Expert opinion on investigational drugs最新文献_第10页

A modest proposal: targeting αv integrin-mediated activation of latent TGFbeta as a novel therapeutic approach to treat scleroderma fibrosis. 一个微不足道的建议：将αv整合素介导的潜伏TGFbeta激活作为治疗硬皮病纤维化的新疗法。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-03-01 Epub Date: 2024-02-26 DOI: 10.1080/13543784.2024.2323528

Andrew Leask, Asmaa Fadl, Angha Naik

引用次数: 0

Correction. 更正。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-02-19 DOI: 10.1080/13543784.2024.2319956

引用次数: 0

Taletrectinib for the treatment of ROS-1 positive non-small cell lung cancer: a drug evaluation of phase I and II data. 治疗 ROS-1 阳性非小细胞肺癌的 Taletrectinib：对 I 期和 II 期数据的药物评估。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-01-29 DOI: 10.1080/13543784.2024.2305131

Misako Nagasaka, Danielle Brazel, Sai-Hong Ignatius Ou

{"title":"Taletrectinib for the treatment of ROS-1 positive non-small cell lung cancer: a drug evaluation of phase I and II data.","authors":"Misako Nagasaka, Danielle Brazel, Sai-Hong Ignatius Ou","doi":"10.1080/13543784.2024.2305131","DOIUrl":"10.1080/13543784.2024.2305131","url":null,"abstract":"Introduction: While crizotinib and entrectinib have been approved to treat ROS1 fusion-positive (ROS1+) non-small-cell lung cancer (NSCLC), unmet needs remain. These unmet needs include treatment options for patients with resistance mutations and efficacious options even in the presence of brain metastasis while simultaneously avoiding unwanted neurological side effects.Areas covered: Taletrectinib was designed to: improve efficacy; overcome resistance to first-generation ROS1 inhibitors; and address central nervous system penetration while conferring fewer neurological adverse events. All of these features are demonstrated and supported by data from the phase I and the regional phase II TRUST-I clinical trial. Here, we describe the preclinical and clinical characteristics of taletrectinib and evaluate the data from phase I and II studies and review the rationale and design of TRUST-II, a global phase II study of taletrectinib, which is enrolling patients in North America, Europe, and Asia.Expert opinion: Taltrectinib has the potential to improve PFS based on its greater potency against ROS1+ tumors and high CNS penetration. By selectively inhibiting ROS1 wild-type and its resistant mutations over TRKB, taltrectinib has a better safety profile with minimal CNS-related AEs compared to other ROS1+ inhibitors.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"79-84"},"PeriodicalIF":6.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139466342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Islatravir: evaluation of clinical development for HIV and HBV. Islatravir：艾滋病毒和 HBV 临床开发评估。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-01-26 DOI: 10.1080/13543784.2024.2305130

Samuel W Gillespie, Athreya S Reddy, Dana M Burris, S Hasan Naqvi, Siddappa N Byrareddy, Christian L Lorson, Kamal Singh

{"title":"Islatravir: evaluation of clinical development for HIV and HBV.","authors":"Samuel W Gillespie, Athreya S Reddy, Dana M Burris, S Hasan Naqvi, Siddappa N Byrareddy, Christian L Lorson, Kamal Singh","doi":"10.1080/13543784.2024.2305130","DOIUrl":"10.1080/13543784.2024.2305130","url":null,"abstract":"Introduction: Islatravir (ISL) is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) that inhibits HIV RT through multiple mechanisms. Contrary to all approved NtRTIs, islatravir retains a 3'OH group. In vitro and clinical data show that ISL is an ultrapotent investigational drug with high tolerability.Areas covered: The historical development of islatravir and its mechanisms of HIV and HBV inhibition and resistance are covered. Additionally, the outcomes of Phase I and Phase II clinical trials are discussed.Expert opinion: Current first-line antiretroviral therapy, preexposure, and postexposure prophylactic interventions are highly effective in maintaining low or undetectable viral load. Despite these measures, an unusually high rate of new infections every year warrants developing novel antivirals that can suppress drug-resistant HIV and improve compliance. ISL, an NRTTI once deemed a long-acting drug, was placed on a clinical hold. The outcome of ongoing clinical trials with a reduced ISL dose will decide its future clinical application. Additionally, MK-8527, which inhibits HIV via same mechanism as that of ISL may supersede ISL. Data on ISL inhibition of HBV are scarce, and preclinical data show dramatically lower ISL efficacy against HBV than currently preferred nucleos(t)ide drugs, indicating that ISL may not be a potent anti-HBV drug.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"85-93"},"PeriodicalIF":6.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139485495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Potential of BGB-11417, a BCL2 inhibitor, in hematological malignancies. BCL2抑制剂BGB-1417在血液恶性肿瘤中的潜力。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-01-26 DOI: 10.1080/13543784.2024.2309873

Antonella Bruzzese, Enrica Antonia Martino, Caterina Labanca, Francesco Mendicino, Eugenio Lucia, Virginia Olivito, Antonino Neri, Fortunato Morabito, Ernesto Vigna, Massimo Gentile

引用次数: 0

Progress in the treatment of anal cancer: an overview of the latest investigational drugs. 肛门癌治疗进展：最新研究药物概览。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-01-30 DOI: 10.1080/13543784.2024.2311191

James Yu, Richard D Kim

{"title":"Progress in the treatment of anal cancer: an overview of the latest investigational drugs.","authors":"James Yu, Richard D Kim","doi":"10.1080/13543784.2024.2311191","DOIUrl":"10.1080/13543784.2024.2311191","url":null,"abstract":"Introduction: Anal cancer, a rare malignancy accounting for 2.5-3.0% of gastrointestinal cancers, primarily manifests as squamous cell carcinoma associated with HPV. Recent years have witnessed significant advancements in managing squamous cell carcinoma of the anus (SCCA), particularly with the introduction of immune checkpoint inhibitors (ICIs) and randomized data on front-line chemotherapy.Areas covered: This review discusses the current standard treatments for both early and advanced SCCA, based on published data. The authors then describe the new approaches, focusing on ICI combinations, targeted agents, T-cell adoptive therapy, and HPV-therapeutic vaccines.Expert opinion: The current standard treatment for SCCA includes front-line carboplatin and paclitaxel, with pembrolizumab and nivolumab as later-line options. While modified DCF has shown promise in single-arm studies, its role as a front-line therapy requires confirmation through randomized data. We eagerly anticipate the results of phase 3 trials investigating the front-line chemo-immunotherapy for metastatic SCCA and ICI consolidation following chemoradiation for early-stage SCCA. Novel approaches like T-cell adoptive therapy, HPV-therapeutic vaccines, and bifunctional antibodies combined with HPV vaccines are in early-stage trials for HPV-mediated tumors, including HPV-positive SCCA. These approaches targeting HPV epitopes may eventually gain tumor-agnostic approval, although their role in SCCA may take time to establish.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"145-157"},"PeriodicalIF":6.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139563601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

New investigational drugs to treat Sjogren's syndrome: lessons learnt from immunology. 治疗 Sjogren's 综合征的新研究药物：从免疫学中汲取的经验教训。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-01-31 DOI: 10.1080/13543784.2024.2312216

Xingyu Zhou, Dong Xu, Mengtao Li, Xiaofeng Zeng

{"title":"New investigational drugs to treat Sjogren's syndrome: lessons learnt from immunology.","authors":"Xingyu Zhou, Dong Xu, Mengtao Li, Xiaofeng Zeng","doi":"10.1080/13543784.2024.2312216","DOIUrl":"10.1080/13543784.2024.2312216","url":null,"abstract":"Introduction: Sjögren's syndrome is a heterogeneous autoimmune condition that impairs quality of life because of dryness, fatigue, pain, and systemic involvements. Current treatment largely depends on empirical evidence, with no effective therapy approved. Clinical trials on targeted drugs often fail to report efficacy due to common factors.Areas covered: This review summarizes the pathogenesis and what caused the failure of new investigational drugs in clinical trials, highlighting solutions for more effective investigations, with greater consistency between research outcomes, clinical use, and patient needs.Expert opinion: Unlinked pathobiology with symptoms resulted in misidentified targets and disappointing trials. Useful stratification tools are necessary for the heterogeneous SS patients. Composite endpoints or improvements in ESSDAI scores are needed, considering the high placebo response, and the unbalance between symptom burden and disease activity. Compared to classic biologics, targeted cell therapy will be a more promising field of investigation in the coming years.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"105-114"},"PeriodicalIF":6.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139641982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Challenges for further successful development of tumor necrosis factor targeting therapies for uveitis. 进一步成功开发葡萄膜炎肿瘤坏死因子靶向疗法面临的挑战。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-02-02 DOI: 10.1080/13543784.2024.2311186

Zheng Xian Thng, Jonathan Regenold, Albert John Bromeo, Amir Akhavanrezayat, Ngoc T T Than, Anadi Khatri, S Saeed Mohammadi, Anh N T Tran, Yong Un Shin, Irmak Karaca, Hashem H Ghoraba, Christopher Chi Mong Or, Quan Dong Nguyen

{"title":"Challenges for further successful development of tumor necrosis factor targeting therapies for uveitis.","authors":"Zheng Xian Thng, Jonathan Regenold, Albert John Bromeo, Amir Akhavanrezayat, Ngoc T T Than, Anadi Khatri, S Saeed Mohammadi, Anh N T Tran, Yong Un Shin, Irmak Karaca, Hashem H Ghoraba, Christopher Chi Mong Or, Quan Dong Nguyen","doi":"10.1080/13543784.2024.2311186","DOIUrl":"10.1080/13543784.2024.2311186","url":null,"abstract":"Introduction: Uveitis is a heterogeneous group of ocular conditions characterized by inflammation of the uveal tract and is one of the leading causes of vision impairment. In developed countries, noninfectious uveitis (NIU) represents most cases and is challenging to treat due to its severity, chronicity, and high recurrence rates. The advent of anti-tumor necrosis factor-α (anti-TNF-α) agents have dramatically improved outcomes and changed treatment paradigms in NIU.Areas covered: The index article summarizes the present experience of anti-TNF-α agents in NIU pharmacotherapy and highlights the barriers to further research and development of anti-TNF-α agents for uveitis. Common challenges faced in NIU clinical drugs trials, specific difficulties in anti-TNF-α drug development, and promising competitor drug candidates are discussed and evaluated.Expert opinion: Anti-TNF-α agents have revolutionized NIU pharmacotherapy and greatly improved outcomes with good safety profiles. The great success of systemic infliximab and adalimumab in NIU treatment has resulted in little impetus for further development of this class of medication. Attempts have been made to deliver anti-TNF-α agents intravitreally but that has not been successful thus far. With expiring patents, competition from biosimilars and newer, novel molecules, it may not be viable to continue pursuing anti-TNF-α drug development.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"95-104"},"PeriodicalIF":6.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Experimental autotaxin inhibitors for the treatment of idiopathic pulmonary fibrosis. 用于治疗特发性肺纤维化的实验性自体表皮生长因子抑制剂。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 DOI: 10.1080/13543784.2024.2305126

Jacopo Simonetti, Marco Ficili, Giacomo Sgalla, Luca Richeldi

{"title":"Experimental autotaxin inhibitors for the treatment of idiopathic pulmonary fibrosis.","authors":"Jacopo Simonetti, Marco Ficili, Giacomo Sgalla, Luca Richeldi","doi":"10.1080/13543784.2024.2305126","DOIUrl":"10.1080/13543784.2024.2305126","url":null,"abstract":"Introduction: Idiopathic Pulmonary Fibrosis (IPF) is a progressive, irreversible, and fatal lung disease with unmet medical needs. Autotaxin (ATX) is an extracellular enzyme involved in the generation of lysophosphatidic acid (LPA). Preclinical and clinical data have suggested the ATX-LPAR signaling axis plays an important role in the pathogenesis and the progression of IPF.Areas covered: The aim of this review is to provide an update on the available evidence on autotaxin inhibitors in IPF and further details on the ongoing clinical studies involving these molecules.Expert opinion: The development of autotaxin inhibitors as a potential therapy for idiopathic pulmonary fibrosis has gained attention due to evidence of their involvement in the disease. Preclinical and early-phase clinical studies have explored these inhibitors' efficacy and safety, offering a novel approach in treating this disease. Combining autotaxin inhibitors with existing anti-fibrotic agents is considered for enhanced therapeutic effects. Large phase III trials assessed Ziritaxestat but yielded disappointing results, highlighting the importance of long-term observation and clinical outcomes in clinical research. Patient stratification and personalized medicine are crucial, as pulmonary fibrosis is a heterogeneous disease. Ongoing research and collaboration are essential for this advancement.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"133-143"},"PeriodicalIF":6.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The impact of current investigational drugs for acne on future treatment strategies. 目前正在研究的痤疮治疗药物对未来治疗策略的影响。

IF 6.1 2区医学

Expert opinion on investigational drugs Pub Date : 2024-02-01 Epub Date: 2024-02-19 DOI: 10.1080/13543784.2024.2313091

Heli A Patel, Lily Guo, Steven R Feldman

引用次数: 0