Drugs / Darinaparsin
Darinaparsin
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT01689220 | Sep 2012 → Jan 2014 | peripheral T-cell lymphoma, not otherwise specified | Solasia Pharma K.K. | Completed | No outcome recorded |
| Phase 1 | NCT01435863 | Sep 2011 → Apr 2015 | peripheral T-cell lymphoma, not otherwise specified | Solasia Pharma K.K. | Completed | No outcome recorded |
| Phase 1 | NCT01139359 | Jun 2010 → Jun 2011 | lymphoma | Alaunos Therapeutics | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01139346 | Jun 2010 → Apr 2012 | cancer | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00592163 | Dec 2007 → Jan 2009 | cancer, lymphoma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00591422 | Aug 2007 → Mar 2010 | cancer of unknown primary site | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00591396 | Jul 2005 → Jul 2008 | cancer | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00592046 | May 2005 → Jun 2008 | acute leukemia, lymphoproliferative syndrome, myelodysplastic syndrome, myeloproliferative neoplasm +1 | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00509782 | May 2005 → Apr 2008 | cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00303199 | Jan 2006 → Aug 2007 | plasma cell myeloma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT02653976 | Mar 2016 → Oct 2020 | peripheral T-cell lymphoma, not otherwise specified | Solasia Pharma K.K. | Completed | Met primary |
| Phase 2 | NCT00423306 | May 2007 → Aug 2008 | hepatocellular carcinoma | Alaunos Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT00423644 | Jan → Dec 2007 | plasma cell myeloma | Alaunos Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00421213 | Dec 2006 → Jun 2009 | bone marrow neoplasm, non-Hodgkin lymphoma | Alaunos Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2011-11-21 | Alaunos Therapeutics | Results Preclinical Darinaparsin Study in PLoS ONE Publication alaunos.com ↗
The study describes darinaparsin's anti-cancer activity as a unique multivalent mitochondrial-targeting agent acting on cell stress induction, microtubule polymerization and sonic hedgehog signaling ("Shh"). |
| 2011-11-13 | Alaunos Therapeutics | Results ZIOPHARM Oncology Presents Preclinical Data for Darinaparsin Effect on Hedgehog Signaling Pathway in Prostate Cancer at AACR-NCI-EORTC Meeting alaunos.com ↗
Data from the studies demonstrate that darinaparsin is a potent inhibitor of DU145 prostate cells, which inhibited prostate spheroid growth (IC 50 :2uM) and prostate stem cell colony formation. |
| 2011-01-20 | Alaunos Therapeutics | Regulatory ZIOPHARM Receives Positive Opinion for Orphan Drug Designation for Darinaparsin from European Medicines Agency alaunos.com ↗
A positive opinion by the COMP immediately precedes official designation of darinaparsin as an orphan drug by the European Commission (EC). |
| 2010-12-06 | Alaunos Therapeutics | Results ZIOPHARM Presents New Darinaparsin Preclinical Lymphoma Data at ASH Annual Meeting alaunos.com ↗
Results demonstrated that darinaparsin inhibited cell growth and induced apoptosis through the AKT and MEK/ERK pathways and all cell lines at 1-3µM. |
| 2010-11-19 | Alaunos Therapeutics | Results ZIOPHARM Presents New Darinaparsin Preclinical Data at EORTC-NCI-AACR Meeting alaunos.com ↗
Results showed that darinaparsin is a potent cytotoxin under both NO and HO conditions and under HO when cells are resistant to radiation. |
| 2010-09-23 | Alaunos Therapeutics | Regulatory ZIOPHARM Receives FDA Orphan Drug Designation for Darinaparsin in the Treatment of Peripheral T-cell Lymphoma alaunos.com ↗
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to darinaparsin (Zinapar(TM) or ZIO-101) for the treatment of peripheral T-cell Lymphoma (PTCL). |
| 2010-04-20 | Alaunos Therapeutics | Results Darinaparsin Data Presented at AACR alaunos.com ↗
Findings showed an enhanced cytotoxic effect of darinaparsin on this otherwise chemotherapeutic resistant solid tumor cell line. |
| 2009-06-01 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Darinaparsin Clinical Data at ASCO's Prestigious Clinical Science Symposium alaunos.com ↗
Of 19 evaluable patients, initial findings are 7 objective responses, for an overall response rate of 37 percent, with 3 complete responses (CRs) and 4 partial responses (PRs). |
| 2008-12-08 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Darinaparsin Phase II Data at ASH Meeting alaunos.com ↗
Of 15 evaluable patients, 4 patients (27%) had objective responses (Complete Response + Partial Response) and 3 patients (20%) had stable disease. |
| 2008-10-23 | Alaunos Therapeutics | Results ZIOPHARM Presents Darinaparsin Molecular Mechanism of Action and Preliminary Oral Administration Phase I Clinical Data at the EORTC-NCI-AACR Symposium alaunos.com ↗
ZIOPHARM Presents Darinaparsin Molecular Mechanism of Action and Preliminary Oral Administration Phase I Clinical Data at the EORTC-NCI-AACR Symposium |
| 2008-08-04 | Alaunos Therapeutics | Results Leukemia Journal Publishes Results from Darinaparsin Study alaunos.com ↗
The study showed that darinaparsin is highly active in vitro against certain leukemia cells that are resistant to inorganic arsenic (arsenic trioxide--ATO) because they express a drug resistance protein (MRP1/ABCC1). |
| 2008-04-16 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive Data from Phase II Study of Darinaparsin in Advanced Hematological Malignancies at AACR 2008 Annual Meeting alaunos.com ↗
Of 14 leukemia patients evaluable for efficacy, 6 patients achieved stable disease (3 MDS and 3 CML) and 1 patient withdrew consent prior to efficacy evaluation. |
| 2007-09-25 | Alaunos Therapeutics | Results Data From Ongoing Hematological Trials With Darinaparsin Presented at European College of Clinical Oncology Annual Meeting alaunos.com ↗
As a measure of clinical activity, five of the 12 AML patients, or 42%, had a decrease in peripheral blood myeloblasts while both of the MDS patients experienced stable disease. |
| 2007-06-28 | Alaunos Therapeutics | Results ZIO-101 (Darinaparsin) Interim Phase II and Preclinical Data Presented at International Myeloma Workshop alaunos.com ↗
ZIOPHARM is presenting darinaparsin (ZIO-101) gene expression profiling data that further elucidates its unique mechanism of action as well as interim Phase II data from two ongoing trials in advanced myeloma. |
| 2007-06-02 | Alaunos Therapeutics | Results ZIO-101 (Darinaparsin) Phase I Advanced Solid Tumor Data Presented at ASCO alaunos.com ↗
Darinaparsin was well tolerated and the Dose Limiting Toxicity was transient and reversible ataxia and confusion. |
| 2007-06-02 | Alaunos Therapeutics | Results ZIO-101 (Darinaparsin) Early Interim Multiple Myeloma Phase I/II Data Presented at ASCO alaunos.com ↗
As reported, of the 14 patients treated 5 consecutive days, there are 10 patients evaluable for efficacy, with 4 out of the 10 (40%) achieving stable disease greater than 4 months duration. |
| 2007-06-01 | Alaunos Therapeutics | Regulatory ZIO-101 Oral Capsule Clears FDA Review for Phase I Study alaunos.com ↗
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a phase I trial with an oral capsule form of ZIO-101, the Company's proprietary small molecule organic arsenic. |
| 2007-04-17 | Alaunos Therapeutics | Results ZIOPHARM Presents Data Highlighting Oral ZIO-101 at AACR alaunos.com ↗
Data from pharmacokinetic analysis of orally administered ZIO-101 in animals showed very high bioavailability. |
| 2007-02-12 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-101 Data at Bone Marrow Transplant Meeting alaunos.com ↗
Data from the phase I study in multiple myeloma showed 6 of 14 patients achieved at least stable disease (SD). |
| 2006-12-11 | Alaunos Therapeutics | Results ZIOPHARM Presents Positive ZIO-101 Myeloma Data at ASH alaunos.com ↗
Of 14 evaluable patients with progressive myeloma, 6 (43%) responded with disease stabilization after having failed a median of eight prior therapies. |
| 2006-11-10 | Alaunos Therapeutics | Results ZIOPHARM Announces Positive ZIO-101 Clinical Data at EORTC-NCI-AACR alaunos.com ↗
There was clinical activity in 13 of 43 (30%) evaluable patients reported today. |
| 2006-11-09 | Alaunos Therapeutics | Results ZIOPHARM Announces New ZIO-101 Mechanism Data at EORTC-NCI-AACR alaunos.com ↗
The mechanism data indicate that certain cancer cells resistant to inorganic arsenic are sensitive to ZIO-101. |
| 2006-10-03 | Alaunos Therapeutics | Results ZIOPHARM Presents ZIO-101 Phase I Solid Tumor Data; Maturing Data Opens Door to Multiple Approval Pathways alaunos.com ↗
Of the 29 subjects receiving ZIO-101, 8 benefited. |
| 2006-09-14 | Alaunos Therapeutics | Results ZIOPHARM Presents at European Society of Hematology Meeting; Updates ZIO-101 Clinical Development Strategy alaunos.com ↗
An anti-leukemia effect was seen in three extensively pre-treated patients; a fourth with prior MDS stopped needing frequent red blood cell (RBC) transfusions and had a marked functional improvement. |
| 2006-06-02 | Alaunos Therapeutics | Results ZIOPHARM Announces Preliminary ZIO-101 Phase I Leukemia Data alaunos.com ↗
In abstract #16503 "A Phase-1 Trial of a Novel Organic Arsenic S-dimethylarsino-glutathione (ZIO-101) in Hematological Malignancies" by Steven Kornblau, M.D. and colleagues at The University of Texas M. D. Anderson Cancer Center, the data show evidence of anti-leukemia activity in persons with advanced acute myelogenous leukemia (AML). |
| 2006-06-02 | Alaunos Therapeutics | Results ZIOPHARM Announces Interim Results in ZIO-101 Phase I alaunos.com ↗
Six of 24 patients treated (number updated after abstract submission) had clinical benefit. |
| 2006-04-05 | Alaunos Therapeutics | Results ZIOPHARM Announces ZIO-101 Anti-Cancer Activity at AACR alaunos.com ↗
ZIOPHARM Oncology, Inc. (OTC BB: ZIOP) announced today the results of a preclinical study that show ZIO-101, a new organic arsenic drug, kills myeloma cells. |
| 2006-01-04 | Alaunos Therapeutics | Regulatory ZIOPHARM Oncology Accomplishes Key Clinical Development Milestone alaunos.com ↗
it received approval from the FDA (U.S. Food and Drug Administration) to initiate a Phase I/II trial with one of its two lead products, ZIO-101, a novel organic arsenic, in patients with advanced myeloma. |
| 2005-11-21 | Alaunos Therapeutics | Results ZIOPHARM Oncology Announces ZIO-101 Data Published in Blood alaunos.com ↗
Data suggest that both ZIO-101 and ATO kill myeloma cells but that different modes of action may be involved. |
| 2005-11-16 | Alaunos Therapeutics | Results ZIOPHARM Oncology Announces ZIO-101 Phase I Data Presented at AACR-NCI-EORTC International Conference alaunos.com ↗
ZIOPHARM Oncology, Inc. (OTC BB: ZIOP) announced today that ZIO-101, a novel organic arsenic, has demonstrated safety at doses approximately 25 times higher than the currently approved dose for arsenic trioxide, an inorganic arsenic, in an ongoing Phase I trial that has treated 11 patients to date at The University of Texas M. D. Anderson Cancer Center. |
| 2005-04-05 | Alaunos Therapeutics | Regulatory ZIOPHARM Announces Approval of IND for ZIO-101 alaunos.com ↗
ZIOPHARM, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug Application (IND) for the clinical development of its proprietary organic arsenic compound, ZIO-101. |
| 2004-09-20 | Alaunos Therapeutics | Results ZIOPHARM Presents Data on New Class of Arsenic Compounds at International Leukemia Meeting alaunos.com ↗
Further testing with ZIO-101 in dogs showed no evidence of heart damage or other severe toxicity. |
All press releases naming this drug 48 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darinaparsin | “420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months” NCT00423644 ↗13“A phase I clinical trial of darinaparsin in patients with refractory solid tumors.” PMID 19584162 ↗ Jul 2009 “ZIO-101 (Darinaparsin)” NCT00592046 ↗ |
| Known as | Darinaparsina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3247378 ↗ |
| Known as | Darinaparsine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3247378 ↗ |
| Known as | SP-02L | “Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)” NCT02653976 ↗2“SP-02L (darinaparsin for injection)” NCT01435863 ↗ “SP-02L (darinaparsin for injection)” NCT01689220 ↗ |
| Known as | ZIO-101 | “ZIO-101 (Darinaparsin)” NCT00303199 ↗ |
| Modality | Small molecule | “new organic arsenic compound” NCT00303199 ↗ |
| Route | Intravenous | “IV zio-101 (Darinaparsin) give for 5 consecutive days” NCT00303199 ↗ |