FDA authorizes new IND for the study of CLBS119 in COVID-19 patients who experienced respiratory failure
BASKING RIDGE, N.J. (April 23, 2020) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease today announced that the U.S. Food and Drug Administration (“FDA”) has authorized its investigational new drug (“IND”) application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage. The study will target patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure.
“We appreciate the FDA’s expeditious review and approval of the IND for CLBS119. Early reports indicate that many of the survivors of COVID-19 that required ventilatory support remain debilitated due to the lung injury sustained as a result of the virus. COVID-19 appears to damage the vasculature of the lungs and repair of that vasculature will be necessary for patients to achieve a full recovery. Although many therapies are targeting the SARS-CoV-2 virus itself or the reduction of severe inflammation during the acute phase of the illness, no therapy has been shown to repair COVID-19 induced lung damage,” said Douglas W. Losordo, M.D., FACC, FAHA, Chief Medical Officer at Caladrius. “CLBS119 offers the potential to repair the lung damage caused by COVID-19 and to address a serious unmet need for patients. In previous clinical trials and preclinical models, CD34+ cells consistently have shown evidence of vascular repair in multiple organs including models of severe lung inflammation. In the proposed trial, Caladrius plans to evaluate whether CD34+ cells can be used to effectively restore lung function in patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure.”
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease. We are developing a first- in-class cell therapy product that is based on the notion that our body contains finely tuned mechanisms for self-repair. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.
Our leadership team collectively has decades of biopharmaceutical development experience and world-recognized scientific achievement in the field of cardiovascular disease, among other fields. Our goal is to build a broad portfolio of novel and versatile products that address important unmet medical needs and bring these products to market to benefit patients, the medical community and our shareholders. Our current product candidates include three developmental treatments for ischemic diseases based on our CD34+ cell therapy platform: CLBS12, recipient of SAKIGAKE designation (a Japanese regulatory status that is similar in certain respects to “breakthrough therapy” designation granted by the U.S. Food and Drug Administration (the “FDA”) to eligible investigational treatments) 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; CLBS16, a recently completed Phase 2 proof-of-concept clinical trial in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); and CLBS14, an RMAT designated therapy for which we have finalized with the FDA a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (“NORDA”).