Caladrius Biosciences Inc. (NASDAQ: CLBS) climbed 4.46% after the FDA approved its Investigational New Drug Application for the CLBS201 study. CLBS201 is a CD34+ cell therapy for diabetic kidney disease treatment.
Caladrius evaluating CLBS20’s efficacy and safety
David J. Mazzo, the company’s CEO and President said, “Our latest development program, CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic patients with reduced kidney function. Specifically, we will be targeting patients with later stage chronic kidney disease. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression, or even reverse the course, of DKD.”
The company plans to commence phase 1/2 proof of concept CLBS201 study in the coming months. Mazzo added that kidney disease is still a significant unmet medical need, more so as the general population ages and hypertension and diabetes incidence grows s.
Caladrius has other products in its pipeline
Caladrius Biosciences develops first-in-class therapies based on fine-tuned self-repair mechanisms existing in the body to reverse disease. Besides CLBS201, the company is completed a CLBS16 Phase 2a study, and currently, it is initiating Phase 2b study in the study of coronary microvascular dysfunction. Also, CLBS12 (HONEDRA®) received orphan designation from the FDA for Buerger’s diseases and SAKIGAKE designation for early approval for critical limb ischemia treatment and Buerger’s diseases in Japan.
The company is in discussions with the US FDA to finalize a third phase protocol for CLBS14 (OLOGO) for Regenerative Medicine Advanced Therapy designation. The company will study OLOGO in the third trial of reduced scope and confirmatory study in patients without refractory disabling angina.
