Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
Summary
Phase II, two arm prospective study of efficacy and safety of ELENAGEN in combination with gemcitabine in comparison with gemcitabine alone in patients with platinum-resistant ovarian cancer.
Timeline
- Start
- 2019-11-15
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
Outcome
Met primary endpoint
release “Now, we are certain that Elenagen is increasing progression-free survival for platinum-resistant ovarian cancer patients in the trial.” curelaboncology.com ↗
release “A statistically significant prolongation of PFS was clearly demonstrated in the trial and continues to extend as the trial continues.” curelaboncology.com ↗
release “Phase 2 clinical trial for platinum-resistant ovarian cancer, Elenagen combined with gemcitabine chemotherapy significantly improved progression-free survival compared to gemcitabine alone” curelaboncology.com ↗
release “significantly improved overall survival compared with gemcitabine monotherapy for patients with platinum-resistant ovarian cancer” curelaboncology.com ↗
release “Elenagen, a novel DNA immunotherapy doubles survival time for ovarian cancer patients in breakthrough Phase II study.” curelaboncology.com ↗
release “Patients in the elenagen group lived significantly longer, with a median survival of more than 25 months, compared to roughly 13 months with gemcitabine alone.” curelaboncology.com ↗
Publications
- Krasny S, Baranau Y, Bakin E, Polyakov S, Streltsova O, Zharkova E, Filimonava A, Levin G, Gabai V, Shneider A. Elenagen, a p62/SQSTM1-encoding plasmid, improves overall survival in patients with platinum-resistant ovarian cancer: a phase II trial. Int J Gynecol Cancer. 2026 Jan 7:104456. doi: 10.1016/j.ijgc.2025.104456. Online ahead of print.
- Krasny S, Baranau Y, Polyakov S, Zharkova E, Streltsova O, Filimonava A, Siarheyeva V, Kazlouskaya S, Khorau A, Gabai V, Shneider A. Clinical efficacy of plasmid encoding p62/SQSTM1 (Elenagen) in combination with gemcitabine in patients with platinum-resistant ovarian cancer: a randomized controlled trial. Front Oncol. 2024 Feb 12;14:1343023. doi: 10.3389/fonc.2024.1343023. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ELENAGEN | Other / unclassified | 2.5 mg | Intramuscular |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |