Drugs / Vacc-4x
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials · 1 met primary | ||||||
| Phase 1/2 | NCT02092116 | Mar 2014 → Aug 2015 | HIV infectious disease | Bionor Immuno AS | Completed | Met primary |
| Phase 1/2 | NCT01704781 | Sep 2012 → Aug 2014 | HIV infectious disease | Bionor Immuno AS | Completed | No outcome recorded |
| Phase 1/2 | NCT01473810 | Nov 2011 → Mar 2012 | HIV infectious disease | Oslo University Hospital | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT01712256 | Dec 2012 → Jan 2014 | HIV infectious disease | Bionor Immuno AS | Completed | No outcome recorded |
| Phase 2 | NCT00659789 | Aug 2008 → Jun 2010 | HIV infectious disease | Bionor Immuno AS | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2016-11-14 | Bionor Immuno AS | Results Poster presentation at NIH “Strategies for an HIV Cure” meeting in Bethesda, Maryland US bionorholding.com ↗
First, the potential to combine with latency reversing agents, such as the histone deacetylase inhibitor romidepsin, is exemplified by data from the company’s REDUC clinical study where Vacc-4x induced a statistically significant reduction in viral reservoirs as measured by total HIV DNA following latency reversal. |
| 2016-06-09 | Bionor Immuno AS | Results The peer-reviewed and highly recognized journal ‘The Lancet HIV’ has accepted the results of the REDUC Part B trial for publication bionorholding.com ↗
Bionor Pharma ASA (Bionor) (OSE:BIONOR), announced today that the positive results from the clinical trial REDUC Part B (BPC01-001) will be published for the first time in the peer-reviewed and highly recognized journalThe Lancet HIV. |
| 2016-02-23 | Bionor Immuno AS | Results The final assay in Bionor’s REDUC trial for measuring latent HIV reservoir, Integrated HIV DNA, supports the Shock & Kill approach using Vacc-4x and romidepsin bionorholding.com ↗
With the results of this assay showing a mean 13% non-statistically significant (p=0.271) reduction, the direction of all three assays is consistent. |
| 2015-11-17 | Bionor Immuno AS | Regulatory Bionor files first clinical trial application for BIOSKILL bionorholding.com ↗
Bionor Pharma ASA (OSE:BIONOR) today announced the submission of a clinical trial application (CTA) to the Danish Medicines Agency requesting approval to initiate BIOSKILL in Denmark. |
| 2015-05-04 | Bionor Immuno AS | Results Bionor announces promising results from an interim analysis of the functional cure HIV study REDUC Part B bionorholding.com ↗
Further, the results suggest that administration of Vacc-4x prior to an HDAC inhibitor enables killing of re-activated virus, as virus in plasma after reactivation is low or undetectable. |
| 2014-11-17 | Bionor Immuno AS | Results Bionor Pharma Announces that the Combination of Vacc-4x + Revlimid® is Well Tolerated and Increases CD4 Counts in People Living with HIV bionorholding.com ↗
The largest increase was in the Vacc-4x + Revlimid group where CD4 count increased by 30% (p=0.009) from baseline. |
| 2014-07-18 | Bionor Immuno AS | Results Bionor Pharma Presents Data at the AIDS 2014 Conference on Potential Biomarker for Reduction of Viral Load Identified for Vacc-4x bionorholding.com ↗
Biomarkers may predict improved reductions in HIV viral load in response to Vacc-4x. |
| 2014-03-28 | Bionor Immuno AS | Results Reboost Data Reconfirms 2010 Study bionorholding.com ↗
A further non-statistically significant reduction in mean viral load was observed compared to the set point in the 2010 trial and effect on viral load reduction by Vacc-4x was consequently reconfirmed. |
| 2014-02-27 | Bionor Immuno AS | Regulatory Bionor Pharma Announces Approval of REDUC Trial bionorholding.com ↗
Bionor Pharma ASA announces that the Company has received approval from the Danish Regulatory Agency for its REDUC trial. |
| 2014-02-10 | Bionor Immuno AS | Results Bionor Pharma’s Phase II Vacc-4x Data Published in The Lancet Infectious Diseases bionorholding.com ↗
The study showed that in subjects that completed a 6 month interruption of anti-retrovirals (ART), there was a log 0.44 (64%) reduction in median viral load set point in the Vacc-4x group compared to placebo. |
| 2014-02-03 | Bionor Immuno AS | Results Potential Biomarker for Reduction of Viral Load Identified for Vacc-4x bionorholding.com ↗
The analysis showed that patients more likely to respond to Vacc-4x, or responders, were characterized by pre-existing high levels of anti-C5 antibodies prior to Vacc-4x vaccination in the 2010 study. |
| 2013-09-12 | Bionor Immuno AS | Results Analysis of Immune Responses in Patients Treated with Vacc-4x Supports Further Development bionorholding.com ↗
The data show that patients carrying a genetic variant (HLA B-35) associated with rapid disease progression of untreated HIV infection are just as likely to respond to Vacc-4x as other patients. |
| 2013-08-07 | Bionor Immuno AS | Results Bionor Pharma’s First Reboost Vacc-4x Study Accepted for Publication in the Vaccine Journal bionorholding.com ↗
The study demonstrated that it is possible to elicit strong memory immune responses up to 7 years after the initial vaccination. |
| 2013-06-13 | Bionor Immuno AS | Results Bionor Pharma Announces Successful Completion of the First Part of its Phase II Clinical Study Combining the HIV Vaccine Vacc-4x with Celgene’s Immunomodulator Lenalidomide (Revlimid®) bionorholding.com ↗
The results showed that all three doses were well tolerated, and the highest dose has been chosen for the second part of the study. |
| 2012-12-05 | Bionor Immuno AS | Regulatory Approved “reboost” with Vacc-4x bionorholding.com ↗
Final Approvals Received for International Study to Reboost Patients From the Completed Vacc-4x Phase II Trial |
| 2012-08-13 | Bionor Immuno AS | Regulatory Study of Vacc-4x Combined with Celgene`s Revlimid® Approved to Begin bionorholding.com ↗
Bionor Pharma ASA (OSE: BIONOR) announced today that the clinical trial application for the placebo-controlled study with Vacc-4x in combination with Celgene`s Revlimid has been approved by the German health regulatory authorities. |
| 2012-07-20 | Bionor Immuno AS | Results Vacc-4x Improves Quality of Immune Responses in HIV Patients, Resulting in Long-Term Reduction in Viral Load bionorholding.com ↗
The results from further immunological analysis of the phase II data with Vacc-4x show improved quality of immune cells, that can in part explain killing of HIV infected cells leading to the reduction in viral load in patients receiving Vacc-4x. |
| 2012-05-10 | Bionor Immuno AS | Results Successfully results from clinical study with Vacc-4x and Endocine bionorholding.com ↗
Bionor Pharma ASA, Eurocine Vaccines AB and Oslo University Hospital today announced that vaccine related immune responses are documented in patients given active vaccine in a nasal immunization study, combining Bionor Pharma’s Vacc-4x and Eurocine Vaccines’ adjuvant Endocine. |
| 2012-02-15 | Bionor Immuno AS | Results Vacc-4x phase IIB bionorholding.com ↗
With final review of phase IIb viral load data completed, researchers confirm statistically significant reduction of HIV viral load on Vacc-4x compared to placebo. |
| 2011-09-15 | Bionor Immuno AS | Results Vacc-4x presented at AIDS Vaccine 2011 in Bangkok bionorholding.com ↗
Results from Phase IIB Placebo Controlled Study of Bionor’s Vacc-4x show excellent safety profile and statistically significant viral load reduction in patients with HIV who suspend antiretroviral therapy. |
| 2011-07-22 | Bionor Immuno AS | Results BIOtechNOW: International AIDS Conference Unveils Four New “Next Generation” Treatments for HIV bionorholding.com ↗
In Vienna, Bionor researchers reported that these same individuals continue to show an immunologic response to the vaccine seven years later, which is unprecedented. |
| 2011-07-18 | Bionor Immuno AS | Results Successful therapeutic vaccination with Vacc-4x bionorholding.com ↗
As previously communicated, a statistically significant difference in viral load set point was observed between the Vacc-4x and placebo arms at the end of the study period (p=0.002). |
| 2010-11-18 | Bionor Immuno AS | Results Vacc-4x shows statistically significant reduction viral load bionorholding.com ↗
Due to the new findings, the Company has reversed its decision to stop development of Vacc-4x. |
All press releases naming this drug 28 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vacc-4X | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01704781 ↗ |
| Modality | Peptide | “Vacc-4x is a peptide-based HIV immunotherapy” NCT00659789 ↗ |
| Route | Intranasal | “Intranasal administration of a therapeutic HIV vaccine (Vacc-4x)” PMID 25398137 ↗ Nov 2014 |