Drugs / STAPULDENCEL
STAPULDENCEL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | castration-resistant prostate carcinoma | — | “July 2013 clinical hold on the VIABLE Study” sotio.com ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05262673 | Jun 2026 → Dec 2029 expected | B-cell acute lymphoblastic leukemia | Shenzhen Geno-Immune Medical Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05277753 | Jun 2026 → Dec 2029 expected | T-cell acute lymphoblastic leukemia | Shenzhen Geno-Immune Medical Institute | Recruiting | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04085159 | Jun 2026 → Dec 2029 expected | cancer | Shenzhen Geno-Immune Medical Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06739226 | Aug 2025 → Dec 2028 expected | melanoma | Shenzhen Geno-Immune Medical Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03514836 | May 2018 → Jan 2021 | castration-resistant prostate carcinoma | SOTIO a.s. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02470468 | Dec 2014 → Jan 2018 | non-small cell lung carcinoma | SOTIO a.s. | Completed | No outcome recorded |
| Phase 210 trials · 1 missed | ||||||
| Phase 2 | NCT04834544 | Apr 2021 → Oct 2024 overdue | fallopian tube carcinoma, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Peking University Third Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03657966 | Nov 2017 → Nov 2020 | ovarian carcinoma | SOTIO a.s. | Completed | No outcome recorded |
| Phase 2 | NCT02107378 | Jan 2014 → Aug 2016 | malignant epithelial tumor of ovary | SOTIO a.s. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02137746 | Dec 2013 → Apr 2015 | prostate cancer | SOTIO a.s. | Completed | No outcome recorded |
| Phase 2 | NCT02107937 | Nov 2013 → Nov 2020 | malignant epithelial tumor of ovary | SOTIO a.s. | Completed | Mixed |
| Phase 2 | NCT02107950 | Nov 2013 → Nov 2016 | malignant epithelial tumor of ovary | SOTIO a.s. | Completed | Missed primary |
| Phase 2 | NCT02107404 | Apr 2012 → Jun 2015 | prostate cancer | SOTIO a.s. | Completed | No outcome recorded |
| Phase 2 | NCT02107391 | Mar 2012 → Dec 2015 | prostate cancer | SOTIO a.s. | Completed | No outcome recorded |
| Phase 2 | NCT02107430 | Mar 2012 → Sep 2013 | prostate cancer | SOTIO a.s. | Completed | No outcome recorded |
| Phase 2 | NCT02105675 | Feb 2012 → Mar 2014 | metastatic prostate carcinoma | SOTIO a.s. | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT03905902 | Aug 2021 | fallopian tube cancer, ovarian cancer, peritoneal carcinoma | SOTIO a.s. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02111577 | May 2014 → Jan 2020 | castration-resistant prostate carcinoma | SOTIO a.s. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2021-06-04 | SOTIO a.s. | Results SOTIO Presents Positive Biomarker Data from DCVAC/OvCa Phase 2 Study in First Line Ovarian Cancer at the 2021 ASCO Annual Meeting sotio.com ↗
The data demonstrate signs of efficacy and safety of DCVAC/OvCa combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma and provide strong rationale for potential study in larger clinical trials. |
| 2019-06-02 | SOTIO a.s. | Results SOTIO’s DCVAC/LuCa Significantly Improves Survival in Patients with Stage IV Non-small Cell Lung Cancer sotio.com ↗
SOTIO, a biotechnology company owned by the PPF Group, presented new statistically and clinically significant results from its Phase I/II clinical trial evaluating DCVAC/LuCa, an active cellular immunotherapy product, in patients with stage IV non-small cell lung cancer. |
| 2019-05-20 | SOTIO a.s. | Results SOTIO to Present Final Phase I/II DCVAC/LuCa Data at ASCO 2019 Annual Meeting sotio.com ↗
Final analysis of SLU01 data confirmed promising clinical efficacy of DCVAC/LuCa active cellular immunotherapy product in patients with stage IV non-small cell lung cancer. |
| 2019-03-19 | SOTIO a.s. | Results SOTIO’s DCVAC/OvCa Significantly Improves Survival in Patients with Recurrent Ovarian Cancer sotio.com ↗ |
| 2019-03-07 | SOTIO a.s. | Results SOTIO to Present Final Phase II DCVAC/OvCa Data at the 2019 SGO Annual Meeting on Women's Cancer sotio.com ↗
Final analysis of SOV02 data confirmed promising clinical efficacy of DCVAC/OvCa in patients with the 1 st recurrence of ovarian cancer. |
| 2018-06-04 | SOTIO a.s. | Results Phase II Clinical Trials of DCVAC Show Significant Benefit for Patients with Ovarian and Lung Cancer sotio.com ↗
The results were statistically and clinically significant and showed that compared to patients who did not receive DCVAC, application of DCVAC/OvCa in patients with ovarian cancer and DCVAC/LuCa in patients with lung cancer decreased the risk of progression or death significantly. |
| 2018-05-22 | SOTIO a.s. | Results SOTIO to Present Results from Phase II Clinical Trial of 1st-Line Ovarian Cancer Treatment in Oral Presentation at ASCO 2018 Annual Meeting sotio.com ↗
Data from our Phase II clinical trials evaluating DCVAC medicinal products show significant benefit of using these products in combination with standard chemotherapy in patients with ovarian and lung cancer. |
| 2018-03-28 | SOTIO a.s. | Regulatory SOTIO Receives Positive Opinion for Orphan Drug Designation for DCVAC/OvCa from European Medicines Agency (EMA) sotio.com ↗
We are delighted to have received the positive opinion for orphan drug designation for DCVAC/OvCa. |
| 2014-04-30 | SOTIO a.s. | Regulatory VIABLE Study to Proceed in US sotio.com ↗
FDA’s removal of the clinical hold represents a major achievement for SOTIO’s global and US development efforts. |
| 2014-02-04 | SOTIO a.s. | Regulatory SOTIO Receives VHP approval to start Phase III Clinical Trial sotio.com ↗
SOTIO a.s., Prague, announced today that it received from the EU Heads of Medicines Agencies (HMA) a positive decision on a substantial amendment to its Phase III VIABLE Clinical Trial of DCVAC/PCa |
| 2013-05-24 | SOTIO a.s. | Regulatory SOTIO receives orphan-drug designation for Ovarian Active Cellular Immunotherapy sotio.com ↗
SOTIO has received orphan-drug designation from the U.S. Food and Drug Administration (FDA) for the active cellular immunotherapy (ACI) DCVAC/OvCa. |
| 2013-03-28 | SOTIO a.s. | Regulatory SOTIO receives EMA approval sotio.com ↗
SOTIO receives European Medicines Agency approval to initiate Phase III VIABLE Clinical Trial of DCVAC/PCa, an active cellular immunotherapy drug targeted for prostate cancer patients. |
All press releases naming this drug 16 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | STAPULDENCEL | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544995 ↗ |
| Known as | DCVAC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02470468 ↗ |
| Known as | DCVAC/LuCa | “Evaluation of Safety and Efficacy of DCVAC/LuCa (Immunotherapy of Lung Cancer) in Patients With Metastatic Lung Cancer” NCT02470468 ↗ |
| Known as | DCVAC/OvCa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03905902 ↗ |
| Known as | DCVac/Pca | “DCVac/Pca consists of activated autologous dendritic cells. This is an experimental therapy.” NCT03514836 ↗ |
| Known as | Estapuldencel | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544995 ↗ |
| Known as | Stapuldencel-t | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544995 ↗ |
| Action | Activate | “The dendritic cell (DC) vaccine leverages DC to activate T cells that specifically recognize target antigens” NCT06739226 ↗ |
| Modality | Cell therapy | “Active Cellular Immunotherapy” NCT02105675 ↗ |
| Route | Subcutaneous | “DCVAC/PCa or placebo was administered subcutaneously every 3 to 4 weeks (up to 15 doses).” PMID 35142815 ↗ Apr 2022 |