Biopharmaceutical company, Caladrius Biosciences (LON: CLBS) confirmed on Tuesday evening that the first patient has been treated in its Phase 2b FREEDOM trial of CLBS16 as a therapy for coronary microvascular dysfunction, sending the company’s share price surging higher.
Caldrius shares are up over 114% premarket, priced at the $3.49 level.
The patient was treated at Christ Hospital Health Network in Cincinnati, Ohio, with the trial following the positive results from the ESCaPE-CMD study, which was also conducted at the hospital.
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In total 105 patients are being enrolled into the double-blind and placebo-controlled clinical trial designed to further evaluate the efficacy and safety of intracoronary delivery of autologous CD34+ cells in subjects with coronary microvascular dysfunction and without obstructive coronary artery disease.
“We are very excited about our CLBS16 program as it represents a potential breakthrough in the treatment of CMD, a condition which afflicts millions of patients in the US alone, many of whom are women,” said David J Mazzo, President and CEO of Caladrius.
“As a result, CMD is a women’s health issue of emerging importance as currently there are no products with approved labeling for coronary microvascular dysfunction,” added Mazzo.