This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.

开始日期2011-11-01

申办/合作机构

BioInvent International AB

[+1]

NCT01258907 / Completed临床2期

A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER - Goal of Oxidized Ldl and Activated Macrophage Inhibition by Exposure to a Recombinant Antibody)

This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.

开始日期2010-03-01

申办/合作机构

Genentech, Inc.

[+1]

100 项与 Orticumab 相关的临床结果

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100 项与 Orticumab 相关的转化医学

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100 项与 Orticumab 相关的专利（医药）

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434

项与 Orticumab 相关的文献（医药）

2024-10-17·Reviews on Recent Clinical Trials

Ongoing Clinical Trials for Polycystic Ovarian Syndrome (PCOS) Afflicted Infertility in Women: A Narrative Review.

Article

作者: Yadav, Aastha ; Adya, Anisha ; Ahmad, Afza ; Chadha, Muskan ; Chauhan, Ranjeet Singh ; Shukla, Ratnakar ; Singh, Nidhi ; Tiwari, Rohit Kumar

Polycystic Ovary Syndrome (PCOS) is a highly prevalent endocrine disorder that affects women of reproductive age. PCOS is further correlated with infertility, menstrual dysfunction, and hyperandrogenism. Despite the advanced understanding of reproductive biology, the exact causes of PCOS remain ambiguous. Nevertheless, several factors are believed to contribute to the development of PCOS, including insulin resistance, hyperinsulinemia, obesity, and genetic predispositions. The diagnosis of PCOS is complicated by its phenotypic heterogeneity, which manifests differently in different individuals. Presently, the therapeutic management of PCOS-afflicted infertility depends upon proper pharmaceutical-based therapies aimed at treating underlying symptoms, such as the use of clomiphene citrate, metformin, ovulation-inducing agents, anti-androgens, exogenous gonadotropin administration, laparoscopic ovarian drilling, and in vitro fertilization. The present review focuses on narrating present therapeutic interventions along with lifestyle modifications in PCOS. Furthermore, it focuses on the ongoing clinical trials of various chemotherapeutics to counter PCOS-induced infertility among women.

2024-10-15·The Journal of clinical endocrinology and metabolism

Impact of Distinct Antiandrogen Exposures on the Plasma Metabolome in Feminizing Gender-affirming Hormone Therapy

Article

作者: Burgner, David ; Pang, Ken ; Lange, Katherine ; Mansell, Toby ; Novakovic, Boris ; Angus, Lachlan M ; Cheung, Ada ; Zajac, Jeffrey D ; Saffery, Richard ; Arman, Bridget ; Kim, Bo Won ; Kerr, Jessica A ; Shepherd, Rebecca

Abstract:

Context:

The plasma metabolome is a functional readout of metabolic activity and is associated with phenotypes exhibiting sexual dimorphism, such as cardiovascular disease. Sex hormones are thought to play a key role in driving sexual dimorphism.

Objective:

Gender-affirming hormone therapy (GAHT) is a cornerstone of transgender care, but longitudinal changes in the plasma metabolome with feminizing GAHT have not been described.

Methods:

Blood samples were collected at baseline and after 3 and 6 months of GAHT from transgender women (n = 53). Participants were randomized to different anti-androgens, cyproterone acetate or spironolactone. Nuclear magnetic resonance-based metabolomics was used to measure 249 metabolic biomarkers in plasma. Additionally, we used metabolic biomarker data from an unrelated cohort of children and their parents (n = 3748) to identify sex- and age-related metabolite patterns.

Results:

We identified 43 metabolic biomarkers altered after 6 months in both anti-androgen groups, most belonging to the very low- or low-density lipoprotein subclasses, with all but 1 showing a decrease. We observed a cyproterone acetate-specific decrease in glutamine, glycine, and alanine levels. Notably, of the metabolic biomarkers exhibiting the most abundant “sex- and age-related” pattern (higher in assigned female children and lower in assigned female adults, relative to assigned males), 80% were significantly lowered after GAHT, reflecting a shift toward the adult female profile.

Conclusion:

Our results suggest an anti-atherogenic signature in the plasma metabolome after the first 6 months of feminizing GAHT, with cyproterone acetate also reducing specific plasma amino acids. This study provides novel insight into the metabolic changes occurring across feminizing GAHT.

2024-10-01·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Review of drug-drug interactions in patients with prostate cancer

Review

作者: Ruplin, Andrew ; Segal, Eve ; McFarlane, Tom

Objective:

The objective of this review is to provide an overview of common drug-drug interactions (DDIs) associated with prostate cancer treatments and outline recommendations for managing polypharmacy.

Data sources:

A literature search of PubMed, Embase, and CINAHL was carried out to identify pharmacokinetic and pharmacodynamic changes caused by DDIs that are relevant for prostate cancer patients, DDIs between prostate cancer therapies and co-administered medications (both prescription and over-the-counter), and measures to prevent DDIs. Medication package inserts were used to identify the impact of DDI on the prostate cancer therapy and suggested interventions.

Data summary:

No DDIs are expected for the LHRH agonists leuprolide acetate, histrelin, goserelin, or leuprolide mesylate. However, DDIs have been reported for GnRH antagonists, anti-androgens, PARP inhibitors, and taxanes. Although there are no confirmed DDIs for sipuleucel-T to date, it is not generally recommended to use sipuleucel-T concurrently with immunosuppressive medications. Interventions to prevent DDIs include the use of software that can detect clinically significant DDIs, up-to-date medication reconciliation, the inclusion of dedicated clinical pharmacists in cancer treatment teams, and patient/caregiver education.

Conclusions:

Prostate cancer patients have a high risk of potential DDIs due to numerous new anti-cancer therapies, the increased use of treatment combinations, and the likelihood of comorbid conditions also requiring drug therapy. Drug-drug interaction screening software, up-to-date medication reconciliation, inclusion of oncology pharmacists on healthcare teams, and patient/caregiver education will aid the development of treatment plans that focus on achieving an optimal risk-benefit profile whilst reducing the risk of DDIs.

项与 Orticumab 相关的新闻（医药）

2022-06-23

·GBIHealth

李氏大药厂ALS治疗药获批注册；美因基因登陆港交所；泰凌医药合作Abcentra

药讯精选GBI NEWS百济神州百泽安联合化疗一线治疗G/GEJ腺癌的sBLA在中国获受理百济神州宣布，百泽安（替雷利珠单抗）联合化疗用于一线治疗肿瘤表达PD-L1的晚期或转移性胃或胃食管结合部（G/GEJ）腺癌患者的新适应证上市许可申请（sBLA）已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理。此次sBLA的递交是基于RATIONALE 305研究期中分析取得的积极结果。这项随机、双盲、安慰剂对照的全球III期临床试验比较了百泽安联合铂类药物和氟尿嘧啶化疗与安慰剂联合铂类药物和氟尿嘧啶化疗，作为局部晚期不可切除的或转移性的G/GEJ腺癌一线治疗的有效性和安全性。**关注GBISOURE数据库公众号在线阅读详情李氏大药厂肌萎缩性脊髓侧索硬化症治疗药Teglutik获批注册6月22日，李氏大药厂控股有限公司发布公告称，Teglutik（利鲁唑口服混悬液）已获中国国家药品监督管理局批准注册，用于延长肌萎缩性脊髓侧索硬化症（ALS）患者的生命或延长其发展至需要机械通气支持的时间。Teglutik（利鲁唑口服混悬液）由Italfarmaco公司开发，2018年在美国获批；李氏大药厂于2019年11月与Italfarmaco公司达成合作，获得独家分销权，于中国内地、香港、澳门及台湾开发及商业化Teglutik。1996年，由赛诺菲（Sanofi）公司开发的利鲁唑片获美国FDA批准上市，是第一个获FDA批准治疗ALS的药物；2002年，赛诺菲利鲁唑片进入中国，商品名：力如太。目前，国内上市的利鲁唑产品还有贝特制药的协一力、万特制药的万全力太。**关注GBISOURE数据库公众号在线阅读详情企业动态GBI NEWS1.56亿元！运盛医疗收购格伦菲尔口腔52%股权运盛（成都）医疗科技股份有限公司发布公告称，与深圳格伦菲尔企业管理有限公司、深圳格伦菲尔口腔管理有限公司、张会图、秦友兵、彭振华及深圳格伦菲尔口腔集团有限公司（格伦菲尔口腔或“标的公司”）签署了《股权收购意向协议》，拟通过支付现金方式收购格伦菲尔口腔52%的股权。各方同意标的公司全部股权价值暂定为 3亿元人民币，对应的标的股权交易价格暂定为1.56亿元人民币。各方同意，受让方以现金方式支付本次交易的交易对价，具体支付方式在正式协议中约定。张会图、格伦菲尔企业及格伦菲尔管理对目标公司2022年至2024年的业绩承诺暂定为：目标公司2022年度净利润不低于1700万、2023年度净利润不低于2300万、2024年度净利润不低于3000万。**关注GBISOURE数据库公众号在线阅读详情美因基因登陆港交所，总募资2.15亿元美因基因有限公司在港交所上市，发行价18港元/股，共发行1196.18万股，由中信建投国际独家保荐。美因基因成立于2016年，是中国领先的基因检测平台公司，专注于消费级基因检测及癌症筛查服务，旗下业务覆盖基因检测的整个价值链。截至2021年年底，美因基因已成功自主开发及商业化80类基因检测服务，已建成全面的基因检测技术平台体系，以及广泛的销售及营销网络。按2020年收入和检测量计，美因基因是中国排名第一的消费级基因检测平台，以及规模最大的癌症筛查基因检测平台。**关注GBISOURE数据库公众号在线阅读详情泰凌医药与Abcentra就商业化Orticumab达成合作6月22日，中国泰凌医药集团发布公告称，已与美国生物技术公司Abcentra LLC（下称“许可人”）签订许可及合作协议，许可人授予泰凌医药全资附属公司Green-Life Technology（Hong Kong）Company Limited（被许可人）在中国（含中国大陆、中国香港、中国澳门、中国台湾）、新加坡、马来西亚和泰国等地区商业化Orticumab单抗的独家永久许可。该产品目前处于临床Ⅱ期，用于治疗动脉粥样硬化性心血管疾病、牛皮癣、类风湿性关节炎、系统性红斑狼疮及钙化性主动脉瓣疾病等五种疾病。根据协议，被许可人将支付200万美元首付款， 22,00万美元的里程碑付款，以及被许可方产品销售收益10%的年度特许使用权费，作为协议的先决条件，泰凌医药还将按发行价每股0.20港元向顾问配发及发行473,186,591股代价股份。**关注GBISOURE数据库公众号在线阅读详情重磅推荐*点击图片阅读详情《剑指全球！中国创新药企下一个十年》白皮书旨在探讨近几年我国本土创新药企频频寻求国际市场发展的时代背景、受阻原由和解决办法，为出海征途上（或准备出海）的本土药企们提供新思路。6-7月，GBI Webinar 线上课堂【海外寻路：解锁创新药企海外增长密码】系列重磅上线，六大板块为您深度解读药企出海白皮书！扫描右侧二维码或点击文末“阅读原文”报名近期课程。点击阅读原文立即报名本期GBI线上课堂

合作抗体

100 项与 Orticumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Orticumab	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
主动脉瓣钙化	临床2期	美国	Abcentra LLC	2022-08-12
类风湿关节炎	临床2期	美国	Abcentra LLC	2022-08-12
系统性红斑狼疮	临床2期	美国	Abcentra LLC	2022-08-12
银屑病	临床2期	美国	Abcentra LLC	2022-01-30
动脉粥样硬化	临床2期	美国	BioInvent International AB	2010-03-01
动脉粥样硬化	临床2期	美国	Genentech, Inc.	2010-03-01
动脉粥样硬化	临床2期	加拿大	Genentech, Inc.	2010-03-01
动脉粥样硬化	临床2期	加拿大	BioInvent International AB	2010-03-01
心肌梗塞	临床前	美国	Abcentra LLC	2022-01-30