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Jaguar Health即将公布用于预防接受靶向治疗的成年癌症患者腹泻的关键性3期OnTarget试验最新数据

Top Line Data for Jaguar Health’s Pivotal Phase 3 OnTarget Trial for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Therapy Forthcoming

BioSpace 等信源发布 2023-11-21 21:23

可切换为仅中文


SAN FRANCISCO, CA / ACCESSWIRE / November 21, 2023 / Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ:JAGX) family company, today announced that the company has not yet been provided with results from the company's GCP (Good Clinical Practice) vendors supporting Napo's pivotal Phase 3 OnTarget trial.

旧金山,加利福尼亚州/ACCESSWIRE/2023年11月21日/美洲豹健康有限公司(纳斯达克:JAGX)家族公司Napo Pharmaceuticals(Napo)今天宣布该公司尚未获得该公司GCP的结果良好的临床实践)供应商支持Napo关键的第3阶段目标试验。

The trial is evaluating the company's plant-based prescription drug crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy, with or without standard chemotherapy. The top line results of the study are forthcoming..

该试验正在评估该公司的基于植物的处方药crofelemer,用于预防接受靶向治疗的实体瘤成人癌症患者的腹泻,有或没有标准化疗。研究的顶行结果即将到来。。

'Napo and all key study-related personnel remain blinded to study results at this time. The OnTarget trial is our paramount near-term clinical milestone,' said Lisa Conte, Jaguar's president and CEO. 'We look forward to announcing and presenting the top line results when they are available.'

'Napo和所有关键的研究相关人员目前仍然对研究结果不知情。OnTarget试验是我们最重要的近期临床里程碑,“美洲虎总裁兼首席执行官丽莎·孔蒂说。”我们期待在可用时公布并呈现顶级成果

The company's abstract outlining the design of the OnTarget trial and the neglected medical need has been accepted by the December 2023 San Antonio Breast Cancer Symposium. Diarrhea is a common side effect of targeted therapies and new treatments are needed.

该公司的摘要概述了OnTarget试验的设计和被忽视的医疗需求已于2023年12月圣安东尼奥乳腺癌研讨会接受。腹泻是靶向治疗的常见副作用,需要新的治疗方法。

About the Phase 3 OnTarget Clinical Trial

关于目标临床试验的第三阶段

The multicenter double-blind, placebo-controlled OnTarget study is a first-of-its-kind prophylactic clinical trial with a primary endpoint based on patient-reported outcomes that address the highly neglected and unmet burden of chemotherapy-induced overactive bowel (CIOB), including specifically diarrhea/loose watery stools.

多中心双盲,安慰剂对照的OnTarget研究是首例预防性临床试验,主要终点基于患者报告的结果,解决了化疗引起的过度活动性肠(CIOB)高度忽视和未满足的负担,包括特别是腹泻/稀水样便。

The study evaluated the efficacy of crofelemer, a botanical drug that modulates intestinal chloride ion channels, for its ability to prevent or substantially reduce cancer therapy-related diarrhea and symptoms of CIOB over the 12-week treatment period, compared to placebo..

该研究评估了与安慰剂相比,调节肠道氯离子通道的植物药物crofelemer在12周治疗期间预防或显着减少癌症治疗相关腹泻和CIOB症状的能力。。

About Crofelemer

Crofelemer

Crofelemer is the only oral prescription drug approved under FDA botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest. Jaguar family company Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities..

Crofelemer是FDA植物指南批准的唯一口服处方药。它是基于植物的,从亚马逊雨林的巴豆lechleri树的红色树皮树液中提取和纯化。美洲虎家族公司Napo Pharmaceuticals已根据公平贸易惯例为克罗菲勒建立了可持续收获计划,以确保高度的质量,生态完整性和对土着社区的支持。。

About the Jaguar Health Family of Companies

关于美洲虎健康家族的公司

Jaguar Health, Inc. (Jaguar) is a commercial-stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, and bowel incontinence.

美洲虎健康公司(美洲虎)是一家商业阶段制药公司,专注于为患有胃肠道不适的人和动物开发可持续衍生自雨林地区植物的新型专有处方药,特别是与肠道过度活动有关,其中包括慢性衰弱性腹泻,紧迫性和肠失禁。

Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo Pharmaceuticals' crofelemer drug candidate is the subject of the OnTarget study, a pivotal Phase 3 clinical trial for preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer and on targeted therapy.

美洲虎家族公司Napo Pharmaceuticals专注于开发和商业化人体处方药,以便在多种复杂疾病状态下对被忽视的胃肠道症状进行必要的支持性护理和管理。Napo Pharmaceuticals的crofelemer候选药物是OnTarget研究的主题,OnTarget研究是预防性治疗成人癌症和靶向治疗化疗引起的过度活动性肠(CIOB)的关键性3期临床试验。

Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021, focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases..

美洲虎家族公司Napo Therapeutics是一家意大利公司美洲虎,于2021年在意大利米兰成立,致力于扩大欧洲尤其是孤儿和/或罕见疾病的crofelemer接入范围。。

For more information about:

有关以下方面的更多信息:

Jaguar Health, please visit https://jaguar.health

美洲虎健康,请访问https://jaguar.health

Napo Pharmaceuticals, visit napopharma.com

Napo Pharmaceuticals,访问napopharma.com

Forward-Looking Statements

前瞻性声明

Certain statements in this press release constitute 'forward-looking statements.' These include statements regarding Jaguar's expectation that the top line results of the OnTarget trial are forthcoming. In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential,' or 'continue,' or the negative of these terms or other similar expressions.

本新闻稿中的某些陈述构成“前瞻性陈述”其中包括有关美洲虎期望OnTarget试用版的顶级成果即将到来的声明。在某些情况下,您可以通过“可能”,“将会”,“应该”,“期望”,“计划”,“目标”,“预期”,“可能”,“打算”,“目标”,“项目”,“考虑”,“相信”,“估计”,“预测”,“潜力”或“继续”,或这些术语或其他类似表达式的否定。

The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified, and some of which are beyond Jaguar's control.

本版本中的前瞻性陈述仅是预测。美洲华的这些前瞻性陈述主要基于其目前对未来事件的期望和预测。这些前瞻性陈述仅在本版本发布之日起发言,并受到若干风险,不确定性和假设的影响,其中一些风险,不确定性和假设无法预测或量化,其中一些超出美洲华的控制范围。

Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise..

除适用法律要求外,无论是由于任何新信息,未来事件,更改情况或其他原因,美洲华均不计划公开更新或修改此处包含的任何前瞻性声明。。

CONTACT:

联系方式:

hello@jaguar.health

hello@jaguar.health

Jaguar-JAGX

捷豹JAGX

SOURCE: Jaguar Health, Inc.

来源:美洲虎健康有限公司。

View source version on accesswire.com:

在AccessWire.com上查看源版本:

https://www.accesswire.com/807366/top-line-data-for-jaguar-healths-pivotal-phase-3-ontarget-trial-for-prophylaxis-of-diarrhea-in-adult-cancer-patients-receiving-targeted-therapy-forthcoming

https://www.accesswire.com/807366/top-line-data-for-jaguar-healths-pivotal-phase-3-ontarget-trial-for-prophylaxis-of-diarrhea-in-adult-cancer-patients-receiving-targeted-therapy-forthcoming