Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Early Results of Activartis AV0113 Cancer Immunotherapy in Glioblastoma Trial Reveal Promising Trend

Published: Thursday, April 11, 2013
Last Updated: Thursday, April 11, 2013
Bookmark and Share
Glioblastoma multiforme (GBM) is the most severe form of brain cancer and progresses rapidly.

With the first-line treatment (surgery, chemo-, and radiotherapy) the prognosis is poor with a median survival rate of 14 to 15 months. This makes novel treatment strategies highly warranted. One such strategy is cancer immunotherapy (CIT).

Activartis has developed a novel patented cancer immunotherapy concept, AV0113, based on dendritic cells (DC).While DCs have already demonstrated their potential in cancer immunotherapy, the novel feature of AV0113 is that exposure to bacterial endotoxins enables the DC to prime type 1 T helper cells, which support cytolytic anti-tumour immune responses. This is comparable to conjugated vaccines, which are a more artificial way to modulate the features of an immune response.

At the beginning of 2013, Activartis completed recruitment of around 100 brain cancer patients for a multi-centre, randomised, phase II clinical trial. This randomised study aims to deliver safety and efficacy data for the first time. Early results do not exhibit an improvement in progression-free survival, but overall survival seems to clearly favour GBM patients.

The study

Activartis has completed recruiting around 100 patients suffering from GBM for the phase II clinical trial (GBM-Vax) designed to provide evidence for the effectiveness of AV0113 cancer immunotherapy. GBM-Vax is being conducted at eight neuro-surgery/neuro-oncology institutions in Austria, three of them being university hospitals. The primary study objective is progression-free survival; the secondary objective is overall survival.

All patients aged 18-70 years receive standard first-line therapy; in the randomised treatment group, the AV0113 DC-CIT is administered as an add-on. The DC-CIT is inoculated into inguinal lymph nodes: after six weeks of chemo and radiotherapy, four weekly applications; accompanying the maintenance chemotherapy, six more applications every 4 weeks; finally one boost immunisation every three months as long as DC-CIT is available.

Preliminary results

Preliminary results presented at the AACR Annual Meeting (April 6-10, 2013, Washington) revealed a very promising trend suggesting a survival benefit of patients in the AV0113 treatment group compared to the randomised control group. This was notably the case for a subgroup for which, although only one third of the patients were available for assessment at this time, the difference in overall survival appeared to be quite remarkable.

At 12 months, 21/33 (64 %) of patients in the treatment group and 17/35 (48 %) of patients in the control group were still alive. At 18 months, 8/15 (50 %) of patients in the treatment and 6/18 (33 %) of patients in the control group were still alive.

Patients receiving AV0113 cancer immunotherapy tended to experience signs of relapse earlier compared to control patients. AV0113-triggered inflammation in the tumour tissue may explain this observation, which was also made in other clinical trials studying cancer immunotherapy.

When tumour growth is controlled by cancer immunotherapy, this is accomplished by inflammation, thereby resulting in a larger oedema and infiltration with immune cells. This may very easily result in pressure-induced neurological symptoms, which then are wrongly interpreted as “progression”. True progression would go along with reduced overall survival – preliminary results of the ongoing study, however, suggest that overall survival may in fact be positively influenced.

AV0113 treatment was well tolerated; no serious adverse events were noted that could clearly be attributed to DC-CIT. Inoculation into inguinal lymph nodes causes local swelling, redness and tenderness; some of the patients ran a temperature of around 40°C. Although these are early data, Activartis has already concluded that the DC-CIT treatment is well tolerated.

Confirmation of that trend is expected in the second half of 2013. If the trend currently observed is confirmed, AV0113 is bound to become part of the standard therapy for GBM.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Activartis’ Cancer Immunotherapy Receives Orphan Drug Designation from FDA
The ODD applies specifically to the use of AV0113 for the treatment of malignant glioma, a very aggressive type of brain cancer.
Monday, July 01, 2013
Activartis Develops Dendritic Cell-Based Therapeutic Cancer Vaccine in Phase II
Results from multi-centre phase II clinical study expected in 2012.
Monday, October 31, 2011
Scientific News
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Study to Assess Shorter-Duration Antibiotics in Children
Physicians plan a clinical trial to evaluate whether short course anti-biotics are effective at treating CAP in children.
Cancer Gene Predicts Treatment Response in Leukaemia
Study indicates the patients suffering from a lethal for of acute myeloid leukemia may live longer when receiving milder chemotherapy drugs.
Injectable Biologic Therapy Reduces Triglycerides
Study finds first-of-its-kind therapy promising for patients with high triglycerides, cholesterol.
Testing Zika Vaccine in Humans Begins
The first of five planned clinical trials to test ZPIV vaccine in humans has begun.
Combination Therapy Improved Chemoresistance in Ovarian Cancer
The study demonstrates how an existing class of targeted therapies could be used to potentiate the tumor suppression induced by cisplatin.
Gene Therapy for Blistering Skin Disease Shows Promise
Grafting genetically altered skin onto patients’ chronic wounds marks the first time skin-based gene therapy has been demonstrated to be safe and effective in humans.
Alzheimer’s Treatment Moves a Step Closer
Merck scientists have reported the discovery of verubecestat, a structurally unique, orally bioavailable small molecule that has been shown to target the most visible sign of the disease in the brain.
Lynparza Phase III Progression-Free Survival Benefit
AstraZeneca announces results from Phase III SOLO-2 trial designed to determine the efficacy of Lynparza as a monotherapy for ovarian cancer.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!