Drugs / Atu027
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | SMARCA4-deficient sarcoma of thorax | — | “Silence submitted the Clinical Trial Application for Atu027 in December 2008 having successfully completed single and repeat dose toxicology” silence-therapeutics.com ↗ “Silence made a regulatory filing in 2008 and expects to commence clinical trials for Atu027 in 2009.” silence-therapeutics.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00938574 | Jun 2009 → Jul 2012 | cancer | Silence Therapeutics GmbH | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT01808638 | Mar 2013 → Aug 2015 | pancreatic ductal adenocarcinoma | Silence Therapeutics GmbH | Completed | Met primary |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2016-04-18 | Silence Therapeutics GmbH | Results Atu027 update silence-therapeutics.com ↗
Silence Therapeutics plc, AIM: SLN (‘Silence’ or ‘the Company’), a leader in the development and delivery of novel RNA therapeutics, provides the final analysis of Atu027 -I-02 Phase IIa study in pancreatic cancer. |
| 2015-06-01 | Silence Therapeutics GmbH | Results AGM statement & pancreatic cancer trial interim analysis 01/06/15 silence-therapeutics.com ↗
Those exposed to the higher dose of Atu027 presented a longer median duration of PFS; 5.33 months compared to 1.81 months for those on the lower exposure regimen. |
| 2015-03-23 | Silence Therapeutics GmbH | Results Clinical trial update silence-therapeutics.com ↗
Silence Therapeutics plc, AIM: SLN (‘Silence’ or ‘the Company’), a leader in the development and delivery of novel RNA therapeutics, provides a draft interim analysis of Atu027-I-02 Phase IIa study in pancreatic cancer. |
| 2014-11-18 | Silence Therapeutics GmbH | Results Publication of first-in-human study data on Atu027 RNAi in advanced solid tumours silence-therapeutics.com ↗
The study found that Atu027 was well tolerated and safe in patients with advanced solid tumours. |
| 2014-06-06 | Silence Therapeutics GmbH | Results Atu027 Demonstrates Promising Antitumor Activity in Phase I Study Presented at ASCO silence-therapeutics.com ↗
In addition to the encouraging antitumor activity, study results show Atu027 to be well tolerated with no observed dose -limited toxicities or evidence of cytokine activation. |
| 2013-06-18 | Silence Therapeutics GmbH | Results Atu027 update: progression into Phase IIa silence-therapeutics.com ↗ |
| 2013-03-05 | Silence Therapeutics GmbH | Regulatory Business Update silence-therapeutics.com ↗
Silence Therapeutics is delighted to report it has received formal approval from the German authorities (BfArM) for its phase 1b/2a combination trial into pancreatic cancer. |
| 2012-06-06 | Silence Therapeutics GmbH | Results Safe and Effective Dose Successfully Identified in Phase I study of Atu027 silence-therapeutics.com ↗
The prospective recommended maximum tolerated dose is 0.336 mg/kg. |
| 2012-05-17 | Silence Therapeutics GmbH | Results New Data from Phase I Study of Atu027 RNAi Therapy silence-therapeutics.com ↗
today announces that top line data from its ongoing Phase I trial of Atu027 show that of the 33 patients treated in the first 10 cohorts of the study, 10 patients experienced stable disease after three months. |
| 2012-03-09 | Silence Therapeutics GmbH | Regulatory Opponents of Tuschl I patent succeed in limiting scope and ambiguity in patent silence-therapeutics.com ↗
The claims as originally granted were modified during the hearing held by the Opposition Division of the EPO. |
| 2011-11-08 | Silence Therapeutics GmbH | Results Silence Therapeutics provides corporate and development update silence-therapeutics.com ↗
Results from the ongoing Phase I trial of Atu027 |
| 2011-05-18 | Silence Therapeutics GmbH | Results New Data from Phase I Study with Atu027 to be presented at 2011 ASCO Annual Meeting silence-therapeutics.com ↗ |
| 2010-10-11 | Silence Therapeutics GmbH | Results Lead RNA Interference Therapeutic Prevents Spread of Cancer to Lungs silence-therapeutics.com ↗ |
| 2009-06-03 | Silence Therapeutics GmbH | Regulatory Silence receives approval to commence Phase I clinical trial with Atu027 silence-therapeutics.com ↗
Silence Therapeutics plc (AIM: SLN) (“Silence” or “the Company”), the leading European biopharmaceutical company focused on RNA interference (RNAi), announces that its Clinical Trial Application (CTA) for Atu027, its lead drug candidate, has been cleared by the German regulator Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). |
| 2009-01-09 | Silence Therapeutics GmbH | Regulatory European Patent Office grants Silence Therapeutics’ Patent on Target for Lead Compound Atu027 silence-therapeutics.com ↗ |
| 2008-12-01 | Silence Therapeutics GmbH | Results Research demonstrates that lead candidate Atu027 inhibits cancer progression silence-therapeutics.com ↗ |
All press releases naming this drug 20 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Atu027 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00938574 ↗ |
| Action | Inhibit | “which silences expression of protein kinase N3 in the vascular endothelium.” PMID 25403217 ↗ Nov 2014 |
| Modality | Small interfering RNA (siRNA) | “Atu027 is a novel liposomal RNA interference therapeutic that includes a short-interfering RNA (siRNA)” PMID 25403217 ↗ Nov 2014 |
| Route | Intravenous | “eight intravenous infusions twice per week during a 28-day cycle” PMID 25403217 ↗ Nov 2014 |
| Target | PKN3 | “which silences expression of protein kinase N3 in the vascular endothelium.” PMID 25403217 ↗ Nov 2014 |