A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules in Healthy Adult Volunteers

The goal of this clinical trial is to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions it aims to answer are: •How well is a single dose of fenretinide tolerated? AND •How is a single dose of fenretinide metabolized in healthy volunteers?
Participants will be asked to:
Remain confined in a clinical research unit for 5 days after dosing.
Provide blood samples for intense PK sampling and safety labs.
Fast for 10 hours prior to administration of study drug (fasted cohorts).
Consume a high fat meal prior to administration of study drug (fed cohort).
Return to the clinic for a single follow-up visit for safety assessments. Researchers will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.

开始日期2023-11-22

申办/合作机构

Island Pharmaceuticals Ltd.

NCT05999435 / Active, not recruiting临床2/3期

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE PHASE 2/3 STUDY OF THE EFFICACY OF LAU-7b IN THE TREATMENT OF ADULTS WITH LONG COVID AND MODERATE TO SEVERE SYMPTOMS

ESSOR is a double-blind, placebo-controlled study of the orally-administered antiviral and inflammation-controlling LAU-7b for the treatment of adults with Long COVID and moderate to severe symptoms.

开始日期2023-11-20

申办/合作机构

Laurent Pharmaceuticals, Inc.

NCT04417257 / Completed临床2/3期

RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease

A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.

开始日期2020-06-29

申办/合作机构

Laurent Pharmaceuticals, Inc.

100 项与芬维A胺相关的临床结果

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100 项与芬维A胺相关的转化医学

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100 项与芬维A胺相关的专利（医药）

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项与芬维A胺相关的文献（医药）

2024-11-01·Anticancer Research

Immunoliposomes for Neuroblastoma: Review of the Past Experience and Design of a Novel Nanoparticle

Review

作者: Panosyan, William S ; Panosyan, Daniel E

BACKGROUND/AIMHigh-risk/refractory neuro-blastoma (NBL) treatments include anti-GD2-monoclonal antibodies (mAbs). Several immunoliposomes (ILs) covered with anti-GD2-mAbs (GD2-ILs) have been tested pre-clinically. We aimed to review literature on GD2-IL for characteristics of nanoparticles/payloads, conjugation of mAb/fragments and preclinical data, as well as to explore the feasibility of a recently proposed GD2-IL loaded with the antimetabolite oxamate.MATERIALS AND METHODSInitial PubMed search was generalized for immunoliposomes in cancer. Further search was focused on papers for GD2-IL [keywords: "Immunoliposomes and cancer (or neuroblastoma)"].RESULTSThere were 811 results on "immunoliposomes"; >50% were on "immunoliposomes, cancer" (n=439, June 2024). Seventeen items resulted from "immunoliposomes, neuroblastoma" (one was "publishers' correction"). Sixteen GD2-IL references were reviewed (1993-current). The mean±SD GD2-ILs size was 124.8±31 nm (range=86-171). Six papers described GD2-ILs with DNA-damaging agents [doxorubicin (n=4), etoposide (n=1), irinotecan+HDAC inhibitor (n=1)]. Other payloads included: fenretinide (n=4 papers), C-myb antisense (n=2), survivin inhibitor (n=1), tyrosine kinase inhibitor (n=1), IL15 (n=1), and oxamate (n=1). These 9 drug-loads included both hydrophilic and hydrophobic molecules. Except for IL15 and C-myb antisense with high molecular weights (MWs), and oxamate with low MW, the remaining compounds had comparable MWs (496±100 g/mol, range=349-588.6). The overall encapsulation efficiency was 66.2±25.6%. There were 17-30 mAb molecules attached to an IL with PEGylation. Experiments with GD2-positive/GD2-negative cells demonstrated selective efficacy/tropism of GD2-ILs. Mouse models confirmed efficacy, GD2-specific tumor accumulation, decreased toxicity, and improved pharmacokinetic-pharmacodynamics.CONCLUSIONPEGylated anti-GD2-IL may allow NBL tropism. A size of approximately 100 nm could allow vascular permeability and packaging of oxamate in amounts needed for profound/selective lactate dehydrogenase-A inhibition. Thus, oxamate-loaded GD2-ILs may allow exploring the great translational potential of Warburg effect inhibition in GD2-positive cancers.

2024-10-02·Journal of Chemotherapy

Prognostic and immunological values of SKA3 for overall survival in lung adenocarcinoma and its RNA binding protein involved mechanisms

Article

作者: Gu, Yinfeng ; Guan, Hongjun ; Li, Jinjin ; Sun, Changpeng

This article aimed to investigate the correlations among SKA3 expression and prognosis, clinical relevance, tumor immunity, and RNA-binding protein (RBP)-involved mechanisms for overall survival (OS) in lung adenocarcinoma (LUAD). To explore the SKA3 expression level in LUAD by analyzing the genomic data as well as related clinical characteristics from the database of TCGA. Nomogram and gene set enrichment analysis (GSEA) were applied, respectively, to evaluate the performance of SKA3 in LUAD. Correlations between SKA3 and immunity and RBP-involved mechanisms were also performed. SKA3 had a higher expression level in LUAD samples than in adjacent normal lung samples, with shorter survival times in the high-SKA3-expressed LUAD subgroup (P < 0.05). qRT-PCR results remained consistent (P < 0.05). Uni-/multivariate Cox analyses revealed that SKA3 could have independent prognostic ability for LUAD (both P < 0.05). The nomogram model constructed with clinical pathological parameters and SKA3 expression levels predicted OS rates for LUAD and GSEA revealed SKA3-related pathways. In aspects of tumor immunity, SKA3 was significantly involved with tumor neoantigen burden, tumor mutational burden, immune cell pathways, and immune checkpoint inhibitor (ICI) molecules (all P < 0.05). The CellMiner database also found significant correlations between SKA3 and the antitumor drug sensitivity of chemotherapy, fenretinide, and PX-316. Besides, a total of nine LncRNA/RBP/SKA3 networks were revealed in LUAD for their RBP-involved mechanisms. SKA3 could serve as a potential biomarker for OS prognosis and immunotherapy in LUAD. LncRNA/RBP/SKA3 networks were identified in LUAD for their RBP-involved mechanisms, paving the way for further experimental verifications.

2024-10-01·Journal of Controlled Release

Novel lipid nanovesicle-loaded dissolving microarray patches for fenretinide in breast cancer chemoprevention

Article

作者: Naser, Yara A ; Vora, Lalitkumar K ; Hutton, Aaron R J ; Lopes, Luciana B ; Sabri, Akmal H ; Donnelly, Ryan F ; Li, Mingshan ; Volpe-Zanutto, Fabiana ; McCarthy, Helen O ; Apolinário, Alexsandra Conceição

The retinoid fenretinide (FENR) is a promising compound for preventing breast cancer recurrence but faces challenges due to poor solubility and low bioavailability. This study explores the development of dissolving microneedles (MNs) containing FENR-loaded ethosomes for minimally invasive breast cancer chemoprevention, aiming to enhance local drug distribution. Ethosomes were formulated using ethanol, propylene glycol, soya lecithin, water, and polysorbate 80 micelles. MNs were created from poly(vinyl alcohol) and poly(vinylpyrrolidone) hydrogels by adding polymer powder directly into ethosomes suspensions, reducing manufacturing time and cost. Two methods were used to load ethosomes into high-density moulds: 1) only in the needle area, and 2) in both the needle area and baseplate. Dynamic light scattering confirmed nanostructures in the hydrogels and MNs. Micelle-based ethosomes dissolved MNs in 15 min, compared to 30 min for other MNs. Skin deposition studies showed greater drug deposition (up to 10 μg/patch) and enhanced skin permeation of FENR (up to 40 μg) with Method 2. In-vivo studies in rats demonstrated that oral administration resulted in plasma FENR levels below 10 ng/g in the first three hours, whereas MN administration delayed delivery, reaching a maximum plasma concentration of 52 ng/g at 48 h. Skin deposition of FENR from MNs decreased from 3 μg/g on day 1 to <0.3 μg/g by the last day. This study indicates that MNs are a potential minimally invasive dosage form for delivering FENR, offering a new approach for breast cancer chemoprevention.

项与芬维A胺相关的新闻（医药）

2023-10-26

·PRNewswire

SciTech Development Announces The Formation of a Distinguished Medical Advisory Board With Top Oncology Specialists

GROSSE POINTE FARMS, Mich., Oct. 26, 2023 /PRNewswire/ -- SciTech Development, LLC, today announced the formation of a distinguished and independent medical advisory board (MAB) comprised of key opinion leaders and world-renowned experts in T-Cell Lymphomas and hematological malignancies. The board will provide strategic and clinical advice for SciTech's outreach and education initiatives within the oncology community. Continue Reading SciTech Medical Advisory Board "SciTech is excited and incredibly proud that this world-class group of medical experts will assist us with innovative insights that enable us to bring ST-001 to patients who have limited options in their cancer treatments," said President and Managing Partner Earle Holsapple. "The clarity they bring in understanding the clinical needs of patients will serve to guide us through the commencement of our phase 1 clinical trial and through our subsequent expedited clinical program." The three medical advisors appointed to the board are Madeleine Duvic, M.D., Larisa Geskin, M.D., and Ajay Gopal, M.D. Madeleine Duvic, MD – "The development of ST-100 is exciting because this new drug holds the promise of improved bioavailability, leading to increased efficacy with low toxicity." Dr. Duvic is a Professor of Medicine and Dermatology practices in Houston, Texas, and holds the Blanche Bender Endowed Chair of Research. Her clinical research includes translational/molecular studies leading to improved therapies for cutaneous T-cell lymphomas. She has written over 500 peer-reviewed papers and a book on Retinoids. She participated in the development of topical and oral tazarotene and bexarotene which both received FDA approval. Larisa J. Geskin, MD, FAAD - "I am thrilled to support SciTech's innovative approach to cancer therapeutics. SciTech's patented nanoparticle platform, SDP, enhances the effectiveness and safety of fenretinide, which has shown promise in treating patients with incurable cutaneous lymphomas in preliminary studies. SciTech's flagship product, ST-001, stands out for its ability to deliver therapeutic doses without toxic side effects, greatly benefiting our patients." Dr. Geskin is a Professor of Dermatology (in Medicine, Division of Hematology-Oncology) at Columbia University Medical Center and the Director of the Comprehensive Cutaneous Oncology Center at the Columbia University Department of Dermatology. Dr. Geskin serves as the Immediate Past-President of the International Society for Cutaneous Lymphomas (ISCL), the Secretary-Treasurer of the US Cutaneous Lymphomas Consortium (USCLC), and the Founding Chair of the New York Cutaneous Lymphoma Consortium (NYCLC), among her many other responsibilities. Ajay K. Gopal, MD - "Based on the encouraging preclinical data from a variety of laboratories, our observed tolerability of fenretinide, and the unmet need in a spectrum of malignancies novel formulations such as ST-001 nanoFenretinide are certainly worthy of further investigation." Dr. Gopal received his undergraduate degree from Duke University and his MD from Emory University. He completed his internal medicine training at Duke University School of Medicine and his oncology training at the University of Washington and Fred Hutchinson Cancer Center, where he currently holds an endowed chair and serves as a Professor and Clinical Research Director for Hematologic Malignancies. Dr. Gopal has over 2 decades of experience in the development of novel therapies for lymphoma, as reflected by over 200 publications in the field, including the first translational and clinical trial data evaluating fenretinide in lymphoma. Contact: Earle Holsapple Email: [email protected] About SciTech Development SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a new drug product with potentially broad effectiveness in many cancers. For more information about the Company, please visit: SOURCE SciTech Development

临床1期高管变更

2023-09-14

·BioSpace

SciTech Development Announces IRB Approval for Human Clinical Trials

Lead cancer drug candidate, ST-001 nanoFenretinide, has received Institutional Review Board ("IRB") approval for its upcoming clinical trials for T-Cell Lymphomas. GROSSE POINTE FARMS, MI / ACCESSWIRE / September 14, 2023 / SciTech Development ("SciTech" or the "Company"), a clinical-stage pharmaceutical company with a novel and patented drug delivery platform, today announced that the company has received IRB approval for its clinical trial protocol for their lead cancer drug candidate, ST-001 nanoFenretinide. SciTech Development ------------------------ Join us here to follow the Company: ------------------------ SciTech is pleased to announce that it has received central IRB approval from WCG to enter the clinic at the University of Pittsburgh Medical Center. USC Keck Medicine also granted SciTech local IRB approval to enter the clinic. Additional clinical sites will be added as the trials expand. ST-001 has FDA Investigational New Drug (IND) approval, orphan drug designation, and is Phase 1 clinical trial ready. An Institutional Review Board (IRB) is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects. IRB approval is a critical and necessary prerequisite to commencing human clinical trials and serves an important role in the protection of the rights and welfare of human research subjects. WCG is the world's largest independent centralized Institutional Review Board with over 200 IRB experts, servicing more than 800 institutions, with hundreds of active sites around the world. "The IRB approval of our accelerated T-Cell Lymphoma trial protocol is an important step that allows us to move forward with recruitment for our Phase 1 clinical trial," commented Earle Holsapple, SciTech's President and CEO. "We are excited to initiate this important study as there have been relatively few new cancer breakthroughs for T-Cell Lymphomas in several years." About SciTech Development SciTech Development, LLC is a clinical-stage pharmaceutical company that has developed a patented nanoparticle drug delivery platform (SDP) that maximizes the bioavailability of water-insoluble therapeutics. SciTech's lead drug candidate, ST-001 nanoFenretinide, combines SDP and the drug fenretinide as a broadly applicable anticancer drug. For more information about the Company, please visit: Safe Harbor - Forward-Looking Statement: This document contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding attempts to identify new products, services or strategic opportunities which may include a strategic transaction, plans regarding partnering activities, service pricing or financial forecasts. Such statements are only predictions, and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that the Company may not be able to identify acceptable strategic opportunities or conclude any identified strategic transaction, the risk that products or services that appeared promising in early use do not demonstrate the same utility in larger-scale uses or trials, the risks associated with the Company's reliance on outside financing to meet its capital requirements, and the risks associated with the Company's reliance on forward-looking contracts. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted, or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underly the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, political, environmental, competitive, and/or other material risks. Contact Information David Schaffer Director Investor Relations drs@scitechdevelopment.com SOURCE: SciTech Development View source version on accesswire.com:

孤儿药临床申请临床1期临床研究细胞疗法

2023-07-31

·药研发

【药研发0801】创胜硬骨素单抗获批Ⅱ期临床 | 浸会大学便秘中药获FDA批准临床...

「本文共：16条资讯，阅读时长约：3分钟」今‍日‍头条创胜硬骨素单抗获批Ⅱ期临床。创胜集团靶向硬骨素的抗体新药TST002（blosozumab）获国家药监局批准开展Ⅱ期临床，评估单次及多次静脉滴注给药在骨密度降低患者的安全性、耐受性及药代动力学。TST002具有增强骨合成代谢和抗骨吸收的双重作用，可促进骨骼形成并抑制骨吸收，从而能快速提升骨骼密度和增加骨骼强度。在Ⅰ期临床中，ST002治疗使患者腰椎骨密度较基线平均增加3.52%~6.20%，均超过最小显著差异（2.77%）。‍‍‍国‍‍‍‍‍‍‍‍‍内‍‍‍‍药‍‍讯‍‍‍‍1.罗氏IL-6单抗启动中国眼科Ⅲ期临床。罗氏IL-6单抗RO7200220在中国登记启动一项国际多中心（含中国）Ⅲ期临床（Meerkat），拟评估用于玻璃体内给药，治疗葡萄膜炎性黄斑水肿（UME）患者的安全性和有效性。该研究的主要终点指标为第16周时平均最佳矫正视力（BCVA）相对基线改善≥15个字母的受试者比例，该项研究中国主要研究者由重庆医科大学附属第一医院杨培增医学博士担任。2.泽璟CD3/DLL3三抗获批实体瘤临床。泽璟制药自主研发的三特异性抗体注射用ZG006（CD3 /DLL3/DLL3）获国家药监局临床试验默示许可，拟开发用于治疗晚期实体瘤。ZG006是全球首个针对DLL3表达肿瘤的三特异性抗体，该产品能衔接肿瘤细胞和T细胞，将T细胞拉近肿瘤细胞，从而利用T细胞特异性杀伤肿瘤细胞。此前，该新药已在美国获批临床，目标适应症为小细胞肺癌和其它实体瘤。3.华东医药三靶点激动剂获批减重临床。华东医药旗下道尔生物1类生物药注射用DR10624获国家药监局批准临床，拟用于超重或肥胖人群的体重管理。DR10624是一款长效三靶点激动剂，同时靶向GLP-1R、GCGR和FGF21R，具有治疗糖尿病、肥胖症、非酒精性脂肪性肝病（NAFLD）、非酒精性脂肪性肝炎（NASH）等潜力。此前，DR10624已在新西兰获批开展Ⅰ期临床。4.璎黎KRAS突变抑制剂国内获批临床。上海璎黎药业自主研发的泛KRAS突变小分子抑制剂YL-17231获国家药监局批准开展临床试验，用于晚期恶性实体瘤的治疗。在临床前研究中，YL-17231能够广泛抑制多种KRAS突变类型，适用于携带KRAS G12C、G12D、G12V、G13D、G12R、G12A等突变，以及KRAS野生型扩增的癌症和对KRAS G12C抑制剂（如sotorasib和adagrasib）产生耐药性的癌症。今年7月初，FDA已批准YL-17231在美国开展I期临床。5.浸会大学便秘中药获FDA批准临床。香港浸会大学中药创新研发中心研发的用于治疗慢性便秘的中药复方新药获FDA临床许可，即将在美国开展Ⅰ期临床试验。这是一款按照FDA新药评审要求、并基于中药古方开发的中药复方，在治疗便秘的同时，还可以调节病人的体质。中药治疗便秘历史悠久，此次香港中药新药获批美国临床，为中药新药走向国际积累经验。6.荣昌首款双抗获批实体瘤临床。荣昌生物自研新型双特异性抗体RC148获国家药监局临床许可，预期用于局部晚期不可切除或转移性实体瘤患者（包括不限于非小细胞肺癌、三阴乳腺癌、卵巢癌、宫颈癌、结直肠癌等其他可能获益的癌种）。这是一项I期临床，旨在评估RC148的安全性、耐受性、药代动力学（PK）、药效动力学、免疫原性、Ⅱ期推荐剂量以及初步的抗肿瘤疗效。‍‍‍‍国‍‍‍‍‍‍‍‍‍‍际‍‍‍‍药‍讯‍‍1.膀胱癌创新疗法两项Ⅲ期临床积极。UroGen公司膀胱灌注溶液UGN-102（丝裂霉素）治疗低分级、中危非肌层浸润性膀胱癌（LG-IR-NMIBC）患者的两项Ⅲ期临床（ATLAS和ENVISION）达到主要终点。在ENVISION试验中，UGN-102治疗3个月时达到79.2%的完全缓解率。在ATLAS试验中，UGN-102使患者复发、疾病进展或死亡的风险降低55%。该公司预计在2024年递交新药申请（NDA）。如果获批，UGN-102将是首个治疗膀胱癌患者亚群的非手术治疗药物。2.默沙东21价PCV两项Ⅲ期临床积极。默沙东21价肺炎球菌结合疫苗V116用于未接种过肺炎球菌疫苗（STRIDE-3试验）和接种过疫苗（STRIDE-6试验）的两项III期研究结果积极。在STRIDE-3试验中，初次接种后30天的血清型特异性嗜溶性蛋白细胞活性 (OPA) 评估显示，与辉瑞Prevnar 20相比，V116对于两种疫苗中共有常见的血清型产生显著的免疫反应。对于V116特有的血清型，也观察到阳性免疫反应。在STRIDE-6试验中，V116对所有21种肺炎球菌血清型都具有免疫原性。V116的安全性与对照药物相当。3.渤健73亿收购罕见病药物公司Reata。渤健将以交易总额约为73亿美元收购Reata公司，预计2023年第四季度完成。Reata公司开发的Nrf2激动剂Skyclarys（Omaveloxolone）已于今年3月获得FDA批准上市，是首款针对弗里德赖希共济失调症（FA）患者的治疗药物。Omaveloxolone靶向Nrf2转录因子并诱导多个分子通路以恢复线粒体功能、降低氧化应激、抑制促炎信号，以减轻炎症反应。预测到2030年，该产品销售值有望达到15亿美元。4.武田EGFR Exon20抑制剂肺癌III期临床失败。武田在2023财年Q1季报中透露，口服EGFR Exon20抑制剂Exkivity (Mobocertinib) 一线治疗EGFR外显子20（Exon20）插入突变的非小细胞肺癌（NSCLC）的III期EXCLAIM-2试验因无效而终止。2021年9月，基于一项Ⅰ/Ⅱ期临床中mobocertinib达到28%的确认客观缓解率的积极数据，FDA加速批准Mobocertinib上市，成为首款用于这类NSCLC患者的口服疗法。今年1月，该新药也获批中国上市。5.辉瑞任命新的首席肿瘤学研发官。辉瑞宣布Chris Boshoff医学博士将加入辉瑞高管团队，担任首席肿瘤学研发官和执行副总裁，向董事长兼首席执行官Albert Bourla汇报。Boshoff博士将成为整个肿瘤产品管线从发现到早期和后期临床开发唯一负责人。此前，Boshoff博士负责监管辉瑞肿瘤学产品组合的临床研究和产品开发活动，包括涉及30多项适应症的24款创新抗肿瘤新药和生物类似药，以及辉瑞行业领先的跨越四个治疗领域的罕见病创新药物组合。6.艾伯维2023H1发布。7月27日，艾伯维公布2023H1财报，上半年总营收260.9亿美元，同比下降7.2%；研发投入40.25亿美元，同比增长29.6%，占总营收的15.4%。自免领域仍是艾伯维业绩的主要来源，上半年收入124亿美元（-7.1%），其中Humira（阿达木单抗）75.53亿美元（-25.2%），Skyrizi（瑞莎珠单抗）和口服JAK1（乌帕替尼）分别收入32.43亿美元（+48%）和16.04亿美元（+51.7%）。‍‍‍‍‍‍‍‍‍医‍‍‍‍‍‍药‍‍‍‍‍‍‍‍‍‍‍‍‍热‍‍‍‍‍‍‍点‍‍‍‍‍‍‍‍‍1.海南医学院将更名海南医科大学。近日，海南医学院官网公布《海南医学院更名事项社会稳定风险评估公示》，海南医学院经认真研究和反复论证，认为已具备更名“医科大学”的基本条件，计划更名为海南医科大学。此前，为了配合更名医科大学，海南省委、省政府给海南医学院在江东新区批了787亩地，前期的总规科研概算均已经批复，2022年年底进行奠基，预计两年半能够建成。2.我国完成全球首例泌尿外科超远程机器人手术。近日，北京大学第一医院泌尿外科与海南省中医院两地的医护团队同步操作，相隔3000公里完成跨海超远程机器人手术，创造了全球首例的记录。这是一台机器人辅助前列腺癌根治术，是国产手术机器人研发应用的又一里程碑事件。手术第一次实现跨海超远程（＞1500公里）实时无延迟通信，系统控制由双控制台实现，新增的“批注”功能增强了手术团队交互能力，通过权威专家教学指导，提升了海南医疗团队完成复杂疑难手术的诊疗能力。3.CDE发布办公地址搬迁有关通知。7月31日，国家药监局药审中心宣布，药审中心将搬迁至新址办公，搬迁时间为2023年8月3日—8月9日，此期间暂停对外办公，8月10日上午8:30恢复对外办公。搬迁后办公地址及联系方式地址：北京市经济技术开发区广德大街22号院二区1—5号楼，邮编：100076，联系电话：010-68585566。自2023年8月10日起，药审中心启用新办公地址接收公函类文件及注册申请资料邮包。‍‍‍‍‍‍‍评‍‍‍‍‍审‍‍‍‍动‍‍态‍‍‍‍‍‍‍ 1. CDE新药受理情况（07月31日) 2. FDA新药获批情况（北美07月28日）股市资讯上个交易日 A 股医药板块 -1.70%涨幅前三跌幅前三赛托生物+10.86% 赛伦生物 -11.53%威尔药业 +7.01% 九典制药 -10.12%哈三联 +6.53% 恩华药业 -9.99%【健友股份】“依诺肝素钠注射液”收到加拿大卫生部批准通知。【重药控股】控股子公司“重药股份”收到国家药监局签发的米拉贝隆缓释片境内注册上市许可申请《受理通知书》。【恒瑞医药】“注射用卡瑞利珠单抗”收到FDA《受理信》。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

临床2期临床1期临床3期申请上市

100 项与芬维A胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04162	芬维A胺	-	DB05076

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新冠肺炎后遗症	临床3期	加拿大	Laurent Pharmaceuticals, Inc.	2023-11-20
新型冠状病毒感染	临床3期	美国	Laurent Pharmaceuticals, Inc.	2020-06-29
肾肿瘤	临床2期	美国	National Cancer Institute	2000-12-01
小细胞肺癌复发	临床2期	美国	National Cancer Institute	2000-11-01
口腔黏膜白斑	临床2期	美国	National Cancer Institute	1997-06-01
HR阳性乳腺癌	临床2期	美国	National Cancer Institute	1995-10-01
原位癌	临床前	美国	National Cancer Institute	1997-12-01
乳腺癌	临床前	-	Laurent Pharmaceuticals, Inc.	-
乳腺癌	临床前	-	Johnson & Johnson	-
卵巢上皮癌	药物发现	美国	National Cancer Institute	2001-09-01

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临床结果

适应症

分期

评价

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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


NCT03265288 (APPLAUD, CTgov)	临床2期	囊性纤维化	166	LAU-7b (LAU-7b)	製鹽餘餘簾壓膚醖選遞(醖淵遞鏇網選願遞鏇壓) = 選繭夢築憲遞鑰簾鏇餘構憲網壓鏇窪襯製積壓 (顧範窪製選膚壓壓鬱鏇, 積製壓醖襯艱顧鏇醖築 ~ 鏇淵窪積願衊憲蓋鏇觸) 更多	-	2024-10-09
				Placebo oral capsule (Placebo)	製鹽餘餘簾壓膚醖選遞(醖淵遞鏇網選願遞鏇壓) = 壓範觸鏇淵憲製顧繭窪構憲網壓鏇窪襯製積壓 (顧範窪製選膚壓壓鬱鏇, 築繭願糧選繭窪願簾餘 ~ 膚淵壓選獵顧襯夢壓獵) 更多
NCT03265288 (APPLAUD, Biospace) 人工标引	临床2期	囊性纤维化	166	LAU-7b	(願築遞繭窪願積衊淵衊): difference = 1.23, P-Value = 0.0486	积极	2022-11-03
				Placebo
NCT00546455 (CTgov)	临床2期	胰岛素抵抗 \| 肝炎 \| 肥胖 \| 代谢功能障碍相关的脂肪肝病	21	Fenretinide (A- Fenretinide)	窪製獵襯餘顧範糧顧選(淵觸憲顧壓積窪夢醖網) = 壓窪壓膚鑰選廠衊鹹壓選窪夢觸簾製選鹽鏇淵 (顧遞壓鹹膚膚觸蓋簾簾, 網觸餘鹹餘餘艱選襯繭 ~ 淵窪廠製膚遞憲觸網糧) 更多	-	2021-02-10
				placebo (B-Placebo)	窪製獵襯餘顧範糧顧選(淵觸憲顧壓積窪夢醖網) = 餘淵遞窪衊構醖廠膚衊選窪夢觸簾製選鹽鏇淵 (顧遞壓鹹膚膚觸蓋簾簾, 選夢窪願鑰願夢鹹憲構 ~ 鑰夢醖膚衊繭網選鹹遞) 更多
NCT00288067 (Pubmed \| Int J Radiat Oncol Biol Phys) 人工标引	临床1/2期	套细胞淋巴瘤 \| B细胞淋巴瘤	32	fenretinide	(齋選獵膚壓醖鏇襯艱醖) = No dose-limiting toxicities were observed. 願繭衊鑰獵醖製醖廠餘 (蓋夢衊範糧醖艱膚餘製 ) 更多	积极	2017-02-01
				fenretinide+rituximab
NCT00295919 (N2004-04, ASCO2014)	临床1期	神经母细胞瘤	80	4-HPR/LXS oral powder	(憲鏇鏇醖艱鑰淵鏇遞製) = 鹹獵衊膚艱獵艱鏇繭鹹鹹繭鑰構繭觸糧鏇壓襯 (鏇壓夢膚觸鬱憲願廠廠, 1.35 ~ 36.9+) 更多	-	2014-05-20
				Ketoconazole	鹽廠遞襯憲憲鏇製鏇壓(選願膚構獵鹹糧餘膚蓋) = 憲遞淵壓衊構醖獵廠願鑰願範鬱獵遞壓積簾醖 (鬱艱壓鏇繭餘鬱觸齋獵, 14.6 ~ 22.1)
PhI-42 (ASCO2012)	临床1期	血液肿瘤	25	Fenretinide (4-HPR) intravenous emulsion	築糧艱鑰鑰範顧夢願獵(願廠遞選廠蓋簾顧淵願) = Reversible hypertriglyceridemia related to the intralipid vehicle accounted for 6/7 DLTs 積顧壓網鬱醖積範選遞 (遞齋顧製廠願憲醖夢衊 )	-	2012-05-20
AACR2012	临床1期	复发性神经母细胞瘤	-	4-HPR/LXS	壓壓蓋膚鹽壓網襯範窪(醖膚願構選膚鹽壓淵衊) = 壓鑰網構齋願齋鬱憲築顧鏇壓鹹壓觸遞糧膚製 (遞繭顧製襯膚遞衊積齋 )	-	2012-04-15
NCT00429936 (ARVO2011)	临床2期	地图样萎缩 serum retinol binding protein	-	Fenretinide	(願製鬱襯艱鏇衊構夢繭) = 糧鏇醖齋選齋憲壓選衊鹹膚鬱選獵糧膚餘遞網 (遞夢艱鏇顧齋鹹遞糧選 ) 更多	-	2011-04-01
				Placebo	(願製鬱襯艱鏇衊構夢繭) = 憲築鹹積鑰憲顧積鬱壓鹹膚鬱選獵糧膚餘遞網 (遞夢艱鏇顧齋鹹遞糧選 ) 更多
ARVO2011	N/A	视网膜变性	-	Brimonidine	蓋鬱鹽襯蓋膚鏇淵製構(壓製憲構範廠糧築選糧) = 鹽築繭鑰廠齋網憲餘淵壓築鏇鬱衊網網簾壓餘 (艱繭網獵製觸簾廠鬱餘 ) 更多	-	2011-04-01
				Fenretinide	蓋鬱鹽襯蓋膚鏇淵製構(壓製憲構範廠糧築選糧) = 獵壓醖遞鏇鹹製願觸築壓築鏇鬱衊網網簾壓餘 (艱繭網獵製觸簾廠鬱餘 ) 更多
NCT00077402 (Pubmed \| Cancer Chemother Pharmacol)	临床2期	去势抵抗性前列腺癌	27	Fenretinide	餘憲觸選繭窪遞淵網餘(積襯鏇憲遞網襯鬱壓積) = 繭夢廠夢遞醖餘衊鬱積餘範鹽鏇築範鹹鹽蓋築 (醖遞願積醖網醖鏇鹽鑰, 19 ~ 73) 更多	不佳	2010-10-01