Drugs / AV-GBM-1
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03400917 | Jun 2018 → Dec 2021 | glioblastoma | Aivita Biomedical, Inc. | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05100641 | Jan 2024 → Mar 2028 expected | glioblastoma | Aivita Biomedical, Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-10-04 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Announces Publication Detailing 50% Enhanced Survival in Phase 2 GBM Study aivitabiomedical.com ↗
AIVITA Biomedical, Inc., a biotech company specializing in innovative cell applications, today announced that the Journal of Oncology Research and Therapy has published data from its completed Phase 2 glioblastoma (GBM) study which demonstrates enhanced progression-free survival (PFS). |
| 2021-06-08 | Aivita Biomedical, Inc. | Results AIVITA Biomedical’s Phase 2 Glioblastoma Trial Shows Improved Progression Free Survival aivitabiomedical.com ↗
AIVITA Biomedical, Inc., a private biotechnology company specializing in innovative stem cell applications, today announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM). |
| 2020-11-17 | Aivita Biomedical, Inc. | Results AIVITA Biomedical’s Phase 2 Glioblastoma Trial Shows Improved Progression Free Survival aivitabiomedical.com ↗
The median length of progression free survival was 10.0 months (95% CI 8.5 to 11.5 months), an improvement of approximately 45% compared to a median of 6.9 months (95% CI 5.8 to 8.2 months) progression free survival in the landmark study that established the standard of care for patients with newly diagnosed GBM. |
| 2020-11-02 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Completes Treatment of Patients in Phase 2 Clinical Trial of Glioblastoma Immunotherapy aivitabiomedical.com ↗
AV-GBM-1 was well-tolerated, and no patients experienced severe adverse events attributed to the treatment, and no patients discontinued treatment because of side-effects. |
| 2020-04-27 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Presents Updates from Ongoing Ovarian Cancer and Glioblastoma Clinical Studies at 2020 AACR Virtual Annual Meeting aivitabiomedical.com ↗
The study has completed enrollment, and the treatment has been well-tolerated to date with encouraging preliminary survival data. |
| 2020-04-08 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Provides Update of Ongoing Phase 2 Glioblastoma Trial from Year-End Survival Analysis aivitabiomedical.com ↗
AIVITA Biomedical, Inc., a biotechnology company specializing in innovative cell therapy applications, announced today updated survival data from a year-end analysis of its ongoing Phase 2 clinical trial of AV-GBM-1 in patients with newly diagnosed glioblastoma (GBM). |
| 2019-11-12 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Announces New Positive Phase 2 Glioblastoma Data at SITC Annual Meeting Podium Presentation aivitabiomedical.com ↗
Dr. Bota presented interim results from the Phase 2 trial testing AIVITA’s patient-specific immunotherapy AV-GBM-1 in patients with glioblastoma multiforme (GBM). |
| 2019-08-14 | Aivita Biomedical, Inc. | Results Brain Cancer Patients Display Decreasing Tumor Biomarkers After Treatment with Novel Immunotherapy in AIVITA Biomedical’s Phase 2 Clinical Trial aivitabiomedical.com ↗
Blood plasma biomarker analyses have identified a robust immune response and a decrease of tumor biomarkers in 65% of treated patients, in a sample that represents 29% of the total Phase 2 clinical trial size. |
| 2019-07-08 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Announces New Clinical Data in Ongoing Phase 2 Brain Cancer Trial aivitabiomedical.com ↗
Blood plasma biomarker analyses have identified predictive markers of efficacy in seven of eight treated subjects, a sample that represents 15% of the total clinical trial size. |
| 2019-02-05 | Aivita Biomedical, Inc. | Results Predictive Markers of Survival Identified for Next Generation Cancer Stem Cell Vaccine aivitabiomedical.com ↗
Serum biomarker analyses and in vitro cellular modeling performed with cancer patient samples collected in a randomized Phase 2 clinical trial demonstrated a statistically significant association between long-term survival and activation of a specific subset of lymphocytes. |
| 2018-06-20 | Aivita Biomedical, Inc. | Regulatory AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial aivitabiomedical.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AV-GBM-1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05100641 ↗ |
| Known as | DC-ATA | “The final products will be manufactured while the patient is being treated with RT/TMZ. After recovery from RT/TMZ, one of the study agents, either the DC-ATA AV-GBM-1 or...” NCT05100641 ↗ |
| Modality | Vaccine | “A multicenter phase II trial was designed to determine: (1) the success rate of manufacturing the Aivita GBM vaccine (AV-GBM-1)” PMID 36517865 ↗ Dec 2022 |
| Route | Subcutaneous | “before every subcutaneous (s.c.) administration” PMID 36517865 ↗ Dec 2022 |