Drugs / CYP-001
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04537351 | Aug 2020 → Apr 2022 | COVID-19, adult acute respiratory distress syndrome | Cynata Therapeutics Limited | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05643638 | Mar 2024 → Mar 2026 overdue | acute graft versus host disease | Cynata Therapeutics Limited | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-06-21 | Cynata Therapeutics Limited | Results Investor Webinar cynata.com ↗
Neither trial met its primary endpoint. |
| 2026-06-17 | Cynata Therapeutics Limited | Results CYP-001 GvHD Trial Primary Evaluation Results cynata.com ↗ |
| 2026-06-02 | Cynata Therapeutics Limited | Regulatory EU Positive Opinion on CYP-001 Paediatric Investigation Plan cynata.com ↗ |
| 2026-05-28 | Cynata Therapeutics Limited | Regulatory WHO Selects Proposed INN for Cymerus MSCs cynata.com ↗ |
| 2025-12-03 | Cynata Therapeutics Limited | Results Positive DSMB Review in Phase 1/2 Kidney Transplant Trial cynata.com ↗
There have been no episodes of kidney transplant rejection in this cohort. |
| 2024-10-07 | Cynata Therapeutics Limited | Results Alliance for Regenerative Medicine Meeting Presentation cynata.com ↗
CYP-001 was shown to be safe and well tolerated, with sustained outcomes up to 2 years after the first infusion |
| 2024-06-26 | Cynata Therapeutics Limited | Results Sharewise Investor Presentation cynata.com ↗
• No serious adverse events or other safety concerns related to CYP-001 |
| 2024-05-22 | Cynata Therapeutics Limited | Results Further GvHD Clinical Data Published in Nature Medicine cynata.com ↗
Key results i nclude a two -year overall survival rate of 60% (9/15 patients), with no treatment- related serious adverse events or safety concerns identified. |
| 2024-03-19 | Cynata Therapeutics Limited | Regulatory EU Approval for Phase 2 CYP-001 Trial in GvHD cynata.com ↗
Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical- stage biotechnology company specialising in cell therapeutics, has received regulatory and ethics approval in the European Union (EU) for its Phase 2 clinical trial of CYP -001 in high -risk acute graft versus host disease (aGvHD). |
| 2023-12-06 | Cynata Therapeutics Limited | Regulatory Phase 2 Trial of CYP-001 in aGvHD Approved in Turkey cynata.com ↗
Cynata Therapeutics Limited (ASX: “ CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, has received regulatory and ethics approval to commence its Phase 2 clinical trial of CYP -001 in patients with High -Risk acute Graft versus Host Disease (HR-aGvHD) at clinical centres in Turkey (Türkiye). |
| 2023-08-20 | Cynata Therapeutics Limited | Regulatory Approval of Clinical Trial of CYP-001 in Kidney Transplant cynata.com ↗
the Competent (regulatory) Authority in the Netherlands (Centrale Commissie Mensgebonden Onderzoek, CCMO) has approved the Phase 1 clinical trial of CYP-001 in patients who have received a kidney transplant. |
| 2023-05-22 | Cynata Therapeutics Limited | Results Two-Year Results of Phase 1 SR-aGvHD Trial Presented at ISCT cynata.com ↗
Patients treated with CYP-001 had a two-year overall survival rate of 60% (9/15 patients) |
| 2022-07-27 | Cynata Therapeutics Limited | Regulatory Quarterly Activity Report & Appendix 4C cynata.com ↗
US Food and Drug Administration (FDA) clears Cynata’s Investigational New Drug (IND) application for a Phase 2 trial in acute graft-versus-host disease (aGvHD) |
| 2022-05-25 | Cynata Therapeutics Limited | Regulatory FDA Clears Cynata IND for Phase 2 Trial in GvHD cynata.com ↗
US FDA has cleared Cynata’s IND application for a Phase 2 clinical trial of CYP -001 in patients with aGvHD – a major milestone and value catalyst for the Company |
| 2020-09-14 | Cynata Therapeutics Limited | Results Cynata Clinical Trial Results Published in Nature Medicine cynata.com ↗
Cynata’s lead product candidate CYP -001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid -resistant acute graft- versus-host disease (GvHD) in a Phase 1 trial. |
| 2020-09-06 | Cynata Therapeutics Limited | Results Cymerus MSCs Effective in Preclinical Lung Disease Study cynata.com ↗ |
| 2020-07-29 | Cynata Therapeutics Limited | Results Cynata Announces Positive Results from GvHD Trial Follow-up cynata.com ↗ |
| 2019-02-06 | Cynata Therapeutics Limited | Results Study of CYP-001 Published in Leading Peer Review Journal cynata.com ↗
Cymerus MSCs reduce GvHD severity and significantly prolong survival in a humanised mouse model of GVHD. |
| 2018-12-17 | Cynata Therapeutics Limited | Results Cynata Completes Clinical Study Report in GvHD cynata.com ↗
Overall Response rate by Day 100 was 87% |
| 2018-11-14 | Cynata Therapeutics Limited | Results Annual General Meeting Presentation cynata.com ↗
All trial endpoints achieved: no adverse safety events, highly encouraging efficacy |
| 2018-11-01 | Cynata Therapeutics Limited | Results Cyanta Outlook and Investor Presentation cynata.com ↗
One patient in cohort A died of pneumonia (unrelated to treatment) and one patient in cohort B withdrew from the trial on Day 22 to commence palliative care. |
| 2018-08-29 | Cynata Therapeutics Limited | Results Cynata GvHD Trial Meets all Safety & Efficacy Endpoints cynata.com ↗
In a Day 100 analysis of patients in the high-dose Cohort B, CYP-001 demonstrated positive safety and efficacy data that is consistent with day 100 data from the lower -dose Cohort A and a day 28 evaluation of Cohort B. |
| 2018-06-20 | Cynata Therapeutics Limited | Results Positive 28-day Clinical Trial Data in Cohort B cynata.com ↗
Overall Response rate by Day 28 was 86 % (six out of seven patients treated with CYP -001 showed an improvement in the severity of GvHD by at least one grade compared to baseline) |
| 2018-06-11 | Cynata Therapeutics Limited | Results Positive 6-Month Data from Cohort 1 in Phase 1 Trial in GvHD cynata.com ↗ |
| 2018-03-27 | Cynata Therapeutics Limited | Regulatory FDA Grants Orphan Drug Designation to Cyanta for CYP-001 cynata.com ↗ |
| 2018-02-26 | Cynata Therapeutics Limited | Results Excellent Data from Final Preliminary Evaluation Period cynata.com ↗
Overall Response rate by Day 100 was 100% (all eight participants showed an improvement in the severity of GvHD by at least one grade compared to baseline) |
| 2018-01-22 | Cynata Therapeutics Limited | Results Encouraging Early Data-Cynata Clinical Trial Proceeds cynata.com ↗
All eight participants in Cohort A (lower dose cohort) have demonstrated at least a Partial Response (defined as an improvement in the severity of GvHD by at least one grade compared to baseline) |
| 2017-02-05 | Cynata Therapeutics Limited | Results Final GvHD Preclinical Report Confirms Treatment Benefit cynata.com ↗
The report confirms and extends the findings from the initial study with the data showing a clear and robust therapeutic effect of CYP-001. |
| 2016-12-15 | Cynata Therapeutics Limited | Regulatory Cynata's Clinical Study Approved in Austrralia cynata.com ↗
Cynata Therapeutics Limited (ASX: CYP), has received approval from the Royal Adelaide Hospital HREC for its Phase 1 clinical trial of CYP-001 in patients with steroid-resistant acute GvHD. |
| 2016-12-12 | Cynata Therapeutics Limited | Regulatory Cynata Receives NHS HRA Approval for Clinical Study cynata.com ↗ |
| 2016-09-19 | Cynata Therapeutics Limited | Regulatory UK Regulatory Authority Approves Cynata GvHD Clinical Trial cynata.com ↗
Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP) has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with its Phase 1 clinical trial of CYP -001 in patients with steroid -resistant graft -versus-host disease (GvHD). |
| 2016-07-31 | Cynata Therapeutics Limited | Regulatory Cynata Files Application to Commence Phase 1 Clinical Trial cynata.com ↗ |
| 2016-04-06 | Cynata Therapeutics Limited | Results Compelling Results from Pre-Clinical Stem Cell Study in GvHD cynata.com ↗
The interim data demonstrate that CYP-001 treatment substantially prolonged survival in this model. |
| 2016-01-27 | Cynata Therapeutics Limited | Regulatory CYP Receives Favourable Advice from UK Regulatory Authority cynata.com ↗
The MHRA confirmed that Cynata’s proprietary Cymerus™ mesenchymal stem cell (MSC) product, CYP-001, is considered to be suitable for use in a proposed Phase 1 clinical trial in patients with graft versus host disease. |
All press releases naming this drug 35 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CYP-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05643638 ↗ |
| Modality | Cell therapy | “The active agent in CYP-001 is Cymerus mesenchymal stem cells (MSCs)” NCT04537351 ↗ |
| Route | Intravenous | “receive an IV infusion of 2 million Cymerus MSCs/kg of body weight” NCT04537351 ↗ |