Articles tagged with: Regenerative Medicine Advanced Therapy (RMAT) Designation

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[ by | Apr 23, 2019 8:05 am | Comments Off ]
ExCellThera’s Lead Technology, ECT-001, Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation

Montreal, QC (Press Release) – ExCellThera Inc., an ad­vanced clin­i­cal stage bio­technology com­pany delivering molecules and bio­engineer­ing solu­tions to expand stem and immune cells for thera­peutic use, announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted regenerative medicine ad­vanced ther­apy (RMAT) desig­na­tion to its lead tech­nology, ECT-001, in the treat­ment of hema­to­logic malig­nan­cies. The RMAT desig­na­tion is based on strong data from Phase I/II clin­i­cal trials using ECT-001 to expand stem and immune cells for the treat­ment of blood cancers.

RMAT desig­na­tion is granted by the FDA under the 21st …

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Press Releases»

[ by | Nov 5, 2018 8:00 am | Comments Off ]
Poseida Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation From FDA For P-BCMA-101

San Diego, CA (Press Release) – Poseida Therapeutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on leveraging pro­pri­e­tary next-generation, non-viral gene engi­neer­ing tech­nolo­gies to create life-saving thera­peutics, today announced the U.S. Food and Drug Admin­istra­tion (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) desig­na­tion to P-BCMA-101, Poseida’s lead CAR-T thera­peutic can­di­date cur­rently in a Phase 1 clin­i­cal trial for the treat­ment of patients with re­lapsed / refractory multiple myeloma. RMAT desig­na­tion in­cludes all of the benefits of the Fast Track and Break­through Therapy desig­na­tion pro­grams, in­­clud­ing early inter­actions with the FDA.

“P-BCMA-101 is the …

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