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Actinium's cyclotron produced Actinium-225 material has demonstrated radiochemical and radionuclidic purity identical to current gold-standard methods and has the potential to be significantly lower cost at commercial scale than currently available production methods
锕的回旋加速器生产的锕-225材料已证明放射化学和放射性核素纯度与当前的金标准方法相同,并且在商业规模上有可能比目前可用的生产方法显着降低成本
Proprietary manufacturing technology supported by 5 issued U.S. patents, 49 issued international patents and significant technical know-how
专有制造技术得到了5项已颁发的美国专利、49项已颁发的国际专利和重要技术诀窍的支持
Actinium to commit to multi-million-dollar investment and pursue collaborations on a global basis to scale its technology for commercial purposes to support internal programs and address growing demand for Actinium-225
锕将致力于数百万美元的投资,并在全球范围内进行合作,将其技术扩展到商业目的,以支持内部计划并满足对锕225不断增长的需求
NEW YORK, March 11, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody-Radio Conjugates (ARCs) and other targeted radiotherapies, today announced that it has launched a strategic initiative focused on the manufacture of the highly sought after medical isotope Actinium-225 (Ac-225) leveraging its propriety cyclotron-based method.
2024年3月11日,纽约/PRNewswire/--Actinium Pharmaceuticals,Inc.(纽约证券交易所美国证券交易所:ATNM)(Actinium or the Company),抗体放射结合物(ARCs)和其他靶向放射疗法开发的领导者,今天宣布,它已启动一项战略计划,重点生产备受追捧的医用同位素Actinium-225(Ac-225)利用其适当的基于回旋加速器的方法。
Actinium-225 is a potent alpha-particle emitter that has high linear energy transfer capable of killing targeted cancer cells via double-strand breaks in DNA for which there is no known resistance or repair mechanism, making it a highly sought after isotope for targeted radiotherapies. Actinium's intellectual property portfolio relating to its cyclotron-based production method includes 5 issued U.S.
锕-225是一种有效的α粒子发射体,具有高线性能量转移,能够通过DNA中的双链断裂杀死靶向癌细胞,而DNA中没有已知的抗性或修复机制,使其成为靶向放射治疗的备受追捧的同位素。锕系元素与基于回旋加速器的生产方法有关的知识产权组合包括5个美国发行的。
patents and 49 issued international patents as well as significant technical know-how. Ac-225 produced using Actinium's method is highly pure and identical to the current gold-standard manufacturing method using a Thorium-229 generator but has the potential to be lower-cost at commercial scale and is a higher yielding approach.
专利和49项国际专利以及重要的技术诀窍。使用锕方法生产的Ac-225纯度很高,与当前使用钍-229发生器的金标准制造方法相同,但在商业规模上有可能降低成本,并且是一种产量更高的方法。
Specifically, Actinium's Ac-225 based technology and production methods are grounded in several U.S. and International patents that cover the following areas:.
具体而言,锕基于Ac-225的技术和生产方法基于多项美国和国际专利,涵盖以下领域:。
End-to-end solution including processing and recycling of Radium-226 starting material
端到端解决方案,包括镭-226原料的加工和回收
Production of up to 100 mCi of Ac-225 per production cycle
每个生产周期生产高达100 mCi的Ac-225
Utilizes a medium energy cyclotron
利用中等能量回旋加速器
Expected cost 10 – 20 times lower than currently available material
预计成本比目前可用的材料低10-20倍
Radiochemical purity > 99%
放射化学纯度>99%
Radioisotopic purity 99.8% with no long-lived contaminants
放射性同位素纯度99.8%,无长寿命污染物
Sandesh Seth, Actinium's Chairman and CEO, said, 'Significant efforts and investments have been made by Actinium in developing our proprietary method and related intellectual property and know-how. With our Ac-225 based Actimab-A program advancing to late-stage trials under our CRADA with the NCI and the rapidly increasing number of Ac-225 based programs in development, the time is now to fully realize the potential of our production method.
Actinium董事长兼首席执行官桑德什·塞思(SandeshSeth)表示,“Actinium在开发我们的专有方法、相关知识产权和专有技术方面做出了重大努力和投资。随着我们的基于Ac-225的Actimab-A计划在我们的CRADA下与NCI一起进入后期试验,以及正在开发的基于Ac-225的计划数量迅速增加,现在是充分发挥我们生产方法潜力的时候了。
We are excited to launch this initiative and are committed to making further strategic investments to bring our method to commercial scale while engaging with potential collaborators and partners globally to maximize the value of our patents and capabilities, as well as to ensure supply for our increasing Ac-225 based product development efforts and address the growing clinical demand.'.
我们很高兴推出这一举措,并致力于进一步进行战略投资,将我们的方法推向商业规模,同时与全球潜在的合作伙伴和合作伙伴合作,以最大限度地提高我们的专利和能力的价值,并确保为我们不断增加的基于Ac-225的产品开发工作提供供应,并满足不断增长的临床需求。”。
Currently, the majority of Ac-225 is supplied by the United States Department of Energy (DOE) who derives Ac-225 from the natural decay of thorium-229 from so-called 'thorium-cows'. Actinium Pharmaceuticals, Inc. has maintained supply agreements with the DOE since 2009. The DOE has stated that it is exploring the generation of new thorium cows and production via a cyclotron.
目前,Ac-225的大部分由美国能源部(DOE)提供,后者从所谓的“钍牛”的钍229的自然衰变中获得Ac-225。Actinium Pharmaceuticals,Inc.自2009年以来一直与美国能源部保持供应协议。美国能源部表示,它正在探索通过回旋加速器产生新的钍母牛和生产。
In addition, multiple government and non-governmental entities globally are focused on Ac-225 production using various methods and have represented that clinical grade Ac-225 could be available over the next several years. However, at this time, the majority of material available is research grade and there is limited availability of clinical grade Ac-225 outside of the material supplied by the DOE. The relative scarcity of Ac-225 has led to rapidly escalating procurement costs in recent years..
此外,全球多个政府和非政府实体都专注于使用各种方法生产Ac-225,并表示未来几年可能会提供临床级Ac-225。然而,目前,大多数可用材料是研究级的,除了DOE提供的材料外,临床级Ac-225的可用性有限。Ac-225的相对稀缺性导致近年来采购成本迅速上升。。
Mr. Seth, added, 'Having already produced highly pure material at scale, we believe our method can be implemented rapidly thereby accelerating supply of highly sought after clinical grade Ac-225. From a technical perspective, our proprietary method addresses the limited availability of source material needed to generate Ac-225 via a cyclotron by purifying and recycling from a variety of different sources.
塞思补充道,“我们已经大规模生产出高纯度的材料,我们相信我们的方法可以迅速实施,从而加速供应备受追捧的临床级Ac-225。从技术角度来看,我们的专有方法通过从各种不同来源进行净化和回收,解决了通过回旋加速器产生Ac-225所需的源材料的有限可用性。
This enables us to leverage the large infrastructure of cyclotrons that already exists globally or the ability to establish new facilities for significantly less cost and faster than reactor or linear accelerator-based production methods. In addition, we have developed several additional technical benefits enabling scalability and manufacturing efficiencies.
这使我们能够利用全球已经存在的大型回旋加速器基础设施,或者能够以比基于反应堆或直线加速器的生产方法更低的成本和更快的速度建立新设施。此外,我们还开发了一些额外的技术优势,实现了可扩展性和制造效率。
Based on our experience to date, we expect to be able to produce material with high radiochemical purity and at yields not possible with thorium-cow based methods. This has the potential to further establish Actinium as a leader in alpha-particle therapies and remain at the forefront of innovation while addressing a significant and rapidly growing addressable patient population.' .
根据我们迄今为止的经验,我们希望能够生产出具有高放射化学纯度的材料,并且以钍-牛基方法不可能的产量生产。这有可能进一步确立锕作为α粒子疗法的领导者,并保持在创新的前沿,同时解决大量且快速增长的可寻址患者群体。”。
For more information, please visit Actinium Pharmaceuticals, Inc. website https://www.actiniumpharma.com/actinium-225-technology or email sseth-bd@actiniumpharma.com
有关更多信息,请访问Actinium Pharmaceuticals,Inc.网站https://www.actiniumpharma.com/actinium-225-technology或电子邮件sseth-bd@actiniumpharma.com
About Actinium Pharmaceuticals, Inc.
关于Actinium Pharmaceuticals,Inc。
Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA & MAA (EU)), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia.
锕开发有针对性的放射疗法,以有意义地提高现有肿瘤治疗失败的人的生存率。骨髓移植前的诱导和调理剂Iomab-B(pre-BLA&MAA(EU))和治疗剂Actimab-A(National Cancer Institute CRADA pivotal development path)已证明有潜力延长复发和难治性急性髓细胞白血病患者的生存结果。
Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium holds more than 220 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron..
Actinium计划推进Iomab-B治疗其他血癌,下一代调理候选Iomab ACT改善细胞和基因治疗结果。锕拥有220多项专利和专利申请,其中包括与在回旋加速器中制造同位素Ac-225有关的多项专利。。
For more information, please visit: https://www.actiniumpharma.com/
有关更多信息,请访问:https://www.actiniumpharma.com/
Forward-Looking Statements
前瞻性声明
This press release may contain projections or other 'forward-looking statements' within the meaning of the 'safe-harbor' provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update.
本新闻稿可能包含1995年《私人证券诉讼改革法案》中“安全港”条款所指的关于公司未来事件或未来财务表现的预测或其他“前瞻性声明”,公司没有义务更新这些预测或声明。
These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the 'SEC'), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time..
这些声明基于管理层当前的预期,并受到可能导致实际结果与预期或估计的未来结果产生重大差异的风险和不确定性的影响,包括与初步研究结果相关的风险和不确定性,这些风险和不确定性与最终结果不同,对正在开发的药物的潜在市场的估计,临床试验,FDA和其他政府机构的行动、监管许可、对监管事项的回应、市场对锕的产品和服务的需求和接受程度、临床研究组织的表现以及锕提交给证券交易委员会(“SEC”)的文件中不时详述的其他风险,包括但不限于表10-K中的最新年度报告、表10-Q和表8-K中的后续季度报告,每一份报告都会不时修订和补充。。
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SOURCE Actinium Pharmaceuticals, Inc.
来源Actinium Pharmaceuticals,Inc。