A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.

开始日期2024-06-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT04218825 / Terminated临床2期

Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

Adult patients with early stage MF-CTCL (stage IA-IB) will be eligible for this study. A total of 100 early stage MF-CTCL patients diagnosed in the past year will be enrolled.
Treatment with CL gel will be applied once daily to all skin areas affected by MF-CTCL and, for 8 weeks, one selected skin area unaffected by MF-CTCL (0.5% body surface area) until treatment response (complete response), study treatment duration completed (56 weeks), progression, or another withdrawal criterion is met.
Depending on the type of skin drug-related reaction (if any) occurring after application of CL gel, this study will categorize patients into three different groups corresponding to three different treatment patterns:
Group A: Patients with no skin drug reaction with CL gel application
Group B: Patients developing a skin drug reaction of any grade with CL gel application, not due to allergic reaction to CL gel, will continue treatment at reduced application frequency
Group C: Patients from Group B unable to tolerate reduced CL gel application frequency will apply a potent topical steroid twice daily in addition to CL gel applied every other day

开始日期2022-03-29

申办/合作机构

Eortc

NCT05303480 / CompletedN/A

An Exploratory, Single-centre, Two-part Study to Describe Mycosis Fungoides Characteristics and Explore Novel Biomarkers With a Multi- Modal Patient Profiling Approach by Comparing MF Patients to Healthy Volunteers

Mycosis fungoides (MF) is an ultra-orphan disease of which the etiology remains unknown. MF is diagnosed by correlating clinical appearance with histopathological analysis of often multiple invasive skin punch biopsies. To move patient care and the development of novel treatments for MF forward, objective, sensitive and reliable tools that are preferably non-invasive are desired. Therefore, the objective of the current study is to phenotype the early stages of mycosis fungoides in detail and to assess the response of chlormethine (CL) gel monotherapy. With this approach the investigators aim to detect novel biomarkers and to establish methodologies for the (non-)invasive monitoring of MF.

开始日期2021-12-07

申办/合作机构

Centre for Human Drug Research

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100 项与盐酸氮芥相关的临床结果

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100 项与盐酸氮芥相关的转化医学

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100 项与盐酸氮芥相关的专利（医药）

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项与盐酸氮芥相关的文献（医药）

2024-02-01·American Journal of Physiology-Lung Cellular and Molecular Physiology

Single-cell resolution of human airway epithelial cells exposed to bronchiolitis obliterans-associated chemicals

Article

作者: Chu, Chin-Yi ; Pryhuber, Gloria S ; McGraw, Matthew D ; Kim, So-Young ; Mariani, Thomas J

Bronchiolitis obliterans (BO) is a devastating fibrotic lung disease of the small airways, or bronchioles. This original manuscript uses single-cell RNA sequencing for identifying common signatures of chemically exposed airway epithelial cells in BO induction. Chemical exposure reduced the proportion of keratin 5+ basal cells while increasing the proportion of keratin 4+ suprabasal cells. Functional pathways contributory to these shifts differed significantly across exposures. These new results highlight similarities and differences in BO induction across exposures.

2024-02-01·Pediatric Blood & Cancer

Treatment of high‐risk Hodgkin lymphoma with a modified Stanford V regimen in the AHOPCA: Substituting chemotherapy agents and hampered outcomes

Article

作者: de Alarcon, Pedro A ; Fuentes-Alabi, Soad ; Baez, L Fulgencio ; Peña Hernandez, Armando ; Devidas, Meenakshi ; Arreola, Magda ; Castellanos, Mauricio ; Nieves, Rosa ; Rossi, Emanuela ; Luna-Fineman, Sandra ; Bonilla, Miguel ; Metzger, Monika L ; Blanco, Jessica ; Chen, Yichen

Abstract:

Background/objectives:

High‐risk Hodgkin lymphoma (HRHL) in children is curable with combined modality therapy. The Association of Pediatric Hematology‐Oncology of Central America (AHOPCA) is a consortium of cancer centers from Central America. In 2004, AHOPCA implemented a guideline with a short course of chemotherapy (mStanfordV), strict diagnostics, and radiation guidelines, aimed at reducing abandonment and improving outcomes.

Methods:

Newly diagnosed children less than 18 years of age with high‐risk HL (Ann Arbor stages: IIB, IIIB, IV) from AHOPCA centers were staged with chest radiography and ultrasound or computed tomography. Therapy was a modified Stanford V (mStanfordV), substituting cyclophosphamide for mechlorethamine and involved field radiation.

Results:

Of 219 patients with HRHL, 181 patients were eligible and evaluable; 146 (81%) were boys, 22% being less than 6 years; 43 were stage IIB, 84 IIIB, and 54 IV. Thirty‐one (17%) abandoned therapy, 28 (15%) progressed, 30 (17%) relapsed, and eight (4%) died of toxicity. Radiation guidelines were not followed. Five‐year abandonment‐sensitive event‐free survival and overall survival (AS‐EFS, AS‐OS ± SE) for the cohort were 46% ± 4% and 56% ± 4%; 5‐year AS‐OS for stages IIB, IIIB, and IV was 76% ± 7%, 59% ± 7%, and 35% ± 7% (p = .0006).

Conclusion:

Despite instituting a short treatment guideline, it did not improve the abandonment rate (17%) and did not achieve the reported outcomes of Stanford V. The cyclophosphamide dose used to replace merchlorethamine was inadequate. Despite strict guidelines, the radiation therapy application was inaccurate. Weekly chemotherapy may have adversely affected abandonment of therapy by increasing the burden of travel time. Based on these results, AHOPCA established a new abandonment strategy and a new guideline.

2024-02-01·Journal of Pharmacology and Experimental Therapeutics

Differential Efficacy of Small Molecules Dynasore and Mdivi-1 for the Treatment of Dry Eye Epitheliopathy or as a Countermeasure for Nitrogen Mustard Exposure of the Ocular Surface

Article

作者: Fini, M Elizabeth ; Pany, Satyabrata ; Martinez-Carrasco, Rafael ; Pan, Jinhong

The ocular surface comprises the wet mucosal epithelia of the cornea and conjunctiva, the associated glands, and the overlying tear film. Epitheliopathy is the common pathologic outcome when the ocular surface is subjected to oxidative stress. Whether different stresses act via the same or different mechanisms is not known. Dynasore and dyngo-4a, small molecules developed to inhibit the GTPase activity of classic dynamins DNM1, DNM2, and DNM3, but not mdivi-1, a specific inhibitor of DNM1L, protect corneal epithelial cells exposed to the oxidant tert-butyl hydroperoxide (tBHP). Here we report that, while dyngo-4a is the more potent inhibitor of endocytosis, dynasore is the better cytoprotectant. Dynasore also protects corneal epithelial cells against exposure to high salt in an in vitro model of dysfunctional tears in dry eye. We now validate this finding in vivo, demonstrating that dynasore protects against epitheliopathy in a mouse model of dry eye. Knockdown of classic dynamin DNM2 was also cytoprotective against tBHP exposure, suggesting that dynasore's effect is at least partially on target. Like tBHP and high salt, exposure of corneal epithelial cells to nitrogen mustard upregulated the unfolded protein response and inflammatory markers, but dynasore did not protect against nitrogen mustard exposure. In contrast, mdivi-1 was cytoprotective. Interestingly, mdivi-1 did not inhibit the nitrogen mustard-induced expression of inflammatory cytokines. We conclude that exposure to tBHP or nitrogen mustard, two different oxidative stress agents, cause corneal epitheliopathy via different pathologic pathways. SIGNIFICANCE STATEMENT: Results presented in this paper, for the first time, implicate the dynamin DNM2 in ocular surface epitheliopathy. The findings suggest that dynasore could serve as a new topical treatment for dry eye epitheliopathy and that mdivi-1 could serve as a medical countermeasure for epitheliopathy due to nitrogen mustard exposure, with potentially increased efficacy when combined with anti-inflammatory agents and/or UPR modulators.

项与盐酸氮芥相关的新闻（医药）

2024-01-29

·PipelineReview

Vidac Pharma reports positive interim Phase 2a data in orphan disease cutaneous T-cell lymphoma (CTCL) with lead asset VDA-1102

LONDON, UK I January 29, 2024 I Vidac Pharma Holdings Plc. (Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a groundbreaking new way of treating cancer, today announces favorable findings from a Phase 2a interim analysis of its lead drug candidate VDA-1102 in Mycosis Fungoides (MF), a form of Cutaneous T-Cell Lymphoma (CTCL) and a rare “orphan” disease which might command fast-track regulatory processing . The data provide further signs of the efficacy and safety of Vidac Pharma’s family of non-toxic small molecules in treating cancer. The interim analysis of 50% of subjects showed an Objective Response Rate (ORR) of 56%, with 22% complete response (CR), and 34% partial response. Responses were observed between 8 and 12 weeks. These results compare favorably to the standard of care of mechlorethamine, which has a 13% CR and a much longer median response time of 26 weeks. Side-effects were local and mild in severity, except in one case, which was moderate. All patients recovered, however, and the disease did not progress in any of the patients during the 4 months of the study. “These interim results are another important confirmation that Vidac Pharma’s approach of attacking cancer at its core has substantial therapeutic potential. Our drug candidates reverse the abnormal metabolism that is a characteristic of all cancer cells, halting tumor proliferation and immune-resistance. What we are seeing bears the promise of applying these drugs across a wide range of cancers,” said Vidac Pharma Chief Executive Officer Max Herzberg. The interim results come from more than 50% of planned patients - 9 out of 16 – in an open-label within-subject placebo-controlled study into the efficacy and safety of VDA-1102 as a topical ointment treatment for 12 weeks in adult subjects with relapsed stage-1 MF. Next milestones are full-population interim results, expected in the second quarter, and final results in Q4. Vidac Pharma is developing a breakthrough new technology which reverses the abnormal metabolism of cancer cells – known as the Warburg effect - by preventing the Hexokinase 2 (HK2) enzyme from blocking the VDAC mitochondrial relay channels. Clinical data have shown the powerful effects this can have in halting cancer cell proliferation and restoring programmed cell death. Vidac’s lead drug candidate VDA-1102 is also at the clinical development stage for patients with actinic keratosis (AK), for which the company will soon launch a second Phase 2b study. About Vidac Pharma Vidac Pharma is a clinical-stage biopharmaceutical company dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncologic and onco-dermatologic diseases. Vidac develops first-in-class anti-cancer drugs by modifying the hyper glycolytic tumor microenvironment, targeting the overexpression and wrong anchoring of the Hexokinase 2 metabolic checkpoint (HK2) in cancer cells, to renormalize tumor microenvironment and selectively provoke their programmed death without affecting surrounding normal tissue. VDA-1102, a first drug candidate of Vidac Pharma was proven effective against advanced Actinic Keratosis (AK) and Cutaneous T-cell Lymphoma (CTCL) in Phase 2 trials in humans. www.vidacpharma.com SOURCE: Vidac Pharma

临床2期临床结果

2023-08-28

·生物制品圈

20年来FDA获批肿瘤治疗药物的发展趋势

21世纪以来，肿瘤治疗领域发生了巨大变化，大幅度地改善了肿瘤患者的治疗效果。美国FDA药物评价与研究中心肿瘤疾病办公室的研究人员总结了从2000年1月1日到2022年10月31日期间FDA批准肿瘤治疗产品的趋势。研究结果表明，21世纪以来，由于靶向治疗的批准，肿瘤适应症批准率增加，新治疗方法的引入率也有所增加。其中，激酶抑制剂（Kinase inhibitors）是批准产品和适应症数量最多的产品类别；尽管免疫检查点抑制剂（Immune checkpoint inhibitors）在2011年才首次获批进入市场，但获批产品和适应症数量仅次于激酶抑制剂。其他趋势包括对生物标志物定义的使用人群的获批略有增加，以及开始出现与肿瘤部位无关（Tumour-site-agnostic）药物的批准。关于肿瘤治疗药物的研究最早可追溯到20世纪初期，“化学治疗”这一术语在此时期被创造出来。1949年，FDA批准首款化疗药氮芥类药物。在此后的几十年间，肿瘤治疗药物领域一直受限于影响快速分裂细胞的系统性细胞毒类药物，这些化疗药物通常具有较大的毒性。在20世纪末和21世纪初期，随着利用癌细胞遗传易感性的“靶向治疗”的出现，肿瘤治疗药物能够选择性地杀伤癌细胞。1998年获批的治疗乳腺癌的曲妥珠单抗（Trastuzumab，抗HER2抗体）和2001年获批的治疗慢性骨髓性白血病的伊马替尼（Imatinib，一种小分子BCR-ABL抑制剂）标志着肿瘤精准治疗时代的到来。21世纪以来，肿瘤治疗药物的发展极大地改善了癌症患者的治疗效果，美国癌症患者死亡人数从1995~1999年的206人/10万人，下降到2014~2018年的155.5人/10万人。在2000年1月1日至2022年10月31日期间，FDA批准了206种不同的癌症治疗产品的573项肿瘤适应症，其中有50项为细胞毒类药物，277项为靶向化学药物，246项为靶向生物药。这些癌症治疗产品由细胞毒类药物、靶向化学药物和靶向生物药三个组组成，被分为31个类别，再细分为99个亚类。在分析期间（2000年1月1日~2022年10月31日）内，药物批准率显著增加，每年平均获批数量从2000~2004年的7.4个/年增加到2017年11月~2022年10月的56个/年，增长率达757%。2009年以来，每年靶向化学药物和靶向生物药的批准率增加，而细胞毒类药物的批准率明显降低。从2000年到2019年，靶向化学药物的批准率略高于靶向生物药，但从2020年开始，靶向生物药的批准率超过了靶向化学药物。在同期间内，癌症治疗产品在不同肿瘤部位的批准数量和批准时间不同，2015年以来，获批产品数量最多的适应症为肺癌、淋巴瘤、泌尿生殖系统肿瘤、乳腺癌、白血病，每种适应症均有超过35个产品获批。乳腺癌、白血病和淋巴瘤等适应症的批准治疗产品自2014年来显著增加，皮肤癌和甲状腺癌等适应症的批准治疗产品自2010年以来显著增加，而脑部肿瘤、头颈癌等适应症的治疗产品获批较少。在分类系统中，三组癌症治疗产品（细胞毒类药物、靶向化学药物和靶向生物药）基于作用机制被分为31种类别。为了评估单个药物类别对肿瘤治疗领域的影响，研究人员将分析期间内的每个类别的不同药物数量与每个类别的批准药物总数进行并列比较。结果显示，与其他类别相比，激酶抑制剂类有数量最多的不同药物和获批药物。免疫检查点抑制剂类药物是获批产品数量第二多的类别，尽管该类药物在2011年才首次上市，并且免疫检查点抑制剂类药物拥有数量第五多的不同药物。这些趋势表明免疫检查点抑制剂类药物自首次被批准以来的11年间对肿瘤治疗领域产生了巨大影响，也展现了激酶抑制剂类药物在肿瘤治疗产品领域中的持续重要性。除了这两大类药物外，还有29种药物对肿瘤治疗产品领域有重要贡献。抗肿瘤相关抗原（Anti-tumour-associated antigen, TAA）抗体类药物拥有数量第二多的不同产品和数量第三多的批准产品。许多细胞毒类药物比如DNA损伤剂、抗代谢物和微管抑制剂等产品在2010年以前就已经获得了大部分批准，然而从2010年开始，有53种靶向化学药物或靶向生物药与细胞毒类药物联合用药的适应症得到批准。按照肿瘤部位划分，皮肤癌和甲状腺肿瘤治疗药物自从2010年以来获得较多批准，但在2010年以前的十年间没有批准产品。在获批的37个皮肤癌治疗药物中，免疫检查点抑制剂类药物占59%（22/37），靶向BRAF或MEK靶点的激酶抑制剂占27%（10/37），剩下的14%（5/37）有双特异性抗体、Hedgehog通路抑制剂、免疫刺激剂、溶瘤病毒治疗产品等类别。关于产品亚类的趋势，31种产品类别根据具体的治疗靶点和作用机制被细分为99种亚类（Subclass），靶向生物药类的平均亚类数量（4.1）比靶向化学药物和细胞毒类药物的亚类数量（分别为3.0和2.0）高。激酶抑制剂拥有数量最多的亚类产品（21个），其次为靶向细胞毒类药物（12个）和抗TAA抗体类药物（11个）。抗PD1抗体是免疫检查点抑制剂类药物类别下的一种亚类产品，获得批准产品最多（75个），是排在第二位的BCR-ABL激酶抑制剂亚类产品获批数量（27个）的三倍左右。新产品亚类的引入是评估治疗药物发展速度和创新癌症治疗方法成功转化的一种方法。新亚类的引入率从2000~2004年的3.8个/年提升至2020~2022年的6.7个/年。值得关注的是，靶向化学药物在2000~2014年的新亚类产品引入率最高，然而从2015年开始，靶向生物药的新亚类产品引入率超过了靶向化学药物。总之，这些趋势展现了肿瘤治疗药物领域的创新速度加快，越来越多的新种类治疗产品被研发出来。大部分（97.4%）的批准药物结合或影响确定的分子靶点，剩余的（2.6%）没有已知的分子靶点。在分析期间，获批的206种癌症治疗产品共有83个靶点，其中73个靶点为单基因编码的蛋白质，其他靶点包括融合蛋白、蛋白质复合物、蛋白质家族、氨基酸、糖脂、肽和DNA。EGFR、DNA、CD19和HER2是拥有不同治疗药物数量最多的靶点。获批药物数量最多的靶点是PD1，其次是EGFR、BCR-ABL1融合蛋白。在73个单基因编码的靶点中，质膜蛋白、细胞质蛋白、核蛋白和细胞外蛋白分别占52%、22%、21%和5%，其中最常见的是跨膜信号受体、代谢物相互转化酶和蛋白质修饰酶。这73个靶点蛋白涉及46个不同的通路，其中涉及靶点最多的通路依次为血管生成通路（12个靶点蛋白）、B细胞激活通路（10个）和PDGF信号通路（9个）。这些结果表明靶点蛋白和信号通路的细胞特征对癌症治疗药物研发至关重要。测序技术的进步和对基因组的探索为根据分子改变进行癌症类型分类提供了极大的帮助，并使利用癌细胞遗传易感性的治疗方法得以发展，开启了精准医疗的时代。生物标志物（Biomarker）以某些基因或表达蛋白的改变或缺失为基础，用于发现肿瘤亚型和识别可能从特定治疗中获益的患者，即生物标志物定义人群（Biomaker-defined populations）。生物标志物的使用在肿瘤适应症批准中呈增长趋势，在2000~2004年、2005~2009年、2020~2022年间批准使用的生物标志物适应症占比分别为32%、30%和43%。使用最多的生物标志物为HER2、EGFR、BRAF和HR。虽然61.1%的批准癌症治疗产品针对生物标志物未选择的人群，但是有38.9%的批准肿瘤治疗药物针对生物标志物定义人群。在生物标志物定义人群中，大部分药物仅用于生物标志物阳性肿瘤（78.5%），而有32个批准药物（占14.3%）要求肿瘤能够对一些生物标志物显阳性并且对其他的生物标记物显阴性，有16个批准药物（占7.2%）仅用于生物标志物阴性肿瘤。2000年以来，在获批的癌症治疗药物中，单药占比接近三分之二（364/551），而联合用药占比为三分之一（187/551）。细胞毒类药物联合用药的频率最高（占52%），其次是靶向生物药（占43%），而靶向化学药联合用药较少。对于某些适应症，联合用药比单药更常见，联合用药批准超过50%的疾病部位包括多发性骨髓瘤（66%）、结直肠癌（65%）、乳腺（63%）、脑（60%）和头颈部（57%）。在细胞毒类药物的联合用药对象中，有78%与其他细胞毒类药物联用，但这一情况主要发生在分析期间早期。靶向化学药物也常用于组内联合治疗，占批准联合用药的58%。剩下的批准联合用药包括皮质甾类（20%）、靶向生物药（19%）和细胞毒类药物（17%）。激酶抑制剂类、免疫检查点抑制剂类和抗TAA抗体有最多的已批准的联合用药适应症（分别为41、40和38个）。组内联合用药仅占已批准的联用适应症的20%，而组间联合用药更为常见。加速审批通道（Accelerated approval, AA）于1992年被引进，是一种替代传统审批的药品审批通道，最初目的是在艾滋病流行期间加快药品研发。加速审批通道能加速用于治疗严重或威胁生命的疾病（包括癌症）的药品批准进程，基于预测临床效益终点的改善，并且能在后续的试验中证实有临床效益。快速审批通道解决了不确定性，并且能使转化产品提前数年批准。截至2022年10月31日，一共有18个加速审批通道产品被撤回，包括7个不同类别的产品，都是靶向化学药物或者靶向生物药，其中有7个免疫检查点抑制剂类药物、5个激酶抑制剂类药物和2个表观遗传修饰剂。在分析期间，有71%（407/573）的抗肿瘤药物经常规批准通道批准，有29%（166/573）的肿瘤药物经快速审批通道批准。近年来经加速审批通道批准的抗肿瘤药物总数有所增加，但这只是抗肿瘤药物批准率总体增加的一个体现，无法表明加速审批在肿瘤学中使用的比例增加。在快速审批的产品中，靶向生物药占比最多（31%），其次是靶向化学药（29%），细胞毒类药物则相对较少（20%）。快速评审和常规评审在不同产品种类的使用情况差异更大，在不同疾病部位也有所差异。综上，自2000年以来，癌症治疗药物的研发速度显著提高，靶向化学药和靶向生物药的研发速度加快，而细胞毒类药物的研发速度有所放缓。通过引入新产品亚类的速度可以衡量肿瘤治疗方法的创新程度，引入的新产品亚类数量增加表明抗肿瘤药领域有较好创新。激酶抑制剂仍是最主要的产品类别。免疫检查点抑制剂类药物自2011年上市后也在抗肿瘤方面发挥了重要的作用。从2009年开始，生物标志物的使用率稳定增加，尽管增长率可能低于近年来精准医疗不断发展下的预期。生物标志物在不同产品类别和疾病部位的使用程度不同，在缺乏传统组织规范的情况下，生物标志物的定义对于所有使用与疾病部位无关的药物的指定人群而言是必要的。单药适应症最为常见，而联合用药适应症在批准抗肿瘤药物中占34%，并且产品组合的方式因产品分类而不同。总之，21世纪以来，肿瘤治疗产品开发和创新的速度都在加快。随着众多有前景的治疗方法进一步创新，这些趋势可能会持续下去，进一步改善肿瘤治疗方法和癌症患者的治疗效果。参考文献1. Scott, E. C.; Baines, A. C.; Gong, Y.; Moore, R.; Pamuk, G. E.; Saber, H.; Subedee, A.; Thompson, M. D.; Xiao, W.; Pazdur, R.; et al. Trends in the approval of cancer therapies by the FDA in the twenty-first century. Nature Reviews Drug Discovery 2023, 22 (8), 625-640.2. FDA. Drugs@FDA: NDA006695 (mechlorethamine hydrochloride). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=006695 2022.3. Howlader, N. et al. SEER Cancer Statistics Review 1975–2018 (National Cancer Institute 2021).识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床研究

2023-07-28

·GlobeNewswire-Health Care

Revive Therapeutics Announces Filing of Patent for Bucillamine in the Treatment of Exposure to Chemical Warfare Agents

TORONTO, July 28, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that it has filed a provisional patent application titled “Compositions, methods and uses of Bucillamine in the treatment of a victim exposed to a chemical warfare agent.” The methods and compositions described in the patent application relate to Bucillamine as a potential treatment of a victim exposed to a chemical agent, including chemical warfare agents such as sulfur mustards, nitrogen mustards, nerve agents of G and V type, lewisite and adamsite. According to the U.S. Department of Homeland Security, a chemical attack is the spreading of toxic chemicals with the intent to do harm, which may include chemical weapons (warfare agents) developed for military use, toxic industrial and commercial chemicals that are produced, transported, and stored in the making of petroleum, textiles, plastics, fertilizers, paper, foods, pesticides, household cleaners, and other products, and chemical toxins of biological origin such as ricin. The Company is commencing to work with advisors in developing a strategic plan to present its case in repurposing Bucillamine as a potential medical countermeasure for chemical warfare agent exposures to the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services. At this time, the Company will only provide regular updates via press releases as information becomes available. About Revive Therapeutics Ltd. Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com. For more information, please contact: Michael FrankChief Executive OfficerRevive Therapeutics Ltd.Tel: 1 888 901 0036Email: mfrank@revivethera.comWebsite: www.revivethera.com Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2022, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

孤儿药快速通道并购

100 项与盐酸氮芥相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04872	盐酸氮芥	L01AA05	DB00888

研发状态

适应症	最高研发状态	国家/地区	公司
霍奇金淋巴瘤	批准上市	中国更多	上海旭东海普药业有限公司更多
皮肤T细胞淋巴瘤	批准上市	澳大利亚更多	Juniper Biologics Pte Ltd. 更多
淋巴瘤	批准上市	中国更多	上海旭东海普药业有限公司更多
真性红细胞增多症	撤市	美国更多	Recordati Rare Diseases, Inc. 更多
蕈样真菌病	撤市	美国更多	Recordati Rare Diseases, Inc. 更多

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临床结果

适应症

分期

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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


EADV2023	N/A	蕈样真菌病二线	21	Chlormethine gel	顧築鑰齋夢糧築鏇膚齋(艱餘製獵壓鏇鑰廠襯窪) = 壓製夢夢簾選壓蓋鏇鏇襯鬱鹽築繭窪選願鏇鏇 (遞鏇顧願繭構夢餘鬱積 ) 更多	积极	2023-10-11
NCT00574496 (CTgov)	临床2期	复发性经典霍奇金淋巴瘤	25	allogeneic hematopoietic stem cell transplantation+vinorelbine tartrate+ifosfamide+mycophenolate mofetil+methotrexate+procarbazine hydrochloride+cyclosporine+fludarabine phosphate+Cyclophosphamide+mechlorethamine hydrochloride+prednisone+melphalan+gemcitabine hydrochloride+vincristine sulfate	淵蓋獵範壓鑰選窪築築(廠壓簾簾選壓鹽積廠鏇) = 鹹憲窪鑰夢遞艱淵夢築餘製淵觸築蓋獵膚顧獵 (選餘繭醖餘醖夢繭醖簾, 選憲築醖夢窪廠蓋範範 ~ 製遞製獵憲窪網鑰簾衊) 更多	-	2023-09-28
ASCO2021	N/A	霍奇金淋巴瘤	87	MOAP regimen	積壓築遞觸鹽夢鹽遞衊(鏇獵鬱觸獵鏇獵鬱淵簾) = 製廠艱觸範範製鏇齋鑰製蓋選顧願鬱願遞憲壓 (製蓋鑰願齋蓋襯鑰積範 )	积极	2021-05-28
NCT03417141 (CTgov)	临床2期	毛发扁平苔癣	12	Mechlorethamine 0.016% Top Gel	鬱艱鑰壓醖壓網簾範鏇(遞鑰築築廠鬱顧遞範鬱) = 艱壓遞齋願憲鹹築範構簾鏇襯夢餘選遞繭製淵 (獵膚繭衊鑰觸衊獵獵顧, 艱鏇壓夢遞膚願築蓋範 ~ 積製鹽獵鏇網簾廠壓蓋) 更多	-	2020-07-02
NCT00535470 (ASCO2014)	临床2期	蕈样真菌病	100	MCH 0.04% gel	積選觸憲築壓夢壓膚醖(網範簾獵窪繭憲選憲糧) = 願襯鹽積糧獵夢齋簾鹽鹽構衊蓋遞鬱積窪鏇遞 (醖夢壓積壓齋網蓋鬱構, 18.6 ~ 35.9)	-	2014-05-20
NCT00168064 (Pubmed \| JAMA Dermatol)	临床2期	皮肤T细胞淋巴瘤 \| 蕈样真菌病	260	Mechlorethamine 0.02% gel	願積艱選繭糧衊餘獵壓(廠壓鑰淵襯範築齋壓淵) = 製積積獵築願壓遞餘憲艱餘鏇襯鑰觸廠獵窪齋 (淵窪齋夢獵選鏇遞鹹繭 ) 更多	积极	2013-01-01
NCT00168064 (Pubmed \| JAMA Dermatol)	临床2期	皮肤T细胞淋巴瘤 \| 蕈样真菌病	260	Mechlorethamine 0.02% compounded ointment	願積艱選繭糧衊餘獵壓(廠壓鑰淵襯範築齋壓淵) = 願襯壓廠遞繭觸顧窪蓋艱餘鏇襯鑰觸廠獵窪齋 (淵窪齋夢獵選鏇遞鹹繭 ) 更多	积极	2013-01-01
NCT00168064 (CTgov)	临床2期	蕈样真菌病	260	mechlorethamine-MCH (Nitrogen Mustard) (PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel)	積鏇繭淵廠餘齋鏇艱壓(鬱築窪鬱鑰廠壓築蓋鹹) = 壓遞選鏇製築憲觸顧鹽壓製憲窪遞鑰願艱醖顧 (繭顧壓醖衊遞網構餘網, 壓壓構餘觸鹹糧糧鑰鏇 ~ 壓鏇窪簾膚鹽鏇觸壓鑰)	-	2012-10-31
NCT00168064 (CTgov)	临床2期	蕈样真菌病	260	Mechlorethamine-MCH (NM)+Mechlorethamine (AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%)	積鏇繭淵廠餘齋鏇艱壓(鬱築窪鬱鑰廠壓築蓋鹹) = 願構簾夢網艱襯觸獵遞壓製憲窪遞鑰願艱醖顧 (繭顧壓醖衊遞網構餘網, 網窪淵憲鑰積窪糧繭鏇 ~ 壓壓餘壓簾觸鏇廠願醖)	-	2012-10-31
ISRCTN64141244 (Pubmed \| J Urol)	N/A	霍奇金淋巴瘤	520	Stanford V regimenStanford V regimenStanford V regimenStanford V regimenStanford V regimenStanford V regimenStanford V regimen	顧艱選壓觸窪糧醖範觸(選窪觸簾顧餘糧襯鏇鏇) = 選願獵膚壓窪糧衊淵壓鏇餘積糧繭構鏇繭願積 (積積構襯鏇憲膚艱蓋壓 ) 更多	-	2009-11-10
ISRCTN64141244 (Pubmed \| J Urol)	N/A	霍奇金淋巴瘤	520	stanford V regimenstanford V regimenstanford V regimenstanford V regimenstanford V regimenstanford V regimenstanford V regimen (ABVD regimen)	顧艱選壓觸窪糧醖範觸(選窪觸簾顧餘糧襯鏇鏇) = 鬱餘餘築齋鬱製製淵鹹鏇餘積糧繭構鏇繭願積 (積積構襯鏇憲膚艱蓋壓 ) 更多	-	2009-11-10
IAS2002	N/A	HIV感染辅助	59	Stanford V regimenStanford V regimenStanford V regimenStanford V regimenStanford V regimenStanford V regimenStanford V regimen	艱鏇願鹹窪製製積壓衊(鑰獵顧鏇鏇繭築鏇餘襯) = 鬱醖網餘網襯積襯簾窪夢窪觸構壓鑰鏇醖廠製 (積糧繭衊襯鏇積夢艱鹽 ) 更多	-	2002-01-01