MimiVax, LLC Receives FDA Approval to Initiate a New Phase 2b Clinical Study for the Treatment of Newly Diagnosed Glioblastoma
- MimiVax has received a "Study May Proceed" notification from the US FDA to initiate a Phase 2b clinical trial of SurVaxM in newly diagnosed glioblastoma
-Completed Phase 2a clinical studies confirm SurVaxM's strong proof of concept efficacy and safety profile to address newly diagnosed glioblastoma, which is currently a severe unmet medical need
-Phase 2b "SURVIVE" clinical trial will evaluate SurVaxM in a randomized, blinded, placebo-controlled, multi-center study to initially enroll at several U.S. sites, additional sites in the United States and China to follow
BUFFALO, N.Y., Nov. 15, 2021 /PRNewswire/ -- MimiVax LLC, a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, announced today that the company has received a "Study May Proceed" notification from the United States Food and Drug Administration (FDA) to begin a Phase 2b trial, for SurVaxM in newly diagnosed glioblastoma entitled "SURVIVE." MimiVax has been operating through Covid related delays but is excited to now be able to launch a new clinical trial in 2021. The "SURVIVE" trial will evaluate SurVaxM in a randomized, blinded, placebo-controlled, multi-center study designated to compare standard of care (temozolomide) with or without the addition of SurVaxM. The primary objective and endpoint for the study will be overall survival. Additional objectives will evaluate molecular predictors of response, including MGMT methylation status, IDH1 mutation and survivin-specific responses.
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