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.

Start Date19 Apr 2018

Sponsor / Collaborator

Universität Ulm

[+1]

NCT02658487 / Active, not recruitingPhase 2IIT

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.

Start Date01 Mar 2016

Sponsor / Collaborator

The Vanderbilt-Ingram Cancer Center

[+1]

NCT02416388 / RecruitingPhase 2/3IIT

Phase II/III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

Start Date01 Jan 2015

Sponsor / Collaborator

Centre Hospitalier Universitaire d'Angers

100 Clinical Results associated with Vosaroxin

100 Translational Medicine associated with Vosaroxin

100 Patents (Medical) associated with Vosaroxin

Literatures (Medical) associated with Vosaroxin

01 Nov 2022·Anti-Cancer Agents in Medicinal ChemistryQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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.

01 Apr 2021·Asian Pacific Journal of Cancer Prevention

A Novel Class of Functionalized Synthetic Fluoroquinolones with Dual Antiproliferative - Antimicrobial Capacities

Article

Author: Kasabri, Violet ; Alalawi, Sundus ; Al-Nuaimi, Abdelrahman ; Khaleel, Sara ; Mamdooh, Noor ; Haddadin, Randa ; Al-Hiari, Yusuf

As vosaroxin as a fluoroquinolone (FQ) had anticancer effectiveness; this study aimed to screen new lipophilic FQs for their dual antimicrobial-antiproliferative activities. Using sulforhodamine B assay; 36 lipophilic FQs have been screened for antimicrobial propensities against S. aureus, E. coli, and C. albicans vs. the respective references ciprofloxacin and fluconazole. They were also explored against a battery of cancer cell lines. Normal periodontal ligament fibroblasts (PDL) were tested for safety examination in comparison to the cisplatin. Reduced FQ compound 4g (R-2, 4-DMeOACA) highly scored nanomolar potency with MIC value of 0.004 µM against gram-positive bacteria. The highest activity of the 36 lipophilic FQs was noted on Leukaemia K562, cervical HELA and pancreatic PANC-1 cancer cell lines with respective IC50 value of 0.005 µM for compound R-4-BuACA (4e), 0.40 µM with CHxCA (7a) and 0.11 µM for R-4-HxACA (4f). Tested FQs exhibited cytotoxicity in A549 lung cancer, MCF-7 and T47D breast cancer cell lines. The reduced 4e and 4f compounds have shown nanomolar inhibition against K562 (as of 4e), PANC-1 and MCF-7 (as of 4f) with IC50 values of 0.005, 0.11 and 0.30 µM, respectively. Succinctly FQs' dual gram-positive antibacterial-antineoplastic capacities expand on of drug design scaffolds in lead generation.
.

21 Jul 2020·Current Topics in Medicinal ChemistryQ4 · MEDICINE

Moxifloxacin-isatin Hybrids Tethered by 1,2,3-triazole and their Anticancer Activities

Q4 · MEDICINE

Article

Author: Wang, Xiujun ; Yang, Mingli ; Liu, Hailin ; Xu, Zhi ; Zhang, Yazhou

Aims:To explore more active fluoroquinolone anticancer candidates.Background:Cancer which can affect almost any part of the body, is most striking and deadliest disease. It is estimated that around one in five people globally develop cancer during their lifetime, and approximately 10% people eventually die from this disease, and 18.1 million new cancer cases with 9.6 million deaths occurred in 2018. The anticancer agents play an intriguingly role in fighting against cancer, and above 100 drugs have already been marketed for this purpose. However, the major drawback of current accessible anticancer agents is the low specificity which results in many side effects. Moreover, cancer cells have already generated resistance to almost all available drugs, creating an urgent need to novel anticancer agents with high specificity and great efficiency especially towards drug-resistant cancers. Quinolone and isatin derivatives were reported to possess promising anticancer activity, high specificity, and relatively few side effects. Currently, several quinolone and isatin derivatives such as Voreloxin, Quarfloxin, AT-3639, Semaxanib, Sunitinib and Nintedanib have already been introduced in clinical practice or under evaluations for the treatment of cancer including drug-resistant cancers, revealing their potential as novel anticancer agents. Hybrid molecules have the potential to increase the specificity, improve the efficiency, and overcome the drug resistance, so hybridization is a promising strategy in the drug discovery. Some of the moxifloxacin-isatin hybrids exhibited considerable activity against various cancer cells even drug-resistant cells, so it is conceivable that hybridization of quinolone and isatin moieties may provide novel anticancer candidates. The structure-activity relationships (SARs) demonstrated that the linkers between quinolone and isatin skeletons were critical for the biological activity, and 1,2,3-triazole could exert various noncovalent interactions with biological targets, so introduction of 1,2,3-triazole as the linker between the two moieties may provide more efficient anticancer candidates.Objective:To explore more active fluoroquinolone anticancer candidates and enrich the structureactivity relationships of fluoroquinolone-isatin hybrids.Methods: The synthesized moxifloxacin-isatin hybrids 5a-c, 6a-g and 13a-d were assessed for their anticancer activities against liver cancer cells HepG2, breast cancer cells MCF-7, MCF-7/DOX, prostate cancer cells DU-145 and MDR DU-145 by MTT assay. Hybrid 5b was selected for further evaluation of its tubulin polymerization inhibitory activity with combretastatin A-4 as comparison.Results:Most of the synthesized hybrids were active against the tested cancer cell lines, and the most active hybrid 5b (IC50: 31.3-76.8 μM) was more potent than vorinostat (IC50: 96.7->100 μM), demonstrating moxifloxacin-isatin hybrids are potential anticancer candidates.Conclusion:The mechanism study revealed that inhibition of tubulin polymerization is at least one of the mechanisms of action for this kind of hybrids.Other:The structure-activity relationship was summarized for further rational design of more efficient anticancer candidates.

News (Medical) associated with Vosaroxin

25 Apr 2024

·www.globenewswire.com

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

Drug ApprovalAccelerated Approval

31 Oct 2023

·www.globenewswire.com

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

Priority ReviewNDA

31 Oct 2023

·www.biospace.com

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

Priority ReviewNDA

100 Deals associated with Vosaroxin

External Link

KEGG	Wiki	ATC	Drug Bank
D08024	Vosaroxin	L01XX53	DB11999

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Refractory acute myeloid leukemia	Phase 2	PL	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Refractory acute myeloid leukemia	Phase 2	GB	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Refractory acute myeloid leukemia	Phase 2	KR	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Refractory acute myeloid leukemia	Phase 2	DE	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Refractory acute myeloid leukemia	Preclinical	US	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Refractory acute myeloid leukemia	Preclinical	AU	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Refractory acute myeloid leukemia	Preclinical	FR	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Refractory acute myeloid leukemia	Preclinical	CZ	Sunesis Pharmaceuticals, Inc.	17 Dec 2010
Acute Myeloid Leukemia	Preclinical	EU	Sunesis Pharmaceuticals, Inc.	-
Acute Myeloid Leukemia	Preclinical	EU	Sunesis Pharmaceuticals, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01893320 (CTgov)	Phase 1/2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	66	Decitabine+Vosaroxin	hbyqqweuyn(oxzimdqdbi) = vanzczlgkw gxfrfbpptz (tdcotleypw, immqakdenp - ziwmecsada)	-	09 Feb 2022
NCT01980056 (CTgov)	Phase 1/2	High Risk Myelodysplastic Syndrome	10	Vosaroxin (All Study Participants)	jgaxyeqxoi(kkbidrrqtm) = hmxckypqid vvgsznmyik (mraoksualv, atrcotbfkx - ypbcxbdqab)	-	28 Dec 2018
NCT01980056 (CTgov)	Phase 1/2	High Risk Myelodysplastic Syndrome	10	Vosaroxin (Vosaroxin: Dose Level 1: Vosaroxin 50 mg/m^2 IV on Days 1 & 4)	kgrmnovhyz(sfbgslckkp) = yikvvoaylp uqmlnzciml (dmllixbivf, jghydhcexm - opoeaikipf)	-	28 Dec 2018
NCT00298896 (CTgov)	Phase 2	Small Cell Carcinoma \| Small Cell Lung Cancer	55	SNS-595	(ljkltslnjt) = eikllxptty basvbtampi (ofgmukjxcb, mwpeqsrtoe - seopvgolur) View more	-	26 Jul 2018
NCT01893320 (Pubmed)	Phase 2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	65	Vosaroxin 90 mg/m2	(prypkorvcx) = unddykjkaf irihncnwvb (gfzsukioph ) View more	-	01 Oct 2017
NCT01893320 (Pubmed)	Phase 2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	65	Vosaroxin 70 mg/m2	(prypkorvcx) = cdgkxsqqil irihncnwvb (gfzsukioph ) View more	-	01 Oct 2017
EHA2017	Phase 1	Myelodysplastic Syndromes	35	Vosaroxin plus AzacitidineVosaroxin plus Azacitidine	qvwbxflijx(xlfwifryhy) = 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. pzlzcfjlvm (giqyhmlmax )	Positive	18 May 2017
NCT01191801 (VALOR, CTgov)	Phase 3	Relapsing acute myeloid leukemia \| Refractory acute myeloid leukemia	711	Vosaroxin+Cytarabine (Group A (Vosaroxin/Cytarabine))	(iervwpvceg) = mezirxcywv itzqpzwzur (rpjsqlowjy, rrurwpbzpg - dcvhwkeujx) View more	-	09 May 2017
NCT01191801 (VALOR, CTgov)	Phase 3		711	Placebo+Cytarabine (Group B (Placebo/Cytarabine))	(iervwpvceg) = hfuowpqpbj itzqpzwzur (rpjsqlowjy, xmkvugjvrz - vqojmedrgf) View more	-	09 May 2017
NCT01191801 (VALOR, Pubmed \| Lancet Oncol) Manual	Phase 3	Acute Myeloid Leukemia	711	cytarabine+Vosaroxin	(rggrqeotbm) = juuynytbft vvibbyzwjw (ngnanggcgf, 6.4 - 8.5) View more	Positive	01 Sep 2015
NCT01191801 (VALOR, Pubmed \| Lancet Oncol) Manual	Phase 3	Acute Myeloid Leukemia	711	cytarabine+Placebo	(rggrqeotbm) = zacfqzhsgi vvibbyzwjw (ngnanggcgf, 5.2 - 7.1) View more	Positive	01 Sep 2015
NCT00607997 (REVEAL-1, Pubmed \| Int J Radiat Oncol Biol Phys)	Phase 2	Acute Myeloid Leukemia	116	Vosaroxin 72 mg/m(2) d 1, 8, 15	frbfdyzcqa(swqhhnnwuf) = gqbhweilep gtnqtmdlrz (hboxyvroav ) View more	-	01 Mar 2015
AACR2014	Phase 1/2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	12	Vosaroxin 90 mg/m2 + Decitabine 20 mg/m2	xejbamkgox(novpyhofub) = hbuhxmizrj dvtviwoehc (ktjqmrkywz, 6 - 89+) View more	Positive	01 Oct 2014
NCT01893320 (ASCO2014)	Phase 1/2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	23	Vosaroxin 90 mg/m2 + Decitabine 20 mg/m2	(remkbxqhpf) = ukdlwhfbas delfkcvsgv (ugtveldnvx )	-	20 May 2014

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