Clinical I/II study of VB-111 gene therapy recurrence GBM.

There is still no effective treatment for glioblastoma (GBM), and the patient's overall median survival (OS) is well below 2 years.
VB-111 (ofranergene obadenovec) is a non-replicative adenovirus that carries a genetically modified Fascini, which can target and induce apoptosis of angioplasty in the tumor and induce an antitumor-specific immune response.
, Andrew J. Brenner of the University of Texas Cancer Center in San Antonio, USA, conducted a multicenter-forward-looking clinical I/II study to assess the effectiveness of different doses of VB-111, accompanied by or withorated with belavitated supres, in the May 2020 issue of the journal Neuro-Oncology.

Research Methods
the study included 72 patients with relapsed GBM, divided into 4 groups: 119 sub-treatment groups (SubT), VB-111 virus with applied doses below 1x1013; VB-111 pre-treatment of the combined beva monobsalystreatment group, every 56 days to 1 VB-111, after the progressofy of the disease to continue VB-111, and combined with every 2 weeks 1 times bevelav it and 410 cases of non-pre-treatment combination group, every 28 days 1 vb-111 combined every 2 weeks 1 time Beva syntod.
the main research endpoint indicator is the median OS, and the secondary endpoint index is safety, overall reactive, and progression-free survival (PFS).

patients are well tolerated with VB-111. The most common adverse reaction to vb-111
is fever.
in the PRE-treatment joint group, according to the RANO standard, 5 (21%) patients in the initial lysie-enhanced area of MRI developed characteristic and widespread necrosis.
1 case of false progress.
there were 4 partial reactions (PR) during VB-111 single drug treatment, 1 case of full reaction (CR), CR lasted more than 5 years, PR appeared on the 392nd day of treatment, and then CR on the 504th day of treatment.
2 cases (20%) of the non-preprocessed federated group had PR.
did not see CR or PR in the SubT and LE groups, and the best treatment responses were 12 (63%) and 10 (53%) for patients in both groups.

imaging examination found that VB-111 combined bevanazumab therapy after start-up significantly reduced tumor volume, tumor volume reduction of 49.7 percent, non-pre-treated combination tumor volume reduction of 22.7 percent, according to UCLA institutional data, bevele sepsine treatment tumor volume decreased by 33 percent.
pre-treatment group enabled belavs of monotortituatary therapy, the tumor volume was significantly reduced compared to the pre-treatment (t-test, P-0.0068) (Figures 1, 2).
Figure 1. Changes in tumor volume in patients with therapeutic reactions in the A-E pretreatment combination group.
was given VB-111 single drug therapy before the disease progressed, and imaging showed a decrease in tumors.
the vertical line on the icon - disease progression time.
the left dotted line of the vertical line indicates the VB-111 single drug treatment time, and the right dotted line indicates the time of VB-111 and beva monoanti-anti-combination therapy.
1C, 1E: MRI showed that 2 patients treated with responsive patients with treatment had characteristic, extensive necrosis (1E) and false progression (1C) in the initial lysi-enhanced region.
Figure 2. Changes in tumor volume.
VB-111 pre-treatment patients significantly smaller tumor volume than those without VB-111 pretreatment, after initiating belavsssmonal attitudinatosis, compared to pre-treatment patients.

research results
results showed that the median PFS period was 90 days for pre-processed joint group patients, 60 days for the LE group (HR,0.36; 95% CI, 0.14-0.93; p-0.032), and 63 days for the pre-processed joint group (HR?1.24; 95% CI, 0.45-3.40;
SubT, LE, pre-processed federated and non-pre-processed federated median OS periods were 315, 223, 414, and 141.5 days, respectively. the median OS period of the
pre-processed joint group was significantly longer than that of the LE group (414:223 days; HR,95% CI, 0.23-0.998; p-0.043) and significantly longer than the non-pre-processed federated group (414:141.5 days; HR-0.24;95% CI, 0.09-0.666;p666).
in addition, 62 patients (45%) develop fever after VB-111 infusion, which may be associated with prolonged survival, and the median OS period in patients with fever and non-fever is 448 days and 235 days, respectively (HR,0.34; 95% CI, CI 0.18-0.62; p.001).

Conclusion The results of the clinical I/II study show that patients with relapsed GBM can obtain better PFS and OS if tumor progression is re-linked with belavite sepsine treatment after pretreatment treatment with VB-111 single drug.
visual examination can see the characteristic changes associated with the mechanism of VB-111 therapeutic action and tumor volume changes.
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