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【drug-news】【资讯翻译】Agenus前噬菌体疫苗临床试验关键数据显示其具有抗癌活性
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认领翻译的战友请跟帖注明“认领本文翻译，48小时内未完成，请其他战友认领！”请根据自己专业背景选择认领，如使用翻译软件翻译，被发现者扣分1-2分请根据自己的专业背景选择相应的资讯认领，经常认领而不能及时提供优质稿件者将被列入黑名单，取消认领资格，请大家注意！新近参与本次活动的会员请查看：寻找最近的翻译贴请查看：翻译时请参照版规 希望参与动态版其他活动的会员请查看版面右边栏的置顶部分LEXINGTON, Mass., Aug. 8, 2012 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN), a biotechnology company working to develop novel immunology-based treatments for cancers and infectious diseases, today announced the publication of key clinical data from a Phase 1 trial of a Prophage Series vaccine (HSPPC-96; vitespen) to treat patients with recurrent glioblastoma multiforme (GBM).The data from the Phase 1 trial were published online by Clinical Cancer Research in an article titled, &Individual patient-specific immunity against high-grade glioma after vaccination with autologous tumor derived peptides bound to the 96 KD chaperone protein,& by Andrew T. Parsa, MD, Ph.D., Professor in the Department of Neurological Surgery at the University of California, San Francisco (UCSF), and principal investigator for the trial. This data will appear in the printed version this fall.&Our data show that a tumor specific immune response to peptides bound to gp96 can be generated with autologous HSPPC-96 derived from GBM patients undergoing surgical resection,& said Dr. Parsa. &In addition, our observations provide evidence for a general mechanism to elicit individual patient-specific immune responses that appear to correlate with clinical outcome. The results affirm the safety and biological activity of an autologous HSPPC-96 approach for recurrent glioma patients.&A total of 12 patients with a mean age of 52 years were treated in the Phase 1 trial receiving HSPPC-96 as a single-agent therapy. Testing of peripheral blood leukocytes (PBLs) before and after vaccination revealed a significant peripheral immune response specific for the peptides bound to HSP-96, in 11 of the 12 patients treated. ? Brain biopsies of immune responders after vaccination revealed focal CD4, CD8 and CD56 IFN-gamma positive cell infiltrates, consistent with tumor site-specific immune responses. Immune responders had a median survival of 47 weeks after surgery and vaccination, compared to 16 weeks for the single non-responder.? There were no serious adverse events associated with vaccine administration.In April 2012, the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) approved a study of the HSPPC-96 vaccine in a large, randomized Phase 2 trial in combination with Avastin?& ( Genentech/Roche) in patients with surgically resectable recurrent GBM. The study is being sponsored by the Alliance for Clinical Trials in Oncology (referred to as the &Alliance&), an NCI cooperative group formed by the merger of the American College of Surgeons Oncology Group (ACOSOG), Cancer and Leukemia Group B (CALGB), and the North Central Cancer Treatment Group (NCCTG).The trial is intended to investigate the combination of HSPPC-96 and bevacizumab in a three-arm study of approximately 220 patients with surgically resectable recurrent GBM with the primary endpoint to assess overall survival. The study would compare efficacy of the HSPPC-96 vaccine given with bevacizumab either concomitantly or at progression, versus bevacizumab alone, in the therapy of surgically resectable recurrent GBM. This study design is supported, in part, by a theoretical synergistic effect between HSPPC-96 and bevacizumab.? The protocol for this trial is currently undergoing final review and the trial should be initiated around the end of 2012 or early 2013.The study aims to advance the treatment of GBM, the most common and most malignant form of brain cancer. The potential clinical benefits of Prophage Series vaccine continue to be reported in peer-reviewed publications and at major international medical meetings.Dr. Parsa has not received any financial support or travel expense reimbursement for this work or for consulting activities on behalf of Agenus.? Dr. Parsa does not have an equity interest in Agenus or a financial relationship with the company.
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文献标题：Individual patient-specific immunity against high-grade glioma after vaccination with autologous tumor derived peptides bound to the 96 KD chaperone protein杂志名称：Clin Cancer Res. PMID：第一页截图：
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LEXINGTON, Mass., Aug. 8, 2012 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN), a biotechnology company working to develop novel immunology-based treatments for cancers and infectious diseases, today announced the publication of key clinical data from a Phase 1 trial of a Prophage Series vaccine (HSPPC-96; vitespen) to treat patients with recurrent glioblastoma multiforme (GBM).马萨诸塞，列克星敦，2日今天，致力于发展新型抗肿瘤及传染病免疫治疗药物的Agenus公司（纳斯达克：AGEN）在杂志上公布了HSPPC-96（vitespen，一种噬菌体疫苗）治疗复发胶质母细胞瘤患者一期临床试验的关键临床资料。The data from the Phase 1 trial were published online by Clinical Cancer Research in an article titled, &Individual patient-specific immunity against high-grade glioma after vaccination with autologous tumor derived peptides bound to the 96 KD chaperone protein,& by Andrew T. Parsa, MD, Ph.D., Professor in the Department of Neurological Surgery at the University of California, San Francisco (UCSF), and principal investigator for the trial. This data will appear in the printed version this fall.该项研究成果已经在线发表于美国《临床肿瘤研究》（Clinical Cancer Research）杂志，印刷版需要今年秋季才可以面世，论文题目为“接种自体肿瘤源性肽与96KD蛋白伴侣链接构成的疫苗，可以在体内诱导针对高级别胶质瘤的特异免疫应答”，作者是旧金山加州大学（UCSF）神经外科教授Andrew T. Parsa（医学博士），他同时也是该课题的项目负责人。&Our data show that a tumor specific immune response to peptides bound to gp96 can be generated with autologous HSPPC-96 derived from GBM patients undergoing surgical resection,& said Dr. Parsa. &In addition, our observations provide evidence for a general mechanism to elicit individual patient-specific immune responses that appear to correlate with clinical outcome. The results affirm the safety and biological activity of an autologous HSPPC-96 approach for recurrent glioma patients.&“我们的实验证明：采用患者手术中切除的胶质母细胞瘤组织制备的自体同源性HSPPC-96疫苗（将源自瘤组织的肽与96KD的蛋白伴侣链接构成的疫苗），可以刺激特异性免疫应答；并且采用这种具有生物活性的自体同源性HSPPC-96疫苗治疗复发胶质瘤患者是安全的，” Parsa医生说道。“此外，我们的研究具有更深层次的意义，有助于揭示患者对肿瘤特异性免疫应答的能力与其临床愈后的相关性。”A total of 12 patients with a mean age of 52 years were treated in the Phase 1 trial receiving HSPPC-96 as a single-agent therapy. Testing of peripheral blood leukocytes (PBLs) before and after vaccination revealed a significant peripheral immune response specific for the peptides bound to HSP-96, in 11 of the 12 patients treated. Brain biopsies of immune responders after vaccination revealed focal CD4, CD8 and CD56 IFN-gamma positive cell infiltrates, consistent with tumor site-specific immune responses. Immune responders had a median survival of 47 weeks after surgery and vaccination, compared to 16 weeks for the single non-responder. There were no serious adverse events associated with vaccine administration.在该项一期临床试验中，共遴选了12名患者，平均年龄为52岁。在疫苗接种前后分别检测外周血白细胞（peripheral blood leukocytes ，PBLs）的结果显示，该疫苗可以在参试的11人中诱导明显的外周免疫反应；在这11位有反应的患者中进行的脑组织活检显示：病灶内有CD4, CD8和CD56 IFN-gamma阳性的细胞浸润，这正是肿瘤原位特异免疫应答的特征。对疫苗产生应答的11位患者术后的中位生存时间为47周，而仅有的没有产生应答的1位患者的中位生存时间为16周。接种疫苗后没有观察到严重的毒副反应。In April 2012, the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) approved a study of the HSPPC-96 vaccine in a large, randomized Phase 2 trial in combination with A ( Genentech/Roche) in patients with surgically resectable recurrent GBM. The study is being sponsored by the Alliance for Clinical Trials in Oncology (referred to as the &Alliance&), an NCI cooperative group formed by the merger of the American College of Surgeons Oncology Group (ACOSOG), Cancer and Leukemia Group B (CALGB), and the North Central Cancer Treatment Group (NCCTG).在今年4月，美国国家肿瘤研究所（NCI）的肿瘤治疗评价计划（CTEP）批准了一项名为 “手术切除后，联合使用HSPPC-96疫苗和Avastin（贝伐单抗；罗氏公司的基因泰克公司生产）治疗复发性胶质母细胞瘤患者”的二期临床试验。该项目由美国肿瘤外科医师学院协作组（ACOSOG）、美国北部癌症治疗中心协作组（NCCTG）、肿瘤及白血病协作组B（CALGB）等三家团体合并而成的肿瘤临床试验联盟（Alliance for Clinical Trials in Oncology）资助。The trial is intended to investigate the combination of HSPPC-96 and bevacizumab in a three-arm study of approximately 220 patients with surgically resectable recurrent GBM with the primary endpoint to assess overall survival. The study would compare efficacy of the HSPPC-96 vaccine given with bevacizumab either concomitantly or at progression, versus bevacizumab alone, in the therapy of surgically resectable recurrent GBM. This study design is supported, in part, by a theoretical synergistic effect between HSPPC-96 and bevacizumab. The protocol for this trial is currently undergoing final review and the trial should be initiated around the end of 2012 or early 2013.该项试验拟遴选约220名复发胶质母细胞瘤患者人，手术切除瘤组织后，联合应用HSPPC-96 疫苗和贝伐单抗，是一项以总生存数为主要观察终点的三手研究。通过比较贝伐单抗单独或联合应用HSPPC-96疫苗（与贝伐单抗同时给药，或者继贝伐单抗给药后，贯序给药）对胶质母细胞瘤患者的治疗效果。HSPPC-96疫苗与贝伐单抗理论上存在的协同效应，是该试验的一部分理论基础。试验的具体治疗方案正在进行最后的商定，估计今年年底至明年年初即可付诸实践。The study aims to advance the treatment of GBM, the most common and most malignant form of brain cancer. The potential clinical benefits of Prophage Series vaccine continue to be reported in peer-reviewed publications and at major international medical meetings.该项研究旨在推进胶质母细胞瘤（颅内最常见的恶性脑肿瘤）的治疗。该噬菌体疫苗的潜在临床价值还会继续在其他同行评议杂志上及大型国际医学会议上报道。Dr. Parsa has not received any financial support or travel expense reimbursement for this work or for consulting activities on behalf of Agenus. Dr. Parsa does not have an equity interest in Agenus or a financial relationship with the company.在该研究中Parsa医生没有收到来自Agenus公司资金上的支持及差旅费的报销。Parsa 医生与Agenus公司没有利益或者经济牵连。
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mengguyelv edited on
（已编译：字数1103）马萨诸塞，列克星敦，2日今天，致力于发展新型抗肿瘤及传染病免疫治疗药物的Agenus公司（纳斯达克：AGEN）在杂志上公布了HSPPC-96（vitespen，一种噬菌体疫苗）治疗复发胶质母细胞瘤患者一期临床试验的关键临床资料。该项研究成果已经在线发表于美国《临床肿瘤研究》（Clinical Cancer Research）杂志，印刷版需要今年秋季才可以面世，论文题目为“接种自体肿瘤源性肽与96KD蛋白伴侣链接构成的疫苗，可以在体内诱导针对高级别胶质瘤的特异免疫应答”，作者是旧金山加州大学（UCSF）神经外科教授Andrew T. Parsa（医学博士），他同时也是该课题的项目负责人。“我们的实验证明：采用患者手术中切除的胶质母细胞瘤组织制备的自体同源性HSPPC-96疫苗（将源自瘤组织的肽与96KD的蛋白伴侣链接构成的疫苗），可以刺激特异性免疫应答；并且采用这种具有生物活性的自体同源性HSPPC-96疫苗治疗复发胶质瘤患者是安全的，” Parsa医生说道。“此外，我们的研究具有更深层次的意义，有助于揭示患者对肿瘤特异性免疫应答的能力与其临床愈后的相关性。”在该项一期临床试验中，共遴选了12名患者，平均年龄为52岁。在疫苗接种前后分别检测外周血白细胞（peripheral blood leukocytes ，PBLs）的结果显示，该疫苗可以在参试的11人中诱导明显的外周免疫反应；在这11位有反应的患者中进行的脑组织活检显示：病灶内有CD4, CD8和CD56 IFN-gamma阳性的细胞浸润，这正是肿瘤原位特异免疫应答的特征。对疫苗产生应答的11位患者术后的中位生存时间为47周，而仅有的没有产生应答的1位患者的中位生存时间为16周。接种疫苗后没有观察到严重的毒副反应。在今年4月，美国国家肿瘤研究所（NCI）的肿瘤治疗评价计划（CTEP）批准了一项名为 “手术切除后，联合使用HSPPC-96疫苗和Avastin（贝伐单抗；罗氏公司的基因泰克公司生产）治疗复发性胶质母细胞瘤患者”的二期临床试验。该项目由美国肿瘤外科医师学院协作组（ACOSOG）、美国北部癌症治疗中心协作组（NCCTG）、肿瘤及白血病协作组B（CALGB）等三家团体合并而成的肿瘤临床试验联盟（Alliance for Clinical Trials in Oncology）资助。该项试验拟遴选约220名复发胶质母细胞瘤患者人，手术切除瘤组织后，联合应用HSPPC-96 疫苗和贝伐单抗，是一项以总生存数为主要观察终点的三手研究。通过比较贝伐单抗单独或联合应用HSPPC-96疫苗（与贝伐单抗同时给药，或者继贝伐单抗给药后，贯序给药）对胶质母细胞瘤患者的治疗效果。HSPPC-96疫苗与贝伐单抗理论上存在的协同效应，是该试验的一部分理论基础。试验的具体治疗方案正在进行最后的商定，估计今年年底至明年年初即可付诸实践。该项研究旨在推进胶质母细胞瘤（颅内最常见的恶性脑肿瘤）的治疗。该噬菌体疫苗的潜在临床价值还会继续在其他同行评议杂志上及大型国际医学会议上报道。在该研究中Parsa医生没有收到来自Agenus公司资金上的支持及差旅费的报销。Parsa 医生与Agenus公司没有利益或者经济牵连。（丁香）
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背景介绍：HSPPCs以下英文来自文章原文Heat shock protein peptide complexes (HSPPCs) found in cancer cells carry tumor-specific antigenic proteins and can facilitate adaptive and innate immune response. Here we show that peptides bound to a 96 kD chaperone protein (HSP-96) from brain tissue containing glioblastoma multiforme (GBM) can be used to safely immunize patients with recurrent GBM.在很多瘤细胞中发现的热休克蛋白复合物（Heat shock protein peptide complexes，HSPPCs）具有肿瘤特异性抗原，可以诱发继发性和固有免疫应答。这本文章中，我们发现将源自胶质母细胞瘤组织的肽与96KD的分子伴侣链接可以刺激复发胶质瘤细胞瘤患者的免疫反应。（需请教，红线部分如何翻译？还有句子中from brain tissue containing glioblastoma multiforme (GBM)是不是修饰peptides ？）关于三手研究一个临床研究不一定只有一个对照组, 可以根据实际情况设立多个对照组, 如在一个阳性药物的临床研究中，增加一个安慰剂对照组, 就形成同时使用安慰剂和阳性药物对照组的研究，常称为三手研究(Three-arm study)。又如在安慰剂对照研究中, 根据医学伦理学要求,有时需对每个受试者在给予一种标准治疗药物的同时, 研究组给予研究药物, 对照组给予安慰剂, 这种研究称为标准治疗加安慰剂的研究(Placebo-Standard study)。 当一种标准治疗已经被证实能够降低死亡率、复发率等, 从而不能中断, 只能继续保持, 受试者从这种标准疗法中肯定得到好处, 这时在安慰剂对照研究中, 设计方案就成为所有受试者都接受这种标准疗法, 研究组接受研究药物, 对照组接受安慰剂, 这种研究称为加载研究(Add-on study)。
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mengguyelv 背景介绍：HSPPCs以下英文来自文章原文Heat shock protein peptide complexes (HSPPCs) found in cancer cells carry tumor-specific antigenic proteins and can facilitate adaptive and innate immune response. Here we show that peptides bound to a 96 kD chaperone protein (HSP-96) from brain tissue containing glioblastoma multiforme (GBM) can be used to safely immunize patients with recurrent GBM.在很多瘤细胞中发现的热休克蛋白复合物（Heat shock protein peptide complexes，HSPPCs）具有肿瘤特异性抗原，可以诱发继发性和固有免疫应答。这本文章中，我们发现将源自胶质母细胞瘤组织的肽与96KD的分子伴侣链接可以刺激复发胶质瘤细胞瘤患者的免疫反应。（需请教，红线部分如何翻译？还有句子中from brain tissue containing glioblastoma multiforme (GBM)是修饰peptides 1.LEXINGTON, Mass., Aug. 8, 2012 (GLOBE NEWSWIRE) -- Agenus Inc.(Nasdaq:AGEN), a biotechnology company working to develop novelimmunology-based treatments for cancers and infectious diseases, todayannounced the publication of key clinical data from aPhase 1 trial of a Prophage Series vaccine(HSPPC-96; vitespen) to treat patients with recurrent glioblastoma multiforme(GBM).马萨诸塞，列克星敦，22012年8月8日今天，致力于发展新型抗肿瘤及传染病免疫治疗药物的Agenus公司（纳斯达克：AGEN）在杂志上公布了HSPPC-96（vitespen，一种噬菌体疫苗）治疗复发胶质母细胞瘤患者一期临床试验的关键临床资料。修改: novelimmunology-based treatments for cancers and infectious diseases癌症和感染性疾病的免疫治疗;the publication出版物;Prophage Series不必翻译.2. &Our data show that a tumor specific immune response to peptides boundto gp96 can be generated with autologous HSPPC-96 derived from GBM patientsundergoing surgical resection,&
said Dr. Parsa.
&In addition,
ourobservations provide evidence for a general mechanism to elicit individualpatient-specific immune responses
appear to correlate with clinicaloutcome.
The results affirm the safety and biological
activity of an autologous HSPPC-96
approach for recurrent glioma patients.&“我们的实验证明：采用患者手术中切除的胶质母细胞瘤组织制备的自体同源性HSPPC-96疫苗（将源自瘤组织的肽与96KD的蛋白伴侣链接构成的疫苗），可以刺激特异性免疫应答；并且采用这种具有生物活性的自体同源性HSPPC-96疫苗治疗复发胶质瘤患者是安全的，”Parsa医生说道。“此外，我们的研究具有更深层次的意义，有助于揭示患者对肿瘤特异性免疫应答的能力与其临床愈后的相关性。”修改: 红色断句有问题: our observations provideevidence for a generalmechanism to elicit individual
patient-specific immune responses [thatappear to correlate with clinical outcome.定语从句修饰immune responses ]3.A total of 12 patients with a mean age of 52 years were treated in the Phase1 trial receiving HSPPC-96 as a single-agent therapy.在该项一期临床试验中，共遴选了12名患者，平均年龄为52岁。修改:红色漏译。4.Testing of peripheral blood leukocytes (PBLs) before and aftervaccination revealed a significant peripheral immune response specific for thepeptides bound to HSP-96, in 11 of the 12 patientstreated.
Brain biopsies of immune
responders after vaccination revealed focalCD4, CD8 and CD56 IFN-gamma positive cell infiltrates,
consistent
site-specificimmune responses. Immune responders had a median survival of 47 weeks
after surgery and vaccination, compared to 16 weeksfor the single non-responder.
There were no serious adverse
associated with
vaccine administration.在疫苗接种前后分别检测外周血白细胞（peripheral blood leukocytes ，PBLs）的结果显示，该疫苗可以在参试的11人中诱导明显的外周免疫反应；在这11位有反应的患者中进行的脑组织活检显示：病灶内有CD4,CD8和CD56IFN-gamma阳性的细胞浸润，这正是肿瘤原位特异免疫应答的特征。对疫苗产生应答的11位患者术后的中位生存时间为47周，而仅有的没有产生应答的1位患者的中位生存时间为16周。接种疫苗后没有观察到严重的毒副反应。修改：tumor site-specificimmune responses.肿瘤部位特异性；16 weeks for the single仅有1位患者怎么会有中位时间呢？5．Thetrial is intended to investigate the combination of HSPPC-96 and bevacizumab ina three-armstudy of approximately 220 patients with surgically resectablerecurrent GBM with the primary endpoint to assess overall survival.该项试验拟遴选约220名复发胶质母细胞瘤患者人，手术切除瘤组织后，联合应用HSPPC-96疫苗和贝伐单抗，是一项以总生存数为主要观察终点的三手研究。修改：主要终点是评价总体生存率；三臂研究(Three-arm study)。6. Dr. Parsa has not received any financial support or travelexpense reimbursement for this work or forconsulting activitieson behalf of Agenus.Dr. Parsa does not have an equity interest in Agenus or a financial relationshipwith the company.在该研究中Parsa医生没有收到来自Agenus公司资金上的支持及差旅费的报销。Parsa医生与Agenus公司没有利益或者经济牵连。修改: 代表Agenus做顾问工作.
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success2009 edited on
这个句子的给的修改意见太好了。非常感谢。目前改为Our observations provide evidence for a general mechanism to elicit individual patient-specific immune responses that appear to correlate with clinical outcome我们的结果也为“诱导与患者临床愈后相关的特异性免疫应答机制”提供了证据。其他部分修改如下。1.LEXINGTON, Mass., Aug. 8, 2012 (GLOBE NEWSWIRE) -- Agenus Inc.(Nasdaq:AGEN), a biotechnology company working to develop novelimmunology-based treatments for cancers and infectious diseases, todayannounced the publication of key clinical data from aPhase 1 trial of a Prophage Series vaccine(HSPPC-96; vitespen) to treat patients with recurrent glioblastoma multiforme(GBM).马萨诸塞，列克星敦，日今天，致力于发展新型癌症及感染性疾病免疫治疗的Agenus公司（纳斯达克：AGEN）在出版物上公布了HSPPC-96（vitespen，一种噬菌体疫苗）治疗复发胶质母细胞瘤患者一期临床试验的关键临床资料。2. &Our data show that a tumor specific immune response to peptides boundto gp96 can be generated with autologous HSPPC-96 derived from GBM patientsundergoing surgical resection,& said Dr. Parsa. &In addition, ourobservations provide evidence for a general mechanism to elicit individualpatient-specific immune responses that appear to correlate with clinicaloutcome. The results affirm the safety and biological activity of an autologous HSPPC-96 approach for recurrent glioma patients.&“我们的实验证明：采用患者手术中切除的胶质母细胞瘤组织制备的自体同源性HSPPC-96疫苗（将源自瘤组织的肽与96KD的蛋白伴侣链接构成的疫苗），可以刺激特异性免疫应答；并且采用这种具有生物活性的自体同源性HSPPC-96疫苗治疗复发胶质瘤患者是安全的，”Parsa医生说道。“此外，我们的结果也为“诱导与患者临床愈合相关的特异性免疫应答机制”提供了证据。”3.A total of 12 patients with a mean age of 52 years were treated in the Phase1 trial receiving HSPPC-96 as a single-agent therapy.在该项一期临床试验中，共遴选了12名患者，平均年龄为52岁，仅使用HSPPC-96进行治疗。4.Testing of peripheral blood leukocytes (PBLs) before and aftervaccination revealed a significant peripheral immune response specific for thepeptides bound to HSP-96, in 11 of the 12 patientstreated. Brain biopsies of immune responders after vaccination revealed focalCD4, CD8 and CD56 IFN-gamma positive cell infiltrates, consistent with tumor site-specificimmune responses. Immune responders had a median survival of 47 weeks after surgery and vaccination, compared to 16 weeksfor the single non-responder. There were no serious adverse events associated with vaccine administration.在疫苗接种前后分别检测外周血白细胞（peripheral blood leukocytes ，PBLs）的结果显示，该疫苗可以在参试的11人中诱导明显的外周免疫反应；在这11位有反应的患者中进行的脑组织活检显示：病灶内有CD4,CD8和CD56IFN-gamma阳性的细胞浸润，这正是肿瘤部位特异性免疫应答的特征。对疫苗产生应答的11位患者术后的中位生存时间为47周，而仅有的没有产生应答的1位患者的生存时间为16周。接种疫苗后没有观察到严重的毒副反应。5．Thetrial is intended to investigate the combination of HSPPC-96 and bevacizumab ina three-armstudy of approximately 220 patients with surgically resectablerecurrent GBM with the primary endpoint to assess overall survival.该项试验拟遴选约220名复发胶质母细胞瘤患者人，手术切除瘤组织后，联合应用HSPPC-96疫苗和贝伐单抗，是一项主要终点是评价总体生存率的三臂研究。6. Dr. Parsa has not received any financial support or travelexpense reimbursement for this work or for consulting activitieson behalf of Agenus.Dr. Parsa does not have an equity interest in Agenus or a financial relationshipwith the company.在该研究及代表做顾问Agenus工作中，Parsa医生没有收到来自Agenus公司资金上的支持及差旅费的报销。Parsa医生与Agenus公司没有利益或者经济牵连。
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mengguyelv edited on
重新编译后马萨诸塞，列克星敦，日今天，致力于发展新型癌症及感染性疾病免疫治疗的Agenus公司（纳斯达克：AGEN）在出版物上公布了HSPPC-96（vitespen，一种噬菌体疫苗）治疗复发胶质母细胞瘤患者一期临床试验的关键临床资料。该项研究成果已经在线发表于美国《临床肿瘤研究》（Clinical Cancer Research）杂志，印刷版需要今年秋季才可以面世，论文题目为“接种自体肿瘤源性肽与96KD蛋白伴侣链接构成的疫苗，可以在体内诱导针对高级别胶质瘤的特异免疫应答”，作者是旧金山加州大学（UCSF）神经外科教授Andrew T. Parsa（医学博士），他同时也是该课题的项目负责人。“我们的实验证明：采用患者手术中切除的胶质母细胞瘤组织制备的自体同源性HSPPC-96疫苗（将源自瘤组织的肽与96KD的蛋白伴侣链接构成的疫苗），可以刺激特异性免疫应答；并且采用这种具有生物活性的自体同源性HSPPC-96疫苗治疗复发胶质瘤患者是安全的，”Parsa医生说道。“此外，我们的结果也为‘诱导与患者临床愈后相关的特异性免疫应答机制’提供了证据。”在该项一期临床试验中，共遴选了12名患者，平均年龄为52岁，仅使用HSPPC-96进行治疗。。在疫苗接种前后分别检测外周血白细胞（peripheral blood leukocytes ，PBLs）的结果显示，该疫苗可以在参试的11人中诱导明显的外周免疫反应；在这11位有反应的患者中进行的脑组织活检显示：病灶内有CD4, CD8和CD56 IFN-gamma阳性的细胞浸润，这正是肿瘤部位特异性特异免疫应答的特征。对疫苗产生应答的11位患者术后的中位生存时间为47周，而仅有的没有产生应答的1位患者的生存时间为16周。接种疫苗后没有观察到严重的毒副反应。在今年4月，美国国家肿瘤研究所（NCI）的肿瘤治疗评价计划（CTEP）批准了一项名为 “手术切除后，联合使用HSPPC-96疫苗和Avastin（贝伐单抗；罗氏公司的基因泰克公司生产）治疗复发性胶质母细胞瘤患者”的二期临床试验。该项目由美国肿瘤外科医师学院协作组（ACOSOG）、美国北部癌症治疗中心协作组（NCCTG）、肿瘤及白血病协作组B（CALGB）等三家团体合并而成的肿瘤临床试验联盟（Alliance for Clinical Trials in Oncology）资助。该项试验拟遴选约220名复发胶质母细胞瘤患者人，手术切除瘤组织后，联合应用HSPPC-96 疫苗和贝伐单抗，是一项主要终点是评价总体生存率的三臂研究。通过比较贝伐单抗单独或联合应用HSPPC-96疫苗（与贝伐单抗同时给药，或者继贝伐单抗给药后，贯序给药）对胶质母细胞瘤患者的治疗效果。HSPPC-96疫苗与贝伐单抗理论上存在的协同效应，是该试验的一部分理论基础。试验的具体治疗方案正在进行最后的商定，估计今年年底至明年年初即可付诸实践。
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关于丁香园}