Caladrius Biosciences is developing innovative products to treat cardiovascular and autoimmune diseases. We have four programs in mid to late stage development centered around two different proprietary technologies, each of which offers multiple product opportunities. Our carefully selected programs involve disease areas in which Caladrius’s management team has significant expertise, where there is a recognized significant unmet medical need and where we believe we can compete effectively.
HONEDRA® (formerly CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) based on the results of an ongoing clinical trial.
OLOGO™ (CLBS14), a Regenerative Medicine Advanced Therapy (“RMAT”) designated therapy for which the Company has finalized with the U.S. Food and Drug Administration a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (“NORDA”).
CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b study in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”).
CLBS119 was conceived and launched as a development program in the early stages of the COVID-19 pandemic based on the then available characterization of the disease, its available treatments, and the anticipated treatable patient population. In recognition of the fact that the characterization of the COVID-19 patient suffering long-term effects continues to evolve, Caladrius has decided to suspend the execution of the pilot study of CLBS119 and future development will be predicated on the identification of an underserved treatable population with a stable profile.
CLBS201 is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for chronic kidney disease (“CKD”).