VBL Therapeutics Malignant Gliomas World's First Drug VB-111 Phase III Study Failure
VBL Therapeutics Malignant Gliomas World's First Drug VB-111 Phase III Study Failure March 09, 2018 Source: Sina Pharmaceutical On March 8th, the Israeli biopharmaceutical company VBL Therapeutics announced the top-line data of the GLOBE study of the key clinical phase 3 trial of the company's VB-111 combined with bevacizumab (Avastin) for the treatment of recurrent malignant glioma (rGBM). The test control group was a patient receiving bevacizumab. This study did not reach the primary endpoint of the pre-defined overall survival (OS). Dr. Dr. Harats, CEO of VBL Therapeutics, said: “The encouraging clinical Phase 2 data has not been reproduced in the GLOBE Phase 3 study, which is disappointing. Once the complete and final data is received, we will carefully analyze it to A better understanding of the findings. I believe that VB-111 may still be promising for other indication areas that we are currently or will study in the future." The GLOBE Clinical Phase 3 Critical Trial was a randomized, controlled, dual-arm, open-label study that was compared with bevacizumab monotherapy for treatment by VB-111 once every two months and bevacizumab once every two weeks. The primary inclusion criteria included patients with first or second stage of progression of malignant glioma receiving temozolomide and radiotherapy, and histologically confirmed patients with glioblastoma and who were able to measure disease progression according to RAO criteria. The study was conducted under the FDA-approved Special Program Assessment (SPA) and received full support from the Canadian Brain Tumor Association (CBTC). VB-111 has been awarded orphan drug identification in the United States and Europe, and has been approved by the FDA Fast Track for its long-term benefit potential for recurrent malignant glioma. GBM is the most common and invasive primary brain tumor. It is estimated that there are approximately 1.2-13,000 newly diagnosed cases in the United States in 2017. The median OS after diagnosis is 12-15 months on average, and patients usually receive surgery, chemotherapy, and radiation therapy. Almost all patients progress within 6 months of treatment, and the median OS is about 6-8 months after progression. Although there is a large amount of research and clinical work focused on improving the treatment of recurrent GBM, there is still no systemic therapy that can improve overall survival, leading to serious unmet medical needs in the field. VB-111 is a candidate for first-in-class potential and is a major oncology product of VBL. It is currently undergoing phase 3 trials of ovarian cancer. In a clinical phase 2 study of rGBM treatment, VB-111 showed statistically significant improvements in OS and PFS compared to standard therapy. In addition, VB-111 successfully completed a conceptual validation and gained survival benefit in a phase 2 clinical trial of radioactive iodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer. (Sina Pharmaceutical Compilation / David) Article Reference Source: VBL Therapeutics Announces Top-Line Results from Pivotal Phase 3 GLOBE Study in Patients with Recurrent Glioblastoma Rice Seeding Machine,Rice Seeder Machine,Rice Seeder Farm Equipment,Rice Seed Sowing Machine Taizhou Yingtian Agricultural Machinery Manufacturing Co., Ltd. , https://www.sakuradaagc.com