Pharma Focus Asia

MimiVax, LLC Receives FDA Approval to Initiate a New Phase 2b Clinical Study for the Treatment of Newly Diagnosed Glioblastoma

Tuesday, November 16, 2021

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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