A Pilot Study to Assess Impact of Low Dose Melphalan on Disease Burden Measured by Next Generation Sequencing Before Autologous Hematopoietic Cell Transplant (AHCT) for Multiple Myeloma Patients

The purpose of this study is to see if Multiple Myeloma (MM) cells are sensitive to the chemotherapy used in transplant or not. The main chemotherapy agent utilized in stem cell transplant is melphalan. The study will utilize 1/10 of the dose used in transplant to study sensitivity of the tumor to melphalan. Melphalan is approved by the U.S. Food and Drug Administration (FDA) for transplant for MM patients.

开始日期2023-09-01

申办/合作机构-

NCT05438394 / Recruiting临床1期IIT

Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for Injection in the Treatment of Relapsed or Relapsed and Refractory Multiple Myeloma

This study is an investigator-initiated clinical study to evaluate the safety and tolerability of melphalan hydrochloride for injection in patients with relapsed or relapsed refractory multiple myeloma. Using the "3 + 3" dose escalation principle, 3-6 subjects per dose were enrolled, depending on the dose limiting toxicity (DLT) observed in the first cycle of chemotherapy for each subject. After completing the 21-day assessment of the first cycle of chemotherapy, if there was no DLT, the study started for the next dose group.

开始日期2022-10-13

申办/合作机构

北京大学人民医院

[+1]

NCT04681417 / Recruiting临床2/3期IIT

Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018

This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients:
Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments.
Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.

开始日期2021-03-25

申办/合作机构

Institut Curie

[+1]

100 项与盐酸美法仑相关的临床结果

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100 项与盐酸美法仑相关的转化医学

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100 项与盐酸美法仑相关的专利（医药）

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1,130

项与盐酸美法仑相关的文献（医药）

2024-05-01·Food chemistry

Identification and molecular binding mechanism of novel pancreatic lipase and cholesterol esterase inhibitory peptides from heat-treated adzuki bean protein hydrolysates

Article

作者: Jiang, Yuanrong ; Fan, Yimeng ; Gu, Jie ; Zhao, Qingyu ; Hao, Zhihui ; Zhao, Liangxing ; Shen, Qun ; Xue, Yong ; Zhu, Yiqing

Heat-treated adzuki bean protein hydrolysates exhibit lipid-reducing properties; however, few studies have reported pancreatic lipase (PL) and cholesterol esterase (CE) inhibitory effects and elucidated the underlying mechanisms. In this study, we accomplished the identification of antiobesity peptides through peptide sequencing, virtual screening, and in vitro experiments. Furthermore, the mechanisms were investigated via molecular docking. The findings reveal that the action of pepsin and pancreatin resulted in the transformation of intact adzuki bean protein into smaller peptide fragments. The < 3 kDa fraction exhibited a high proportion of hydrophobic amino acids and displayed superior inhibitory properties for both PL and CE. Five novel antiobesity peptides (LLGGLDSSLLPH, FDTGSSFYNKPAG, IWVGGSGMDM, YLQGFGKNIL, and IFNNDPNNHP) were identified as PL and CE inhibitors. Particularly, IFNNDPNNHP exhibited the most robust biological activity. These peptides exerted their inhibitory action on PL and CE by occupying catalytic or substrate-binding sites through hydrogen bonds, hydrophobic interactions, salt bridges, and π-π stacking.

2024-04-01·Journal of the science of food and agriculture

Synergistic effects of ferulic acid esterase‐producing lactic acid bacteria, cellulase and xylanase on the fermentation characteristics, fibre and nitrogen components and microbial community structure of Broussonetia papyrifera during ensiling

Article

作者: Cheng, Qiming ; Yang, Fuyu ; Xu, Jinyi ; Yu, Qiang ; Li, Ping ; Li, Mengxin ; Xi, Yulong ; Sun, Hong ; Xie, Yixiao ; Chen, Chao ; Zheng, Yulong

Abstract:

BACKGROUND:

The high fibre content of whole plants of Broussonetia papyrifera limits its efficient utilization. Ferulic acid esterase (FAE), in combination with xylanase, can effectively cleave the lignin–carbohydrate complex, promoting the function of cellulase. However, little is known about the impact of these additives on silage. To effectively utilize natural woody plant resources, FAE‐producing Lactiplantibacillus plantarum RO395, xylanase (XY) and cellulase (CE) were used to investigate the dynamic fermentation characteristics, fibre and nitrogen components and microbial community structure during B. papyrifera ensiling.

RESULTS:

Broussonetia papyrifera was either not treated (CK) or treated with FAE‐producing lactic acid bacteria (LP), CE, XY, LP + CE, LP + XY or LP + CE + XY for 3, 7, 15, 30 or 60 days, respectively. In comparison with those in the CK treatment, the L. plantarum and enzyme treatments (LP + CE, LP + XY and LP + XY + CE), especially the LP + XY + CE treatment, significantly increased the lactic acid concentration and decreased the pH and the contents of acid detergent insoluble protein and NH3‐N (P < 0.05). Enzyme addition improved the degradation efficiency of lignocellulose, and a synergistic effect was observed after enzyme treatment in combination with LP; in addition, the lowest acid detergent fibre, neutral detergent fibre, hemicellulose and cellulose contents were detected after the LP + CE + XY treatment (P < 0.05). Moreover, CE, XY and LP additions significantly improved the microbial community structure, increased the relative abundance of Lactiplantibacillus and Firmicutes, and effectively inhibited undesirable bacterial (Enterobacter) growth during ensiling.

CONCLUSION:

FAE‐producing L. plantarum and the two tested enzymes exhibited synergistic effects on improving the quality of silage, which indicates that this combination can serve as an efficient method for improved B. papyrifera silage utilization. © 2023 Society of Chemical Industry.

2024-03-01·Phytomedicine : international journal of phytotherapy and phytopharmacology

Isolation of Calenduloside E from Achyranthes bidentata Blume and its effects on LPS/D-GalN-induced acute liver injury in mice by regulating the AMPK-SIRT3 signaling pathway

Article

作者: Feng, Weisheng ; Jia, Jufang ; Guo, Pengli ; Zeng, Mengnan ; Zheng, Xiaoke ; Liu, Meng ; Liang, Shulei ; Zhang, Yuhan ; Zhang, Ziyu

BACKGROUND:

Acute liver injury (ALI) is a frequent fatal liver disease with a high mortality. Calenduloside E (CE) is a pentacyclic triterpenoid derived from Achyranthes bidentata Blume. It has been found that liver injury is associated with mitochondrial dysfunction, and activation of the AMPK-SIRT3 signaling pathway protects the mitochondrial function to play a role in resistance to the disease. However, whether CE is protective against ALI through the AMPK-SIRT3 signaling pathway is unclear.

PURPOSE:

To clarify the influences of Calenduloside E (CE) isolated from Achyranthes bidentata Blume on LPS/D-GalN-induced Acute liver injury (ALI).

METHODS:

A mouse model of ALI was developed, intraperitoneal injection of 10 μg/kg LPS and 700 mg/kg D-GalN, histopathological, oxidative stress, and immune inflammation of the mice were monitored. The mechanism of CE influencing liver injury was investigated by examining the gut microbiota, mitochondrial dysfunction, and the AMPK-SIRT3 signaling pathway. The antagonistic effects of specific AMPK and SIRT3 blocker, as well as AMPKα1, AMPKα2, SIRT3 transfection-mediated silencing were investigated to confirm the role of the AMPK-SIRT3 signaling pathway in this process.

RESULTS:

CE relieved liver pathological damage of mice and led to reduced oxidative stress and immune inflammation in mice, affected the balance of gut microbiota in mice with liver injury, as well as energy metabolism, and regulated mRNA and protein expressions of AMPK-SIRT3 signaling pathway. In addition, in vitro studies showed that CE relieved mitochondrial respiratory and protein expressions of AMPK-SIRT3 signaling pathway in LPS/D-GalN-induced AML12 and LX2 cells, and such effect was blocked by AMPK and SIRT3 inhibitors. Furthermore, silencing of AMPKα1, AMPKα2, and SIRT3 blocked the effects of CE. Overall, the influences of CE on mice with liver injury is tuned by the AMPK-SIRT3 signaling pathway.

CONCLUSION:

CE mediates mitochondrial function and eventually regulate energy metabolism by regulating the AMPK-SIRT3 signaling pathway. The results of this study provide molecular evidences for application of CE in treatment of ALI and provide references to the drug development for ALI.

128

项与盐酸美法仑相关的新闻（医药）

2024-06-26

·PRNewswire

CASI Pharmaceuticals Announces Plan To Submit IND Application For CID-103, an Anti-CD 38 Antibody in Antibody-Mediated Rejection, and Receipt of a Non-Binding Proposal to Acquire Entire China Business of the Company

BEIJING, June 26, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, announced today that the Company is planning to submit an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for CID-103 for the treatment of antibody-mediated rejection ("AMR") in kidney transplant recipients by the end of 2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. The Company believes that with the proceeds from the previously announced private placement financing, together with its existing cash and cash equivalents, it will have sufficient capital to complete the Phase II clinical trial for AMR. CASI also announced that its board of directors (the "Board") received a preliminary non-binding proposal letter (the "Proposal Letter") dated June 21, 2024, from Dr. Wei-Wu He, Chairman of the Board and CEO of the Company, to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company's pipeline products, including but not limited to EVOMELA®, FOLOTYN®, CNCT19, BI-1206, CB-5339,CID-103 and Thiotepa, for an aggregate purchase price of $40.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the "Proposed Transaction"). On June 25, the Board has formed a special committee comprised solely of incumbent independent directors (the "Special Committee") to evaluate the transaction contemplated under the Proposal Letter and such other strategic and business alternatives available to the Company in respect of the Company's business operations in China. The Board and the Special Committee caution the Company's shareholders and others considering trading the Company's securities that no decisions have been made with respect to the Proposed Transaction or any alternative strategic option that the Company may pursue. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the Proposed Transaction or that any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law. About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. Forward-Looking Statements This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China, our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the FDA, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. COMPANY CONTACT: Rui Zhang CASI Pharmaceuticals, Inc. 240.864.2643 [email protected] SOURCE CASI Pharmaceuticals

临床申请临床2期临床1期

2024-05-28

·BioSpace

Delcath Systems Announces Appointment of Bridget Martell, MA, MD to Delcath’s Board of Directors

NEW YORK--(BUSINESS WIRE)-- Delcath Systems, Inc., (Nasdaq: DCTH) (the “Company” or “Delcath”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, is pleased to announce the appointment of Dr. Bridget Martell to the Company’s Board of Directors effective May 23, 2024. “We are pleased to welcome Dr. Martell to the Delcath Board,” said John Sylvester, Chairman of the Delcath Board of Directors. “Dr. Martell’s extensive experience serving both in senior management roles and as a director at multiple biotechnology companies, as well as her expertise in oncology clinical development, will be a great asset to Delcath as we strive to achieve our mission of improving patient outcomes.” Dr. Martell is currently an independent director at the publicly traded companies Aligos Therapeutics (Nasdaq:ALGS) and Achieve Life Sciences (Nasdaq: ACHV). She was a director of POINT Biopharma Global, Inc. (Nasdaq: PNT), a cancer treatment biotechnology company, from June 2023 until its acquisition by Eli Lilly and Company in December 2023 and Ayala Pharmaceuticals, another oncology focused company whose assets were sold to Immunome in March of 2024. She recently joined Two Bear Capital as a Biotechnology Operating Partner. Prior to this she was the founder and managing partner of BAM Consultants, a biotechnology focused consulting practice and during that tenure has served in a full time capacity as a C-suite executive including as President and Chief Executive Officer of Artizan Biosciences, Inc., a privately held biotechnology company, and as a Chief Medical Officer for various early-stage and mid-stage private and public biotechnology companies. Dr. Martell holds a B.S. in microbiology from Cornell University, an M.A. in Molecular Immunology from Boston University and an M.D. from Chicago Medical School. She completed her internship and residency in internal medicine and was an internal medicine chief resident and RWJ Faculty Clinical Scholar at Yale University. Dr. Martell is board certified in both Internal and Addiction Medicine. Dr. Martell was a Teaching Attending and Clinical Associate Professor at Yale from 2005 to 2020 and has continued her engagement at Yale as an Entrepreneur In Residence at Yale Ventures since 2017. “I am excited to be joining Delcath’s Board of Directors at this crucial time in the Company’s growth and evolution,” said Dr. Martell. “I look forward to supporting the Delcath team both in its near-term commercial goals and longer-term clinical development strategy.” About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.

高管变更上市批准并购

2024-05-14

·BioSpace

Delcath Systems Reports First Quarter 2024 Results and Business Highlights

Conference Call Today at 8:30 am Eastern Time QUEENSBURY, N.Y., May 14, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported financial results and business highlights for the first quarter ended March 31, 2024. Recent Business Highlights During and since the first quarter, Delcath: Recognized over $2.0 million of revenue from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.1 million in CHEMOSAT sales through March 31, 2024; Updated U.S. center activation guidance from 15 active centers to a total of 20 active centers by the end of 2024; Activated four treating centers during the first quarter with an additional two centers in April. A further five centers are accepting patient referrals in anticipation of activation; Raised $7.0 million in a private placement transaction with certain accredited investors comprised of existing investors, Delcath senior executives, and members of its Board of Directors; Appointed Martha S. Rook, Ph.D, an experienced industry leader with more than 25 years of academic and industry experience, as Chief Operating Officer; Received a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO KIT from the Centers for Medicare & Medicaid Services (CMS) which became effective on April 1, 2024; Executed an amendment with Synerx Pharma, LLC and Mylan Teoranta for Delcath's supply of melphalan hydrochloride which extends the term of the original agreement to December 31, 2028; and Announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma on May 4, 2024, in the journal Annals of Surgical Oncology. "We continue to make steady progress in the training and activation of new treatment centers which is a testament to both the emerging role of HEPZATO in the treatment of patients with metastatic uveal melanoma and the capability and dedication of our field force," said Gerard Michel, Delcath's Chief Executive Officer. "We are committed to expanding the availability of HEPZATO to patients in need and I am confident that we will reach our goal of 20 treating centers by the end of 2024." First Quarter 2024 Results Cash, cash equivalents and investment totaled $27.2 million as of March 31, 2024, which includes a $7.0 million private placement financing which closed on March 19, 2024. Total revenue for the quarter ended March 31, 2024 was $3.1 million compared to $0.6 million for the same period in the prior year from our sales of HEPZATO in the U.S. and CHEMOSAT in Europe. Research and development expenses for the quarter ended March 31, 2024, were $3.7 million compared to $4.6 million for the same period in the prior year. The change in research and development expenses is primarily due to a decrease in clinical trial activities and expenses related to the FDA inspection offset by an increase in personnel related expenses. Selling, general and administrative expenses for the quarter ended March 31, 2024, were $8.8 million compared to $4.2 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Safe Harbor / Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company's filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. Investor Relations Contact: Westwicke Partners investorrelations@delcath.com Company Codes: NASDAQ-NMS:DCTH

高管变更临床3期财报上市批准

100 项与盐酸美法仑相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D08173	盐酸美法仑	L01AA03	DB01042

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
葡萄膜黑色素瘤	美国	Delcath Systems, Inc.	2023-08-14
急性淋巴细胞白血病	欧盟	Adienne SRL	2020-11-16
急性淋巴细胞白血病	冰岛	Adienne SRL	2020-11-16
急性淋巴细胞白血病	列支敦士登	Adienne SRL	2020-11-16
急性淋巴细胞白血病	挪威	Adienne SRL	2020-11-16
急性髓性白血病	欧盟	Adienne SRL	2020-11-16
急性髓性白血病	冰岛	Adienne SRL	2020-11-16
急性髓性白血病	列支敦士登	Adienne SRL	2020-11-16
急性髓性白血病	挪威	Adienne SRL	2020-11-16
霍奇金淋巴瘤	欧盟	Adienne SRL	2020-11-16
霍奇金淋巴瘤	冰岛	Adienne SRL	2020-11-16
霍奇金淋巴瘤	列支敦士登	Adienne SRL	2020-11-16
霍奇金淋巴瘤	挪威	Adienne SRL	2020-11-16
乳腺腺癌	欧盟	Adienne SRL	2020-11-16
乳腺腺癌	冰岛	Adienne SRL	2020-11-16
乳腺腺癌	列支敦士登	Adienne SRL	2020-11-16
乳腺腺癌	挪威	Adienne SRL	2020-11-16
神经母细胞瘤	欧盟	Adienne SRL	2020-11-16
神经母细胞瘤	冰岛	Adienne SRL	2020-11-16
神经母细胞瘤	列支敦士登	Adienne SRL	2020-11-16

未上市

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适应症	最高研发状态	国家/地区	公司	日期
眼部黑色素瘤	申请上市	美国	Delcath Systems, Inc.	2023-03-27
黑色素瘤	临床3期	美国	Delcath Systems, Inc.	2022-06-10

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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


NCT03417284 (EHA2024) 人工标引	临床1/2期	多发性骨髓瘤一线	60	EVOMELA (short infusion)	鬱鏇艱鑰鹽艱壓選鹹獵(鏇築蓋繭齋壓鑰遞獵蓋) = 襯壓壓獵鏇築鹹鹽壓遞餘蓋積構選簾齋壓顧餘 (鬱壓壓艱夢窪窪築觸觸 ) 更多	积极	2024-05-14
				EVOMELA (extend infusion)	鬱鏇艱鑰鹽艱壓選鹹獵(鏇築蓋繭齋壓鑰遞獵蓋) = 範壓選膚襯憲鏇夢窪醖餘蓋積構選簾齋壓顧餘 (鬱壓壓艱夢窪窪築觸觸 ) 更多
ChiCTR2300077686 (EHA2024)	N/A	多发性骨髓瘤	44	Kangfuxin + G-CSF cryotherapy	網醖蓋艱糧衊鏇膚繭鹹(蓋積鬱願網顧簾壓構網) = 觸齋夢顧鹽鏇糧淵簾獵壓鹹選衊願艱艱積獵糧 (憲齋夢醖蓋鑰鹽製齋鹹 ) 更多	积极	2024-05-14
				Ice saltwater cryotherapy	網醖蓋艱糧衊鏇膚繭鹹(蓋積鬱願網顧簾壓構網) = 鹹鹹範簾糧餘糧鹽範艱壓鹹選衊願艱艱積獵糧 (憲齋夢醖蓋鑰鹽製齋鹹 ) 更多
FOCUS (PRNewswire) 人工标引	N/A	葡萄膜黑色素瘤	91	HEPZATO KIT	糧蓋淵鑰遞膚製獵積積(遞餘糧築壓窪鏇壓襯願) = 夢顧構獵積遞願築蓋顧窪積膚鏇觸艱艱廠鏇簾 (鏇齋艱願顧艱憲範鑰夢 ) 更多	积极	2024-05-06
ASH2023	临床1/2期	多发性骨髓瘤	60	Evomela (Short infusion)	衊觸膚壓窪顧廠選製夢(鏇獵餘衊膚鬱窪壓鹹醖): HR = 9.5 (95% CI, 1 ~ 91.2), P-Value = 0.022	-	2023-12-11
				Evomela (Extended infusion)
FDA 人工标引	N/A	多发性骨髓瘤	295	Melphalan hydrochloride (Oral)	艱獵糧蓋糧襯觸膚簾鏇(觸憲築遞製齋齋醖積襯) = 糧築網鏇鑰夢築齋顧鹽積鹹醖製糧憲選顧齋鬱 (積獵窪鑰廠鬱鑰淵鹹製 ) 更多	积极	2023-08-18
				Melphalan hydrochloride + Intravenous	艱獵糧蓋糧襯觸膚簾鏇(觸憲築遞製齋齋醖積襯) = 選夢艱構襯憲膚願網糧積鹹醖製糧憲選顧齋鬱 (積獵窪鑰廠鬱鑰淵鹹製 ) 更多
P125 (EBMT2021)	N/A	巩固	59	High-dose melphalan	顧齋糧壓築衊壓遞鏇製(構願夢壓糧簾製憲鹹廠) = 鹽鏇簾鹹鬱襯憲鹹窪夢鬱獵鬱觸簾鹹鏇艱餘獵 (製鹽積網築遞築製壓襯, 59 ~ 112) 更多	积极	2021-03-14
P154 (EBMT2018)	N/A	难治性霍奇金淋巴瘤	112	BEAM	餘築築鹽糧鬱鹹窪範糧(齋鏇窪鏇夢製醖壓膚憲) = 鹹憲憲獵壓襯網製簾製製膚淵夢鏇鹹觸鹽遞鬱 (廠廠蓋願襯淵糧製衊鏇 ) 更多	-	2018-11-19
				High Dose Melphalan (HDM)	餘築築鹽糧鬱鹹窪範糧(齋鏇窪鏇夢製醖壓膚憲) = 鏇艱壓膚鹽憲鏇遞鬱遞製膚淵夢鏇鹹觸鹽遞鬱 (廠廠蓋願襯淵糧製衊鏇 ) 更多
NCT01648283 (CTgov)	N/A	-	78	IV racemic methadone HCl	齋膚構鏇繭鬱選簾範構(獵鬱鏇積餘獵廠觸簾鏇) = 襯憲獵範網積夢夢選壓衊糧範鬱鑰鹹襯構築鑰 (積製醖廠醖艱顧艱衊鏇, 鹽顧鹽繭積範壓繭積艱 ~ 鏇構願襯選齋鏇製糧廠) 更多	-	2018-06-20
NCT01293539 (CTgov)	临床2期	小儿眼内视网膜母细胞瘤	10	Melphalan	醖顧積築網鏇積製廠願(獵襯壓窪齋獵糧鹽遞廠) = 襯鹽鑰網窪膚製選夢窪鏇齋襯網獵艱範夢鹹憲 (齋製範廠壓簾餘夢衊醖, 鏇積顧淵蓋醖鑰蓋鬱簾 ~ 鏇簾艱顧獵壓築憲鹽顧) 更多	-	2017-07-21
NCT00925782 (CTgov)	临床2期	多发性骨髓瘤	24	Melphalan (Melphalan)	壓鬱窪壓鹹憲鏇餘蓋艱(窪廠製餘製製鹹觸鹽積) = 淵積齋築鬱網艱簾艱餘遞襯遞構壓餘鑰夢簾襯 (夢簾繭顧襯願艱繭積膚, 夢膚選淵鹽窪艱壓衊鏇 ~ 鑰獵鏇鹹鏇鑰齋鏇範廠) 更多	-	2014-08-20
				Melphalan+Propylene Glycol+Alkeran (Alkeran)	壓鬱窪壓鹹憲鏇餘蓋艱(窪廠製餘製製鹹觸鹽積) = 築鑰糧夢構鏇糧選顧選遞襯遞構壓餘鑰夢簾襯 (夢簾繭顧襯願艱繭積膚, 鑰醖獵繭選淵築願艱觸 ~ 鏇襯遞艱蓋憲鑰壓鑰繭) 更多