Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Genasense | — | 2007-10-15 | europa.eu ↗ |
Trials 45
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | oblimersen sodium | “Oblimersen sodium is a bcl-2 antisense oligonucleotide complementary to the first six codons of the open-reading frame of bcl-2 mRNA that can decrease transcription of Bcl-2...” PMID 19373653 ↗ Apr 200920“BACKGROUND: This randomized, phase II study assessed the activity of oblimersen sodium, a Bcl-2 antisense oligonucleotide, administered before docetaxel (Taxotere) to patients...” PMID 19297314 ↗ Mar 2009 “Randomized phase III trial of fludarabine plus cyclophosphamide with or without oblimersen sodium (Bcl-2 antisense) in patients with relapsed or refractory chronic lymphocytic leukemia.” PMID 17296974 ↗ Feb 2007 “This phase II trial studies how well carboplatin and etoposide with or without oblimersen sodium works in treating patients with extensive stage small cell lung cancer.” NCT00042978 ↗ “A Phase II study of Bcl-2 antisense (oblimersen sodium) combined with gemtuzumab ozogamicin in older patients with acute myeloid leukemia in first relapse.” PMID 16730060 ↗ May 2006 “Phase I to II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in patients with advanced chronic lymphocytic leukemia.” PMID 16186597 ↗ Sep 2005 “A phase I-II study of oblimersen sodium (G3139, Genasense) in combination with doxorubicin in advanced hepatocellular carcinoma (NCI # 5798).” PMID 18060598 ↗ Dec 2007 “Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein.” NCT00078234 ↗ “G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide” NCT00543231 ↗ “Genasense® (, oblimersen sodium G3139)” NCT00517218 ↗ “Genasense® (G3139, oblimersen sodium)” NCT00542893 ↗ |
| Known as | augmerosen | “augmerosen” NCT00064259 ↗ |
| Known as | D-G3139 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109229 ↗ |
| Known as | G3139 | “Evaluate the safety and plasma concentration profiles of oblimersen (G3139) administered alone or in combination with docetaxel in patients with advanced solid tumors...” NCT00003103 ↗10“A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia” NCT00078234 ↗ “A phase I-II study of oblimersen sodium (G3139, Genasense) in combination with doxorubicin in advanced hepatocellular carcinoma (NCI # 5798).” PMID 18060598 ↗ Dec 2007 “Oblimersen (G3139) may help dacarbazine kill more cancer cells by making tumor cells more sensitive to the drug.” NCT00016263 ↗ “patients receive oblimersen (G3139) IV continuously on days 1-7 and 15-21” NCT00017602 ↗ “dacarbazine plus Genasense (oblimersen, G3139)” NCT00518895 ↗ “oblimersen (G3139) IV continuously on days 1-5” NCT00070343 ↗ “Genasense® (, oblimersen sodium G3139)” NCT00517218 ↗ “Genasense® (G3139, oblimersen sodium)” NCT00542893 ↗ “Oblimersen Sodium (G3139, Genasense)” NCT00055822 ↗ |
| Known as | Genasense | “Randomized Phase III Study of Dexamethasone With or Without Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Relapsed or Refractory Multiple Myeloma” NCT00017602 ↗10“A phase I-II study of oblimersen sodium (G3139, Genasense) in combination with doxorubicin in advanced hepatocellular carcinoma (NCI # 5798).” PMID 18060598 ↗ Dec 2007 “Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein.” NCT00078234 ↗ “Genasense® (G3139, oblimersen sodium)” NCT00543205 ↗ “Oblimersen Sodium (G3139, Genasense)” NCT00055822 ↗ “Genasense® (oblimersen)” NCT00409383 ↗ |
| Known as | oblimersen | “Oblimersen was administered at doses ranging from 3 to 7 mg/kg/d as a 5-day continuous intravenous infusion in cycle 1” PMID 16186597 ↗ Sep 200535“dacarbazine plus Genasense (oblimersen, G3139)” NCT00518895 ↗ |
| Action | Inhibit | “can decrease transcription of Bcl-2 protein” PMID 19373653 ↗ Apr 2009 |
| Modality | Antisense oligonucleotide | “Phosphorothioate Antisense Oligonucleotide Directed to Bcl-2” NCT00004870 ↗ |
| Route | Intravenous | “Patients receive oblimersen (G3139) IV continuously over days 1-6” NCT00016263 ↗ |
| Target | BCL2 | “Phosphorothioate Antisense Oligonucleotide Directed to Bcl-2” NCT00004870 ↗ |