A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma

This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.

开始日期2024-09-30

申办/合作机构

广州誉衡生物科技有限公司

100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的临床结果

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100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的转化医学

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100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的专利（医药）

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项与 G-CSF(Guangzhou Gloria Biosciences) 相关的文献（医药）

2018-11-01·Journal of Child and Adolescent Psychopharmacology3区 · 医学

Group Cognitive Behavioral Therapy and Attention Bias Modification for Childhood Anxiety Disorders: A Factorial Randomized Trial of Efficacy

3区 · 医学

Article

作者: Koller, Silvia H. ; Bar-Haim, Yair ; Jarros, Rafaela B. ; DeSousa, Diogo ; Toazza, Rudineia ; Pine, Daniel S. ; Petersen, Circe S. ; Salum, Giovanni A. ; Abend, Rany ; Manfro, Gisele G. ; Castro, Stela ; Barrett, Paula ; Borba, Lidiane Nunes ; Gallegos, Julia

BACKGROUNDThe objective of this study is to assess group differences in symptom reduction between individuals receiving group cognitive behavioral therapy (G-CBT) and attention bias modification (ABM) compared to their respective control interventions, control therapy (CT), and attention control training (ACT), in a 2 × 2 factorial design.METHODSA total of 310 treatment-naive children (7-11 years of age) were assessed for eligibility and 79 children with generalized, separation or social anxiety disorder were randomized and received G-CBT (n = 42) or CT (n = 37). Within each psychotherapy group, participants were again randomized to ABM (n = 38) or ACT (n = 41) in a 2 × 2 factorial design resulting in four groups: G-CBT + ABM (n = 21), G-CBT + ACT (n = 21), CT + ABM (n = 17), and CT + ACT (n = 20). Primary outcomes were responder designation as defined by Clinical Global Impression-Improvement (CGI-I) scale (≤2) and change on the Pediatric Anxiety Rating Scale (PARS).RESULTSThere were significant improvements of symptoms in all groups. No differences in response rates or mean differences in PARS scores were found among groups: G-CBT + ABM group (23.8% response; 3.9 points, 95% confidence interval [CI] -0.3 to 8.1), G-CBT + ACT (42.9% response; 5.6 points, 95% CI 2.2-9.0), CT + ABM (47.1% response; 4.8 points 95% CI 1.08-8.57), and CT + ACT (30% response; 0.8 points, 95% CI -3.0 to 4.7). No evidence or synergic or antagonistic effects were found, but the combination of G-CBT and ABM was found to increase dropout rate.CONCLUSIONSWe found no effect of G-CBT or ABM beyond the effects of comparison groups. Results reveal no benefit from combining G-CBT and ABM for anxiety disorders in children and suggest potential deleterious effects of the combination on treatment acceptability.

2012-03-01·Targeted Oncology3区 · 医学

Presently available biosimilars in hematology-oncology: G-CSF

3区 · 医学

Review

作者: Gascon, Pere

Biopharmaceuticals were copies of endogenous human proteins developed in the mid-1990s that were characterized by complex three-dimensional, high-molecular weight compounds. What made them unique was that contrary to classical chemotherapeutical drugs, they were manufactured by living cells. One of these biopharmaceuticals was granulocyte-colony stimulating factor (G-CSF). Once their patent expired, generic versions appeared in pharmacies. They are now called biosimilars. There are several biosimilar G-CSFs approved in Europe: Biograstim®/Filgrastim ratiopharm/Ratiograstim®/Tevagrastim® (XM02); Zarzio® and Nivestim®. All these new products are manufactured in facilities with state-of-the-art technology. All products have passed the regulatory requirements for approval, mainly phase I and phase III, with the consequent PD/PK evaluations and studies on efficacy and safety. However, there are still some concerns regarding their long-term evaluation, in particular, the limited experience at the time of approval of these products in terms of efficacy, safety and immunogenicity. For this reason, pharmacovigilance should be rigorous. A lot of work remains to be done in terms of clarification with regard to substituting a biosimilar G-CSF for the innovator product and, finally, information must be provided to physicians, pharmacists and patients to allow for proper decision-making. Ultimately, only clinical trials and effective post-marketing pharmacovigilance will provide definitive evidence that a biosimilar is comparable to the originator-reference product in terms of efficacy and safety.

Scientific Reports

MRI grading for informed clinical decision-making in Peutz–Jeghers syndrome patients with cervical lesions

Article

作者: Ning, Yan ; Xu, Congjian ; Kang, Yu ; Chen, Yiqing ; Ma, Fenghua ; Jiang, Anqi ; Wang, Hui ; Yu, Bing

AbstractThe preoperative diagnosis and management of Peutz–Jeghers syndrome (PJS) patients with cervical lesions remain problematic. This study analysed the associations between pathological types of cervical lesions in PJS patients and their MRI features. A total of 34 PJS patients were included and two experienced radiologists reviewed the MRIs independently. Based on the pathological diagnosis, the patients were categorized into four groups: normal (n = 4), lobular endocervical glandular hyperplasia (LEGH, n = 11), atypical LEGH (aLEGH, n = 8), and gastric-type endocervical adenocarcinoma (G-EAC, n = 11). By observing the MRI features, we found statistically significant differences in the extent of lesions (P = 0 .001), distribution of microcysts (P = 0 .001), proportion of microcysts (P < 0.001) and endometrial involvement (P = 0.019) among the four groups. Notably, solid components and disrupted cervical stromal rings were found only in the aLEGH and G-EAC groups (P < 0.001). Consequently, we created a novel grading system based on the aforementioned MRI features to align with the potential malignancy of cervical lesions in PJS patients. This system enables patients to receive timely and appropriate treatment recommendations while facilitating collaboration between radiologists and physicians.

项与 G-CSF(Guangzhou Gloria Biosciences) 相关的新闻（医药）

2024-09-19

·美通社

创胜集团于ESMO 2024年会公布Osemitamab (TST001)三联疗法一线治疗胃或胃食管结合部腺癌令人鼓舞的更新疗效数据

更长随访时间的更新数据显示， CLDN18.2高/中表达且已知PD-L1 CPS患者的确认客观缓解率(ORR)为68%，中位无进展生存期(PFS)为14.2个月(n=66)。新泽西州普林斯顿和苏州 2024年9月19日 /美通社/ -- 创胜集团（06628.HK），一家具备生物药品发现、研发、工艺开发和生产全流程整合能力的临床阶段的国际生物制药公司，今日公布Osemitamab (TST001)联合纳武利尤单抗和CAPOX作为晚期胃或胃食管结合部腺癌(TranStar102)一线治疗的G队列更新研究数据。该队列的数据自ASCO 2024年会公布以来，持续显示出令人鼓舞的疗效。研究结果显示，在已知CLDN18.2和PD-L1表达水平的患者中， CLDN18.2高/中表达患者的中位无进展生存期(mPFS)为14.2个月，确认客观缓解率为68%。其中绝大部分患者是PD-L1 CPS<5。以CLDN18.2极低/无表达的患者群体作为替代对照组，三联疗法在CLDN18.2高/中表达（无论CPS表达水平如何）的患者群体中，降低了50%的疾病进展或死亡的风险(HR为0.505， 95%CI, 0.244-1.045)。该数据进一步证实了本公司在ESMO 2023年会上报告的CLDN18.2靶向药物与检查点抑制剂之间存在协同作用机制，即CLDN18.2靶向抗体甚至能够在PD-L1低或无表达的胃癌肿瘤细胞中诱导PD-L1表达和T细胞浸润。截至数据统计日期，由于事件数量有限，中位总生存期尚未达到，该队列中总体人群（82名患者）的12个月生存率为73.8%（95% CI：62.0-82.4%）。先前研究发现，无论PD-L1表达水平如何， Zolbetuximab和CAPOX的联用可以将CLDN18.2阳性患者的无进展生存期从6.80个月提高至8.21个月（ HR=0.687（95% CI， 0.544-0.866）（来源：Shah, Manish A et al. Nature Medicine 2023 Aug 29 (8): 2133-2141）。更新的Cohort-G研究数据显示， Osemitamab (TST001)联合Nivolumab和CAPOX，在疗效上显著优于Nivolumab联合CAPOX或Zolbetuximab联合CAPOX的治疗方案。更新数据以墙报形式（摘要#1419p）已于2024年9月16日在西班牙巴塞罗那举办的ESMO 2024年会公布。 "Cohort-G试验的更新数据表明，Osemitamab (TST001)联合Nivolumab和CAPOX作为晚期胃或胃食管结合部腺癌一线治疗的疗效令人鼓舞。与CLDN18.2不表达的患者相比，CLDN18.2高/中表达且已知PD-L1表达水平患者的确认客观缓解率和中位无进展生存期证实了Osemitamab (TST001)与检查点抑制剂之间的协同作用，展示了三联疗法的潜力，并且有可能惠及PD-L1低表达患者，"创胜集团全球药物开发执行副总裁，首席医学官Caroline Germa博士表示，"这些临床结果突显了Osemitamab (TST001)在改善晚期胃或胃食管结合部腺癌患者预后方面的前景。" "在2024年欧洲肿瘤医学学会(ESMO)年会上公布的Cohort-G队列研究数据，为三联疗法的临床获益提供了令人信服的证据。无进展生存期和客观缓解率显著提高，这在CLDN18.2表达水平高/中且PD-L1表达水平低的患者群体中尤其突出，这充分展示了该治疗方案的潜力。"北京大学肿瘤医院消化肿瘤内科及I期临床试验病区主任，本次研究的主要研究者沈琳教授表示，"我们对这种疗法可能为患者带来的积极影响感到高兴。" 研究概要如下：试验设计 TranStar102研究G队列(NCT04495296)包含安全导入阶段和剂量扩展阶段，旨在探索Osemitamab (TST001) 联合纳武利尤单抗和CAPOX作为晚期胃或胃食管结合部腺癌一线治疗的安全性和有效性。在剂量扩展期交替给药3或6mg/kg。符合入组条件的对象为HER2阴性或未知，不可切除的局部晚期或转移性胃或胃食管结合部腺癌患者，无论其CLDN18.2或PD-L1的表达水平如何。在中心实验室，我们采用IHC 14G11 LDT方法和PD-L1 IHC 28-8 pharmDx回顾性分析患者的CLDN18.2和PD-L1表达水平。根据按Claudin18.2 IHC 14G11 LDT方法得出的CLDN18.2蛋白在肿瘤细胞膜染色， CLDN18.2表达水平分为三个亚组：H/M（高/中）， L（低）和R（其余：更低或阴性）。令人鼓舞的客观缓解率与中位无进展生存期截至统计日期， 82名患者已接受治疗，随访中位时间为15.2个月。对总体患者、总体具有/已知CLDN18.2/PD-L1表达水平患者以及具有PD-L1 CPS<5亚组患者的亚组疗效的探索性分析结果如下：总体患者组： CLDN18.2高/中等表达(H/M)患者的中位无进展生存期为12.6个月，低表达(L)患者为7.1个月，其余患者(R)为8.5个月。确认客观缓解率分别为58.1%、 52.4%和55.6%。总体人群（n=82）的12个月生存率为73.8%。总体具有/已知CLDN18.2/PD-L1表达水平患者组(n=66)： CLDN18.2高/中等表达(H/M)患者的中位无进展生存期为14.2个月，低表达(L)患者为8.5个月，其余患者(R)为6.7个月。确认客观缓解率分别为68.0%、 61.1%和50.0%。 PD-L1 CPS<5亚组患者(n=56)： CLDN18.2高/中等表达(H/M)患者的中位无进展生存期为16.6个月，低表达(L)患者为7.1个月，其余患者(R)为5.7个月。确认客观缓解率分别为71.4%、 60.0%和47.1%。可控的安全性所有患者均经历了与治疗相关的不良事件(TRAE)。最常见的TRAE是低白蛋白血症、恶心和呕吐，其中大多数为可控的CTC AE1级或2级。其安全性特征与此前展示的TST001联合CAPOX大体一致（《临床肿瘤学杂志》第41卷，第16期， 2023年，摘要#4046）。关于Osemitamab (TST001) Osemitamab (TST001) 是一种高亲和力的靶向CLDN18.2的人源化单克隆抗体，具有增强的抗体依赖性细胞毒性（ADCC），在异种移植试验中显示出强大的抗肿瘤活性。Osemitamab (TST001) 是全球范围内开发的第二个最先进的CLDN18.2靶向抗体药物，由本公司通过其免疫耐受突破(IMTB)技术平台开发。Osemitamab (TST001) 通过ADCC机制杀死表达CLDN 18.2的肿瘤细胞。利用先进的生物加工技术，Osemitamab (TST001) 的岩藻糖含量在生产过程中大大降低，进一步增强了Osemitamab (TST001) 的NK细胞介导的ADCC活性。中国和美国均一直在进行Osemitamab (TST001) 的临床试验(TranStar101/NCT04396821, TranStar102/NCT04495296)。美国食品和药品监督管理局(FDA)已授予Osemitamab (TST001) 用于治疗胃癌或胃食管结合部腺癌和胰腺癌患者的孤儿药资格认定。关于创胜集团创胜集团是一家临床阶段的在生物药发现、研发、工艺开发和生产方面具有全面综合能力的生物制药公司。创胜集团总部位于苏州，已成功搭建了全球的业务布局：在苏州设有药物发现、临床和转化研究中心，在杭州拥有工艺与产品开发中心以及药物生产基地，在美国普林斯顿、北京、上海、广州分别设有临床开发中心，并在美国波士顿、洛杉矶设立了业务拓展中心。创胜集团的开发管线已有十四个治疗用抗体新药分子，涵盖肿瘤、骨科和肾病等领域。如需了解关于创胜集团的更多信息，请访问公司网站： www.transcenta.com 或领英账号：Transcenta。媒体联系： Bryan Cheng , bryan.cheng@transcenta.com , 15067129733

临床结果ASCO会议申请上市

100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的药物交易

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