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MimiVax granted Fast Track Designation from FDA for vaccine for newly diagnosed glioblastoma

MimiVax has been granted Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) for its SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma (nGBM).

A randomized, blinded placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) is now recruiting at 11 cancer centers across the USA.

Positive Final Data from the previous Phase 2a Study of SurVaxM for nGBM, published in the Journal of Clinical Oncology, found that 51% of patients receiving SurVaxM survived at least 2 years and 41% survived at least 3 years.

The median Overall Survival of 25.9 months with nGBM in this study is considerably higher than would be expected with standard therapy alone. MimiVax is focused on completing the Phase 2b SURVIVE study and securing funding necessary to bring SurVaxM through the FDA approval process.

“The receipt of Fast Track Designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma,” said Michael Ciesielski, CEO of MimiVax. “This designation is a key component in our journey to help patients with glioblastoma to live longer.”

Fast Track is a process designated to facilitate the development and expedite the review of drugs to treat serious medical conditions and fulfill unmet medical need.

 

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