1. <video id="oovo1"></video>
          <b id="oovo1"><p id="oovo1"></p></b><source id="oovo1"></source>
            <source id="oovo1"></source>
          1. 中文 英文
             

            產品中心

             降糖藥物
             抗腫瘤藥
             心血管藥
             其他

            聯系方式

            總機:021-64556180
            傳真:021-021-69018966*808
            地址:上海市閔行區曲吳路589號夢谷6號樓4樓
            郵編:200241
            聯系人:林女士
            Q Q:2377734184

            郵箱:service@caerulumpharma.com
            網址:www.tmesiep.cn

            研發動態

            GSK單抗mepolizumab 2個關鍵III期取得成功
            2014-03-16         

             

            GSK單抗mepolizumab 2個關鍵III期取得成功

            2014年3月12日訊 /生物谷BIOON/ --葛蘭素史克(GSK)3月12日宣布,美泊利單抗(mepolizumab)III期項目2個關鍵性III期研究(MEA115588和MEA115575)均達到了主要終點。該項目的全部數據,將提交至未來的科學會議。GSK計劃于今年年底提交mepolizumab的監管文件。mepolizumab是一種實驗性白介素5(IL-5)拮抗劑,有望為嚴重失控性難治性哮喘群體提供一個重要的治療選擇。

            MEA115588研究評估了mepolizumab 2種劑量方案用于嚴重嗜酸性粒細胞哮喘(eosinophilic asthma)的療效。在整個研究過程中,患者仍保持其當前的哮喘維持治療,并隨機接受每4周一次mepolizumab 75mg靜脈注射(IV)、100mg皮下注射(SC)或安慰劑。研究數據表明,與安慰劑組相比,mepolizumab 2個治療組臨床顯著病情加重的發作頻率得到了統計學意義的顯著降低(75mg IV, 47%, p<0.001; 100mg SC, 53%, p<0.001),達到了研究的主要終點。該項研究中,不良事件在所有治療組相似。最常見的不良反應為鼻咽炎、頭痛、上呼吸道感染和哮喘。不良事件發生率,安慰劑組為83%,75mg IV組為84%,100mg SC組為78%。嚴重不良事件發生率,安慰劑組為14%,75mg IV組為7%,100mg SC組為8%。

            MEA115575研究評估了每4周一次100mg皮下注射(SC)mepolizumab作為輔助療法,相對于安慰劑對每日口服皮質類固醇劑量的降低作用。該項研究中中,患者同時接受當前的哮喘維持治療。研究數據表明,在20-24周,100mg SC mepolizumab能夠更大幅度地降低維持性療法中口服糖皮質激素的劑量(p=0.008),并能夠維持哮喘控制,達到了研究的主要終點。該項研究中,不良事件在各治療組相似。最常見的不良反應為頭痛、鼻咽炎、支氣管炎、鼻竇炎、疲勞和哮喘。不良事件發生率,安慰劑組為92%,mepolizumab治療組為84%。嚴重不良事件發生率,安慰劑組為18%,mepolizumab治療組為1%。

            關于mepolizumab,葛蘭素史克有一個雄心勃勃的開發計劃。就在上個月,該公司宣布啟動一項關鍵性III期研究MEA115921,調查mepolizumab用于治療嗜酸細胞性肉芽腫性多血管炎(EGPA)的療效和安全性。

            EPGA即Churg-Strauss綜合征,是一種罕見的全身性炎癥性疾病,特征是小血管內壁廣泛的炎癥(血管炎,vasculitis),該病可累及多個器官,包括心臟、肺、皮膚、胃腸道、腎臟及神經系統。EGPA臨床治療的主要目標是誘導和維持緩解,同時減少糖皮質激素等免疫療法的使用。

            關于III期項目

            mepolizumab III期項目包括2個關鍵性研究:MEA115588和MEA115575。

            MEA115588是一項32周、雙盲、雙模擬(double-dummy)、安慰劑對照、平行組多中心研究,在576例既往經高劑量吸入性糖皮質激素(ICS)及至少一種其他控制藥物治療后仍經歷頻繁病情加重的哮喘患者中開展。在治療開始時,血液嗜酸性粒細胞計數高于150個細胞/微升的預先指定水平或在過去12個月內曾經嗜酸性粒細胞計數≥300個/微升的患者才有資格參與該項研究。研究的主要終點是,調查每4周1次75mg靜脈注射(IV)和100mg皮下注射(SC)mepolizumab相較于安慰劑,對臨床顯著病情加重頻率的改善。

            MEA115575是一項24周、雙盲、安慰劑對照、平行組多中心研究,在135例正接受口服糖皮質激素、高劑量ICS及一種額外的控制藥物常規治療的嚴重患者中開展。在治療開始時,血液嗜酸性粒細胞計數高于150個細胞/微升的預先指定水平或在過去12個月內曾經嗜酸性粒細胞計數≥300個/微升的患者才有資格參與該項研究。研究的主要終點是,調查每4周接受1次100mg皮下注射mepolizumab作為輔助治療,對類固醇使用劑量的減少。

            關于mepolizumab

            mepolizumab是一種實驗性全人源化單克隆抗體,特異靶向于白介素5(IL-5),開發用于經高劑量吸入性(ICS)或口服皮質類固醇激素(OCS)和長效β2激動劑治療后病情仍無法控制的嚴重難治性哮喘患者。IL-5是一種細胞因子,能夠調節嗜酸性粒細胞(白細胞)的生長、活化、存活,并能夠為嗜酸性粒細胞從骨髓遷移至肺部提供重要的信號。mepolizumab與人IL-5的結合,能夠阻斷IL-5與嗜酸性粒細胞表面受體的結合。以這種方式抑制IL-5對受體的結合作用,能夠降低血液、組織、痰液中的嗜酸性粒細胞水平,這反過來又能夠降低哮喘急性發作的頻率。目前mepolizumab還未獲任何監管批準。(生物谷bioon.com)

            英文原文:GSK announces positive results from phase III studies for mepolizumab in severe eosinophilic asthma

            Issued: Wednesday 12 March 2014, London UK – LSE Announcement

            GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that a pivotal phase III study of mepolizumab, an investigational IL-5 antagonist monoclonal antibody, met its primary endpoint of reduction in the frequency of exacerbations, in patients with severe eosinophilic asthma.

            The study (MEA115588) evaluated the efficacy of two dose regimens of mepolizumab in the treatment of patients with severe eosinophilic asthma. Patients remained on their current asthma maintenance therapy throughout the study and were randomised to receive either mepolizumab 75mg intravenous (IV), 100mg subcutaneous (SC), or placebo every four weeks.

            For the primary end point, both mepolizumab treatment arms showed statistically significant reductions in the frequency of clinically significant exacerbations of asthma compared to placebo (75mg IV, 47%, p<0.001; 100mg SC, 53%, p<0.001).

            Adverse events reported in the study were similar across all treatment groups. The most common reported adverse events across all treatment groups were nasopharyngitis, headache, upper respiratory tract infection and asthma. The frequency of adverse events was 83% in the placebo group, 84% in the mepolizumab 75mg IV and 78% in the mepolizumab 100mg SC group. The frequency of serious adverse events was 14% in the placebo group, 7% in the mepolizumab 75mg IV and 8% in the mepolizumab 100mg SC group.

            Dave Allen, Head, GSK Respiratory Therapy Area Unit, R&D, said: “We are really pleased to have generated further positive data on mepolizumab, consistent with the findings from our earlier exacerbation study. We now have two studies showing a reduction in exacerbations in a specific group of patients with a severe form of asthma who continue to exacerbate despite treatment with high doses of their current maintenance therapies. This is very positive news for patients. For GSK it is exciting that this is the first non-inhaled treatment for severe asthma and we will be progressing towards global filings at the end of the year.”

            In addition, a second phase III study (MEA115575) designed to evaluate the use of mepolizumab 100mg SC, every 4 weeks in comparison to placebo in reducing daily oral corticosteroid use while maintaining asthma control also met its primary endpoint. The study showed that patients on mepolizumab 100mg SC were able to achieve greater reductions in their maintenance oral corticosteroid dose during weeks 20-24 compared to patients on placebo (p =0.008), while maintaining asthma control.

            In this study adverse events were similar across treatment groups. The most common reported adverse events in the two treatment groups were headache, nasopharyngitis, bronchitis, sinusitis, fatigue and asthma. The frequency of adverse events was 92% in the placebo and 84% in the mepolizumab treatment group. Frequency of serious adverse events was 18% in the placebo group and 1% in the mepolizumab group.

            The full results of these studies will be posted onto the GSK clinical study register, clinicaltrials.gov and presented at a future scientific meeting.

            About the studies:

            Study MEA115588 was a 32-week double-blind, double-dummy, placebo-controlled, parallel group multicentre study that randomised and treated 576 patients with severe asthma, who had experienced frequent exacerbations despite treatment with high dose inhaled corticosteroids (ICS) plus at least one other controller medication. All patients were also required to have a blood eosinophil count above a pre-specified threshold of ≥150 cells/μl at initiation of treatment or who have had blood eosinophils ≥300 cells/μl in the past 12 months to be eligible for the study.

            Study MEA115575 was a 24-week double-blind, placebo-controlled, parallel group multicentre study that randomised and treated 135 patients. To be eligible for the study patients had severe asthma and were on regular treatment with oral corticosteroids, high dose ICS plus an additional controller medication. All patients were also required to have a blood eosinophil count above a pre-specified threshold of ≥150 cells/μl at initiation of treatment or who have had blood eosinophils ≥300 cells/μl in the past 12 months to be eligible for the study.

            About severe eosinophilic asthma and mepolizumab

            The presence of eosinophils may represent a subtype of severe asthma. Although asthma is a heterogeneous disease it is often characterised by an accumulation of eosinophils (white blood cells) in lung tissues and in general, raised eosinophils correlate with severity and frequency of exacerbations. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung.

            Mepolizumab is an investigational fully humanised IgG1 monoclonal antibody specific for IL-5, which binds to IL-5, stopping it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.

            Mepolizumab is in development for severe eosinophilic asthma in patients who exacerbate despite high-dose oral or inhaled corticosteroids (ICS) and an additional controller such as long-acting beta-2 agonist. In addition, mepolizumab is being investigated in COPD and Eosinophilic Granulomatosis with Polyangiitis (EGPA).

            Mepolizumab is not approved anywhere in the world.

             

            關鍵詞:葛蘭素史克,單抗,IL-5拮抗劑,mepolizumab,嗜酸性粒細胞哮喘

            信息來源:生物谷

             


            總機:021-64556180 傳真:021-021-69018966*808 網址:www.tmesiep.cn 郵箱:service@caerulumpharma.com
             上??β端{科技有限公司 版權所有 © 2014 技術支持 華夏化工網 后臺管理 企業郵箱

            滬公網安備 31011202007132號

            国产亚洲欧美在线人成|亚洲国产成人无码网|国产在线自在拍91精品|亚洲国产精品无码
                1. <video id="oovo1"></video>
                  <b id="oovo1"><p id="oovo1"></p></b><source id="oovo1"></source>
                    <source id="oovo1"></source>