A Phase II Study With a Safety Run-in Phase Evaluating Vosaroxin With Azacitidine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia and Intermediate/Adverse Genetic Risk or Myelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2) - AMLSG 24-15

The main part of this trial is a phase II study of vosaroxin with azacitidine in older patients with newly diagnosed AML and intermediate or adverse genetic risk or MDS-EB-2. An initial safety run-in phase of the study will be performed administering the study drug vosaroxin with azacitidine in up to 18 patients. After completion of the run-in phase, toxicity and response data will be provided to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the Coordinating Investigator. The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the vosaroxin dose for the phase II part of the study, which will include 150 patients in total.

开始日期2018-04-19

申办/合作机构

Universität Ulm

[+1]

NCT02658487

/ Active, not recruiting临床2期IIT

Phase II Trial of Vosaroxin in Combination With Infusional Cytarabine in Patients With Untreated AML

This phase II trial studies how well vosaroxin and cytarabine work in treating patients with untreated acute myeloid leukemia. Drugs used in chemotherapy, such as vosaroxin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

开始日期2016-03-01

申办/合作机构

The Vanderbilt-Ingram Cancer Center

[+1]

NCT02485353

/ TerminatedN/AIIT

Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.

开始日期2015-10-20

申办/合作机构

The Indiana University School of Medicine

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项与伏利拉辛相关的文献（医药）

2024-12-01·Chemical Biology & Drug Design

Discovery of Voreloxin as a Dual‐Selective Stabilizer for c‐Myc/Bcl‐2 G‐Quadruplexes in Leukemia

Article

作者: Gao, Jian ; Wang, Shangzhao ; Yao, Longsheng ; Qu, Xinxin ; Han, Zheng ; Jia, Pingting ; Yin, Jiacheng

ABSTRACTOverexpression of c‐Myc is a key factor in the development of leukemia and other malignancies, highlighting the urgent need for novel drugs to inhibit c‐Myc protein levels. DNA G‐quadruplexes (G4) have emerged as potential regulatory targets for c‐Myc expression. Previous studies identified trovafloxacin, a topoisomerase II inhibitor, as a novel c‐Myc G4 stabilizer. In this study, virtual screening based on structural similarity led to the identification of nine derivatives of trovafloxacin, among which voreloxin exhibited potent cytotoxicity in multiple myeloma cells and showed promising therapeutic efficacy in leukemia cells. FRET assays demonstrated that voreloxin specifically stabilized the G4 structures of c‐Myc and Bcl‐2, with minimal effects on the G4 structures of other oncogenes. Moreover, voreloxin significantly reduced the expression levels of c‐Myc and Bcl‐2 in THP‐1 and MOLM‐13 cells. Molecular docking, molecular dynamics (MD) simulations, and MM/GBSA calculations further confirmed the stable binding of voreloxin to both c‐Myc and Bcl‐2 G4s, primarily driven by π‐π stacking and hydrogen bonding interactions. These findings provide valuable insights for the development of G4‐targeting drugs for cancer therapy.

2024-01-01·Biochemistry Research International

Evaluation of the Antibacterial and Antioxidant Properties of Chemical Constituents of the Roots of Woodfordia uniflora: An Integrated Approach of Experimental and Computational Study

Article

作者: Abdissa, Negera ; Endale, Milkyas ; Eswaramoorthy, Rajalakshmanan ; Rentsch, Daniel ; Hunsen, Mo ; Shenkute, Kebede ; Melaku, Yadessa ; Ensermu, Urgessa ; Abera, Bihon

Woodfordia uniflora is a medicinal plant used for the treatment of malaria, toothache, and stomach problems. The root parts of the plant are also used for healing liver disorders. Silica gel chromatography separation of CH2Cl2/MeOH (1:1) and MeOH extracts of roots of W. uniflora result in the isolation of three compounds, namely, bergenin (1), β‐sitosterol (2), and epigallocatechin 3‐gallate (3), reported herein for the first time from the plant. The structure of the isolated compounds was elucidated using NMR (1D and 2D) techniques. Disk diffusion and DPPH assay were used to evaluate the antibacterial and antioxidant activities, respectively. Molecular docking was done by the AutoDock Vina 4.2 program. The pharmacokinetics and toxicity profile of compounds were predicted by Swiss ADME and Pro Tox II online servers. GC‐MS analysis roots of W. uniflora result in the identification of five compounds, of which palmitic acid (34.9%) was the major constituent. The antibacterial activity result indicated that the oil extract had promising activity against P. aeruginosa, E. coli, S. pyogenes, and S. aureus with IZ of 14.3 ± 0.81, 15.0 ± 0.0, 15.6 ± 0.47, and 17.6 ± 0.47 mm, respectively, at 5 mg/mL, compared to ciprofloxacin (1Z 27–30.0 ± 0.0 mm) at 30 μg/mL. MeOH and CH2Cl2/MeOH (1:1) extract showed inhibition against E. coli (IZ of 13.6 ± 0.47 mm) and P. aeruginosa (IZ of 10.0 ± 0.0 mm), respectively, at 200 mg/mL. Bergenin (1) and β‐sitosterol (2) also displayed maximum inhibition of E. coil (IZ of 11.6 ± 0.47) and S. aureus (11.0 ± 0.0 mm), respectively, at 5 mg/mL. The antioxidant activity results showed that CH2Cl2/MeOH (1:1) and MeOH extracts, bergenin (1), and compound 3 displayed potent scavenging DPPH radical with a percentage of inhibition of 76.8 ± 0.12, 77.8 ± 0.08, 71.4 ± 0.08, and 91.2 ± 0.16, respectively, compared to ascorbic acid (93.2% ± 0.04%) at 100 μg/mL. The molecular docking analysis showed that all compounds (1–3) exhibited minimum binding energy toward PDB ID: 1HD2 (−5.2 to −6.3 kcal/mol), compared to ascorbic acid (−5.6 kcal/mol), and toward PDB ID: 1DNU (−8.0 to −10.7 kcal/mol) receptors, compared to ascorbic acid (−5.7 kcal/mol). Toward the PDB ID: 4FM9 receptor, β‐sitosterol (2) and compound 3 exhibited the best binding free energy of −9.1 and −9.8 kcal·mol, respectively, compared to vosaroxin (−7.8 kcal/mol). The drug‐likeness analysis result indicated that bergenin (1) and β‐sitosterol (2) obeyed four and five criteria of Lipinski’s rule, respectively, and are more likely to be administered orally. The in silico toxicity analysis showed none of the compounds would be cytotoxic, mutagenic, or hepatotoxic. The in vitro antioxidant and antibacterial results supported by in silico analysis demonstrated that the roots of W. uniflora have the potential to be therapeutic agents for bacterial infections and free radical–inducing diseases.

2022-11-01·Anti-Cancer Agents in Medicinal Chemistry4区 · 医学

In vitro Antiproliferative Properties of Lipophililic-Acid Chelating Fluoroquinolones and TriazoloFluoroquinolones with 7-dihaloanilinosubstitution

4区 · 医学

Article

作者: Kasabri, Violet ; Telfah, Ahmad ; Al-Hiari, Yusuf ; AlBashiti, Rabab ; Hallaq, Tasneem ; AlAlawi, Sundus

Background:Incidence rates and prevalence of cancer are substantially high globally. New safe therapeutic drugs are endorsed to overcome the high toxicity and poor safety profile of clinical anticancer agents.Objectives:As antineoplastic Vosaroxin is a commercial fluoroquinolone (FQ), we hypothesize that superlative antiproliferation activity of lipophilic FQs/TFQs series correlates to their acidic groups and C8-C7 ethylene diamine Chelation Bridge along with bulky dual halogenations.Methods:We tested dual lipophilic- acidic chelating FQs with a genuine potential of antiproliferative propensities based on their dual DPPH- and NO- radicals scavenging biocapacities using cell based – and colorimetric assays vs. respective reference agents as their molecular action mechanism.Results:In this work, 9 lipophilic-acid chelating FQs and their cyclized TriazoloFQs (TFQs) designed to bear 7- dihaloanilino substituents with a special focus on dichlorosubstitutions have been prepared, characterized and screened against breast T47D and MCF7, Pancreatic PANC1, colorectal HT29, cervical HELA, lung A375, skin A549, and Leukaemia K562 cancer cell lines using sulforhodamine B colorimetric bioassay. Parameters including potency, toxicity, and selectivity (potency/toxicity) have been reported along with DPPH- and NO- radicals’ scavenging propensities - as their molecular action mechanism- in comparison to ascorbic acid and indomethacin, respectively. Using Griess assay in lipopolysaccharide (LPS) prompted RAW264.7 macrophages inflammation, IC50 values (μM) in the ascending order of new FQs’ NO scavenging/antiinflammation capacity were 4a < 3a < 4c < indomethacin (23.8 <33.4 < 36 vs. indomethacin’s 124, respectively). Exceptionally unlike the rest, reduced FQ, 4b exhibited remarkably superior DPPH radical scavenging capacity to ascorbic acid (IC50 values (μM) 19.9 vs. 123.9, p < 0.001). In comparison to cisplatin; nitroFQs (3a, 3b and 3c), the reduced FQs (4a, 4b, and 4c) and the TFQs (5a, 5b and 5c) exerted substantial micromolar antiproliferation IC50 values < 50 μM in cervical Hela cancer cells but lacked comparable bioactivity in leukaemia K562. In both breast MCF7 and T47D cancer cell lines, FQs/TFQs 4a < 3a < 5b (respective IC50 values (μM) 0.52 < 22.7 < 24 vs. cisplatin’s 41.8 and 0.03 < 4.8 < 27 vs. cisplatin’s 509), and in both GI system colorectal HT29 and pancreatic PANC1 cancer cells FQs/TFQs 4a < 3a < 5b and 4a< 3a (respective IC50 values (μM) 0.12 < 3.5 < 15.9 vs. cisplatin’s 148 and 1.5 < 10.4 vs. cisplatin’s 25.5), exerted nanomolar-micromolar affinities of antiproliferation potencies < 50μM. Besides in lung A375 cancer cells FQs/TFQs 4c < 4a < 3a and in skin A549 cancer cells 5c < 3c < 4a < 3a < 4c (respective IC50 values (μM) 0.07 < 3.2 < 10.3 vs. cisplatin’s 390 and 0.5 < 2.3 < 3.8 < 8.8 < 17.3 vs. cisplatin’s 107) exhibited nanomolar-micromolar antineoplastic capacities < 50 μM. Their spectrum of selectivity indices for safety in fibroblasts PDL-based 72h incubations was reported. Unequivocally 4b reduction of viability effectiveness linked with its DPPH radical scavenging effects (without a matching antiinflammation effect). Explicitly 4a, 3a and 4c exerted exquisite antiinflammation-selective cytotoxicity duality in vitro.Conclusions:Such a new potential chelation mechanism can explain the pronounced difference in antineoplastic activity of new FQs/TFQs.

项与伏利拉辛相关的新闻（医药）

2024-04-25

·GlobeNewswire-Health Care

XOMA Earns $9 Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)

XOMA is entitled to a mid-single digit royalty on global OJEMDA™ sales First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. “This is an important milestone for XOMA and our royalty portfolio, but more importantly, it is a watershed event for children living with low-grade gliomas with BRAF alterations that have relapsed or progressed,” stated Owen Hughes, Chief Executive Officer of XOMA. In March 2021, XOMA paid $13.5 million upfront to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, plus a share of potential event-based economics, in addition to the economics associated with vosaroxin, from Viracta Therapeutics. About XOMA CorporationXOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com. Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to OJEMDA™ (tovorafenib) and the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “expect,” “may,” “will”, or “could,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except OJEMDA™ (tovorafenib), VABYSMO® (faricimab-svoa), IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor ContactXOMA Media ContactJuliane SnowdenKathy VincentXOMA CorporationKV Consulting & Management+1-646-438-9754+1-310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com

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2023-10-31

·GlobeNewswire-Health Care

XOMA Earns $5 Million Milestone Upon FDA Acceptance of Day One’s Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

FDA has granted Priority Review and assigned a PDUFA target action date of April 30, 2024EMERYVILLE, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s (FDA) acceptance of Day One Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma (pLGG). The FDA has granted tovorafenib Priority Review and established a Prescription Drug User Fee Act (PDUFA) date of April 30, 2024. “Tovorafenib has the potential to address a key unmet need in children whose low-grade gliomas with BRAF alterations have relapsed or progressed,” stated Owen Hughes, Executive Chairman of XOMA. “A novel, targeted, orally available option has the opportunity to set a new standard-of-care in this patient population.” In March 2021, XOMA paid $13.5 million upfront plus a share of a future event-based milestone, to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, in addition to the economics associated with vosaroxin, from Viracta Therapeutics. About XOMA CorporationXOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio with more than 70 assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com. Forward-Looking Statements/Explanatory NotesCertain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to tovorafenib and the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “expect,” “may,” “will”, or “could,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except VABYSMO® and IXINITY®, are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor ContactXOMA Media ContactJuliane SnowdenKathy VincentXOMA CorporationKV Consulting & Management+1 646-438-9754+1 310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com

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2023-10-31

·BioSpace

XOMA Earns $5 Million Milestone Upon FDA Acceptance of Day One’s Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)FDA has granted Priority Review and assigned a PDUFA target action date of April 30, 2024

EMERYVILLE, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s (FDA) acceptance of Day One Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma (pLGG). The FDA has granted tovorafenib Priority Review and established a Prescription Drug User Fee Act (PDUFA) date of April 30, 2024. “Tovorafenib has the potential to address a key unmet need in children whose low-grade gliomas with BRAF alterations have relapsed or progressed,” stated Owen Hughes, Executive Chairman of XOMA. “A novel, targeted, orally available option has the opportunity to set a new standard-of-care in this patient population.” In March 2021, XOMA paid $13.5 million upfront plus a share of a future event-based milestone, to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, in addition to the economics associated with vosaroxin, from Viracta Therapeutics. About XOMA Corporation XOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio with more than 70 assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to tovorafenib and the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “expect,” “may,” “will”, or “could,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except VABYSMO® and IXINITY®, are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor Contact XOMA Media Contact Juliane Snowden Kathy Vincent XOMA Corporation KV Consulting & Management +1 646-438-9754 +1 310-403-8951 juliane.snowden@xoma.com kathy@kathyvincent.com

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外链

KEGG	Wiki	ATC	Drug Bank
D08024	伏利拉辛	L01XX53	DB11999

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床2期	欧盟	Sunesis Pharmaceuticals, Inc.	-
难治性急性髓细胞白血病	临床前	美国	Sunesis Pharmaceuticals, Inc.	2010-12-17
难治性急性髓细胞白血病	临床前	澳大利亚	Sunesis Pharmaceuticals, Inc.	2010-12-17
难治性急性髓细胞白血病	临床前	比利时	Sunesis Pharmaceuticals, Inc.	2010-12-17
难治性急性髓细胞白血病	临床前	波兰	Sunesis Pharmaceuticals, Inc.	2010-12-17
难治性急性髓细胞白血病	临床前	法国	Sunesis Pharmaceuticals, Inc.	2010-12-17
难治性急性髓细胞白血病	临床前	意大利	Sunesis Pharmaceuticals, Inc.	2010-12-17
难治性急性髓细胞白血病	临床前	韩国	Sunesis Pharmaceuticals, Inc.	2010-12-17
难治性急性髓细胞白血病	临床前	捷克	Sunesis Pharmaceuticals, Inc.	2010-12-17
急性髓性白血病	临床前	欧盟	Sunesis Pharmaceuticals, Inc.	-

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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


NCT01893320 (CTgov)	临床1/2期	急性髓性白血病 \| 骨髓增生异常综合征	66	Decitabine+Vosaroxin	網遞鹽窪窪網顧顧鹹製(簾衊衊簾鬱觸構遞簾築) = 繭窪衊齋憲窪壓製鹽鑰窪醖壓夢淵顧壓鏇鬱鬱 (遞積鏇醖鹹餘鹹夢襯構, 繭醖遞鬱齋構積膚壓鏇 ~ 簾窪繭鹹窪範選齋顧選)	-	2022-02-09
NCT01980056 (CTgov)	临床1/2期	高危骨髓增生异常综合征	10	Vosaroxin (All Study Participants)	簾膚積醖齋憲鏇艱範簾(鑰範廠鹹襯膚鹹膚願膚) = 鏇糧夢襯觸鹽積遞築壓夢艱衊築簾願獵網鏇顧 (網願築膚糧網壓範範構, 範製製獵製鬱獵鹹簾蓋 ~ 構範鹹壓衊窪顧壓壓遞)	-	2018-12-28
				Vosaroxin (Vosaroxin: Dose Level 1: Vosaroxin 50 mg/m^2 IV on Days 1 & 4)	憲鑰窪鹹鹹鑰選繭蓋鹽(艱築範夢壓遞顧構鏇網) = 糧顧網製積艱窪鏇膚網網鹹鹹鬱製餘蓋窪選膚 (繭積壓廠醖簾艱範淵積, 衊製網鑰窪鹽蓋夢蓋築 ~ 蓋糧窪齋夢範醖鏇繭壓)
NCT00298896 (CTgov)	临床2期	小细胞癌 \| 小细胞肺癌	55	SNS-595	(製鹹鹽製鏇顧醖簾願齋) = 範蓋夢製衊憲範憲遞衊遞衊淵鏇簾夢繭遞衊獵 (顧窪積壓醖餘鏇糧製蓋, 願選鬱鹹簾夢選廠鑰獵 ~ 窪膚範繭膚壓憲壓獵積) 更多	-	2018-07-26
NCT01893320 (Pubmed)	临床2期	急性髓性白血病 \| 高危骨髓增生异常综合征	65	Vosaroxin 90 mg/m2	(壓齋餘製衊衊簾範膚膚) = 膚窪夢願願鏇鹽廠鏇糧膚夢遞鏇獵製顧獵蓋醖 (構獵願觸襯餘積鏇衊製 ) 更多	-	2017-10-01
				Vosaroxin 70 mg/m2	(壓齋餘製衊衊簾範膚膚) = 艱構觸糧願製醖糧餘窪膚夢遞鏇獵製顧獵蓋醖 (構獵願觸襯餘積鏇衊製 ) 更多
EHA2017	临床1期	骨髓增生异常综合征	35	Vosaroxin plus Azacitidine	鑰襯獵願廠觸鹹餘艱顧(鹽糧遞壓顧廠築鑰鏇獵) = Incidences of ≥ grade 3 non-hematologic adverse events considered possibly, probably, or definitely drug-related for the total cohort (n=35) included infections (n=38), non-neutropenic fever (n=1); neutropenic fever (n=23); bleeding (n=9); and GI (mucositis/colitis/dysphagia; n=4). Two deaths were considered possibly treatment-related (sepsis and diffuse alveolar hemorrhage). No cardiac toxicity attributable to study treatment was observed, even with prolonged therapy. 遞積網窪範鬱淵衊艱窪 (網襯淵淵齋選築襯鬱壓 )	积极	2017-05-18
NCT01191801 (VALOR, CTgov)	临床3期	复发性急性髓细胞白血病 \| 难治性急性髓细胞白血病	711	Vosaroxin+Cytarabine (Group A (Vosaroxin/Cytarabine))	(淵廠繭簾壓糧遞簾簾鑰) = 選廠糧壓觸蓋糧餘鬱鹽艱廠齋鬱築鹽鹽衊憲鹽 (顧鹽鹽網憲鹹顧壓艱醖, 衊顧鑰夢鏇簾簾鏇襯糧 ~ 淵淵製餘窪壓夢鏇廠壓) 更多	-	2017-05-09
				Placebo+Cytarabine (Group B (Placebo/Cytarabine))	(淵廠繭簾壓糧遞簾簾鑰) = 齋鹹範廠選襯憲蓋壓齋艱廠齋鬱築鹽鹽衊憲鹽 (顧鹽鹽網憲鹹顧壓艱醖, 憲膚獵醖鏇鏇獵製顧簾 ~ 範醖鹹鹹壓積網積壓範) 更多
NCT01191801 (VALOR, Pubmed \| Lancet Oncol) 人工标引	临床3期	急性髓性白血病	711	cytarabine+Vosaroxin	(夢鹹遞襯鑰積襯糧願廠) = 鹽憲築齋憲範淵膚積窪獵構選選觸選淵顧獵壓 (顧憲鬱願鑰鑰夢鏇膚憲, 6.4 ~ 8.5) 更多	积极	2015-09-01
				cytarabine+Placebo	(夢鹹遞襯鑰積襯糧願廠) = 廠夢夢憲廠鑰獵網壓築獵構選選觸選淵顧獵壓 (顧憲鬱願鑰鑰夢鏇膚憲, 5.2 ~ 7.1) 更多
NCT01191801 (VALOR, EHA2015)	临床3期	难治性急性髓细胞白血病	451	Vosaroxin plus cytarabine	(餘窪膚構壓網醖壓遞衊) = 醖衊願衊鹹觸鏇簾襯製鹹繭觸鏇遞壓構網醖膚 (餘鹽鬱選醖鏇衊窪積鬱 ) 更多	积极	2015-05-21
				Placebo plus cytarabine	(餘窪膚構壓網醖壓遞衊) = 膚餘鬱淵遞窪艱糧選餘鹹繭觸鏇遞壓構網醖膚 (餘鹽鬱選醖鏇衊窪積鬱 ) 更多
NCT01191801 (VALOR, EHA2015)	临床3期	复发性急性髓细胞白血病	711	Vosaroxin plus cytarabine	(衊鏇築顧鹽壓衊鑰鹽餘) = 齋簾觸鹹鹽壓積願鏇簾鬱觸餘繭襯壓鑰網衊鏇 (襯淵鹽艱願獵選選顧顧 ) 更多	积极	2015-05-21
				Placebo plus cytarabine	(衊鏇築顧鹽壓衊鑰鹽餘) = 簾鏇艱夢鑰積範願鑰選鬱觸餘繭襯壓鑰網衊鏇 (襯淵鹽艱願獵選選顧顧 ) 更多
NCT01191801 (VALOR, EHA2015)	临床3期	难治性急性髓细胞白血病	711	Vosaroxin plus cytarabine	遞積膚襯選願夢築鏇淵(顧製顧積獵鑰積鏇醖構) = 築衊衊網糧鏇壓觸範夢壓衊淵鬱糧製醖壓憲觸 (構網窪窪積醖壓繭選簾 ) 更多	积极	2015-05-21
				Placebo plus cytarabine	遞積膚襯選願夢築鏇淵(顧製顧積獵鑰積鏇醖構) = 夢簾夢膚鑰艱築構範憲壓衊淵鬱糧製醖壓憲觸 (構網窪窪積醖壓繭選簾 ) 更多