On February 12, 2025 MimiVax, Inc., a leader in clinical-stage pharmaceutical research, reported that its now fully enrolled Phase 2b clinical trial of SurVaxM in glioblastoma, [SURVIVE] (NCT05163080), has successfully progressed following the first interim analysis of trial data (Press release, MimiVax, FEB 12, 2025, View Source;utm_medium=rss&utm_campaign=mimivax-survaxm-interim-analysis [SID1234650255]). The analysis, conducted as part of the company’s rigorous clinical development program, has provided valuable insights that support the continued advancement of the trial. The purpose of this study is to determine whether adding SurVaxM to standard-of-care (resection, radiation/chemotherapy) is better than standard treatment alone for patients with newly diagnosed glioblastoma.
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While the company is unable to disclose specific details about the interim analysis due to regulatory requirements set forth by the U.S. Food and Drug Administration (FDA), MimiVax remains confident in the potential of SurVaxM and is committed to advancing the study as planned.
"We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program," said Dr. Michael Ciesielski, CEO of MimiVax. "We are working closely with the FDA to ensure compliance with regulatory guidelines as we move forward with the trial."
Based on the results of the recent interim futility analysis, and ongoing review by the study’s Independent Data Safety Monitoring Committee, the SURVIVE trial will continue as designed without modification.
The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM at 11 participating major Cancer Centers in the United States. The company will provide updates at appropriate milestones, in accordance with regulatory requirements.
MimiVax thanks all participants, healthcare professionals, clinical support teams and investigators involved in the study for their continued support and commitment to the advancement of SurVaxM.
About SurVaxM:
SurVaxM is a peptide mimic immunogen that targets ‘survivin’, a cell-survival protein present in most glioblastomas and in many other cancers. SurVaxM stimulates a patients’ own immune response to control tumor growth and prevent disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in many other forms of cancer.