Caladrius has revealed that the US FDA has granted regenerative medicine advanced therapy (RMAT) designation to its late-stage CD34+ cell therapy programme 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.
According to a press release, Caldadrius acquired an exclusive worldwide license to the late-stage CD34+ program from Shire in March of this year. The acquisition included the data set and regulatory filings for the CD34+ cell therapy programme 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.
David J Mazzo, president and chief executive officer of Caladrius says: “We are delighted and encouraged that the FDA has recognised 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.”