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'I would like to thank the site teams and investigators, as well as all of the patients who participated in this trial,' said Laurence Cooper, M.D., Ph.D., CEO of Ziopharm, 'This study demonstrated that our Controlled IL-12 platform as monotherapy provides rapid activation of the immune system and is associated with improved overall survival for patients with rGBM, with a favorable safety profile.
PharmAbcine's lead candidate TTAC-0001, an investigational therapy, is a highly selective and potent anti-VEGFR2 (KDR/flk-1) mAb in clinical development for rGBM indications.
Results were presented from a radiographic analysis conducted at the Brain Tumor Imaging Laboratory at UCLA of the Phase 2 and Phase 3 trials of VB-111 in rGBM. This analysis provides independent, quantitative data that priming with VB-111 results in clinically-meaningful activity in rGBM, which can be seen by MRI signature, demonstrates objective response to VB-111 and is correlated with a statistically significant survival advantage.
The survival data from patients who received the preferred dosing regimen of Controlled IL-12 with 20mg veledimex and low-dose steroids compare favorably to a benchmark mOS of 6 to 9 months for patients with rGBM that serves as historical control.
VBL Therapeutics reported results from its Phase 3 GLOBE study in patients with recurrent glioblastoma, or rGBM, which was designed to evaluate VB-111 in combination with bevacizumab, compared to bevacizumab.
Phase 1 data has shown that Ad-RTS-hIL-12 with a 20mg dose of veledimex and less than 20mg of the steroid dexamethasone is the preferred dosing regimen to treat patients with rGBM. When treating patients with Ad-RTS-hIL-12 plus veledimex, higher doses of steroids appear to suppress the immune response and negatively affect survival compared to low-dose steroids.
- The US Food and Drug Administration has granted Vancouver, Canada-based cancer therapies developer DelMar Pharmaceuticals (NASDAQ: DMPI) fast track designation for its lead product candidate, VAL-083, in recurrent glioblastoma (rGBM), the company said.
Ziopharm (ZIOP) announced a clinical supply agreement with Regeneron (REGN) to evaluate Ziopharm's Ad-RTS-hIL-12 plus veledimex in combination with Regeneron's PD-1 antibody Libtayo to treat patients with recurrent glioblastoma, or rGBM. Ad-RTS-hIL-12 plus veledimex is an investigational gene therapy designed to induce and control the production of human interleukin 12 that activates the immune system and recruits cancer-fighting T cells into tumors.
The poster presentation provided an overview of the safety and efficacy results from clinical trials of the targeted immunotherapy, MDNA55, in 66 patients with recurrent glioblastoma (rGBM), the most common and deadly form of brain cancer.
Ziopharm announced it will update data from its Phase 1 trial of Ad-RTS-hIL-12 plus veledimex, a gene therapy designed to control the expression of interleukin 12, or IL-12, a powerful cytokine that has demonstrated a targeted, anti-tumor immune response for the treatment of recurrent glioblastoma, or rGBM, at the meeting for Society for Neuro-Oncology, or SNO.