JP6820841B2 - ペグ化インターフェロンのための投薬計画 - Google Patents
ペグ化インターフェロンのための投薬計画 Download PDFInfo
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- JP6820841B2 JP6820841B2 JP2017519649A JP2017519649A JP6820841B2 JP 6820841 B2 JP6820841 B2 JP 6820841B2 JP 2017519649 A JP2017519649 A JP 2017519649A JP 2017519649 A JP2017519649 A JP 2017519649A JP 6820841 B2 JP6820841 B2 JP 6820841B2
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- A61K38/19—Cytokines; Lymphokines; Interferons
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Description
本出願は、2014年11月6日付で出願された欧州特許出願公開第14192114.8号の優先権を主張する。
R1、R2、R3、R4及びR5は各々独立してH、C1〜5アルキル、C2〜5アルケニル、C2〜5アルキニル、アリール、ヘテロアリール、C3〜8シクロアルキル又はC3〜8ヘテロシクロアルキルであり、
A1及びA2は各々独立してポリマー部分であり、
G1、G2及びG3は各々独立して結合又は連結官能基であり、
Pはインターフェロン−α部分であり、
mは0又は1〜10の整数であり、
nは1〜10の整数である)のコンジュゲートとすることができる。
AOP2014/P1101は、他の市販のペグ化インターフェロンとは対照的に主に1つのアイソフォームのみからなる次世代長時間作用型ペグ化IFN−α−2bである。
コホート拡大を用いる第1相/第2相単一群用量漸増研究は、細胞減少療法を受けていなくても又は前治療されていてもよい51人のPV患者を含むものであった。AOP2014/P1101を、50μg〜540μgの用量範囲で2週間に1回皮下投与した。主要目的は最大耐量を規定し、血液パラメーターの正常化及び分子異常の点での長期安全性及び有効性を観察することであった。
患者に、切り替え選択肢の前に第2相投薬規則に基づいて2週間に1回投薬した(期間A−34週間の曝露期間中央値及び484μgの平均月用量)。最初の1年を超えて2週間に1回投薬され(期間B−12週間の曝露期間中央値及び413μgの平均月用量)、治療の利益を示した33人の患者が、切り替えに適格と評価された。次いで、28人の患者を4週間に1回のスケジュールに切り替えた(期間C−42週間の曝露期間中央値及び221μgの平均月用量)。9人の患者が各々、切り替え後に100μg以下の用量であった。参加患者の基本特徴を表1に示す。
コホート拡大を用いる第1相/第2相単一群用量漸増研究は、細胞減少療法を受けていなくても又は前治療されていてもよい少なくとも30人の本態性血小板血症患者を含む。AOP2014/P1101を50μg〜540μgの用量範囲で2週間に1回皮下投与する。最大耐量、並びに血液パラメーターの正常化及び分子異常の点での長期安全性及び有効性を観察する。
本明細書に開示の特徴は全て、任意に組み合わせて併用することができる。本明細書に開示のそれぞれの特徴は、同じ、同等又は同様の目的に役立つ代替の特徴に置き換えることができる。したがって、他に明記されない限り、開示のそれぞれの特徴は、一般的な一連の同等又は同様の特徴の一例に過ぎない。
Claims (15)
- ペグ化I型インターフェロンを含む、骨髄増殖性疾患を治療するための組成物であって、それを必要とする被験体に、50μg〜540μg用量の該ペグ化I型インターフェロンが治療期間にわたって3週間〜4週間の一定間隔で投与されることを特徴とし、前記骨髄増殖性疾患が真性赤血球増加症であり、前記ペグ化I型インターフェロンが
である、組成物。 - 前記間隔が4週間である、請求項1に記載の組成物。
- 前記治療期間が少なくとも2ヶ月〜12ヶ月である、請求項1又は2に記載の組成物。
- 前記治療期間が少なくとも12ヶ月である、請求項3に記載の組成物。
- 前記被験体が、以前に少なくとも2ヶ月〜12ヶ月にわたって1週間に1回のI型インターフェロンの投与を受けていることをさらに特徴とする、請求項1〜4のいずれか一項に記載の組成物。
- 前記被験体が、以前に少なくとも2ヶ月〜12ヶ月にわたって1週間に1回の12.5μg〜25μg用量のI型インターフェロンの投与を受けている、請求項5に記載の組成物。
- ペグ化I型インターフェロンを含む、骨髄増殖性疾患を治療するための組成物であって、
それを必要とする被験体に、50μg〜540μg用量の該ペグ化I型インターフェロンが第1の治療期間にわたって1週間〜4週間の第1の一定間隔で投与され、
前記被験体に、50μg〜540μg用量の前記ペグ化I型インターフェロンが第2の治療期間にわたって3週間〜4週間の第2の一定間隔で投与されることを特徴とし、
前記骨髄増殖性疾患が真性赤血球増加症であり、前記ペグ化I型インターフェロンが
である、組成物。 - 前記第2の治療期間において所与の期間当たりに前記被験体に投与される前記ペグ化I型インターフェロンの総量が、前記第1の治療期間において所与の期間当たりに投与される総量よりも低い、請求項7に記載の組成物。
- 前記第1の治療期間を、前記被験体が(i)少なくとも1つの血液学的パラメーターの正常化、及び/又は(ii)JAK2V617F変異量の少なくとも50%の低減を示すまで継続する、請求項8に記載の組成物。
- 前記少なくとも1つの血液学的パラメーターがヘマトクリット値、白血球数(WBC)又は血小板数である、請求項9に記載の組成物。
- 前記ヘマトクリット値が45%未満であり、前記WBCが10×109/L以下であり、前記血小板数が400×109/L以下である、請求項10に記載の組成物。
- 前記第1の間隔が1週間〜2週間である、請求項11に記載の組成物。
- 前記第2の間隔が4週間である、請求項12に記載の組成物。
- 前記第2の治療期間が少なくとも2ヶ月〜12ヶ月である、請求項7〜13のいずれか一項に記載の組成物。
- 前記第1の治療期間が少なくとも2ヶ月〜12ヶ月である、請求項7〜14のいずれか一項に記載の組成物。
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