CN110585184A - 癌症的治疗 - Google Patents
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Abstract
本发明涉及用于治疗个体癌症用途的曲古抑菌素A(TSA),所述治疗包括:从由所述个体的身体获得的肿瘤样品确定极光激酶A(AURKA)的表达水平;和在AURKA表达水平表明过表达的情况下,对所述个体施用曲古抑菌素A(TSA)以降低个体的AURKA水平。
Description
本申请是分案申请,其原申请的申请号为201480046624.5,申请日为2014年8月22日,发明名称为“癌症的治疗”。
相关申请的交叉引用
本申请要求2013年8月22日提交的61/869,039号美国临时专利申请的权益,其在此并入本文。
背景技术
已经对组蛋白脱乙酰基酶(HDAC)在癌症治疗中的应用进行了研究,原因在于其以相对较少的毒性抑制肿瘤细胞生长的能力。已知的HDAC抑制剂包括例如Rocilinostat(ACY-1215)、Zolinza(伏立诺他)、Abexinostat盐酸(PCI-24781)、辛二酰苯胺异羟肟酸(SAHA)、丙戊酸(VPA)、Pracinostat(SB939)、PCI-24781(CRA-024781)、JNJ-26481585、Mocetinostat(MGCD0103,MG0103)、Droxinostat、MC1568、Givinostat(ITF2357)、Tubastatin A盐酸、PCI-34051、泰克地那林(Tacedinaline)(CI994)和帕比司他(Panobiostat)(LBH589,NVP-LBH589)。
极光激酶A(AURKA)是已知对维持正常有丝***染色体分离重要的丝氨酸和苏氨酸激酶家族中的一员。其蛋白定位在间期细胞的中心体中和有丝***细胞的纺锤体内。AURKA的过表达与人类的癌变有关,并且已在***、胃组织、结肠直肠组织、膀胱、胰腺、卵巢、***和肺部的肿瘤中被检测出。但是,任何癌症都可能过表达AURKA,这可例如通过测试肿瘤的AURKA过表达来确定。AURKA表达的抑制已经显示出减少了体内的细胞侵袭。由此,AURKA也是一种通常通过小分子抑制的癌症治疗靶标。已知的AURKA抑制剂包括例如VE465、陶扎色替(tozasertib)(VX-680)、MK-0457、MK-5108、阿立色替(Alisertib)(MLN8237)。
由于HDAC抑制剂和AURKA抑制剂自身在阻断癌症进展中的功效,研究已经评价了其在非人类癌症模型中组合施用的效果。例如,Li等人发现,VPA和VE465的共同治疗诱导了比单独使用任一化合物时更多的细胞凋亡。类似地,Okabe等人发现伏立诺他或帕比司他与陶扎色替的组合施用对癌细胞增殖具有协同抑制作用。因为即使在癌症治疗中需要HDAC和AURKA的双重阻断效应,但通常知晓没有单一的实体具有此双重效果,所以进行了导致本发明的发现的研究。
发明内容
本发明的一个实施方式提供了一种治疗个体的癌症的方法,该方法包括:对所述个体施用有效量的曲古抑菌素A(TSA)。
本发明的另一个实施方式提供了一种药物组合物,其包含:作为唯一或主要的极光激酶A(AURKA)抑制剂的曲古抑菌素A(TSA);和药学上可接受的赋形剂或载剂。
在另一个实施方式中,本发明提供了一种治疗个体的癌症的方法,该方法包括:从由个体的身体获得的肿瘤样品确定极光激酶A(AURKA)的表达水平;和在AURKA表达水平表明过表达的情况下,对所述个体施用有效量的曲古抑菌素A(TSA)。
在本发明的其它实施方式中,利用TSA进行的治疗与一种或多种其它癌症治疗相组合。此种其它治疗可以包括,例如,小分子AURKA抑制。在一些情况下,这样的组合治疗可以将AURKA水平降至接近零。
具体实施方式
曲古抑菌素A(TSA或7-[4-(二甲基氨基)苯基]-N-羟基-4,6-二甲基-7-氧代庚-2,4-二烯酰胺)是一种抗真菌的抗菌素和已知的I类和II类HDAC抑制剂。TSA的结构在下式I中示出。
申请人已经惊奇地发现,TSA虽然先前已知为HDAC抑制剂,但其也能够抑制AURKA表达。因此,TSA可以在癌症治疗中用作主要或唯一的AURKA抑制剂。可根据本发明实施方式进行治疗的癌症包括例如:乳腺癌、胃癌、结肠癌、直肠癌、膀胱癌、胰腺癌、卵巢癌、***癌、肺癌、血液癌症、皮肤癌和恶性肿瘤。
用曲古抑菌素或载质处理人视网膜色素上皮细胞系24小时,并且使用Affymetrix仪器生成覆盖12,490种基因的22,238个探针集的基因表达。曲古抑菌素A对AURKA表达的影响显示在下表1中,并且表明了AURKA表达明显超过十倍的下调。
表1
实例ID | 探针 | 秩值 | 倍数表达变化 | 基因名称 | 基因 |
10005532 | 208079_s_at | 22253 | -20.0837023 | 极光激酶A | AURKA |
10005533 | 208079_s_at | 22245 | -18.95510102 | 极光激酶A | AURKA |
10005533 | 204092_s_at | 22238 | -17.32256882 | 极光激酶A | AURKA |
10005532 | 204092_s_at | 22227 | -15.79825298 | 极光激酶A | AURKA |
10005542 | 204092_s_at | 22222 | -14.33801143 | 极光激酶A | AURKA |
10005542 | 208079_s_at | 22221 | -14.19814583 | 极光激酶A | AURKA |
这些结果支持了TSA在癌症治疗中的应用。例如,通过向个体施用有效量的TSA,可对个体的癌症进行治疗,其中所述有效量是足以抑制所述个体中的AURKA的表达的量。此量也可足以抑制个体中的HDAC活性。在本发明的一些实施方式中,所述有效量为约0.1mg/kg/日~约10mg/kg/日,例如约0.5mg/kg/日~约5mg/kg/日。
在一些实施方式中,对个体的治疗可以进一步包括由从个体的身体获得的肿瘤样品确定AURKA表达的水平。此种确定可以包括任何已知的或以后开发的方法或技术,包括例如定量抗原-抗体相互作用、示踪核苷酸探针的使用等。
可将TSA以药物组合物的形式施用至待治疗的个体。根据本发明各实施方式使用的药物组合物包括治疗有效量的TSA或TSA的活性代谢物,或其药学上可接受的盐或其它形式(例如,溶剂化物),以及一种或多种药学上可接受的赋形剂或载剂。短语“药物组合物”是指适合于在医疗应用中施用的组合物。应当理解的是,为特定患者确定适宜的剂型、剂量和施用途径是在制药和医疗领域的普通技术人员的水平之内的。
施用可以是口服的,但也可以采用其它施用途径,例如,肠胃外、经鼻、经颊、经皮、舌下、肌内、静脉内、直肠、***等。用于口服施用的固体剂型包括胶囊、片剂、丸剂、粉剂和颗粒剂。在此种固体剂型中,将化合物与至少一种惰性的药学上可接受的赋形剂混合,所述赋形剂如为:(a)填充剂或膨胀剂,例如,淀粉、乳糖、蔗糖、葡萄糖、甘露醇和硅酸;(b)粘合剂,例如,羧甲基纤维素、藻酸盐、明胶、聚乙烯吡咯烷酮、蔗糖和***胶;(c)保湿剂,例如甘油;(d)崩解剂,例如琼脂、碳酸钙、马铃薯或木薯淀粉、藻酸、某些复合硅酸盐和碳酸钠;(e)溶液缓凝剂,例如石蜡;(f)吸收促进剂,例如,季铵类化合物;(g)润湿剂,例如,鲸蜡醇和单硬脂酸甘油酯;(h)吸附剂,例如,高岭土和膨润土;和(i)润滑剂,例如滑石、硬脂酸钙、硬脂酸镁、固体聚乙二醇、月桂基硫酸钠或它们的混合物。在胶囊、片剂和丸剂的情况下,所述剂型也可以包括缓冲剂。诸如片剂、糖锭剂、胶囊、丸剂和颗粒剂等固体剂型也可以制备有包衣和外壳,例如肠溶包衣和本领域公知的其它包衣和外壳。固体剂型还可以含有遮光剂,并且也可以具有在肠道的某一部分内以延时方式释放一种或多种活性化合物的组成。可以使用的包埋组合物的实例是聚合物和蜡。适当的时候,活性化合物也可以是具有一种或多种上述赋形剂的微囊封装形式。这些固体剂型一般可以含有1%~95%(w/w)的活性化合物。在某些实施方式中,所述活性化合物为5%~70%(w/w)。
用于口服施用的固体组合物可以以单位剂型配制,每一剂量含有约1mg~约500mg的活性成分。术语“单位剂型”是指适合作为用于人受试者和其它哺乳动物的单元剂量的物理上离散的单位,每个单位含有与所需药物载剂结合的预定量的活性成分,所述预定量的活性成分经计算能够在治疗期间产生所需的效果。TSA可以被配制成例如这样的单位剂型:其是具有赋形剂和1mg~500mg活性成分的胶囊。
用于口服施用的液体剂型包括药学上可接受的乳剂、溶液、悬浮液、糖浆和酏剂。除了该化合物或组合物,所述液体剂型可以含有本领域中常用的惰性稀释剂,比如水或其它溶剂、增溶剂和乳化剂,例如乙醇、异丙醇、碳酸乙酯、乙酸乙酯、苄醇、苯甲酸苄酯、丙二醇、1,3-丁二醇、二甲基甲酰胺、油类(特别是棉籽油、花生油、玉米胚芽油、橄榄油、蓖麻油和芝麻油)、甘油、四氢糠醇、聚乙二醇类和山梨聚糖的脂肪酸酯或这些物质的混合物。除了这些惰性稀释剂,所述组合物还可以包括佐剂,例如润湿剂、乳化剂和悬浮剂、增甜剂、调味剂和芳香剂。
在本发明的一些实施方式中,TSA以液体形式提供,并且静脉内地施用至个体。
虽然已结合以上概述的具体实施方式描述了本发明,但很明显,许多替换、修改和变型对本领域技术人员而言是显而易见的,或者旨在以其它方式涵盖在内。因此,如上所述的本发明的实施方式旨在为说明性的,不是限制性的。在不脱离下面权利要求书所限定的本发明的主旨和范围的情况下,可以进行各种改变。本文引用的所有专利、专利申请、科学论文和其他发表的文献以其公开的实质内容而整体并入本文。
Claims (6)
1.用于治疗个体癌症用途的曲古抑菌素A(TSA),所述治疗包括:
从由所述个体的身体获得的肿瘤样品确定极光激酶A(AURKA)的表达水平;和
在AURKA表达水平表明过表达的情况下,对所述个体施用曲古抑菌素A(TSA)以降低个体的AURKA水平。
2.如权利要求1所述的用途的TSA,其中,TSA还抑制组蛋白脱乙酰基酶(HDAC)活性。
3.如权利要求1所述的用途的TSA,其中,TSA的有效量为约0.1mg/kg/日~约10mg/kg/日,或约0.5mg/kg/日~约5mg/kg/日。
4.如权利要求1所述的用途的TSA,其中,TSA是施用至所述个体的唯一AURKA抑制剂。
5.如权利要求1所述的用途的TSA,其中,所述癌症包括选自由乳腺癌、胃癌、结肠癌、直肠癌、膀胱癌、胰腺癌、卵巢癌、***癌、肺癌、血液癌症、皮肤癌和恶性肿瘤组成的组中的至少一种癌症。
6.如权利要求1所述的用途的TSA,其中,TSA为口服施用或静脉内施用。
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US201361869039P | 2013-08-22 | 2013-08-22 | |
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US (5) | US20160199323A1 (zh) |
EP (2) | EP3036007B1 (zh) |
JP (4) | JP2016528297A (zh) |
KR (5) | KR20170126018A (zh) |
CN (2) | CN105579101A (zh) |
AU (4) | AU2014308700A1 (zh) |
CA (1) | CA2921036A1 (zh) |
CL (1) | CL2016000397A1 (zh) |
EA (1) | EA037667B1 (zh) |
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KR20170126018A (ko) * | 2013-08-22 | 2017-11-15 | 반다 파마슈티칼즈, 인코퍼레이티드. | 암 치료 |
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