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符合「Clinical Trials/Medical Discoveries」新聞搜尋結果, 共 1477 篇 ,以下為 121 - 144 篇 訂閱此列表,掌握最新動態
Antennova Presents Latest Phase I/II Data on ATN-022 in Advanced/Metastatic Gastric Cancer, Including an ORR of 42.9%, at ASCO GI 2025

BOSTON, Jan. 22, 2025 /PRNewswire/ -- Antennova, a clinical-stage biotech company focused on oncology today announced the presentation of latest data from its Phase I/II CLINCH study ongoing in China and Australia evaluating ATN-022 (CLDN18.2 antibody-drug conjugate [ADC]) in patients with advanced or metastatic gastric cancer at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2025 (ASCO GI 2025). The CLINCH study is a Phase I/II study ongoing in China and Australia with a dose escalation phase followed by a dose expansion phase. As of November 22, 2024, among 21 gastric cancer patients in dose expansion phase with CLDN 18.2 expression of IHC 2+ ≥ 20% who had at least 1 tumor evaluation, the overall response rate (ORR) was 42.9%, and the disease control rate (DCR) was 95.2% (9 partial responses [PRs] including 8 confirmed PRs; and 11 stable diseases [SDs]).  Among 10 gastric cancer patients with CLDN 18.2 expression of IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg, the ORR was 30.0% (1 complete response [CR] and 2 PRs, all PR/CR were confirmed with CLDN 18.2 expression of IHC 2+ < 5%), and the DCR was 50.0%. The patient with CR has demonstrated durable response and has been on the study for over 14 months as of the cut-off date. ATN-022 demonstrated a manageable safety profile and promising preliminary antitumor activity in late stage gastric cancer patients across various levels of CLDN18.2 expression, supporting further clinical investigations of ATN-022 in gastric cancer patients. The enrollment of gastric cancer patients for dose optimization and patients with other solid tumors is ongoing in China and Australia. Details of the Poster Presentation: ATN-022 (also known as ATG-022, CLDN18.2 antibody-drug conjugate) Title: Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH) Abstract Number: 456  Session: Poster Session A: Cancers of Esophagus and Stomach and Other Gastrointestinal Cancers Presenter: Jinfeng Ma  Shanxi Cancer Hospital Date: Thursday, January 23, 2025 Time: 11:30 AM - 1:00 PM (Pacific time)            3:30 AM - 5:00 AM, January 24, 2025 (Beijing time) About ATN-022 ATN-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, pancreatic and other cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATN-022, for gastric and pancreatic cancers. Data from the ongoing CLINCH study of ATN-022 has shown promising clinical efficacy in gastric cancer patients with various levels of CLDN18.2 expression. The efficacy already observed across all levels of CLDN18.2 expression in patients with gastric cancer suggests that ATN-022 holds the promise as a competitive treatment option. About Antennova Antennova, a Delaware corporation and a subsidiary of Antengene (HKEX: 6996), is a clinical-stage biotech company specialized in developing innovative therapeutics that target the critical biological mechanisms that enable cancers to evade and resist treatment by current drugs. Antennova is developing a pipeline of oncology candidates that can potentially enhance the effectiveness of standard therapies. Forward-Looking Statements The forward-looking statements made in this document relate only to the events or information as of the date on which the statements are made in this document. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this document completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this document, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this document. Any of these intentions may alter in light of future development. For more information, please contact: Investor RelationsEmail: ir@antennova.com

文章來源 : PR Newswire 美通社 發表時間 : 瀏覽次數 : 129 加入收藏 :
Ascletis Announces Positive Results from U.S. Phase Ia Single Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30 and Provides Program Update

ASC30 oral tablet demonstrated dose-proportional pharmacokinetic (PK) properties and a long half-life (t1/2) up to 60 hours in the single ascending dose (SAD) study of patients with obesity, supporting once-daily or less frequent oral dosing. ASC30 oral tablet was generally safe and well tolerated. All adverse events (AEs) were mild (grade 1) or moderate (grade 2), and most of the AEs were gastrointestinal (GI)-related. There were no grade 3 or higher AEs as well as no serious AEs (SAEs). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and other liver enzymes were in normal ranges. ASC30 oral tablet is stable at room temperature. Relative oral bioavailability of ASC30 tablet is 99% in animal models. Data from the animal models utilizing a new tablet formulation of ASC30 support up to once-weekly oral dosing. Topline results, including weight loss, safety and PK, from the U.S. Phase Ib multiple ascending dose (MAD) study of ASC30 oral tablet, once daily, in obese patients are expected by the end of March 2025. HONG KONG, Jan. 21, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces today positive topline results from its U.S. single ascending dose (SAD) study  (NCT06680440) of ASC30 oral tablet in patients with obesity (body mass index (BMI): 30-40 kg/m2). The SAD study consists of five cohorts (2 mg, 5 mg, 10 mg, 20 mg and 40 mg) with a total of 40 patients with obesity under fasting conditions. ASC30 oral tablet demonstrated dose-proportional pharmacokinetic (PK) properties and a long half-life (t1/2) up to 60 hours in the SAD study of patients with obesity, supporting once-daily or less frequent oral dosing. Cross-trial comparison indicates that in humans, drug exposure (area under the curve, "AUC") of 5 mg ASC30 single dose is 2.2-fold of that of 6 mg orforglipron single dose [1]. ASC30 oral tablet demonstrated superior PK properties (including a longer t1/2 and higher AUC) to other small molecule oral GLP-1 receptor (GLP-1R) agonists in development [1-3], suggesting ASC30 oral tablet has the potential to be a best-in-class small molecule GLP-1R agonist to treat obesity. In Cohort 5, 40 mg ASC30 oral tablet single dose was given orally to patients with obesity under both fasting and fed conditions. The data indicated that ASC30 oral tablet's PK properties including AUC and t1/2 were essentially identical in the absence or presence of food, suggesting that ASC30 oral tablet can offer patient-friendly, once-daily oral dosing without food and water restrictions. ASC30 oral tablet was generally safe and well tolerated in the Phase Ia SAD study.  All adverse events (AEs) were mild (grade 1) or moderate (grade 2), and most of the AEs were gastrointestinal (GI)-related. There were no grade 3 or higher AEs, as well as no serious AEs (SAEs). GI-related safety profiles of ASC30 oral tablet were consistent with or better than other small molecule oral GLP-1R agonists in development [1, 3, 4] (Table 1). Furthermore, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and other liver enzymes were in normal ranges. Table 1. All GI-related AEs of ASC30 oral tablet were mild (grade 1) or moderate (grade 2)  TEAE, n (%) Placebo(N = 10) Cohort 12 mg ASC30(N=6) Cohort 25 mg ASC30(N=6) Cohort 310 mg ASC30(N=6) Cohort 420 mg ASC30(N=6) Cohort 540 mg ASC30(N=6) GI-related TEAE 1 (10.0) 0 1 (16.7) 4 (66.7) 5 (83.3) 6 (100.0) Diarrhea 0 0 1 (16.7) 0 0 0 Constipation 1 (10.0) 0 0 0 1 (16.7) 1 (16.7) Vomiting 0 0 0 2 (33.3) 5 (83.3) 5 (83.3) Nausea 1 (10.0) 0 1 (16.7) 3 (50.0) 5 (83.3) 6 (100.0) TEAE: Treatment-Emergent Adverse Event; GI: Gastrointestinal; n: Number of patients who had GI-related TEAE ineach dose level; N: Number of patients who received the study drug. ASC30 oral tablet formulation, which is stable at room temperature, was developed using Ascletis' proprietary technology and has a relative oral bioavailability of 99% at steady state in animal models. Data from the animal models utilizing a new tablet formulation (stable at room temperature) of ASC30 support up to once-weekly oral dosing. ASC30 was discovered and developed in-house at Ascletis as a GLP-1R biased small molecule agonist without β-arrestin recruitment.  ASC30 has unique and differentiated properties that enable the administration of one small molecule as both a once-monthly subcutaneous injection and a once-daily oral tablet. ASC30 has two- to three-fold better in vitro potency against GLP-1R when compared head-to-head with orforglipron. In the intravenous glucose tolerant test (IVGTT) in non-human primates (NHPs), ASC30 (1.5 mg/kg dose) stimulated statistically and significantly more insulin secretion when compared head-to-head with orforglipron (6 mg/kg dose). ASC30 is the first and only small molecule GLP-1R biased agonist that can be dosed once monthly subcutaneously and once daily orally for the treatment of obesity. ASC30 oral tablet has the potential to be a best-in-class GLP-1R small molecule agonist given its PK and safety profiles as well as potency against GLP-1R. "We are excited that the results from our Phase Ia SAD trial of ASC30 oral tablet, once daily in patients with obesity demonstrated potential best-in-class characteristics. With superior PK properties observed in the SAD study, we are looking forward to sharing efficacy, safety, and PK data from Phase Ib 28-day multiple ascending dose (MAD) trial of patients with obesity by the end of March this year," said Dr. Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis, "As one small molecule, ASC30 potentially offers both once-daily oral and once-monthly subcutaneous injection dosing options." ASC30 Oral Tablet U.S. Phase Ib MAD Study Update The ASC30 oral tablet MAD study consists of 3 cohorts with weekly titrations in which patients with obesity are treated for 28 days with ASC30 oral tablet once daily or placebo. Cohort 1 (2 mg, 5 mg, 10 mg and 20 mg) has been completed. Cohort 2 (2 mg, 10 mg, 20 mg and 40 mg) and Cohort 3 (5 mg, 15 mg, 30 mg and 60 mg) are expected to be completed in late February and March 2025, respectively. Topline results from the MAD study, including weight loss, safety and PK, are expected by the end of March 2025. ASC30 Oral Tablet U.S. Phase Ia and Ib Clinical Studies for the Treatment of Obesity The Phase Ia study of ASC30 oral tablet once-daily is a randomized, double-blind, placebo-controlled, single ascending dose (5 cohorts) study to evaluate the safety, tolerability, and PK of ASC30 oral tablet in patients with obesity (BMI: 30-40 kg/m2). The Phase Ib study of ASC30 oral tablet once daily is a randomized, double-blind, placebo-controlled, multiple ascending dose (3 cohorts, weekly titration, once-daily treatment for 28 days) study to evaluate the safety, tolerability, PK and efficacy of ASC30 in patients with obesity (BMI: 30-40 kg/m2). About ASC30 ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both subcutaneous injection and oral tablet administrations. ASC30 is a new molecular entity (NME), with U.S. and global compound patent protection until 2044.  References Diabetes Obes Metab. 2023; 25:2634–2641. Obesity 2024: Volume 32, Issue S1, Poster 342. Obesity 2024: Volume 32, Issue S1, Poster 219. Diabetes 2023: Volume 72, Issue Supplement_1, Poster 754. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on two therapeutic areas with unmet medical needs from a global perspective: metabolic diseases and viral diseases. Ascletis has multiple clinical stage drug candidates in its R&D pipeline. For more information, please visit www.ascletis.com. Contact:Peter VozzoICR Healthcare443-231-0505 (U.S.)Peter.vozzo@icrhealthcare.com Ascletis Pharma Inc. PR and IR teams+86-181-0650-9129 (China)pr@ascletis.comir@ascletis.com

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TAHO Pharmaceuticals Completes Pivotal Trial of TAH3311, the First Oral Dissolving Film Anticoagulant

TAIPEI, Jan. 21, 2025 /PRNewswire/ -- TAHO Pharmaceuticals is pleased to announce the successful completion of the pivotal trial for TAH3311, the first anticoagulant oral dissolving film (ODF). This trial was conducted following detailed discussions and alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), marking a major milestone in the advancement of this innovative product under the 505(b)(2) regulatory pathway. The trial enrolled 60 healthy volunteers to compare TAH3311 ODF with the Apixaban tablet (brand name Eliquis®) under the bioequivalence (BE) regulatory framework. Apixaban, a Factor Xa inhibitor, is widely used for stroke prevention and treatment of thromboembolic conditions due to its lower dosage requirements and reduced gastrointestinal bleeding risk compared to other anticoagulants. TAH3311 addresses a significant unmet need in this market by offering the first ODF formulation, providing a water-free alternative that is especially beneficial for patients with swallowing difficulties, including the elderly, stroke survivors, and children. According to IQVIA, the global market for anticoagulants is rapidly expanding, with apixaban achieving U.S. sales of $22.1 billion in 2023, making it the leading small-molecule drug globally and the second best-selling drug overall.* This remarkable growth highlights a significant opportunity for TAH3311 to address existing clinical unmet needs while offering a unique differentiation in an increasingly competitive landscape. With the trial's completion, TAHO Pharmaceuticals plans to prepare regulatory submissions in both the United States and Europe. Simultaneously, the company is actively pursuing strategic collaborations with international partners to accelerate the global launch of TAH3311 and maximize its impact in key markets. "The completion of this pivotal study is a significant step forward in TAHO's mission to bring innovative Transepithelial Delivery System (TDS) drug delivery solutions to patients worldwide," said Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals. "As the first ODF formulation in the anticoagulant space, TAH3311 has the potential to transform how these life-saving therapies are delivered, especially for patients who face difficulties with traditional tablet forms." *Source: www.pharmacompass.com About Apixaban Apixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including reduction of stroke risk in non-valvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, the treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism. With notable safety advantages, it is the leading novel oral anticoagulant (NOAC). According to various industry reports, apixaban was the second-highest-selling drug globally in 2023. About TAHO Pharmaceuticals Ltd. Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO's diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan.

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YolTech Therapeutics to Initiate a Clinical Trial for YOLT-204, a First-in-Class Bone Marrow-Targeted In Vivo Gene Editing Therapy for β-Thalassemia

SHANGHAI, Jan. 21, 2025 /PRNewswire/ -- YolTech Therapeutics, a clinical-stage gene editing company dedicated to delivering lifelong cures, announced the initiation of a clinical trial for YOLT-204, an investigational therapy for the treatment of transfusion-dependent beta-thalassemia (TDT). TDT is a severe genetic blood disorder where mutations in the beta-globin gene leads to reduced or absence of hemoglobin, a condition where regular blood transfusion is required to manage anemia and prevent other complications. YOLT-204 is a first-in-class in vivo gene editing therapy leveraging YolTech's proprietary lipid nanoparticles (LNP). The therapy edits the regulatory region of hemoglobin to induce expression of fetal hemoglobin, potentially alleviating the imbalance of hemoglobin production and normalizing the number of red blood cells in TDT patients. In pre-clinical models, YOLT-204 showed effective and sustained induction of fetal hemoglobin, suggesting therapeutic potential for TDT. YOLT-204 may also be an effective treatment for patients with sickle cell disease (SCD), as increased expression of fetal hemoglobin in these patients has been associated with less polymerization of sickle hemoglobin as well as reduced complications and mortality. The clinical trial for YOLT-204 is a dose-escalation study to preliminarily examine the safety and efficacy of a single-dose regimen with YOLT-204 in TDT. If successful, YOLT-204 may eventually provide an off-the-shelf curative treatment for TDT patients without conditioning chemotherapy and HSCT (Hematopoietic Stem Cell Transplantation). "The initiation of clinical trial for YOLT-204 represents a significant milestone of gene editing therapy development for TDT and SCD," said Dr. Yuxuan Wu, founder and Chief Executive Officer of YolTech Therapeutics. "We are excited to collaborate with our clinical investigators to bring this innovative therapy to patients." For further details about the trial or YolTech's ongoing programs, please visit [www.yoltx.com] or contact [info@yoltx.com]. About YOLT-204YOLT-204 is an off-the-shelf in vivo gene editing therapy developed for TDT without conditioning chemotherapy and HSCT. YOLT-204 delivers a gene editor to hematopoietic stem cells through YolTech's proprietary lipid nanoparticles. The editor together with a guide RNA targets the hemoglobin regulatory region to induce expression of fetal hemoglobin. The expression of fetal hemoglobin has the potential to normalize hemoglobin composition and the red blood cell counts in patients with transfusion-dependent beta-thalassemia, eventually making them transfusion independent. About YolTechYolTech Therapeutics is a clinical-stage in vivo gene editing company committed to pioneering the next generation of precision genetic medicines. Our approach combines innovative gene editing technologies with an advanced lipid nanoparticle (LNP) delivery system, creating a versatile platform designed to address a wide range of serious diseases. Central to our mission is the development of internal capabilities, including end-to-end manufacturing, to ensure the highest standards of quality and scalability. Our lead candidate, targeting ATTR, marks a significant milestone as China's first LNP-mediated in vivo gene editing therapy to enter clinical development. With promising early clinical outcomes, YolTech is also advancing therapies for familial hypercholesterolemia (FH) and primary hyperoxaluria type 1 (PH1). As a company dedicated to transforming the treatment landscape, YolTech continues to push the boundaries of what is possible in gene editing. For more information, please visit: www.yoltx.com 

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CARsgen's Allogeneic CD38 CAR-T Therapy Administers First Dose in an Investigator-Initiated Trial

SHANGHAI, Jan. 20, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that KJ-C2320, an allogeneic CAR T-cell therapy targeting CD38, has administered the first dose to a patient in an investigator-initiated trial (IIT). KJ-C2320 is developed based on CARsgen's THANK-uCAR® platform. An investigator-initiated trial is ongoing in China to evaluate KJ-C2320 for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML). About THANK-uCAR® THANK (Target to Hinder the Attack of NK cells)-uCAR® is CARsgen's proprietary technology to generate allogeneic CAR-T cells with improved expansion and persistence by modifying donor-derived T cells. To minimize graft versus host disease (GvHD) and host versus graft response (HvGR) from allogeneic T cells, we disrupt the genomic loci encoding TCR and beta-2 microglobulin (B2M) to eliminate surface expression of the TCR or the human leukocyte antigen class I (HLA-I), an approach that has been validated by previous research. However, natural killer (NK) cells can attack T cells without HLA-I expression, which then limits the expansion and persistence of the allogeneic CAR-T cells. To protect the allogeneic CAR-T cells from the patient's NK cells' attacks, we arm these TCR-/B2M-T cells with a CAR that recognizes NKG2A to hinder the NKG2A-positive NK cell rejection of the CAR T cells and therefore allow the THANK-uCAR-T cells to resist the attack by NK cells. Clinical studies have demonstrated that the BCMA CAR-T therapy developed on the THANK-uCAR® platform can expand in patients achieving complete response to levels comparable to autologous CAR-T, showing preliminary evidence of controllable safety and promising efficacy. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit https://www.carsgen.com/

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SIRPAD - WORLD'S LARGEST RCT INVESTIGATING MAGICTOUCH PTA SIROLIMUS COATED BALLOON COMPLETES PATIENT ENROLMENT

TAMPA, Fla., Jan. 20, 2025 /PRNewswire/ -- Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled. Concept Medical proudly announces that over 1,250 patients have successfully enrolled in the SirPAD Trial. The SirPAD (Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated or uncoated balloon) randomised controlled trial is the world's largest study evaluating the treatment of Peripheral Artery Disease (PAD) using the MagicTouch PTA Sirolimus Coated Balloon (Concept Medical Inc.) versus uncoated balloons and one of the largest device studies ever performed for PAD. More than 1,250 patients have been enrolled and will be followed up at 12 months to assess the primary outcome of major adverse limb events (MALE). Final results are expected by Q1-Q2 2026. SirPAD is an investigator-initiated, multi-centre, randomized, open-label trial that aims to determine whether the MagicTouch PTA sirolimus-coated balloon is non-inferior to plain old balloon angioplasty (POBA). The trial will also explore the potential for superiority. Principal Investigators Prof. Dr. med. Nils Kucher and Prof. Dr. med. Stefano Barco, from the University Hospital Zurich, who leads this ambitious study, said, "Sirolimus-coated balloons represent a promising technology in treating symptomatic PAD, supported by evidence primarily from studies with surrogate endpoints. While trials like SIRONA and ongoing studies such as SirPAD are expanding knowledge, robust data from randomized controlled trials with clinical outcomes are needed to guide treatment and shape future guidelines. This result, having been able to randomize so many patients in a PAD device study, is unprecedented and we are very thankful to all investigators and patients for having supported the trial" on achieving the significant milestone of enrolling 1,250+ patients and successfully completing this phase of the study. With sirolimus-coated balloons gathering global momentum and MagicTouch PTA at the forefront, SirPAD is a crucial milestone in expanding the evidence for PAD treatment options. While patients with PAD have limited therapeutic avenues, SirPAD aims to bolster data supporting sirolimus-coated balloon technology. This large RCT was critical to evaluating treatment alternatives, and its year-long follow-up will provide much-anticipated answers. "At Concept Medical, we are committed to generating robust clinical evidence to support our innovative technologies. Following the successful completion of SIRONA—the largest superficial femoral artery (SFA) trial comparing our device against paclitaxel drug-coated balloons (DCBs), which demonstrated non-inferiority—we are proud to announce the completion of enrollment for another historical milestone: the largest randomised clinical trial for peripheral all-comers patients, completed enrolment of 1250+ patients. With this achievement, Concept Medical continues to lead the way with the most extensive and advanced clinical trial program in the field, reinforcing our position as a global pioneer in patient-centric vascular innovations," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. About Concept Medical Concept Medical Inc., headquartered in Tampa, Florida, has a global presence and is dedicated to enhancing patient care through cutting-edge research and development of drug-delivery technologies. Its proprietary platforms are designed to deliver pharmaceutical agents across vascular luminal surfaces with unparalleled precision. Concept Medical is the developer of the MagicTouch family of Sirolimus Coated Balloons (SCBs)—the world's first and most utilized SCB technology—well recognized for its versatility and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have been used to treat over a million patients globally, setting a new standard for vascular therapy. For more information, please visit www.conceptmedical.com  

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2025 年 4 月 3 日 (星期四) 農曆三月初六日
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