasts60094Around Day 35 33%16000 (was 7000 but3139patient had Necrotizingfasciitis (NF) infection)

[0159]The data demonstrates that, although the patient ultimately had progressive disease, the treatment showed clinical benefit w...

example 3

Clinical Study: Treatment with SNS-595

[0160]A black / African-American male patient (58 years old) with relapsed CMML (transformed to AML) was enrolled. The patient was diagnosed about 17 months prior to the study, was treated with 1 cycle of a Southwest Oncology Group (SWOG) regimen after diagnosis. He was given 4 cycles of azacitidine (Vidaza®) about 14 months prior to the study and 1 cycle of decitabine, about 6 months before the study.

[0161]The treatment with SNS-595 was started at 50 mg / m2 (twice a week, as slow IV push). The patient showed initial marrow at baseline 20% blasts.[0162]Post Cycle 1: marrow showed 8% blasts[0163]Post Cycle 2: marrow showed 1% with 4% circulating blasts.[0164]Post Cycle 3: there was 8% circulating blasts.[0165]Post Cycle 4: there was 12% circulating blasts.[0166]At the time of undergoing treatment with third cycle of SNS-595, the patient's absolute neutrophil count (ANC) was 1600.

[0167]The data demonstrates that the treatment showed clinical benefit ...

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Abstract

Methods of treating, preventing or managing antecedent hematologic disorders, such as myelodysplastic syndrome, including chronic myelomonocytic leukemia are disclosed. The methods encompass the administration of SNS-595. Also provided are methods of treatment using this compound with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy. In certain embodiments, the method of treatment comprise administering SNS-595 in combination with cytarabine. Pharmaceutical compositions and single unit dosage forms suitable for use in the methods are also disclosed.

Description

1. RELATED APPLICATIONS[0001]This application claims priority to U.S. provisional application Ser. No. 61 / 007,229, filed Dec. 10, 2007, entitled “Methods of using (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid for treatment of antecedent hematologic disorders”. The disclosure of the above referenced application is incorporated by reference herein in its entirety.2. FIELD OF THE INVENTION[0002]Provided herein are methods of treating, preventing or managing antecedent hematologic disorders, including myelodysplastic syndrome, with enantiomerically pure (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, which is also known as SNS-595 or AG-7352.[0003]Further provided is a combination therapy for treatment of antecedent hematologic disorders comprising administering a combination of (+)-1,4-dihydro-7-[(3S,45)-3-methoxy-4-(methylamin...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07D471/04A61K31/4375A61K31/7068
CPCA61K31/4375A61K31/513A61K45/06C07D471/04A61K31/7068A61K2300/00A61K31/706A61K38/18A61K38/19A61P7/06A61P35/00A61P35/02A61K39/39558A61K2039/505A61K2039/54
Inventor MICHELSON, GLENN
Owner SUNESIS PHARMA INC
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