TR201816532T4 - Spesifik olarak CD38'i tanıyan antikorlar ve bortezomib içeren antitümör kombinasyonları. - Google Patents
Spesifik olarak CD38'i tanıyan antikorlar ve bortezomib içeren antitümör kombinasyonları. Download PDFInfo
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Abstract
Farmasötik bileşim spesifik olarak CD38'i tanıyan bir antikor ve bortezomib içerir.
Description
Tarifnameye göre bilesimler tercihen parental olarak uygulanabilen bilesimlerdir. Bununla birlikte bu bilesimler lokalize bölgeler terapiler durumunda oral olarak, subkütanöz olarak veya intraperitonal olarak uygulanabilir. Parental uygulamaya yönelik bilesimler genellikle, kullanim zamaninda istege bagli olarak gerekli oldugu kadar hazirlanabilen farmasötik olarak kabul edilebilir, steril solüsyonlar veya süspansiyonlardir. Aköz olmayan solüsyonlar veya süspansiyonlarin hazirlanmasina yönelik olarak zeytinyagi, susam yagi veya sivi petrol gibi dogal bitkisel yaglar veya etil oleat gibi enjekte edilebilir organik esterler kullanilabilir. Steril aköz solüsyonlar su içinde bir ürün solüsyonundan olusabilir. Aköz solüsyonlar, pH degerinin uygun sekilde ayarlanmasi ve solüsyonun örnegin yeterli bir sodyum klorid veya glukoz miktari ile izotonik hale getirilmesi sartiyla intravenöz uygulama için uygundur. Sterilizasyon islemi, isitma yoluyla veya bilesimi olumsuz sekilde etkilemeyen herhangi bir diger sekilde gerçeklestirilebilir. Kombinasyonlar ayrica Iipozomlar formunu veya siklodekstrinler veya polietilen glikoller olarak tasiyicilar ile iliskili formu olabilir. Oral, subkütanöz veya intraperitoneal uygulamaya yönelik bilesimler tercihen aköz süspansiyonlar veya solüsyonlar olabilir. Bulusa göre kombinasyonlarda bilesenlerinin uygulanmasi bir zaman periyodunda es zamanli, ayri veya aralikli olabilir, hümanize anti-CD38 antikor miktarinin kombinasyonun agirliginca %10 ila 90 arasinda bulunmasi özellikle avantajlidir, bu bilesenin iliskili maddenin yapisi, aranan etkinlik ve tedavi edilecek kanserin yapisina göre degiskenlik göstermesi mümkündür. Bulusa göre kombinasyonlar özellikle asagidakiler dahil (ancak bunlarla sinirli olmamak üzere) birkaç kanser türünün tedavisinde faydalidir: karsinom ve adenokarsinom, mesane, meme, kolon, bas ve boyun, prostat, böbrek, karaciger, mide, serviks, tiroid ve deri karsinomlari dahil ve skuamöz hücreli karsinom dahil; Ienfoid soylu hematopoietik tümörler, multipl miyelom, lösemi, akut ve kronik Ienfositik (veya Hodgkin olmayan Ienfoma (örnegin Burkitt) dahil; miyeloid soylu hematopoietik tümörler, akut ve kronik miyelojenöz (miyeloid veya miyelositik) Iösemiler ve promiyelositik lösemi dahil; mezenkimal kökenli tümörler, fibrosarkom, osteosarkom ve rabdomiyosarkom dahil; merkezi ve periferik sinir sistemi tümörleri, astrositom, nöroblastom, gliyom ve schwannomlar dahil ve diger tümörler, melanom, teratokarsinom, kserodermi pigmentosum, keratoakantom ve seminom dahil ve CD38'in ifade edildigi henüz belirlenmedigi diger kanserler. Bunlar çogunlukla, tarifnameye ait anti-CD38 antikorlarinin benzersiz bir hareket mekanizmasina sahip olmasi nedeniyle lösemi, Ienfoma ve yaygin sekilde kullanilan antikanser ajanlarina dirençli kanserlerin tedavi edilmesine yönelik faydalidir. Bir düzenlemede kombinasyonunun antitümör etkinligi yaklasik %11-42 T/C'dir. T/C(%), tedavi edilenin Medyan tümör hacmi / kontrolün Medyan tümör hacmi X 100 olan oranidir. Diger bir düzenlemede kombinasyonunun antitümör etkinligi yaklasik %0-10 T/C'dir. Dolayisiyla, bulusun bir açisi kanserin tedavisinde kullanima yönelik yukaridaki kombinasyonlardir. Diger bir açida, tarifname ayrica kanserin tedavisine yönelik bir ilacin üretilmesine yönelik olarak yukaridaki kombinasyonlarin kullanimini kapsar. Burada açiklanan diger bir düzenleme asagidaki unsurlari içeren bir üretim maddesidir: a) bir ambalajlama materyali b) spesifik olarak CD38li taniyan bir antikor ve en az bortezomibin bir kombinasyonu, burada söz konusu antikor apoptoz, antikor bagimli hücre aracili sitotoksisite (ADCC) ve k0mpleman bagimli sitotoksisite (CDC) yoluyla bir CD38+ hücresini öldürebilir ve c) bunun söz konusu kombinasyonunun kanserin tedavi edilmesine yönelik etkili oldugu belirten, söz konusu ambalajlama materyali içinde bulunan bir etiket veya kullanma talimati. Bu örnekte tümör büyüme inhibisyonuna yönelik bulusa ait bir anti-CD38 antikor/bortezomib kombinasyonunun etkinligi in vivo gösterilmistir. Test Maddesi Uygulamasi: Hu388819 ve Bortezomib tedavileri hücre inokülasyonunundan otuz dört gün sonra baslatilmistir ve dozlar, dozlama öncesinde alinan son ölçümden belirlenen ayri hayvanlarin vücut agirliklarina bagli olarak hesaplanmistir. PBS ve hu388819 antikorunun uygulamasi intraperitoneal (IP) enjeksiyonu yoluyla ve bortezomib intravenöz (IV) enjeksiyon araciligiyla 27 kalibre, V2 inç olan bir igne ile donatilan 1.0 mL'Iik bir siringa kullanilarak kuyruk damari vasitasiyla gerçeklestirilmistir. Spesifik Çalisma Tasarimi: NCl-H929 multipl miyelom subkütanöz ksenogreft modeli fare basina 1 X 107 hücre olan subkütanöz enjeksiyon araciligiyla disi CB.17 SCID farelerde baslatilmistir, 0.1 ml serum-içermeyen kültür ortaminda süspanse edilmistir. Tümör hücre inokülasyonundan otuz-üç gün sonra, altmis-dört fare tümör hacmi (19.4 ± 1.1, Medyan ± SD) gram arasinda olmustur. Her gruptaki fareler kulaktaki bir delik ile tanimlanmistir. Tedavi gruplari PBS kontrolü (, hu3BSB19 antikoru (5.0 kombinasyon grubu (5.0 mg/kg/tedavi) ve bortezomib (1.0, 0.6 ve 0.4 mg/kg/tedavi) içermistir. PBS, hu38SB19 ve borteZOmib bir hafta boyunca haftada iki kez uygulanmistir (toplamda 2 tedavi boyunca günler 34 ve 37). Tedaviler tümör hücrelerinin inokülasyonu sonrasinda 34"üncü günde baslatilmistir. Tümör hacimleri bir kaliper kullanilarak üç boyutlu olarak haftada bir ila iki kez ölçülmüstür. Tümör hacmi asagidaki formül kullanilarak mm3 (veya mg) cinsinden ifade edilmistir: V = Uzunluk X Genislik X Yükseklik X 1/2. Vücut agirliklari test ajani toksisitesinin yaklasik bir indeksi olarak haftada iki kez ölçülmüstür. Tümör hacmi ve vücut agirligi Labcat yazilimi araciligiyla belirlenmistir ve kaydedilmistir. Sonuçlar: hu388819 antikoru ve bortezomibin tek basina ve kombinasyon halinde anti-tümör aktivitesi, subkütanöz NCI-H929 tümör ksenogreftlari, bir insan multipl miyelom modeli tasiyan disi SCID farelerde degerlendirilmistir. Asagidaki uç noktalar kullanilmistir: Toksisite, 2 %20 vücut agirligi kaybi veya 2 %10 ilaç ölümünü indükleyen dozajlarda belirtilmistir, Antitümör etkinligi asagidaki unsurun hesaplanmasi araciligiyla belirlenmistir: T/C (70) = Tedavi edilenin medyan tümör hacmi 1 Kontrolün medyan tümör hacmi X 1 00, burada bir TIC s %42 durumu, anti-tümör aktivitesinin minimum seviyesidir. T/C TR TR TR TR TR TR TR TR TR TR
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| TR2018/16532T TR201816532T4 (tr) | 2010-12-10 | 2011-12-08 | Spesifik olarak CD38'i tanıyan antikorlar ve bortezomib içeren antitümör kombinasyonları. |
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| EP2191843A1 (en) * | 2008-11-28 | 2010-06-02 | Sanofi-Aventis | Antitumor combinations containing antibodies recognizing specifically CD38 and cyclophosphamide |
| DK2621531T3 (en) | 2010-09-27 | 2017-02-27 | Morphosys Ag | ANTI-CD38 ANTIBODY AND LENALIDOMIDE OR BORTEZOMIB FOR TREATMENT OF MULTIPLE MYELOM AND NHL |
| UA112170C2 (uk) | 2010-12-10 | 2016-08-10 | Санофі | Протипухлинна комбінація, що містить антитіло, яке специфічно розпізнає cd38, і бортезоміб |
| JOP20210044A1 (ar) | 2010-12-30 | 2017-06-16 | Takeda Pharmaceuticals Co | الأجسام المضادة لـ cd38 |
| MX368288B (es) | 2012-09-25 | 2019-09-27 | Morphosys Ag | Una combinación de anticuerpos anti-cd38 y melfalán para usarse en el tratamiento de mieloma múltiple. |
| SG10201913777XA (en) * | 2013-03-13 | 2020-03-30 | Sanofi Sa | Compositions comprising anti-cd38 antibodies and carfilzomib |
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