Ammonia N-13 Myocardial Blood Flow Absolute Quantification by Positron Emission Tomography in Patients With Known or Suspected Coronary Artery Disease (Ammonia MAP)

This study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called Positron Emission Tomography (PET), using a specific radioactive drug called Ammonia N-13 (Ammonia), referred to simply as an Ammonia PET scan, which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart. The scanner used in this study may be a stand-alone PET scanner or a PET/CT scanner, which combines the PET scanner and a Computed Tomography (CT) scanner into a single device. Unless otherwise stated in this consent form, the term PET will be used to refer to both stand-alone PET and PET/CT scanners. While physicians have used the Ammonia PET test for many years to visualize (image) the blood flow into the heart muscle (perfusion), it is now possible to also measure the flow of blood into the heart muscle. Research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle. Therefore, this study will establish a database of a large number of Ammonia PET measured blood flow values to serve as a future reference.

开始日期2020-09-14

申办/合作机构

Ionetix Corp.

100 项与 Ionetix Corp. 相关的临床结果

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0 项与 Ionetix Corp. 相关的专利（医药）

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项与 Ionetix Corp. 相关的文献（医药）

2021-02-01·Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology3区 · 医学

Initial clinical experience of N13-ammonia myocardial perfusion PET/CT using a compact superconducting production system

3区 · 医学

Article

作者: Nelson, Jacob R ; Murthy, Venkatesh L ; Patel, Vaiibhav N ; Poitrasson-Rivière, Alexis ; Freiburger, Nick ; Ficaro, Edward P ; Shreves, Christopher K ; Weinberg, Richard L ; Rothley, Jill ; Hubers, David ; Pieper, Justin ; Escolero, Sylvia ; Corbett, James R ; Oliverio, Joseph

BACKGROUND:

Although N13-ammonia has favorable properties among FDA approved radiotracers, complexity of implementation has limited its use. We describe the initial patient experience of N13-ammonia PET imaging using a compact N13-ammonia production system.

METHODS:

N13 was produced using the ION-12SC, a 12MeV, 10uA superconducting minimally shielded cyclotron, and reduced to N13-ammonia in an automated multi-use purification unit. Patients were power injected with 9.3 ± 1.1 mCi (344.1 ± 40.7 MBq) of N13-ammonia for rest imaging, and 18.8 ± 0.9 mCi (695.6 ± 33.3 MBq) of N13-ammonia was injected at peak hyperemia for stress testing. Images were interpreted for relative perfusion, left ventricular volumes/function, blood flow quantification, and scored for image quality.

RESULTS:

In total 97 patients underwent 98 N13-ammonia PET scans (32 rest only/65 rest-stress/1 stress only). Image quality was 91.8% good or excellent. None were poor/non-diagnostic. Study durations were acceptable. Tracer related radiation dosimetry to patients was 0.7 ± 0.1 mSv (rest only), and 2.1 ± 0.1 mSv (rest-stress).

CONCLUSION:

Clinical N13-ammonia production by the Ionetix ION-12SC delivers high quality myocardial PET perfusion images in a rapid protocol.

项与 Ionetix Corp. 相关的新闻（医药）

2025-06-26

·EndPoints

Bharat, GSK to cut malaria vaccine price; Emergent's US stockpile deal expands

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Bharat Biotech and GSK said they will reduce the price of their malaria vaccine for children where the disease is endemic. They will do so “progressively” to less than $5 by 2028, which is a price drop of more than half, the companies said Wednesday. The price cut is due to “process improvements, expanded production capacity, cost-effective manufacturing, and minimal profit margins.” The vaccine, codenamed RTS.S, was developed by GSK, PATH and their partners. Emergent BioSolutions’ partnership with the Administration for Strategic Preparedness and Response had a “ contract modification ” worth $62.4 million for its botulism antitoxin. The deal update was made on an existing 10-year contract stating Emergent would supply the antitoxin for stockpiling purposes. Drug supplier Sterling Distributors was handed an FDA Warning Letter after the company was found to be purchasing and distributing prescription drugs across different states, including Florida, Arkansas and Mississippi, without a license. The letter, published Tuesday, states Sterling shipped illegitimate products to customers and failed to investigate any deficiencies even after patient complaints. Six major issues were found in total and the FDA has given Sterling 15 working days to respond. AGC Biologics will start offering its cell therapy services from a site in Yokohama Technical Center in Japan starting next month, the company said Wednesday. This means the company would have cell therapy manufacturing presence in three places, including Milan and Colorado. Catalent now has the upstream phase for the production of GenSight Biologics gene therapy lenadogene nolparvovec, which it calls Lumevoq. The batches will be used for an early access program and a dose-ranging study in France, the pharma company said Thursday. The asset is under investigation for Leber hereditary optic neuropathy. Adial Pharmaceuticals said it tapped Thermo Fisher Scientific and Cambrex to make its alcohol use disorder drug, codenamed AD04, according to a Wednesday release. Ionetix and AlfaRim will be working together to market actinium-225, the companies said last Friday. Additional reporting by Anna Brown.

细胞疗法疫苗基因疗法

2025-06-23

·FiercePharma

Ratio, Ionetix ink separate deals to speed production of in-demand radiopharmaceutical isotopes

The radiopharmaceutical industry has enjoyed explosive growth in recent years and is forecasted by Insight Partners to swell to $26.5 billion in 2031. Ratio Therapeutics and Ionetix have inked separate deals to boost production of the much-needed radioisotope actinium-225, which is helping fuel the explosive growth of radiopharmaceuticals in cancer treatment. On Ratio's end, the company has linked up with Bill Gates-founded TerraPower Isotopes, which will supply undisclosed quantities of non-cGMP actinium-225 to incorporate into or use in the development of Ratio's radiopharmaceuticals, the company said in a June 20 press release.Ratio said that it needs a “reliable supply” of the radioisotope to support its pipeline leveraging the company's Trillium and Macropa platforms. The two platforms are equipped to design and develop new radiopharmaceuticals that can selectively target and eradicate cancer cells, the company said."Securing a reliable supply of Actinium-225 is a critical step in advancing our pipeline of targeted alpha therapies," John Babich, Ph.D., Ratio’s president and chief executive, said in the release. Separately, Michigan-based isotope manufacturer Ionetix inked a deal to commercialize cyclotron-produced actinium-225 with Dutch deeptech firm AlfaRim. A cyclotron is a type of particle accelerator used to make medical radioisotopes from non-radioactive materials, according to the International Atomic Energy Agency. The pact is designed to help boost the ‘near-term scale-up” of actinium-225 in a bid to build a sustainable, commercial-scale supply of the isotope for next-generation targeted alpha therapies, Ionetix and AlfaRim said in a June 20 press release.Neither Ratio nor Ionetix disclosed financial details of their respective deals.The radiopharmaceutical industry—which has enjoyed explosive growth in recent years and is forecasted by Insight Partners to swell to $26.5 billion in 2031—hinges on the steady supply of radioisotopes like actinium-225. Production of actinium-225 has historically been lacking though, particularly for large-scale clinical trials, partly because the isotope isn't naturally abundant and is typically produced as a byproduct from the decay of thorium-229.AlfaRim has developed methods to produce actinium-225 at the industrial scale using technology that bombards radium-225 with protons. The company is currently working on a Dutch manufacturing facility utilizing the tech that it says has the potential to increase the global supply of actinium-225 tenfold.“We are excited to be working with AlfaRim to bring these desperately needed radioisotopes to patients globally,” Kevin Cameron, CEO at Ionetix, said in the companies' joint release. “Reliable commercial supply will be crucial to ensuring patients get the benefits of these treatments.” In another deal announced on June 17, Ratio signed an agreement for radioisotope supplier Nusano to provide access to commercial-scale supplies of copper-64 for PET imaging diagnostics, plus the medical isotopes lutetium-177 and actinium-225. Lutetium-177 is typically used in therapies designed to treat malignancies like neuroendocrine tumors and prostate cancer.The financial terms of the Nusano deal were not disclosed.

放射疗法

2025-04-30

·药智网

核药五霸的厮杀

一个新的百亿美元药物市场正在形成。Precedence Research发布的报告显示，2024年全球放射性药物市场规模为67.4亿美元，预计到2033年，这个数字将以8.2%的复合增长率，达到136.7亿美元。图片来源：同写意虽然该赛道涌现出一批Biotech，凭借创新的技术和管线，正把这种先进疗法带向更广阔的应用市场，可最后的故事不太可能由它们来主导——以诺华、拜耳为代表的制药巨头环伺左右，摩拳擦掌。过去几年，资金越发频繁地流向这片蓝海：不仅是风投机构，还包括来自药企的钱。MNC通过参与Biotech的融资，或者直接引进管线，买下公司，深度参与到这场创新竞赛里。由此，行业格局似乎也逐渐呼之欲出。下文，将梳理五家制药巨头在放射性药物上的布局。它们采取各种策略，希望建立起自己的话语权。1拜耳：先驱不易作为最早一批押注放射性药物的MNC，拜耳2009年就与Algeta达成合作，获得Xofigo的全球独家销售权。Xofigo不包含靶向部分。相反，该药物利用镭的化学性质，使其能够与骨矿物质结合，从而帮助将药物定位到骨周转率高的部位。2013年，FDA批准Xofigo上市，作为全球首款α粒子放射性药物，用于治疗晚期骨转移型去势抵抗性前列腺癌。次年，拜耳顺势斥资29亿美元并购Algeta，完全将Xofigo收入囊中。通过这次收购，拜耳希望借此提振其药物部门。Algeta曾预计，到2018年，Xofigo全球销售额将超过10亿美元，但事实上，它在2017年达到的峰值是4.08亿美元。问题出在临床数据。2017年底，拜耳公布Xofigo与强生的Zytiga、类固醇联合使用的III期出现死亡和骨折事件后，该药物的销售额一直在下降。拜耳2024年财报并未披露Xofigo的销售额。GlobalData预计，Xofigo在2024年的销售收入仅为2.44亿美元，到2030年将降至1.61亿美元。不过，这家巨头正试图重铸自己的荣光。2021年，拜耳收购Noria Therapeutics和PSMA Therapeutics，获得一款靶向PSMA的小分子α粒子疗法的开发权益，进一步扩展其靶向α疗法的肿瘤学产品组合。2023年，通过战略合作，拜耳以4500万美元的预付款和高达17亿美元的里程碑付款，从Bicycle Therapeutics获得专有肽的使用权，计划将之用于开发针对几种未公开的癌症靶点的靶向放射疗法。根据其管线信息，拜耳至少有两种临床阶段的放射性药物正在开发中：225Ac-Pelgifatamab和225Ac-PSMA-Trillium，这两种都是针对晚期前列腺癌的早期研究中的候选药物。2诺华：一骑绝尘有目共睹，当前在放射性药物领域最为成功的MNC，非诺华莫属。跟拜耳相似，这家瑞士制药商通过并购快速建立起自己的版图：2017年，以39亿美元收购的Advanced Accelerator Applications，获得Lutathera——2024年营收同比增长20%，达到7.24亿美元；2018年，以21亿美元收购Endocyte，获得Pluvicto——2024年营收同比增长42%，达到13.92亿美元。Pluvicto以及即将突破“重磅炸弹”门槛的Lutathera证明，监管、制造复杂的放射性药物，同样有自己的广阔市场前景。诺华放射性配体治疗实体瘤战略副总裁Geoff Towle认为，与竞争对手相比，诺华在全球范围内建设了“行业领先的放射性配体研究和生产基地”。这一定程度促成其商业化产品飞速放量。尽管遥遥领先，诺华仍在持续投资放射性药物领域，加强自己的管线组合。2024年，该公司斥资10亿美元收购Mariana Oncology及其前景看好的产品线，其中最有潜力的产品线是MC-339，这是一种正在研究用于治疗小细胞肺癌的放射性疗法。Towle透露，诺华最近还启动了下一代放射疗法AAA817的两项关键试验，用于治疗前列腺癌。与Pluvicto一样，AAA817靶向PSMA，但携带的是基于锕的有效载荷，可以提供更高的效力。除了拓展产品线，另一大被诺华采用的策略，是扩大商业化产品的适应症。例如，3月底，诺华赢得FDA对Pluvicto的关键批准，使该药的潜在患者人数增加三倍，允许其在紫杉烷类化疗之前治疗PSMA阳性转移性去势抵抗性前列腺癌（mCRPC）。诺华介绍，化疗前mCRPC是Pluvicto实现50亿美元峰值销售额的最重要的适应症。现阶段，诺华还在尝试将放射性药物从前列腺和神经内分泌肿瘤，推向患者需求尚未得到满足的其他领域，例如乳腺癌和肺癌。3阿斯利康：抗癌新篇肿瘤治疗业务长期是阿斯利康的“现金牛”。2024年，该板块营收同比增长24%，达到223.53亿美元，占据阿斯利康总营收的41%。而随着产品的迭代，放射性疗法逐渐进入这家英国制药巨头的视野。它透露，核素偶联药物（RDC）已经成为公司肿瘤学研发战略的重要组成部分，也是多元化产品组合的关键——预计RDC将在2030年之后成为阿斯利康业务的强大推动力。2024年，阿斯利康以高达24亿美元收购Fusion Pharmaceuticals，正是进入放射性药物市场。Fusion为其带来了一款候选药物FPI-2265。阿斯利康生物工程和肿瘤靶点发现高级副总裁Puja Sapra透露，FPI-2265针对PSMA阳性mCRPC患者的II/III期试验，预计在2025年下半年获得读数。不过，距离获批上市可能尚需时日。GlobalData认为，该疗法最早将于2028年商业化，到2030年的销售收入也仅为1.82亿美元。阿斯利康还在研究AZD2068，这同样是Fusion开发的另一种RDC，旨在靶向表达EGFR和cMET标记的细胞。目前，AZD2068正处于针对晚期实体肿瘤的I期临床。根据管线规划，预计该研究最早在2026年就会有结果。产品管线之外，阿斯利康也对“分子成像和计算病理学”饶有兴趣。Sapra表示，这将“增强放射性结合物的输送和监测”，最终目标是“为正确的患者提供正确的治疗”。4BMS：锕系先锋诺华的重磅产品虽然正在跑马圈地，但并非没有薄弱环节。例如，Pluvicto、Lutathera选择镥-177这种β核素放射性同位素，就没有α粒子那样能提供更高的能力——比β粒子高400倍，进而引起更频繁的双链DNA断裂，实现高效、精确杀灭肿瘤细胞。理论上，利用锕-225的放射性药物，有可能比已经批准的Lutathera带来更佳的疗效。BMS正着手打造自己的锕系元素产品矩阵。2023年，BMS以41亿美元收购了RayzeBio及其基于锕-225的平台，在放射性药物赛道迈出重大一步。虽然成立时间尚短，RayzeBio却在锕系元素放射性药物治疗方面占据领先地位，拥有多个潜在First-in-Class和Best-in-Class项目。其中，RYZ-101靶向生长抑素受体2（SSTR）的RDC，这是一种通常在某些实体肿瘤中表达的蛋白。围绕RYZ-101，BMS开展了三项临床试验：一项针对胃肠胰神经内分泌肿瘤（GEP-NET）的III期研究，以及一项针对不可切除的转移性乳腺癌和广泛期SCLC的I期研究。BMS透露，针对SCLC的研究结果将于2025年晚些时候公布，而GEP-NET的关键数据预计在2026年对外揭晓。如果一切顺利，RYZ101有望成为美国首个获批的基于锕-255的放射性药物。RYZ-801则是另一款值得关注的候选产品。该药由一种肽与锕-225放射性有效载荷结合而成。据悉，RYZ-801靶向GPC3蛋白，已经在2024年底进入临床，用于治疗肝细胞癌，目前正在招募患者。此外，收购RayzeBio还为BMS带来了“IND生成引擎”，可以在未来几年内产生“几种候选治疗药物”。相关负责人称，BMS正在推进多个临床前项目。而生产制造能力方面，BMS位于美国印第安纳波利斯的工厂已全面投入运营，可以支持临床样品供应。BMS还打算扩大该工厂，以支持商业规模运营。5礼来：全线出击对于治疗用放射性药物，即眼下投资关注的主要细分领域，礼来可谓是刚进“新手村”。2023年10月，通过一笔14亿美元的收购，该MNC真正下场。礼来肿瘤学部门总裁Jacob Van Naarden称，他们对这种新兴治疗方式的潜力感到非常兴奋，并将收购Point Biopharma视为“投资开发多种治疗癌症的放射性药物的开始”。与Point的交易披露时，礼来获得PNT2002、PNT2003这两款处于III期临床的药物，以及几个处于早期阶段项目。不过，PNT2002、PNT2003与诺华两款商业化产品适应症存在重合，意味着它们的上市和销售道路可能并不容易走。2023年12月，PNT2002的III期结果令人失望：与雄激素受体阻断相比，该药物将死亡或疾病进展的风险降低了29%——符合统计学显著性，但低于分析师的预期。这笔14亿美元巨额收购的更大价值，或许是让礼来拥有一个工厂平台。Point是自带生产能力的Biotech，18万平方英尺的园区，属于世界上最大的放射性药物制造工厂之一。并且，陆空交通区位的优势，让货物可以快速进出，覆盖欧美等主要市场。但作为后来者，礼来不打算将鸡蛋放在一个篮子里。相反，它要发挥自己的体量优势，多次下注，尤其是在靶点技术方面，以此提高成功概率。2024年，礼来加快了进军放射性药物的步伐。5月，它从Aktis Oncology引进新型小蛋白技术平台生产放射性药物。7月，礼来又跟Radionetics Oncology签署投资协议，有机会以10亿美元的价格后者收购。此外，作为放射性药物的重要一环，核素的布局也没有被礼来落下。Point已与德国Lu-177生产商ITM Isotope Technologies Munich签订并扩大供应协议，一定程度减轻了礼来在核素方面的压力。2024年8月，礼来还通过可转换贷款方式，向一家名为Ionetix的同位素供应商投资了1000万美元。Ionetix位于美国的工厂运行着一台回旋加速器，该机器通过用质子束轰击镭-226来生产锕-225。来源 | 同写意（药智网获取授权转载）撰稿 | 写意君责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

放射疗法并购临床3期财报

100 项与 Ionetix Corp. 相关的药物交易

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100 项与 Ionetix Corp. 相关的转化医学

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