CD34+ Cell Therapy Receives Regenerative Medicine Advanced Therapy Designation by FDA for Refractory Angina

Caladrius Biosciences, Inc., announced that the US Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) to the late-stage CD34+ cell therapy program for treatment of refractory angina.

The CD34+ program, which Caladrius acquired from Shire in March, includes the former responsibility of manufacturing, preclinical (in vivo and in vitro) and phase 1, 2 and 3 clinical study data for treatment of no-option refractory angina, along with corresponding regulatory filings.

“We are delighted and encouraged that the FDA has recognized our CD34+ cell therapy program with an RMAT designation,” David Mazzo, PhD, president, chief executive officer, Caladrius, said in a statement. “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.”

Preclinical studies have established the mechanism of action of the CD34+ cell therapy which restores microcirculation and improves myocardial tissue perfusion.

The cell therapy program is supported by data from 3 randomized placebo-controlled clinical trials.

Data recently published in the European Heart Journal demonstrated that patients treated with CD34+ experienced improvement in exercise capacity, angina frequency and reduced mortality.

A patient-level pooled analysis combines the data from all 3 studies, which encompassed more than 300 patients, revealing the statistically significant improvements in mortality, exercise capacity and chest pain frequency. The clinical trials demonstrated the clinical benefit of CD34+ in a patient population that has utilized all over therapeutic options.

It’s estimated that as many as 1 million people in the United States have refractory angina that is unamenable to medical therapy and conventional revascularization procedures. With an aging population and an increased incidence of diabetes mellitus, refractory angina is expected to become more prevalent.