This phase III trial studies how well pafolacianine works for identifying cancerous lesions in children and adolescent patients with primary solid tumors or solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Pafolacianine is a fluorescent imaging agent that targets folate receptors which are overexpressed in many cancers and is used with near infrared (NIR) imaging during surgery to identify tumor cells. NIR uses a special camera that uses wavelengths in the infrared range to visualize and locate the tumor cells that are lit up by the pafolacianine. Giving pafolacianine for NIR imaging may work better than other imaging agents in identifying cancerous lesions in pediatric patients with solid tumors.

开始日期2025-04-15

申办/合作机构

Mayo Clinic

NCT06511037

/ Recruiting早期临床1期IIT

The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - a Pilot Study

This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.

开始日期2024-11-13

申办/合作机构

University of California, Irvine

[+1]

NCT06434909

/ Recruiting临床1期IIT

An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer

This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)

开始日期2024-09-19

申办/合作机构

Indiana University

[+1]

100 项与 Pafolacianine 相关的临床结果

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100 项与 Pafolacianine 相关的转化医学

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100 项与 Pafolacianine 相关的专利（医药）

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项与 Pafolacianine 相关的文献（医药）

2025-08-01·BIOMATERIALS

Matrix-designed bright near-infrared fluorophores for precision peripheral nerve imaging

Article

作者: Hubbell, Grace E ; Wang, Lei G ; Montaño, Antonio R ; Barth, Connor W ; Szafran, Dani A ; Gibbs, Summer L ; Masillati, Anas ; Shams, Nourhan A

The FDA's recent approval of pafolacianine, the first molecular targeted contrast agent for fluorescence-guided surgery (FGS), signifies a remarkable milestone in precision medicine. This advance offers new hope for cancer patients by enabling guided removal of cancerous tissues, where completed surgical removal remains a consistent challenge without real-time intraoperative guidance. For optimal surgical outcomes, delicate nerve tissues must be preserved to maintain patient quality of life. Despite advances in the clinical translation pipeline, the development of clinically viable nerve-specific contrast agents for FGS remains a significant challenge. Herein, a medicinal chemistry-based matrix design strategy was applied to effectively generate a synthetic roadmap permitting management of nerve-specificity within the near-infrared (NIR) oxazine fluorophore family. Many of these newly developed fluorophores demonstrated robust nerve-specificity and superior safety profiles, while also offering spectral profiles that are compatible with the clinical surgical FGS infrastructure. Notably, improving observed brightness in vivo enabled exceptional visibility of buried nerve tissue, a priority during surgical procedures. Critically, the lead probe showed a large dosage safety window capable of generating substantial contrast at doses 100x lower than the maximum tolerated dose. Following clinical translation, such NIR nerve-specific fluorophores stand poised to significantly improve outcomes for surgical patients by improving identification and visualization of surface and buried nerve tissues in real time within the surgical arena.

2025-03-01·Clinical Lung Cancer

Intraoperative Molecular Imaging With Pafolacianine: Histologic Characteristics of Identified Nodules

Article

作者: Sarkaria, Inderpal S ; Martin, Linda W ; Singhal, Sunil ; Reddy, Rishindra M ; Murthy, Sudish C ; Barret, Tina ; Biro, Timothy G ; Lopez, Alex S ; Rice, David C ; Stevens, Gary

BACKGROUND:

With increased early detection efforts, surgery for early-stage lung cancer is expected to rise. Pafolacianine is the first FDA approved targeted optical imaging agent indicated as an adjunct for intraoperative identification of malignant and nonmalignant pulmonary lesions in adult patients with known or suspected cancer in the lung.

METHODS:

This is a retrospective review of the malignant and nonmalignant lesions identified by pafolacianine with intraoperative molecular imaging (IMI) in the multi-center Phase 2 and Phase 3 ELUCIDATE clinical trials. All lesions meeting the intent to treat criteria from the combined studies were included. Histopathology for malignant and nonmalignant lesions and immunohistochemistry (ICH) for folate receptor alpha (FRα) and folate receptor beta (FRβ), which pafolacianine binds to, were assessed.

RESULTS:

A total of 273 lesions resected from 191 patients were analyzed. The identification of primary and occult malignant lesions with pafolacianine in combination with standard practice was improved (P < .001) when compared to standard practice alone. A range of histologies were demonstrated including adenocarcinoma (primary and metastatic), squamous cell carcinoma, adenoid cystic carcinoma, chordoma, lymphoma, and papillary thyroid cancer. Ninety-two percent (205 of 223) of lesions tested for folate expression were positive for FRα or FRβ expression.

CONCLUSIONS:

While initially intended to identify adenocarcinoma, IMI with pafolacianine targets a broad histological cross-section of malignant and nonmalignant primary and metastatic lesions in the lung. As real-world use expands, additional insight will continue to inform utility of pafolacianine in clinical practice and may broaden clinical applicability.

2025-02-01·PHARMACOLOGICAL RESEARCH

Optical imaging guidance in oncologic surgery and interventional oncology

Review

作者: Yang, Xiaoming ; Zheng, Chuansheng ; Monsky, Wayne ; Valji, Karim ; Liu, Yiming

Over recent decades, optical imaging (OI) has become an integral part of medical imaging, offering significant advantages over other modalities, such as computed tomography (CT) and magnetic resonance imaging (MRI). OI is distinguished by its real-time imaging capability, cost-effectiveness, portability, absence of ionizing radiation, and high patient acceptability. The introduction of advanced optical dyes (including FDA-approved agents like indocyanine green, Cytalux, and Gleolan) has greatly enhanced its clinical utility. OI has shown clear benefits in the management of patients with cancer, originally by open surgery and now extending to minimally invasive, image-guided interventional procedures. This review highlights recent developments in OI for oncology, emphasizing its benefits for clinicians in guiding surgical and interventional procedures.

项与 Pafolacianine 相关的新闻（医药）

2024-12-30

·美迪西Medicilon

美迪西助力合作伙伴南京诺源1类新药培泰菁绿IND获FDA批准

12月20日，南京诺源医疗器械有限公司（以下简称“诺源医疗”）自主研发的1类新药培泰菁绿获得美国食品药品监督管理局（FDA）的新药临床试验（IND）许可！这是继FDA首个靶向叶酸受体造影剂Cytalux（OTL-38）上市后，我国首个叶酸受体靶向造影剂IND许可，标志着该领域的重大突破。培泰菁绿已获中、美、欧、日专利授权，彰显其全球创新实力。上海美迪西生物医药股份有限公司（以下简称“美迪西”）作为诺源医疗的合作伙伴，为培泰菁绿的研发提供了药学研究（包括原料药和制剂）、临床前研究（包括药理学、药代动力学和安全性评价），以及IND注册申报等一站式研发服务，共同加速了新药研发进程。培泰菁绿有望解决OTL-38存在的问题推动中国分子影像领域飞跃针对OTL-38临床假阳性率、稳定性等方面存在的问题，诺源医疗率先倡导药械并举，应用AIDD技术开发的培泰菁绿，作为叶酸α受体靶向荧光造影剂。临床前体外及体内药效学结果表明，培泰菁绿能够选择性地与FRα结合，是与FRβ结合能力的数倍，有望降低临床假阳性率；稳定性研究结果表明，与OTL-38相比将显著改善储存和运输条件，降低成本，促进医疗资源分布的可及性和公平性。培泰菁绿作为原创小分子靶向药物，从实验室研究到成功获得临床试验许可，不仅是诺源医疗在分子影像领域取得的重大突破，也是中国在该领域实现的重要飞跃。这一里程碑式的成就彰显了诺源医疗在精准医疗技术领域的深厚积淀，也为其在分子影像领域取得世界竞争力奠定了坚实基础。 MEDICILON 440+肿瘤药效模型一站式助力肿瘤新药临床前研发在新药研发的激烈角逐中，速度与品质均为制胜的关键。美迪西二十年来凭借对行业动态的持续创新和拓展，成功构建了一站式生物医药临床前研发服务平台。该平台实现了从药物发现、药学研究至临床前研究的无缝对接，形成了一条高效流畅的研发链路，为新药迅速获得临床试验许可提供了坚实支撑。在肿瘤药物研发的进程中，构建一个高效且精确的药效评价模型具有举足轻重的地位。美迪西在这一领域，已构建起一套全面且先进的药效评价体系。该体系涵盖了超过440种肿瘤药效模型，包括118种PD原位模型、同种肿瘤移植模型、异种肿瘤移植模型以及人源化肿瘤移植模型等，积累了丰富的研发实力与宝贵经验。此外，美迪西已建立并完善了针对CAR-T、TCR-T、CAR-NK、溶瘤病毒、抗体（单抗、双抗、多抗等）、siRNA、AAV等免疫疗法的药效评价模型和方法，为创新疗法的研究进程注入了强大动力。美迪西祝贺诺源医疗1类新药培泰菁绿获批FDA临床，期待在临床试验中取得积极结果，也期待该药物早日获NMPA临床试验许可，实现中美双报双批。美迪西将继续创新技术，不断迭代升级肿瘤药物临床前研发一站式服务平台，为全球肿瘤药物的研发注入新动力，赋予新速度。关于诺源医疗南京诺源医疗器械有限诺源医疗是集高端医疗器械和创新型靶向造影剂药品的研发、生产和销售为一体，具有持续创新能力的国家高新技术企业。诺源医疗“药械”并举，专注于为肿瘤精准诊疗提供全链解决方案；聚焦分子荧光、拉曼光谱、人工智能、计算机辅助药物分子设计（CADD）及AI辅助药物设计等核心技术，拥有丰富的产品管线。诺源医疗是江苏省医疗器械行业协会副会长单位、南京医疗器械管理协会常务副会长单位、中国医学装备协会常务理事单位、“2021、2022及2023年度”南京市培育独角兽企业，并在2023年1月获批江苏省博士后创新实践基地。诺源医疗自成立以来，深受国家和江苏省政府重视，诺源医疗牵头完成了“国家十三·五重点研发计划”、“国家重大科研仪器研制项目”、“国家工信部人工智能医疗器械创新任务揭榜”和“江苏省关键核心技术攻关项目”等十余项国家级、省级重大重点攻关项目；截止到目前，已授权国内外发明专利141项。2022年荣获中国发明协会“发明创业奖创新奖”最高奖项：一等奖，2023年荣获沙利文GIL：中国功能性内窥镜创新奖，2024年荣获BioCon Awards年度投资价值创新企业、沙利文GIL：全球靶向分子荧光示踪剂研发领导奖。往期推荐美迪西助力 | 济民可信JM045缓释微球获批临床➠ 美迪西助力 | 济民可信JMX-2002脂质体注射液获批临床➠ 美迪西助力 | 江苏亚尧晚期肿瘤1类新药YY2201片IND获FDA批准➠ 美迪西助力 | 开悦生命针对RNA解旋酶的新药中美双报获批 ➠ 美迪西助力 | 英矽智能MAT2A抑制剂中美双报获批➠ 美迪西助力 | 中国生物上海生物制品研究所创新型ADC药物获批临床➠ 美迪西助力 | 常山药业1类新药CSCJC3456片获批开展临床研究➠ 关于美迪西美迪西（股票代码：688202.SH）成立于2004年，总部位于上海，致力于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研究服务。美迪西的一站式综合服务以强有力的项目管理和更高效、高性价比的研发服务助力客户加速新药研发进程，服务涵盖医药临床前新药研究的全过程，包括药物发现、药学研究及临床前研究。至2024年6月底，美迪西已为全球超2000家客户提供药物研发服务，参与研发完成的新药及仿制药项目已有490件IND获批临床，与国内外优质客户共同成长。美迪西将继续立足全球视野，聚力中国创新，为人类健康贡献力量！

临床申请免疫疗法细胞疗法

2024-12-10

·PRNewswire

On Target Laboratories Appoints Bill Peters as CEO

WEST LAFAYETTE, Ind., Dec. 10, 2024 /PRNewswire/ -- On Target Laboratories, Inc., a leading biotechnology company specializing in the development of intraoperative molecular imaging agents to target and illuminate cancer during surgery, today announced the appointment of Bill Peters as president and chief executive officer. Peters has also joined the company's board of directors. He succeeds Ben Lundgren, who served as CEO since 2023 and was with the company for nearly six years. Continue Reading Bill Peters, president and chief executive officer, On Target Laboratories "Ben has been a pivotal force in advancing the commercialization of CYTALUX, building our Sales and Marketing organization, establishing strategic partnerships, and forging key customer relationships. We are deeply grateful for his leadership," said Scott Huennekens, Executive Chairperson of the Board at On Target Laboratories. "We are excited to welcome Bill as our new CEO. His impressive track record of driving success at large organizations uniquely positions him to scale On Target and continue delivering value for both our customers and investors." Peters brings more than 20 years of leadership experience in the medical technology sector, including a decade of executive leadership at ConMed. Most recently, he served as President of the Advanced Surgical and Advanced Endoscopic Technologies businesses in ConMed's General Surgery division, where he played a crucial role in driving a significant portion of the company's sales and profit growth. Under his leadership, General Surgery completed three successful acquisitions, launched innovative new products and emerged as the primary growth engine for the company. Prior to ConMed, Peters held senior commercial roles at Mako Surgical Corporation, which was acquired by Stryker in 2013, and at Intuitive Surgical. Earlier in his career, he also held sales leadership positions at Stryker Corporation. Peters holds a Bachelor of Business Administration in Finance from Ohio University. "I am both honored and excited to take on this leadership role at such an impactful company," said Peters. "The work we are doing to provide patients with groundbreaking technology and renewed hope is incredibly inspiring. I look forward to working alongside our exceptional team to advance our mission to illuminate cancer intraoperatively so it can be removed completely." About On Target Laboratories, Inc. On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University's Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind. CYTALUX, the company's first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information, visit and . Media Contact: On Target Laboratories, Inc. Jessica Todd 513-325-5706 [email protected] SOURCE On Target Laboratories, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更并购

2024-05-17

·动脉网

碳纳医疗：全球首创广谱肿瘤特异性碳量子点，剑指肿瘤药物靶向递送和术中导航市场

2023年10月，诺贝尔化学奖授予了Moungi G. Bawendi、Louis E. Brus、Alexei I. Ekimov，以表彰他们“发现和合成了量子点，为纳米技术埋下了重要种子”。当材料进入纳米尺度范围时，它们将会具有量子尺寸效应、小尺寸，表面效应和量子隧道效应等特性，从而表现出与普通块体材料迥异的物理化学性能。量子点 (Quantum dots，QDs) 又称半导体纳米晶体，是一种尺寸极小的纳米材料。正如诺贝尔化学委员会主席Johan Aqvist说的：“量子点具有许多引人入胜和不寻常的特性。重要的是，它们的颜色取决于它们的大小”。量子点的出现为调控和改变材料的性能提供了一种全新的方法，为纳米技术更广泛应用提供了无限的可能。 1998年起，量子点技术就被首次作为生物荧光标记应用于生命科学中，例如将量子点与生化分子相连接，以绘制细胞和器官图谱；研究用量子点追踪体内肿瘤组织的潜在效用；应用外科手术切除肿瘤组织等。不过，长期以来量子点多由重金属组成，尽管其优异性能在生物成像、能量转换等领域有广泛应用，但重金属元素会引起环境污染和影响生物体健康, 在人体体内的医学应用还是很有限。成立于2019年的北京碳纳医疗科技有限公司（后简称“碳纳医疗”），其关键技术是世界上首次合成的、具有肿瘤特异性新型纳米材料碳量子点（carbon quantum dots, CQDs）。这一新纳米材料有望颠覆癌症的靶向治疗和精确诊断效果。近日，动脉网采访了碳纳医疗创始人兼CEO欧阳兆槐博士。欧阳兆槐，碳纳医疗创始人兼CEO，留美博士，教授级高级工程师。中美两国30年药物研发及管理经验。曾任北京因美未来生物医药科技副总裁；北京博奥晶典生物技术有限公司副总裁兼首席科学家。广谱主动靶向肿瘤细胞的新型碳纳米材料作为药物载体,纳米材料具有基于纳米结构的尺度效应，能增加药物的有效性和安全性，改善服药方式，为解决抗癌药物的靶向性问题提供可能。CQDs指以碳为主要元素，粒径小于10nm、具有石墨晶型或类金刚石结构的新型荧光碳纳米材料。纳米载药的靶向性包括被动靶向和主动靶向两种方式。由于材料本身的特征，几乎所有的纳米载药系统都具有被动靶向性。正常组织的血管壁间隙较小、结构完整。与之相比，肿瘤组织区域的血管丰富，血管壁的间隙较大，结构完整性差。因此，纳米尺度合适尺寸的材料可以借助实体瘤组织间隙的EPR(Enhanced Permeability and Retention)效应在肿瘤组织区域选择性分布，完成被动靶向。“但不同肿瘤之间血管壁间隙存在差异，被动靶向性不具有普适性，效率不高。临床结果证明，基于EPR效应的纳米药物大多富集在肝脏、脾脏和骨髓等器官，难以实现精准靶向肿瘤。”欧阳兆槐提到，“现有纳米递送体系的主动靶向都是通过偶联特异性配体或抗体成分，与细胞表面特异受体结合。这种结合可以明显提高药效，增强对肿瘤的杀伤力并降低副作用。但这种主动靶向也存在一些局限性，比如靶向受体有限、难以找到泛癌靶点、工艺与质控难度等。”因此，寻找自身具有肿瘤主动靶向性的纳米材料就成为急中之急、重中之重。与普通细胞相比，癌细胞需要充足的营养来满足其快速增殖的需求，因此L型氨基酸转运蛋白LAT1在多种肿瘤细胞或组织中过表达。利用这一特性，碳纳医疗自研的CQDs，通过类似大型氨基酸的结构，可与肿瘤细胞中过表达的LAT1结合，不论肿瘤的来源、位置和种类，广谱、精准、主动靶向肿瘤细胞。重要的是，CQDs可以负载各种抗癌药物，载药后仍然能够保持其特异的肿瘤靶向性。这种靶向性已在超40类肿瘤细胞和超6类动物模型实验中观察到。CQDs在小鼠体内的选择性富集，受访者供图这种特殊的CQDs材料诞生于北京师范大学范楼珍教授的实验室。经过近30年纳米材料研究的积累，她首次发现这类新型CQDs能对各种各样的肿瘤细胞有特异性，并在后续的动物实验、机理验证中均显示明确的主动靶向效应。相比传统半导体量子点，CQDs不仅继承了优良的光学性能，还弥补了其在细胞毒性、环境及生物危害性等方面的不足。除此之外，CQDs具有良好的水溶性、化学稳定性、成本较低、易于表面功能化和大规模制备等特点。随着科研成果发刊、PCT国际专利申请递交，范楼珍教授与拥有30年中美生物医药研发和管理经验的大学同学欧阳兆槐（曾任北京博奥晶典生物技术有限公司副总裁兼首席科学家、因美未来副总裁），提到这一具有重要临床意义的研发成果。在对于项目与产业端深入考察后，二人一拍即合，创立了碳纳医疗，开启了人生的创业之路。发展至今，碳纳医疗已经拥有一支学有所长，具有丰富的专业经验和国际视野的研发及产业团队，并邀请到首个靶向HER2阳性乳腺癌单抗药物赫赛汀发明者之一、2019年拉斯克奖得主Mike Shepard担任CMO。治疗端：可负载化药、核酸等，广谱肿瘤靶向的药物递送在治疗端，CQDs的肿瘤广谱性和主动靶向可以转化为具有通用平台性质的药物递送系统。“作为平台型技术，CQDs纳米递送拥有着巨大的想象空间。我们可以把没有靶向的普通药物变成癌症靶向，实现高效递送与更好的疗效。对标目前已上市的纳米递送，CQDs具有更优的、无需修饰的主动靶向效应，可以应用至化疗、生物疗法、放疗（PET、中子）、光疗、免疫等肿瘤疗法之中。”以恶性肿瘤治疗中应用最广泛的化疗药物阿霉素为例，在临床应用中对妇科肿瘤、肝癌、肺癌、乳腺癌、淋巴瘤、多发性骨髓瘤、头颈部肿瘤等都有很好的疗效。但阿霉素毒副反应严重，杀伤肿瘤细胞同时将杀伤健康细胞，带来心脏毒性、脱发等副作用，严重影响患者的生活质量和生存期。“现有的纳米药物（如脂质体）在递送过程中改变药物的代谢途径和组织内分布，减少对正常组织的伤害。但只能达到一定程度的减毒增效。CQDs因为它的主动靶向性，可以有效把药物靶向递送到肿瘤细胞，从而减少全身副作用，提高最大耐受剂量和极大改善治疗效果。”此外，CQDs载药有体内稳定、在合适的条件下释放。CQDs能改善药物水溶性、给药方式、易操作和控制等特点。目前，CQDs可以共价或非共价和各种药物结合，已测试阿霉素等二十多种化药和siRNA核酸分子。CQDs本身或和药结合后能突破血脑屏障，靶向脑内肿瘤。欧阳兆槐介绍，“与目前市面上现有纳米递送系统相比，我们的CQDs不需要偶联肿瘤识别配体，而依靠材料本身具有的主动靶向性，特异性识别进入肿瘤细胞。这决定了碳纳医疗在工艺、生产上更简单，更容易实现产品量产与产业化。我们实验室已经实现CQDs从毫克级到克级的放大，最终达到公斤级别的量产不是问题。”诊断端：革新传统荧光标记材料，开发肿瘤术中导航管线在诊断端，作为一类新型的荧光标记材料，CQDs在长时间生命活动监测及活体示踪方面具有独特的应用优势。与传统的有机荧光试剂相比较，CQDs荧光比有机荧光染料的发射光强的20倍，稳定性强100 倍以上。此外还具有激发光谱宽，发射光谱窄、不易漂白、光化学稳定性高、不易分解等诸多优点，主要应用在活细胞实时动态荧光观察与成像。手术切除通常是实体肿瘤的首选治疗方案，是否能够完全切除肿瘤组织很大程度上影响患者术后生存周期和质量。目前虽然有多种方式可以实现肿瘤诊断和术前规划，但由于设备等的限制，尚无有效手段实时辅助医生判断肿瘤边缘，是否完全切除主要依靠主刀医生经验，存在切缘阳性的风险。术中显像剂技术为手术医生提供了实时指引，便于医生观察，进一步提高患者手术成功率，拥有巨大的潜在蓝海市场。2021年11月，全球首款近肿瘤靶向荧光显像剂Cytalux获得FDA批准上市。Cytalux是一种靶向叶酸受体的近红外肿瘤靶向造影剂，目前已获得卵巢癌和肺癌的NDA批证。与靶向叶酸受体的Cytalux不同，碳纳生物的CQDs具有广谱肿瘤特异性，可应用于基于所有实体瘤的术中成像。此外，由于CQDs光学特性，它能产生更稳定、更持久、更强荧光信号。因此，以CQDs为基础的术中导航产品，其应用广泛性和性能将极大优于已经上市的产品。目前，碳纳医疗已达成CQDs在体外诊断领域的多家授权合作，下一步将全力推进首条CQDs递送化疗药物管线及术中成像管线的临床前研发。欧阳兆槐表示，“碳纳医疗致力于把CQDs打造成世界上独一无二的癌症靶向药物开发平台。在CQDs开发前所未有的抗癌靶向纳米新药，同时技术授权给药企，为合作伙伴提供创新性和颠覆性的解决方案和支持。”写在最后从1998年量子点技术被首次作为生物荧光标记应用于生命科学，到2004年碳点（包括碳量子点CQDs）被首次报道，再到后期被陆续应用于POCT、生物传感，到今天的术中诊断、药物递送。在量子点技术身上，我们可以看到一项医疗领域的全新材料在前沿科研驱动下寻找可能性的探索过程。当然，底层创新往往面临着更多元的竞争——量产实现、工艺迭代、成本竞争、科研成果转化、工业与产业端的认可、监管与审批的挑战。欧阳兆槐谈到，“量子点本身用于药物递送、治疗领域确实是新的。但它的本质还是一种纳米材料，审批可适用于纳米药物的审核标准。”2021年，CDE发布《纳米药物质量控制研究技术指导原则（试行）》《纳米药物非临床药代动力学研究技术指导原则（试行）》《纳米药物非临床安全性评价研究技术指导原则（试行）》。采访最后，欧阳兆槐提到，在碳纳医疗的小动物实验里，CQDs的安全性、有效性都有很好地验证，也正在洽谈和药企合作。我们希望得到各种支持系统地推进大动物实验，尽早拿到IND批件。这对于整个CQDs平台是一个大的台阶，认可度会上升，随之就会有一些大型的合作与验证，推动我们更快走上商业化轨道。”对于“First-in-class”的新材料而言，其应用价值和工具性、平台性需要不断地挖掘与探索，风险与机遇是并存的，而市场与用户最终将为价值买单。不过在此之前，我们或许要让源头创新先活过寒冬。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

100 项与 Pafolacianine 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Pafolacianine	-	DB15413

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肺癌	美国	On Target Laboratories LLC	2022-12-16
造影剂	美国	On Target Laboratories LLC	2021-11-29
卵巢癌	美国	On Target Laboratories LLC	2021-11-29

未上市

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
FOLR1阳性卵巢癌	临床3期	美国	On Target Laboratories LLC	2018-01-26
FOLR1阳性卵巢癌	临床3期	荷兰	On Target Laboratories LLC	2018-01-26
肺腺癌	临床2期	美国	On Target Laboratories LLC	2017-05-04
肺腺癌	临床2期	荷兰	On Target Laboratories LLC	2017-05-04
肺结节	临床2期	美国	On Target Laboratories LLC	2017-05-04
肺结节	临床2期	荷兰	On Target Laboratories LLC	2017-05-04
子宫内膜癌	临床2期	荷兰	On Target Laboratories LLC	2014-08-18
肾细胞癌	临床2期	荷兰	On Target Laboratories LLC	2014-08-18
胃肠道肿瘤	临床1期	美国	University of California, Irvine	2024-11-13
腹膜癌	临床1期	美国	University of California, Irvine	2024-11-13

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临床结果

适应症

分期

评价

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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


NCT02872701 (CTgov)	临床2期	肺癌 \| 肺腺癌 \| 肺结节	100	Endoscopic or Thoracic Surgery+OTL38 for Injection	衊網鑰膚鑰窪積齋廠鬱 = 範壓憲廠鬱餘艱網鑰鑰觸醖齋衊觸壓範齋壓蓋 (蓋醖鏇醖遞繭構選鑰窪, 襯鬱襯衊廠顧艱築窪淵 ~ 憲廠餘範獵築範膚繭廠) 更多	-	2023-03-24
NCT04241315 (Elucidate, CTgov)	临床3期	肺癌	112	Near infrared camera imaging system+OTL38 for Injection (Near-Infrared Imaging Group)	獵選遞壓鏇膚選壓餘廠(願淵壓簾窪衊齋遞範願) = 觸簾膚鹽廠選範範顧鏇醖網鑰築構糧襯觸襯構 (夢憲憲範觸構膚蓋衊鹹, 淵襯糧窪窪壓憲鏇顧鹽 ~ 膚網範鹽築醖醖壓醖憲) 更多	-	2023-03-23
NCT04241315 (Elucidate, CTgov)	临床3期	肺癌	112	OTL38 for Injection (No Imaging Group)	獵選遞壓鏇膚選壓餘廠(願淵壓簾窪衊齋遞範願) = 鹹獵夢憲願獵網築襯選醖網鑰築構糧襯觸襯構 (夢憲憲範觸構膚蓋衊鹹, 鑰範範窪築憲餘願夢廠 ~ 蓋夢憲網憲膚製壓網襯) 更多	-	2023-03-23
NCT03180307 (Study 006, Pubmed) 人工标引	临床3期	FOLR1阳性卵巢癌 FR Positive	150	Pafolacianine	蓋糧壓觸鹹鬱築壓膚簾(壓鹽衊製願窪選構齋廠) = 觸廠壓顧範網餘糧遞蓋築襯顧廠壓糧簾獵餘鑰 (網醖鏇獵願醖顧齋網窪, 24.3 ~ 42.7) 更多	积极	2022-09-07
NCT03180307 (Study 006, Pubmed) 人工标引	临床3期	FOLR1阳性卵巢癌 FR Positive	150	Pafolacianine (patients who underwent interval debulking surgery)	-	积极	2022-09-07
NCT02317705 (CTgov)	临床2期	FOLR1阳性卵巢癌	48	Laparotomy+OTL38	構願餘遞艱糧餘願蓋鑰(艱願餘齋觸鏇蓋築餘鏇) = 夢繭齋夢蓋憲憲繭餘蓋構築蓋構遞築鑰憲憲繭 (壓網壓艱襯願夢廠蓋衊, 構醖膚願膚艱憲願襯選 ~ 鏇鹹襯選糧築襯醖廠夢) 更多	-	2022-06-21
NCT03180307 (ASCO2021)	临床3期	FOLR1阳性卵巢癌	150	Pafolacianine sodium	繭窪糧襯餘網窪糧構蓋(襯簾醖餘淵觸網鹽構憲) = 4.7% 衊糧膚觸淵憲遞膚觸夢 (餘蓋顧餘鏇鹹艱蓋網願 ) 更多	-	2021-05-28
NCT02645409 (CTgov)	N/A	肾细胞癌	14	Intraoperative fluorescence imaging system+OTL38 (Partial Nephrectomy)	夢糧願壓觸範艱夢夢窪 = 夢鹹鏇蓋廠壓願壓鑰構齋淵壓簾網憲獵構範鏇 (膚夢積製構膚蓋選鏇衊, 壓鏇網鹹鑰壓齋鹽繭鹹 ~ 齋衊襯糧積網選願獵鹽) 更多	-	2020-01-07
NCT02645409 (CTgov)	N/A	肾细胞癌	14	Intraoperative fluorescence imaging system+OTL38 (Radical Nephrectomy)	糧積選繭憲構顧築願顧(艱鹹選築遞鬱鏇遞壓獵) = 襯遞窪鹹鑰願憲獵壓淵襯鹹鏇繭觸襯鏇艱糧壓 (餘鹹願醖夢範淵窪鏇憲, 壓選遞艱憲艱窪鑰醖鑰 ~ 鏇積窪憲齋壓觸遞鹹遞) 更多	-	2020-01-07
NCT02317705 (Pubmed \| Obstet Gynecol Surv) 人工标引	临床2期	FOLR1阳性卵巢癌 folate receptor-alpha positive	44	OTL38	範積鏇簾襯夢構襯簾鏇(製膚構艱鹽壓衊築衊衊) = infusion reaction, nausea, vomiting, and abdominal pain 製鬱廠衊糧選顧觸憲製 (鏇糧獵觸獵鏇網製繭繭 )	积极	2019-10-01