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非在研适应症- |
最高研发阶段批准上市 |
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首次获批日期2019-04-25 |
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最高研发阶段批准上市 |
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首次获批日期1991-08-23 |
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最高研发阶段批准上市 |
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首次获批日期1985-12-26 |
24 Week Open Label, Single Arm Study of Colesevelam in High Risk South Asians With Suboptimal LDL-c Levels Despite Maximally Tolerated Statin Therapy
To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains above target despite optimal statin use.
Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients. The goal of this initiative is to create a registry of subjects with FH across Canada. Rare diseases of lipoprotein metabolism are also included. Using a "hub and spoke" model, the registry extends in various communities to link primary care physicians with provincial academic centers. The registry includes clinical, biochemical and demographic information. Specimens (plasma/serum and DNA) are collected for biobanking. The "local" portion of the registry is available for clinicians to manage patient care, and identify relatives for screening and treatment (cascade screening). The Canada-wide registry, which is completely anonymized, will be made available to provide advice to general practitioners and to support collaborative studies in biomedical, clinical, health outcomes and health economics research. The data extracted for the provincial portion of the database will allow administrative database research that will provide important information to key stakeholders and permit allocation of resources. It will also allow a sound and uniform rationale for the use of novel therapeutic agents and provide expert advice to regulatory agencies. At the Canadian level, the database will allow clinicians and researchers to determine the burden of disease and the long-term effects of treatment. Through the creation of a Canada-wide network of academic clinics, integrating lipid specialists, endocrinologists and cardiologists, the Canadian FH registry will lead to significant benefits for FH patients, clinicians and researchers, biopharmaceutical industry and government.
A Randomized Double-blind Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Phantom Limb Pain
The purpose of this proposed study is to conduct a randomized double-blind placebo controlled trial assessing the benefit of nabilone in pain management and improvement of quality of life in patients with phantom limb pain.
Our Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the phantom limb pain and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the Groningen Sleep Quality Scale and daily prosthetic wearing time.
100 项与 Valeant Canada Ltd. 相关的临床结果
0 项与 Valeant Canada Ltd. 相关的专利(医药)
昨日(2022年8月10日),根据国家药监局药品审评中心(CDE)官网,四川康德赛医疗科技有限公司(以下简称康德赛)申报的“CUD002注射液”临床试验申请,已经获得受理。CUD002是一款个体化的肿瘤疫苗,是基于患者肿瘤新生抗原的mRNA编辑DC肿瘤疫苗,主要被开发用于卵巢癌,可作为肿瘤切除后的辅助治疗。CUD002能激发患者自身免疫系统对卵巢癌相关抗原和新生抗原产生免疫反应并杀伤肿瘤细胞,从而减少复发,以期根除肿瘤。根据康德赛的官网信息,康德赛拥有mRNA技术平台和Cunde®细胞平台,并基于这两个平台开发了多款候选产品,其中包括CUD002。康德赛首先利用Cunde®细胞平台,将患者的单核细胞体外诱导为树突状细胞(DC),然后组合生物信息平台和RNA技术平台,将构建的肿瘤新生抗原mRNA导入DC内,进行mRNA编辑DC疫苗的制备。值得一提的是,这是国内首款利用mRNA技术编辑的DC疫苗产品。树突状细胞(DC)疫苗树突状细胞(DC)作为强大的抗原提呈细胞(APC),在增强免疫反应方面非常有效。DC被认为是免疫系统的中心,因为它在先天免疫反应和获得性免疫反应之间提供了纽带桥梁作用。因此,DC疫苗也被认为是抗肿瘤的一种潜力治疗方式。一般对肿瘤切除/消退后,接种DC疫苗以消除残留肿瘤灶,防止复发。另外可以反复接种,以获得尽可能长的保护效果,是期望达到的效果。目前,DC可以通过三种途径获得:(1)单核细胞来源;(2)CD34+造血前体来源;(3)体内循环DC的扩增。获得DC之后,我们第一步需要对其进行肿瘤抗原荷载,目前研究中大多用合成抗原肽、自体癌细胞裂解物、或mRNA等进行抗原荷载,肿瘤抗原大致分为肿瘤特异性抗原(TSA)和肿瘤相关抗原(TAAs)。随后要进行DC成熟,DC成熟一般需要在接种疫苗之前完成。目前还没有达成共识的合适的成熟刺激方法,多种刺激成熟的组合已经在实验中被测试,例如促炎症因子(TNF,IL-1β,IL-6,PEG2等)+TLRs激动剂,TNF+ IL1b + IFNg + IFNa + poly(I:C),电转染活化TLR4,CD40L,CD70。DC疫苗的发展2010年,美国FDA批准的人类历史上第一个用于前列腺癌的治疗性肿瘤自体DC疫苗PROVENGE(sipuleucel-T)(2017年原研厂家Valeant将其卖给了中国三胞集团),开创了癌症免疫治疗的新时代。2011年诺贝尔医学奖授予拉尔夫·斯坦曼(Ralph Steinman),表彰他发现了DC及其在适应性中的作用,从而极大地承认了DC在免疫调节方面的重要性。因此基于DC的免疫治疗在抗癌免疫治疗中,被认为是一种非常有前途的策略。但是,在真实世界中,DC疫苗的发展并不顺利。除了PROVENGE曾获得FDA批准之外,韩国和印度都曾在本国批准DC疫苗,但对肿瘤免疫治疗影响甚微。不过近年来,DC肿瘤疫苗领域也有不少进展。包括前些日子,荷兰的Amphera B.V,宣布其DC疫苗MesoPher 2/3期临床最后一例给药患者完成12个月随访。预计在2022年第四季度报告相关数据,并基于此在2023年上半年申请欧洲上市。延伸阅读:艰难的DC疫苗,喜迎突破...肿瘤免疫知多少:DC疫苗免疫疗法参考资料:1.https://cunde.com/article/toPlatformInfo2.https://cunde.com/article/toProductInfo?articleId=6a9edbfaecbee1488b5011122b2844ab点亮在看,传递信息♥
100 项与 Valeant Canada Ltd. 相关的药物交易
100 项与 Valeant Canada Ltd. 相关的转化医学