Expert opinion on investigational drugs最新文献

Promising experimental drugs for obsessive-compulsive personality disorder. 治疗强迫性人格障碍的试验性药物。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-07-24 DOI: 10.1080/13543784.2025.2536846

Donatella Marazziti, Riccardo Gurrieri, Matteo Gambini, Gerardo Russomanno, Umberto Albert

{"title":"Promising experimental drugs for obsessive-compulsive personality disorder.","authors":"Donatella Marazziti, Riccardo Gurrieri, Matteo Gambini, Gerardo Russomanno, Umberto Albert","doi":"10.1080/13543784.2025.2536846","DOIUrl":"10.1080/13543784.2025.2536846","url":null,"abstract":"Introduction: Obsessive-compulsive personality disorder (OCPD) is a common psychopathological condition that generally causes a significant maladjustment in affected individuals. Despite its prevalence, there are no univocal and defined guidelines for the treatment of this condition, and the literature evidence on this topic is scant and controversial.Areas covered: This narrative review synthesizes clinical trials, case reports, and experimental proposals for OCPD treatment in the light of the most recent neurobiological models. We aimed to review current therapeutic evidence for the disorder and evaluate their effectiveness, proposing potential rationales to guide future strategies.Expert opinion: Although no guidelines are available for OCPD, given the paucity of controlled studies, a possibility to overcome this gap might rely on identifying among the currently available and emerging therapies those that may appear most promising for improving the outcome of the disorder and suggesting novel therapeutic targets. In this way, this paper might represent a sort of 'call to action' to the scientific deepening of the mode of action of those treatments that could be of help to improve the detrimental quality of life of OCPD patients.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"1-15"},"PeriodicalIF":4.9,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674269","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

Isatuximab for the treatment of multiple myeloma: current clinical advances and future directions. 依沙妥昔单抗治疗多发性骨髓瘤：目前的临床进展和未来的方向。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-07-23 DOI: 10.1080/13543784.2025.2532446

Paul G Richardson, Elisabeth K O'Donnell, Peter O'Gorman, Lisa B Leypoldt, Jacob Laubach, Francesca Gay, Xavier Leleu, Thierry Facon, Philippe Moreau, Meletios A Dimopoulos, Hartmut Goldschmidt, Elias K Mai, Michele Cavo, Katja C Weisel, Jesus G Berdeja, Robert Z Orlowski, Meral Beksaç, Aurore Perrot, Joseph Mikhael, Thomas Martin

{"title":"Isatuximab for the treatment of multiple myeloma: current clinical advances and future directions.","authors":"Paul G Richardson, Elisabeth K O'Donnell, Peter O'Gorman, Lisa B Leypoldt, Jacob Laubach, Francesca Gay, Xavier Leleu, Thierry Facon, Philippe Moreau, Meletios A Dimopoulos, Hartmut Goldschmidt, Elias K Mai, Michele Cavo, Katja C Weisel, Jesus G Berdeja, Robert Z Orlowski, Meral Beksaç, Aurore Perrot, Joseph Mikhael, Thomas Martin","doi":"10.1080/13543784.2025.2532446","DOIUrl":"10.1080/13543784.2025.2532446","url":null,"abstract":"Introduction: The addition of the anti-CD38 monoclonal antibody isatuximab to standard therapies is transforming the care of patients with newly diagnosed multiple myeloma (NDMM), as previously seen in the relapsed/refractory setting. This is particularly important for patients with NDMM as early treatment with effective, well tolerated therapies may ensure better clinical outcomes.Areas covered: Here, we examine recent results from pivotal Phase 3 and 2 clinical trials that demonstrate efficacy and safety of isatuximab across multiple combinations, for both transplant-ineligible and transplant-eligible NDMM patients. We then evaluate long-term outcomes from the IKEMA and ICARIA-MM trials as well as real-world evidence emerging from analyses conducted in patients with relapsed/refractory MM (RRMM). Further, we address current approaches to optimize treatment with isatuximab-based combinations involving changes in bortezomib or dexamethasone dosing. Lastly, we review current findings with new administration modalities developed to optimize delivery of isatuximab in the clinic.Expert opinion: Supported by multiple lines of high-level evidence, isatuximab in combination with standard-of-care backbone therapies produces triplet or quadruplet regimens with enhanced efficacy and consistent safety for the treatment of patients with NDMM and RRMM.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"1-19"},"PeriodicalIF":4.9,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625773","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

Investigational DNA topoisomerase I inhibitors for colorectal cancer: preclinical and early phase developments. 研究DNA拓扑异构酶I抑制剂用于结直肠癌：临床前和早期发展。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-07-19 DOI: 10.1080/13543784.2025.2532447

Endika Martin-Encinas, Maria Fuertes, Carme Masdeu, Asier Selas, Concepcion Alonso

{"title":"Investigational DNA topoisomerase I inhibitors for colorectal cancer: preclinical and early phase developments.","authors":"Endika Martin-Encinas, Maria Fuertes, Carme Masdeu, Asier Selas, Concepcion Alonso","doi":"10.1080/13543784.2025.2532447","DOIUrl":"https://doi.org/10.1080/13543784.2025.2532447","url":null,"abstract":"Introduction: Colorectal cancer, a significant global challenge, requires innovative treatment strategies. DNA topoisomerase I inhibitors, which disrupt DNA replication in rapidly proliferating cancer cells, have shown great potential. Natural product derivatives, such as camptothecin (CPT), and emerging compounds for CRC treatment have made significant progress.Areas covered: This review article summarizes the state of the art in the development of selective topoisomerase I inhibitors, which show in vitro and in vivo activity against colorectal cancer in preclinical and early stage clinical trials. The compounds are classified into natural compounds and derivatives and new synthetic compounds classified according to their cyclic structure.Expert opinion: Despite the success of CPT derivatives like irinotecan, topotecan and belotecan (approved drugs), drawbacks such as lactone instability have led to the development of modified compounds. Structural modifications in CPT derivatives, like derived homocamptothecins, show enhanced efficacy and reduced toxicity. Additionally, synthetic compounds like indenoisoquinolines and quinolines have emerged as potent TOP1 inhibitors. Dual inhibitors, combination therapies, integration with immunotherapy and personalized medicine further enhances treatment efficacy. Ongoing preclinical studies offer hope for improved CRC management.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667469","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

Development of gene expression inhibitors for the treatment of cutaneous carcinomas. 基因表达抑制剂治疗皮肤癌的研究进展。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-07-15 DOI: 10.1080/13543784.2025.2533442

Dhruv Sharma, Aniruddha Roy, Gautam Singhvi

引用次数: 0

Investigational new drugs to treat brain metastasis from non-small cell lung cancer. 治疗非小细胞肺癌脑转移的新药研究。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-07-11 DOI: 10.1080/13543784.2025.2532449

Pasquale Vitale, Giuseppe Lamberti, Ilaria di Giovanni, Raffaele Addeo

{"title":"Investigational new drugs to treat brain metastasis from non-small cell lung cancer.","authors":"Pasquale Vitale, Giuseppe Lamberti, Ilaria di Giovanni, Raffaele Addeo","doi":"10.1080/13543784.2025.2532449","DOIUrl":"https://doi.org/10.1080/13543784.2025.2532449","url":null,"abstract":"Introduction: Lung cancer is a leading cause of cancer-related mortality. Brain metastasis (BM) has a high incidence in non-small cell lung cancer (NSCLC) and represents a devastating complication associated with poor prognosis and symptoms that significantly reduce the quality of life (QOL) in patients. Managing and controlling BM is critical for prolonging survival and improving QOL. Surgical resection, stereotactic radiosurgery, and whole-brain radiation therapy are key treatment modalities for patients with NSCLC and BM.Areas covered: Molecular targeted drugs developed against driver gene mutations and immune checkpoint inhibitors have shown efficacy against BM. This review examines newly approved therapies by conducting a literature search on these topics. Therefore, it is essential to determine the most appropriate local and systemic therapies and the optimal timing to maximize overall survival and QOL.Expert opinion: Despite the effectiveness of new drugs, a high mortality rate persists. We discuss future strategies for overcoming resistance and progression.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"1-14"},"PeriodicalIF":4.9,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144607894","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

Investigational thrombolytic drugs for acute ischemic stroke. 急性缺血性脑卒中的溶栓药物研究。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-07-09 DOI: 10.1080/13543784.2025.2532445

David S Liebeskind

引用次数: 0

Prospects of current AXL-targeting therapies in early phase cancer trials. 当前axl靶向治疗在早期癌症试验中的前景。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-06-01 Epub Date: 2025-05-31 DOI: 10.1080/13543784.2025.2511178

Juhye Yim, Chloe Hope, Justus M Huelse, Douglas K Graham

{"title":"Prospects of current AXL-targeting therapies in early phase cancer trials.","authors":"Juhye Yim, Chloe Hope, Justus M Huelse, Douglas K Graham","doi":"10.1080/13543784.2025.2511178","DOIUrl":"10.1080/13543784.2025.2511178","url":null,"abstract":"Introduction: AXL, a member of the TAM (TYRO3, AXL, and MERTK) family of receptor tyrosine kinases, controls pro-tumorigenic signaling cascades and cancer-immunological functions, and promotes drug resistance. Due to AXL's multifaceted role and therapeutic activity in preclinical studies, a variety of AXL inhibitors are being developed and tested in clinical trials for cancer treatment. Some clinical studies are showing promising results for AXL inhibitors as monotherapy and in combination with standard of care therapeutics. Currently, no selective AXL-targeting therapy has reached FDA-approval, but several compounds have entered phase II and III studies.Area covered: We elaborate on the role of AXL in cancer progression and suppressing anti-cancer immunity at both the molecular level and immune cell interaction level. Additionally, we review pre-clinical and clinical data of AXL-targeting agents.Expert opinion: Preclinical and several early clinical trials demonstrated the safety of AXL-targeting monotherapies with some evidence of efficacy. Additionally, multiple novel combination regimens including AXL-targeting agents to overcome resistance mechanisms are being actively examined with some promising results. However, patient selection and companion biomarkers may be critical for the success of AXL-targeting therapies.","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"473-505"},"PeriodicalIF":4.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141807","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

A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (70 mg/mL) in healthy male adults. 一项随机、双盲、单剂量、平行组、两组研究，评估候选生物类似药AVT03 （70 mg/mL）在健康成年男性中的药代动力学相似性、安全性、耐受性和免疫原性。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-06-01 Epub Date: 2025-05-16 DOI: 10.1080/13543784.2025.2505469

Monika Tomaszewska-Kiecana, Felicitas Bullo, Lukasz Jaskiewicz, Serena Stamatakos, Hendrik Otto, Masna Rai, Abid Sattar, Steffen Leutz, Fausto Berti

{"title":"A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (70 mg/mL) in healthy male adults.","authors":"Monika Tomaszewska-Kiecana, Felicitas Bullo, Lukasz Jaskiewicz, Serena Stamatakos, Hendrik Otto, Masna Rai, Abid Sattar, Steffen Leutz, Fausto Berti","doi":"10.1080/13543784.2025.2505469","DOIUrl":"10.1080/13543784.2025.2505469","url":null,"abstract":"Background: This study (NCT05876949) compared the pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT03, a candidate biosimilar, with reference product (RP) denosumab (Xgeva).Methods: Healthy male participants (N = 208, including 24 Japanese participants) were randomized 1:1 to receive one 120 mg dose of AVT03, or RP. PK similarity was demonstrated if the 90% confidence intervals (CI) for the ratio of geometric means for the primary PK parameters Cmax and AUC0-t were within 80.00% and 125.00%. Additional PK parameters included AUC0-inf, tmax, Kel, t1/2, Vz/F, and CL/F. Safety and immunogenicity were also assessed.Results: The 90% CIs for the ratio of geometric means for the primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (Cmax [98.26, 110.00]; AUC0-t [102.30, 113.60]), supporting demonstration of PK similarity. Consistency between Japanese participants and the overall population was shown. Safety and immunogenicity profiles were comparable between the two treatment arms.Conclusion: Results supported demonstration of PK similarity between AVT03 and RP. AVT03 had a safety and immunogenicity profile comparable to RP.Clinical trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05876949); and 2022 -003,659-32 (EudraCT).","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":" ","pages":"539-546"},"PeriodicalIF":4.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143992716","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

Preclinical development of siRNA conjugates to target tumor antigens. 靶向肿瘤抗原的siRNA偶联物的临床前开发。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-06-01 Epub Date: 2025-05-24 DOI: 10.1080/13543784.2025.2511181

Takanori Kubo, Toshio Seyama

引用次数: 0

Prospects for multi-focal motor neuropathy treatment by complement inhibition. 补体抑制治疗多灶性运动神经病的前景。

IF 4.9 2区医学

Expert opinion on investigational drugs Pub Date : 2025-06-01 Epub Date: 2025-05-30 DOI: 10.1080/13543784.2025.2511177

Hans Katzberg, Carlos Alberto Soto Rincón

引用次数: 0