A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Symptomatic Polycystic Liver Disease

The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD).
In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 120-week open-label extension part of the trial and then only receive the same CAM2029 treatment.
The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.

开始日期2022-06-28

申办/合作机构

Camurus AB

NCT05050942

/ Active, not recruiting临床3期

A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients with GEP-NET

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

开始日期2021-10-22

申办/合作机构

Camurus AB

EUCTR2021-000598-95-ES

/ Not yet recruiting临床2期

A Phase 2, randomized, double-blind, placebo-controlled, multi-center trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders

开始日期2021-07-30

申办/合作机构

Camurus AB

100 项与奥曲肽相关的临床结果

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100 项与奥曲肽相关的转化医学

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100 项与奥曲肽相关的专利（医药）

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4,364

项与奥曲肽相关的文献（医药）

2025-01-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Utilizing erythrosine B absorption spectrum shifts for quantitative determination of octreotide and bromocriptine in their pure forms and pharmaceutical formulations. Evaluation of the method greenness

Article

作者: Attia, Tamer Z ; Attia, Tamer Z. ; Abdulrazik, Shrouk G. ; Abdulrazik, Shrouk G ; Derayea, Sayed M ; Derayea, Sayed M.

In the present study, two drugs for treating acromegaly are investigated which are either synthetic growth hormone inhibiting hormone (GHIH) or dopamine receptor agonist. Octreotide (OCT) and bromocriptine (BCT) were quantified with a quick, simple, and sensitive spectrophotometric approach in their authentic forms and commercial dosage forms. This approach was based upon formation of ion pair complex between erythrosine B and investigated drugs in an aqueous buffered solution. For OCT determination the higher sensitivity was obtained using ΔA at 525 nm. On the other hand, BCT was estimated using the absorbance at 556 nm. Under optimal conditions for the reaction, construction of calibration curves were performed within concentration range of 0.4-4 µg ml^-1 for OCT and 1-9 µg ml^-1 for BCT with with low detection limits (0.094 and 0.235 µg ml^-1) and low quantitation limits (0.29 and 0.71 µg ml^-1) for OCT and BCT respectively. The developed approach was assessed for linearity, accuracy, precision, limits of detection, and limits of quantitation in compliance with ICH validation recommendations. The suggested approaches demonstrated good linearity, as evidenced by determination coefficients (r²) of 0.999 with a slope 0.14 for OCT and 0.9989 with a slope 0.06 for BCT. Additionally, the environmental friendliness of the investigated method was assessed with some of the recent green analytical chemistry metrics.

2025-01-01·AMERICAN JOURNAL OF THE MEDICAL SCIENCES

Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial

Article

作者: Lara, Luis F ; De Melo, Silvio ; Agrawal, Deepak ; Feagins, Linda A ; Malespin, Miguel ; Rockey, Don C. ; Shuja, Asim ; Allam, Jad ; Rockey, Don C ; Lara, Luis F.

BACKGROUND:

Current guidelines lack clarity about the optimal duration of octreotide therapy for patients with esophageal variceal hemorrhage (EVH). To address this lack of evidence, we conducted a randomized clinical trial (RCT) of 24-hr versus 72-hr continuous infusion of octreotide for patients with EVH.

METHODS:

This multi-center, prospective RCT (NCT03624517), randomized patients with EVH to 24-hr versus 72-hr infusion of octreotide. Patients were required to undergo esophageal variceal band ligation prior to enrollment. The primary endpoint was rebleeding rate at 72 hr. The study was terminated early due to an inability to recruit during and after the COVID-19 epidemic.

RESULTS:

For patients randomized to 72-hr (n = 19) of octreotide vs 24-hr (n = 15), there were no differences in the need for transfusion, average pRBC units transfused per patient (3 units vs 2 units), infection (5% vs 0%), mechanical ventilation (11% vs 7%), or the need for vasopressors (5% vs 3%), respectively (none of these differences were statistically significantly different). There were 2 re-bleeding events in the 72-hr group (11%), and no re-bleeding events in the 24-hr group (p = 0.49). 8/15 of patients receiving 24 hr of octreotide were discharged at or before hospital day 3 while none in the 72-hr group was discharged before day 3 (p < 0.001). There was one death (in the 72-hr group) within 30 days.

CONCLUSIONS:

A 24-hr infusion is non-inferior to a 72-hr infusion of octreotide for prevention of re-bleeding in patients with EVH. We propose that shortened octreotide duration may help reduce hospital stay and related costs in these patients.

2024-12-18·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine

Article

作者: Bidlingmaier, Martin ; Gadelha, Mônica R ; Fan, Xiaolin ; Krasner, Alan ; Strasburger, Christian J ; Trainer, Peter J ; Struthers, R Scott ; Raverot, Gerald ; Boguszewski, Cesar L ; Buchfelder, Michael ; Guitelman, Mirtha A ; Clemmons, David ; Mezősi, Emese ; Doknic, Mirjana ; Shimon, Ilan ; Biller, Beverly M K ; Casagrande, Alessandra ; Snyder, Peter J ; Tóth, Miklós

Abstract:

Context:

Paltusotine is a nonpeptide selective somatostatin receptor 2 agonist in development as once-daily oral treatment for acromegaly.

Objective:

To evaluate the efficacy and safety of paltusotine in the treatment of patients with acromegaly previously controlled with injected somatostatin receptor ligands (SRLs).

Methods:

This phase 3, randomized, double-blind, placebo-controlled trial enrolled adults with acromegaly who had IGF-I ≤1.0 times the upper limit of normal (×ULN) while receiving a stable dose of depot octreotide or lanreotide. Patients were switched from injected SRLs and randomized to receive paltusotine or placebo orally for 36 weeks. The primary endpoint was proportion of patients maintaining IGF-I ≤1.0× ULN. Secondary endpoints were change in IGF-I level, change in Acromegaly Symptom Diary score, and maintenance of mean 5-sample GH <1.0 ng/mL.

Results:

The primary endpoint was met: 83.3% (25/30) of patients receiving paltusotine and 3.6% (1/28) receiving placebo maintained IGF-I ≤1.0× ULN (odds ratio, 126.53; 95% CI, 13.73->999.99; P < .0001). Paltusotine was also superior to placebo for all secondary endpoints: mean (± SE) change in IGF-I of 0.04 ± 0.09× ULN vs 0.83 ± 0.1× ULN (P < .0001); mean (± SE) change in Acromegaly Symptom Diary score of −0.6 ± 1.5 vs 4.6 ± 1.6 (P = .02); mean GH maintained at <1.0 ng/mL in 20/23 (87.0%) vs 5/18 (27.8%) patients (odds ratio, 16.61; 95% CI, 2.86-181.36; P = .0003). The most common adverse events were acromegaly symptoms and gastrointestinal effects characteristic of SRLs.

Conclusion:

Replacement of injected SRLs by once-daily oral paltusotine was effective in maintaining both biochemical and symptom control in patients with acromegaly and was well tolerated.

项与奥曲肽相关的新闻（医药）

2024-11-09

·ioncology

例例在望丨首例DLL3阳性肺类癌患者对Tarlatamab有治疗反应的报告

点击蓝字关注我们例例在望微专辑扫描二维码可查看更多内容 Tarlatamab是一种靶向DLL3的双特异性T细胞接合剂，已迅速成为晚期广泛期小细胞肺癌（SCLC）的后线治疗的新标准。本文介绍一名转移性非典型类癌患者的病例，该患者在既往接受多种治疗后疾病进展，DLL3蛋白高表达，并对Tarlatamab治疗有临床应答。该病例表明，Tarlatamab可能是其他肺神经内分泌癌的有效选择。肺类癌是肺神经内分泌肿瘤的一种罕见亚型，约占成人肺恶性肿瘤的1-2%。根据有丝分裂计数和有无坏死，肿瘤被分为“典型类癌”（低级别）或“非典型类癌”（中级别）。典型类癌通常惰性生长，转移发生率不高，而非典型类癌可能更具侵袭性，肿瘤生长和播散更快。对于被诊断为转移性肺类癌的患者，指南推荐的治疗方案很少，而且通常治疗缓解率较低[1,2,3]。DLL3表达通常见于高级别神经内分泌癌，例如小细胞肺癌（SCLC），但DLL3表达也发生于30%-40%的肺类癌[4]。因此，新型DLL3靶向药为SCLC以外的肺神经内分泌癌患者的有效治疗带来了新希望。例如，研究显示obrixtamig（DLL3靶向T细胞接合剂）治疗10名大细胞神经内分泌癌患者，其中7名产生客观缓解[5]。本文报告一例对多种疗法均耐药的转移性非典型类癌病例，其肿瘤强烈表达DLL3，并对Tarlatamab治疗产生强烈的临床反应。病例介绍一名61岁的女性，无吸烟史，既往有甲状腺功能减退症病史，在过去十个月内出现咳嗽和呼吸困难加重。胸部CT扫描发现一个5 cm肿块侵入纵隔，累及支气管，隆突下淋巴结肿大。利用超声支气管镜（EBUS）对右主支气管内肿块和隆突下淋巴结进行活检，发现肿瘤，最初诊断为小细胞肺癌。随后，患者来到弗吉尼亚大学癌症中心就诊。脑部MRI发现一个2 mm病变，性质不确定。FDG-PET/CT显示已知胸部肿块为高代谢，左肾上腺小结节存在不确定的摄取。多学科胸部肿瘤委员会一致认为可能是IV期（广泛期）疾病，因此给予患者卡铂、依托泊苷和阿替利珠单抗治疗。鉴于患者从不吸烟，在开始全身治疗前一天，介入肺病学部门开展进一步检查，并进行了更多活检和右主支气管清创。病理学结果更符合非典型类癌（中等Ki-67增殖指数[30%]，RB基因保留，p53表达野生型）。血清嗜铬粒蛋白A升高至158。PET/dotatate显示原发病变和右锁骨上淋巴结的摄取增加，而没有其他部位摄取的确凿证据。值得注意的是，左肾上腺没有异常摄取。患者被诊断为IIIC期非典型类癌，需要局部疾病控制，没有肿瘤转移的确凿证据。患者从第2周期开始同步放疗，并停用阿替利珠单抗。化疗和放疗完成后，CT显示肿瘤大小无变化，但有右主支气管的软组织增厚，并伴有咳嗽加剧。患者再次接受了支气管镜检查，包括肿瘤清创和氩气刀。右主支气管组织显示非典型类癌残留，EBUS活检显示转移性类癌，Ki-67为16.4%。鉴于存在残留病灶，患者开始每月注射长效释放奥曲肽（LAR）。不幸的是，在开始使用奥曲肽四个月后，PET/Dotatate显示发生多处新的骨转移和新的左腋窝淋巴结增大。对左腋窝淋巴结进行活检并证实为非典型类癌转移。脑部MRI发现10个新的转移瘤，均≤1cm。在患者初次确诊后11个月（图1），基于其癌症具有侵袭性临床特征和先前文献记录的肺类癌中DLL3表达，患者开始接受Tarlatamab治疗。治疗开始后进行了DLL3免疫组化检查，结果显示100%的细胞均强烈表达（图2）。图1 图2 在Tarlatamab治疗第1周期第3天，针对脑转移瘤接受了立体定向放射外科（SRS）治疗。Tarlatamab治疗6周后CT显示产生治疗反应，左腋窝淋巴结从1.5 cm缩小到0.9 cm，左肾上腺结节从1.3 cm缩小到0.5 cm（图3，A-D）。先前放疗的右侧气管旁肿块从2.4 cm缩小到1.9 cm，隆突下淋巴结从1.6 cm缩小到1.1 cm。第12周的PET/Dotatate成像（图3E-F）显示右肺门肿块、左肾上腺结节和左腋窝淋巴结进一步减小。右侧气管旁的标准摄取值（SUV）从基线6.4降至4.7，左腋窝从2.2降至1.3，左额颅骨病变从2.4降至1.2。不幸的是，脑部MRI发现了两个非常小的新病变，采用SRS治疗第二疗程，并继续使用Tarlatamab。在前四个疗程的Tarlatamab治疗中，没有发生细胞因子释放综合征（CRS）或免疫效应细胞相关神经毒性综合征（ICANS）。第1疗程期间出现了1级疲劳，现已缓解，1级味觉障碍一直持续存在。图3 讨论今年5月，FDA加速批准Tarlatamab用于治疗在铂类化疗期间或之后疾病进展的广泛期小细胞肺癌，为SCLC患者的治疗带来了革命性的变化。鉴于除SCLC外的其他临床侵袭性神经内分泌肿瘤的有效疗法有限，有必要将这种新研发的疗法应用于可能受益的患者。虽然DLL3表达高可能在本病例中对Tarlatamab的治疗活性产生了影响，但尚不清楚产生临床获益需要什么水平的DLL3。一些病例报告（包括本病例）显示这类新疗法治疗非典型类癌的临床活性有前景（尽管随访时间有限），为开展进一步研究提供了依据，进而扩大这些新疗法的适应症。结论本病例证明，Tarlatamab在表达DLL3的非典型类癌患者中具有临床活性。该病例凸显了需要进一步研究Tarlatamab在治疗方案有限的罕见肺神经内分泌癌中的应用。参考文献（上下滑动可查看） 1. Yao JC, Fazio N, Singh S, et al. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract （RADIANT-4）: a randomised, placebo-controlled, phase 3 study. Lancet. 2016 Mar 5;387（10022）:968-977. doi: 10.1016/S0140-6736（15）00817-X. 2. Chong CR, Wirth LJ, Nishino M, et al. Chemotherapy for locally advanced and metastatic pulmonary carcinoid tumors. Lung Cancer. 2014;86（2）:241-6. doi: 10.1016/j.lungcan.2014.08.012. 3. Crona J, Fanola I, Lindholm DP, et al. Effect of temozolomide in patients with metastatic bronchial carcinoids. Neuroendocrinology. 2013;98（2）:151-5. doi: 10.1159/000354760. Journal Pre-proof 4. Xie H, Boland JM, Maleszewski JJ, et al. Expression of delta-like protein 3 is reproducibly present in a subset of small cell lung carcinomas and pulmonary carcinoid tumors. Lung Cancer. 2019 Sep:135:73-79. doi: 10.1016/j.lungcan.2019.07.016. 5. Wermke M, Gambardella V, Koboki Y, et al. Phase I Trial of DLL3/CD3 IgG-Like T-Cell Engager BI 764532 in Patients with DLL3-Positive Tumors: Patients with LCNEC. IASLS 2024 World Conference on Lung Cancer. San Diego, CA. September 7-10, 2024. Abstract: OA10.05. （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

免疫疗法

2024-11-07

·camurus.com

Camurus’ Interim Report Third Quarter 2024

“Solid third quarter and raised full-year outlook” Summary third quarter 2024 July - September January - September Significant events after the period Financial summary third quarter 2024 Excluding one-time milestones related to the Brixadi approval by the FDA in the US in 2023 At constant exchange rate Fredrik Tiberg, President and CEO: “Camurus has had another good quarter with positive financial development and excellent performance across our businesses. Sales of Buvidal and Brixadi continued to grow, resulting in our best result to date, excluding one-time revenues. Our pipeline progressed well with positive Phase 3 results from the ACROINNOVA 2 study, confirming the long-term safety profile and efficacy of CAM2029 in patients with acromegaly. In parallel, our clinical studies of CAM2029 for the treatment of neuroendocrine tumors and polycystic liver disease advanced. In the US, the FDA continued its review of our new drug application for CAM2029 in acromegaly. After the quarter, a Complete Response Letter was received from the Agency, solely relating to a cGMP-inspection at a third-party manufacturing site and pending issuance of an inspection classification.” Audiocast Financial analysts and media are invited to attend a telephone conference and presentation of the results today at 2.00 pm (CET). The conference call can also be followed by a link on www.camurus.com or via external link: https://financialhearings.com/event/48851 For more information: Fredrik Tiberg, President and CEO Tel. +46 (0)46 286 46 92 fredrik.tiberg@camurus.com Fredrik Joabsson, Chief Business Development Officer Tel. +46 (0)70 776 17 37 ir@camurus.com About Camurus Camurus is a Swedish science-led biopharmaceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus’ clinical pipeline includes products for the treatment of dependence, pain, cancer, and endocrine disease, developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com. This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and to the Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, at 07.00 am CET on 7 November, 2024.

财报临床结果上市批准临床3期

2024-10-22

·EndPoints

FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues

The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at a third-party manufacturer. The therapy, dubbed CAM2029, had a PDUFA date of Oct. 21 for acromegaly, but production issues were found at a third-party factory in September. There were no issues with the candidate’s efficacy or safety, Camurus said in a Tuesday release. CAM2029 does not have a new decision date, but Camurus said “timely resolution of the CRL” will depend on the unnamed third-party manufacturer’s responses. Labeling discussions for the asset were already in the final stages when the CRL was given, the company said. Acromegaly occurs when the body makes too much growth hormone, which leads to abnormally large hands and feet. Subcutaneously administered CAM2029 features a peptide inhibitor of growth hormones called octreotide. Camurus announced data from a pair of Phase 3 trials investigating CAM2029 in June and July 2023, showing acromegaly symptoms improved in patients. In May, Camurus said the EMA had received its regulatory application. Jefferies analysts said the delay could lead to Camurus launching its drug later than expected. Crinetics Pharmaceuticals has its own acromegaly candidate and announced the submission of its FDA application last month. CAM2029 is also being investigated for gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.

临床3期申请上市

100 项与奥曲肽相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肢端肥大症	申请上市	美国	Camurus AB	2024-03-05
常染色体显性多囊肾病	临床3期	美国	Camurus AB	2022-06-28
常染色体显性多囊肾病	临床3期	比利时	Camurus AB	2022-06-28
常染色体显性多囊肾病	临床3期	德国	Camurus AB	2022-06-28
常染色体显性多囊肾病	临床3期	荷兰	Camurus AB	2022-06-28
多囊肝病	临床3期	美国	Camurus AB	2022-06-28
多囊肝病	临床3期	比利时	Camurus AB	2022-06-28
多囊肝病	临床3期	德国	Camurus AB	2022-06-28
多囊肝病	临床3期	荷兰	Camurus AB	2022-06-28
胃肠胰神经内分泌肿瘤	临床3期	美国	Camurus AB	2021-10-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04125836 (ACROINNOVA 2, PRNewswire) 人工标引	临床3期	肢端肥大症	135	Octreotide SC depot (CAM2029)	鹽壓艱製築獵簾網獵憲(窪顧壓鹽襯鏇齋淵窪襯) = The most common adverse events (AEs) were mild to moderate injection site reactions and gastrointestinal events. 遞鏇襯構獵憲獵繭醖鏇 (餘淵膚築醖糧夢觸範醖 ) 更多	积极	2024-07-15
NCT04125836 (ACROINNOVA 2, ENDO2024)	临床3期	肢端肥大症 IGF-1	81	CAM2029 20 mg	膚鑰廠壓淵蓋範構壓築(衊製膚積膚夢築淵鏇製) = n=12 遞鏇齋鹽餘構鏇齋艱繭 (鏇鏇願襯襯蓋襯齋鑰齋 ) 更多	积极	2024-06-01
ESMO2018	N/A	复发性间变性（恶性）脑膜瘤	31	Octeotride/Everolimus	糧獵憲顧構遞蓋膚艱壓(範鏇糧鏇製遞憲願襯夢) = 憲簾夢築築憲鬱獵夢憲廠鏇構願壓願醖憲積廠 (蓋醖願壓觸積願觸鹽醖, 9.2 ~ 21.1) 更多	积极	2018-10-22
ESMO2018	N/A	复发性间变性（恶性）脑膜瘤	31	Sunitinib	糧獵憲顧構遞蓋膚艱壓(範鏇糧鏇製遞憲願襯夢) = 鏇築遞蓋築鹽衊築鹹夢廠鏇構願壓願醖憲積廠 (蓋醖願壓觸積願觸鹽醖, 6.8 ~ 16.8)	积极	2018-10-22
ESPE2018	N/A	生长激素过多 \| 神经纤维瘤病1型	7	Long-acting octreotide	餘願積糧衊襯構艱鹹觸(鹹鑰鑰願繭鹹憲顧選衊) = Except for mild diarrhea, no other adverse events were observed 繭廠鏇網獵廠顧範顧鹹 (醖鹹顧膚廠獵範齋簾構 )	积极	2018-09-27
WCLC2017	N/A	胸腺上皮肿瘤	26	LAR octreotide and prednisone	憲簾鹹艱夢蓋蓋範繭醖(遞願願築獵鹹製遞膚範) = 窪淵範壓獵簾範餘製鏇衊廠選餘築獵構鏇範觸 (廠廠襯窪淵觸築衊窪襯 ) 更多	积极	2017-10-16