The poten­tial new multiple myeloma ther­apy ECT-001 has been designated a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Admin­istra­tion (FDA).

The RMAT desig­na­tion is very similar in sig­nif­i­cance to the better known Break­through Therapy desig­na­tion, which also is granted by the FDA. Both the RMAT and Break­through Therapy desig­na­tions are in­tended to shorten the time it takes im­por­tant new ther­a­pies to gain FDA mar­ket­ing approval.

The key dif­fer­ence be­tween the two desig­na­tions is that the RMAT desig­na­tion is for cell-based ther­a­pies, while the Break­through Therapy desig­na­tion is for …

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 …