Caladrius Receives FDA Regenerative Medicine Advanced Therapy Designation for CD34+ Cell Therapy for Treating Refractory Angina
BASKING RIDGE, N.J. (June 19, 2018) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases, announces today that that the U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designation to the Company’s late-stage CD34+ cell therapy program for the treatment of refractory angina.
The FDA grants the RMAT designation to regenerative medicine therapies intended to treat a serious condition for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition. The RMAT designation affords regenerative therapies the advantages of expedited development and review of marketing applications as are available to drugs that receive breakthrough therapy designation, including increased meeting opportunities, early interactions to discuss potential surrogate or intermediate endpoints, shortened biologics license application (“BLA”) review times and the potential of accelerated approval.
“We are delighted and encouraged that the FDA has recognized our CD34+ cell therapy program with an RMAT designation. Refractory angina is a serious condition with high morbidity and no known effective treatments. We look forward to working with the FDA to define a path to registration for our therapy with the aim of providing expeditious treatment to patients suffering from this condition,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.
Caladrius acquired an exclusive worldwide license to the late-stage CD34+ program from Shire plc in March of this year. The acquisition included the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina. This includes manufacturing procedures, preclinical (in vivo and in vitro) and Phase 1, Phase 2 and Phase 3 clinical study data of CD34 cell therapy as a treatment for no-option refractory angina, along with the corresponding regulatory filings.
