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Sns-595 and methods of using the sameRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Heterocyclic Carbon Compounds Containing A Hetero Ring Having Chalcogen (i.e., O,s,se Or Te) Or Nitrogen As The Only Ring Hetero Atoms Doai, Hetero Ring Is Six-membered Consisting Of One Nitrogen And Five Carbon Atoms, Polycyclo Ring System Having The Six-membered Hetero Ring As One Of The Cyclos, Bicyclo Ring System Having The Six-membered Hetero Ring As One Of The Cyclos, Plural Hetero Atoms In The Bicyclo Ring SystemSns-595 and methods of using the same description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060025437, Sns-595 and methods of using the same. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] This application is a continuation-in-part of application Ser. No. 11/080,283, filed Mar. 14, 2005, which claims priority under 35 USC .sctn. 119, to U.S. Provisional Application Ser. No. 60/553,578 filed Mar. 15, 2004, the entire disclosures of which are hereby expressly incorporated by reference. TECHNICAL FIELD [0002] SNS-595 is novel naphthyridine cytotoxic agent that was previously known as AG-7352 (see e.g., Tsuzuki et al., Tetrahedron-Asymmetry 12: 1793-1799 (2001) and U.S. Pat. No. 5,817,669). The chemical name of SNS-595 is (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrroli- dinyl]-4-oxo-1-(2-thiazoyl)-1,8-naphthyridine-3-carboxylic acid and has the structure shown below [0003] The present invention relates to pharmaceutical compositions and methods of using SNS-595 to treat cancer. DESCRIPTION OF THE FIGURES [0004] FIG. 1 depicts the plasma concentrations of SNS-595 over time among the various patient cohorts. DETAILED DESCRIPTION [0005] In one aspect of the present invention, pharmaceutical composition is provided comprising: [0006] a) SNS-595 and [0007] b) an acid in an aqueous solution wherein the pH of the solution is 2-3.5. As used herein, a numerical range is intended to be inclusive. For example, the range of pH 2-3.5 includes both pH 2 and pH 3.5. In one embodiment, the pH of the composition is 2-3. In another embodiment, the pH of the composition is 2.3-2.7. As used herein, an aqueous solution is a liquid comprising water. [0008] Suitable examples of acids include both organic and inorganic acids such as acetic acid, ascorbic acid, benzene-sulfonic acid, ethansulfonic acid, glycolic acid, hydrogen chloride, hydrogen bromide, hydroxyethanesulfonic acid, lactic acid, maleic acid, methanesulfonic acid, proprionic acid, succinic acid, sulfuric acid, trifluoroacetic acid, and toluenesulfonic acid. In one embodiment, the acid is hydrochloric acid, methanesulfonic acid or lactic acid. In another embodiment, the acid is methanesulfonic acid. [0009] In another embodiment, the pharmaceutical composition further comprises a tonicity agent. Suitable examples of a tonicity agent include amino acids (e.g., alanine and glycine), electrolytes (e.g., sodium chloride and potassium chloride), monosaccharides (e.g. glucose or galactose), disaccharides (e.g. sucrose) and hexahydric alcohols (e.g., mannitol and sorbitol). In another embodiment, the tonicity agent is sodium chloride, glucose, mannitol, or sorbitol. In another embodiment, the tonicity agent is a hexahydric alcohol. In another embodiment, the tonicity agent is sorbitol. [0010] SNS-595 is a cytotoxic agent for the treatment of cancer. The types of cancers that can be treated using the inventive methods include but are not limited to: bladder cancer, breast cancer, cervical cancer, colon cancer (including colorectal cancer), esophageal cancer, head and neck cancer, leukemia, liver cancer, lung cancer (both small cell and non-small cell), lymphoma, melanoma, myeloma, neuroblastoma, ovarian cancer, pancreatic cancer, prostate cancer, renal cancer, sarcoma (including osteosarcoma), skin cancer (including squamous cell carcinoma), stomach cancer, testicular cancer, thyroid cancer, and uterine cancer. [0011] In another aspect of the invention, a method of using SNS-595 to treat a human cancer is provided. The method comprises administering to a patient on the basis of body surface area, a dose of 10 mg/m.sup.2-150 mg/m.sup.2 of SNS-595. Body surface area calculations can be calculated for example, with the Mosteller formula wherein: BSA(m.sup.2)=square root of [(height(cm).times.weight(kg)/3600]. [0012] In another embodiment, the dose is 10 mg/m.sup.2-100 mg/m.sup.2. In another embodiment, the dose is 30 mg/m.sup.2-75 mg/m.sup.2. In another embodiment, the dose is 40 mg/m.sup.2-80 mg/m.sup.2. In another embodiment, the dose is 50 mg/m.sup.2-90 mg/m.sup.2. In another embodiment, the dose is 15 mg/m.sup.2-80 mg/m.sup.2. [0013] In another embodiment the dose is 20 mg/m.sup.2-30 mg/m.sup.2. In another embodiment the dose is 25 mg/m.sup.2-35 mg/m.sup.2. In another embodiment the dose is 40 mg/m.sup.2-50 mg/m.sup.2. In another embodiment the dose is 45 mg/m.sup.2-55 mg/m.sup.2. In another embodiment the dose is 50 mg/m.sup.2-60 mg/m.sup.2. In another embodiment the dose is 55 mg/m.sup.2-65 mg/m.sup.2. In another embodiment the dose is 60 mg/m.sup.2-70 mg/m 2. In another embodiment the dose is 65 mg/m.sup.2-75 mg/m.sup.2. In another embodiment the dose is 70 mg/m.sup.2-80 mg/m.sup.2. In another embodiment the dose is 75 mg/m.sup.2-85 mg/m.sup.2. In another embodiment the dose is 80 mg/m.sup.2-90 mg/m.sup.2. In another embodiment the dose is 85 mg/m.sup.2-95 mg/m.sup.2. In another embodiment the dose is 90 mg/m.sup.2-100 mg/m.sup.2. [0014] The administered dose of SNS-595 can be delivered simultaneously (e.g. a single bolus injection) or over a 24-hour period (e.g., continuous infusion over time or divided bolus doses over time) and is repeated until the patient experiences stable disease or regression, or until the patient experiences disease progression or unacceptable toxicity. For example, stable disease for solid tumors generally means that the perpendicular diameter of measurable lesions has not increased by 25% or more from the last measurement. See e.g., Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines, Journal of the National Cancer Institute 92(3): 205-216 (2000). Stable disease or lack there of is determined by methods known in the art such as evaluation of patient symptoms, physical examination, visualization of the tumor that has been imaged using X-ray, CAT, PET, or MRI scan and other commonly accepted evaluation modalities. [0015] The administered dose of SNS-595 can be expressed in units other than as mg/m.sup.2. For example, doses can be expressed as mg/kg. One of ordinary skill in the art would readily know how to convert doses from mg/m.sup.2 to mg/kg to given either the height or weight of a subject or both (see e.g., http:///www.fda.gov/cder/cancer/animalframe.htm). For example, a dose of 10 mg/m.sup.2-150 mg/m.sup.2 for a 65 kg human is approximately equal to 0.26 mg/kg-3.95 mg/kg. In another example, a dose of 15 mg/m.sup.2-80 mg/m.sup.2 for a 65 kg human is approximately equal to 0.39 mg/kg-2.11 mg/kg. [0016] In another aspect of the present invention, SNS-595 is administered according to a dosing schedule. In one embodiment, the method comprises: [0017] i) administering a dose of 10 mg/m.sup.2-150 mg/m.sup.2 of SNS-595 to a patient; [0018] ii) waiting a period of at least one day where the subject is not administered any SNS-595; [0019] iii) administering another dose of 10 mg/m.sup.2-150 mg/m.sup.2 of SNS-595 to the patient; and, [0020] iv) repeating steps ii)-iii) a plurality of times. [0021] In another embodiment, the method comprises administering a dose of 10 mg/m.sup.2-100 mg/m.sup.2 in steps i) and iii). In yet another embodiment, the method comprises administering a dose of 15 mg/m.sup.2-80 mg/m.sup.2 in steps i) and iii). [0022] In the above methods, if the waiting period were 6 days, then the initial dose of SNS-595 is administered on Day 1 (step i); the waiting period is six days (step ii); and the following dose of SNS-595 is administered on Day 8 (step iii). Other exemplary time periods include 2 days, 3 days, 13 days, 20 days, and 27 days. In another embodiment, the waiting period is at least 2 days and steps ii) through iii) are repeated at least three times. In another embodiment, the waiting period is at least 3 days and steps ii) through iii) are repeated at least five times. In another embodiment, the waiting period is at least 3 days and steps ii) through iii) are repeated at least three times. In another embodiment, the waiting period is at least 3 days and steps ii) through iii) are repeated at least five times. In another embodiment, the waiting period is at least 6 days and steps ii) through iii) are repeated at least three times. In another embodiment, the waiting period is at least 6 days and steps ii) through iii) are repeated at least five times. In another embodiment, the waiting period is at least 20 days and steps ii) through iii) are repeated at least three times. In another embodiment, the waiting period is at least 20 days and steps ii) through iii) are repeated at least five times. In another embodiment, the waiting period is at least 27 days and steps ii) through iii) are repeated at least three times. In another embodiment, the waiting period is at least 27 days and steps ii) through iii) are repeated at least five times. [0023] In another embodiment, the dosing method comprises administering a weekly dose of SNS-595 to a subject. In another embodiment, the dosing method comprises administering a dose of SNS-595 to a subject every two weeks. In another embodiment, the dosing method comprises administering a dose of SNS-595 to a subject every three weeks. In another embodiment, the dosing method comprises administering a dose of SNS-595 to a subject every four weeks. [0024] In another embodiment, the dosing method comprises a cycle wherein the cycle comprises administering a dose of SNS-595 to a subject once a week for three weeks followed by a period of at least two weeks where no SNS-595 is administered to said subject and wherein the cycle is repeated a plurality of times. In another embodiment, the period where no SNS-595 is administered is two weeks. In another embodiment, the period where no SNS-595 is administered is three weeks. [0025] In another aspect of the invention, a method of treating a solid tumor is provided. The method comprises: [0026] i) administering a dose of 10 mg/m.sup.2-100 mg/m.sup.2 of SNS-595 to a patient; [0027] ii) waiting a period of at least six days where the subject is not administered any SNS-595; [0028] iii) administering another dose of 10 mg/m.sup.2-100 mg/m.sup.2 of SNS-595 to the patient; and, [0029] iv) repeating steps ii)-iii) a plurality of times. [0030] In another aspect of the invention, another method of treating solid tumors is provided. The method comprises administering a dose of 15 mg/m.sup.2-40 mg/m.sup.2 of SNS-595 to a patient once a week wherein the one-week period comprises a treatment cycle and the treatment cycle is repeated at least twice. In another embodiment, the dose is 15 mg/m.sup.2-35 mg/m.sup.2. In another embodiment, the dose is 20 mg/m.sup.2-30 mg/m.sup.2. In another embodiment, the dose is 20 mg/m.sup.2-25 mg/m.sup.2. Continue reading about Sns-595 and methods of using the same... Full patent description for Sns-595 and methods of using the same Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Sns-595 and methods of using the same patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. 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