Drugs / fostroxacitabine bralpamide
fostroxacitabine bralpamide
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03781934 | Sep 2018 → Jan 2025 | hepatocellular carcinoma, intrahepatic cholangiocarcinoma | Medivir | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2025-02-20 | Medivir | Results Medivir presents positive final phase 1b/2a fostrox + Lenvima data in advanced liver cancer at EASL Liver Cancer Summit medivir.com ↗
Fostrox, in combination with Lenvima®, final data confirm improved outcomes in second-line advanced liver cancer with a median overall survival (OS) of 13.7 months (95% CI 7.6 – NR), median time to progression of 10.9 months (95% CI 4.2 – 18.1) and an objective response rate (ORR) of 24% [1] . |
| 2024-12-16 | Medivir | Regulatory Medivir obtains IND approval for fostrox - the first oral, liver-targeted treatment for advanced liver cancer medivir.com ↗
today announced the approval of the US Investigational New Drug application (IND) for evaluating fostrox + Lenvima vs Lenvima alone in a phase 2b study in 2nd line advanced HCC. |
| 2024-10-24 | Medivir | Results Medivir’s phase 1 study of fostrox monotherapy published in Journal of Hepatocellular Carcinoma medivir.com ↗
The study established safety and tolerability with clinical proof-of-concept for fostrox monotherapy, including biopsy confirmed selective induction of DNA damage in tumor cells. |
| 2024-09-16 | Medivir | Results Medivir’s fostrox + Lenvima confirm promise of improved outcomes in advanced liver cancer, detailed and mature data presented at ESMO medivir.com ↗
Mature results from Medivir’s phase 1b / 2a open label trial of fostrox + Lenvima® confirm improved outcomes in second-line advanced liver cancer with a median time to progression (TTP) of 10.9 months 1 (4.1 – 18.1). |
| 2024-06-27 | Medivir | Results Fostrox + Lenvima® holds promise of greatly improved outcomes for advanced liver cancer patients, reveals new data from Medivir at ESMO GI medivir.com ↗
Fostrox + Lenvima® achieved a 24% overall response rate (ORR) and estimated median time to progression (TTP) of 10.8 months 1 (4.1 – NE) – with one patient still on treatment after 22 months |
| 2024-02-22 | Medivir | Results Medivir presents data that strengthens the fostrox/Lenvima combination in primary liver cancer at EASL Liver Cancer Summit medivir.com ↗
In addition, the study shows that the exposure of fostrox is not impacted by administration of Lenvima, providing additional support for this combination. |
| 2024-01-17 | Medivir | Results Fostrox + Lenvima shows further improved response rates and time to progression in advanced liver cancer (HCC) at ASCO GI Symposium medivir.com ↗
Overall Response Rate (ORR) has increased to 25% (local review RECIST 1.1) |
| 2023-12-19 | Medivir | Results Fostrox + Lenvima demonstrates further improvement in durable clinical benefit in HCC, supporting the accelerated development plan medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today improved durable clinical benefit in maturing data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC), measured by local review. |
| 2023-09-07 | Medivir | Results Medivir presents data on additive activity of fostrox in combination with Lenvima or sorafenib in non-clinical tumor models at ILCA medivir.com ↗
In line with this, our preclinical results show that fostrox has the potential to enhance anti-tumor activity together with kinase inhibitors such as Lenvima or sorafenib |
| 2023-09-04 | Medivir | Results Medivir reports promising interim data, including a first complete response in phase 1b/2a HCC study with fostrox in combination with Lenvima medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today promising interim safety and efficacy data from its ongoing phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima® in advanced hepatocellular carcinoma (HCC) patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. |
| 2023-08-14 | Medivir | Results Promising tumor control for fostrox in combination with Lenvima in ongoing phase 2a study in HCC, 15th patient included medivir.com ↗
The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show encouraging clinical results as the disease has been stabilized in the majority of patients and they remain on treatment. |
| 2023-06-02 | Medivir | Results Medivir has completed the dose escalation part (phase 1b) of the 1b/2a study in HCC and focuses on the combination of fostrox and Lenvima medivir.com ↗
It is very gratifying that we have now completed the dose escalation part for both dose arms and established a safe dose,” says Medivir’s CMO Pia Baumann. |
| 2023-04-17 | Medivir | Results Medivir presents new data at AACR showing significantly improved antitumor efficacy in non-clinical tumor models with fostrox in triple combination medivir.com ↗
The poster supports this potential as it exhibits that fostrox combined with both anti-PD1 and Lenvima® shows a synergistic anti-tumor effect in a non-clinical tumor model characterized by the same low, underlying DNA damage seen in patients with HCC. |
| 2023-03-17 | Medivir | Results Medivir to present data on additive efficacy of fostrox in triple combination with anti-PD1 and kinase inhibitor in nonclinical tumor models at AACR medivir.com ↗
The presentation includes study results describing the potential for enhanced anti-tumor effects when fostrox is combined with both an anti-PD1 antibody and a kinase inhibitor. |
| 2023-02-20 | Medivir | Results Medivir has determined the recommended phase 2 dose for fostrox in combination with Lenvima in HCC medivir.com ↗
The preliminary results from the dose cohorts are positive with a good safety and tolerability profile and no dose-limiting toxicity has been observed. |
| 2022-11-09 | Medivir | Results Medivir presents new data on additive efficacy of fostrox in combination with anti-PD1 in nonclinical tumor models at the SITC Immunotherapy Conference medivir.com ↗
The poster supports this potential as it shows that combination therapy with fostrox and anti-PD1 significantly improved anti-tumor efficacy in a pre-clinical mouse model for HCC, compared with either treatment alone. |
| 2022-09-08 | Medivir | Results Medivir to present data on additive efficacy of fostrox in combination with anti-PD1 in nonclinical tumor models at the SITC 2022 Annual Meeting medivir.com ↗
The presentation includes study results outlining the potential for enhanced anti-tumour effects when an anti-PD1 antibody is combined with fostrox. |
| 2021-09-16 | Medivir | Results Medivir invites to a conference call on new clinical data and further studies with MIV-818 medivir.com ↗
An important sign of efficacy was that four patients with hepatocellular carcinoma (HCC) showed stable disease in the liver over an extended period of time. |
| 2021-08-31 | Medivir | Regulatory Medivir receives regulatory approval from MHRA for phase 1/2a combination study with MIV-818 medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR) today announced that the company has received regulatory approval from the British Medicines & Healthcare products Regulatory Agency (MHRA) for its upcoming phase 1/2a combination study with the company's leading candidate drug MIV-818 against liver cancer. |
| 2021-04-19 | Medivir | Results Medivir has determined the starting dose for the next part of the phase Ib study with MIV-818 medivir.com ↗
The results were positive and the recommended dose for the next phase has thus been determined. |
| 2021-01-12 | Medivir | Results Medivir presents MIV-818 data at ASCO Gastrointestinal Cancers Symposium medivir.com ↗
The results from the completed phase Ia intra-patient dose escalation part of the study show that MIV-818 has an acceptable safety and tolerability profile and a selective effect on liver cancer cells. |
| 2020-06-25 | Medivir | Regulatory The European Commission has granted Orphan Medicinal Product Designation in the EU for MIV-818 medivir.com ↗ |
| 2020-05-06 | Medivir | Regulatory FDA grants MIV-818 Orphan Drug Designation for the treatment of hepatocellular carcinoma medivir.com ↗
Medivir AB (Nasdaq Stockholm: MVIR) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer. |
| 2020-04-30 | Medivir | Regulatory Medivir receives positive opinion on Orphan Medicinal Drug Designation by the European Medicines Agency for MIV-818 medivir.com ↗ |
| 2020-03-02 | Medivir | Results Medivir presents positive data from the completed phase Ia study with MIV-818 in patients with advanced liver cancer medivir.com ↗
Based on an independent expert analysis of liver tumor growth, five of the nine patients were assessed to have stable liver disease after treatment. |
| 2019-10-30 | Medivir | Results Medivir presents MIV-818 data at AACR-NCI-EORTC in Boston medivir.com ↗
The data shows that MIV-818 exerts favorable immunomodulating effects in vitro by increasing immune cytokine levels in complex tumor microenvironment models, and the white blood cell mediated killing of cancer cells. |
| 2019-06-13 | Medivir | Results Selective effect signal on liver cancer tissue in phase Ia study with MIV-818 medivir.com ↗
An effect signal, measured as DNA damage, has been observed in liver biopsies from tumor tissue in MIV-818 treated patients. |
All press releases naming this drug 43 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fostroxacitabine bralpamide | “MIV-818 (fostroxacitabine bralpamide) + pembrolizumab” NCT03781934 ↗ |
| Known as | FOSTROXACITABINE BRALPAMIDE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314416 ↗ |
| Known as | MIV-818 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03781934 ↗ |
| Known as | MIV-818 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314416 ↗ |
| Modality | Small molecule | — CHEMBL5314416 ↗ |
| Route | Oral | “MIV-818 - oral capsules” NCT03781934 ↗ |