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, and can solve the problems of variable risk of progression to acute leuk

Inactive Publication Date: 2011-01-13
SUNESIS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0024]Provided herein are methods of treating, preventing or managing antecedent hematological disorders, including myelofibrosis, aplastic anemia, paroxysmal nocturnal hemoglobinuria, polycythemia vera, and myelodyspla...

Problems solved by technology

MDS possesses a variable risk of progression to acute leukemia, resulting from ineffective blood cell production.
These drugs are associated with a high incidence of chromosomal abnormalities following exposure and at the time of MDS or acute leukemia diagnosis.
Further, MDS is associated with complications associated with severe cytopenias.
Other complications are development of myelofibrosis, which can accelerate decline in blood counts and increase transfusion requirements.
This type of therapy, however, is both painful for donor and recipient, because of the involvement of invasive procedures and can cause severe and even fatal complications to the recipient, particularly with allogeneic transplant an...

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

Experimental program
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example 1

Pharmaceutical Composition Suitable for Injection or Intravenous Infusion

[0164]Acidic compositions (

example 2

Clinical Study: Treatment with SNS-595

[0165]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+VP 16 for 1 cycle, about 4 months prior to the study. The disease had progressed to AML prior to treatment with SNS-595.

[0166]The treatment with SNS-595 was started at 72 mg / m2 (once per week for three weeks, as slow IV push).

[0167]The patient had initial marrow blast count of 39%. The following observations were noted on days 15 and 35.

Peripheral White blood cell Absolute neutrophil Blasts(WBC) countcount (ANC)Day 15No blasts60094Around Day 3533%16000 (was 7000 but3139patient had Necrotizingfasciitis (NF) infection)

[0168]The data demonstrates that, although the patient ultimately had progressive disease, the treatment showed clinical benefit...

example 3

Clinical Study: Treatment with SNS-595

[0169]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.

[0170]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.

[0171]Post Cycle 1: marrow showed 8% blasts

[0172]Post Cycle 2: marrow showed 1% with 4% circulating blasts.

[0173]Post Cycle 3: there was 8% circulating blasts.

[0174]Post Cycle 4: there was 12% circulating blasts.

[0175]At the time of undergoing treatment with third cycle of SNS-595, the patient's absolute neutrophil count (ANC) was 1600.

[0176]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,4S)-3-methoxy-4-(methylamin...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K31/4375A61K31/7048A61K31/704A61K38/12A61K33/24A61K31/519A61K31/7068A61K31/513A61K31/58A61P35/00A61P35/02A61P7/06
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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