Industry Trend Analysis - Caladrius On Track To Emerge As New Force In Type I Diabetes - APR 2018

BMI View: Caladrius Biosciences' Phase II trial for its lead product, CLBS03, is progressing and could represent a new method of treatment for Type I diabetes which could result in a reduced reliance on insulin injections for patients. Although Caladrius is concentrating on Type I diabetes, CLBS03 has potential for other autoimmune conditions, as it aims to enhance a patient's regulatory T cells (Tregs); it is believed that deficient Treg activity is a cause of autoimmune dysfunction. Direct competition in Type I diabetes is limited; success in this indication would establish Caladrius as a potent player in this market.

Caladrius Biosciences has reported results from the predetermined interim analysis in The Sanford Project: T-Rex Study, a prospective, randomised, placebo-controlled, double-blind Phase II trial of 110 patients to evaluate the safety and efficacy of the company's CLBS03 therapy as a treatment for recent-onset Type I diabetes. The interim analysis was triggered by 50% of the targeted total number of subjects in the trial completing six months of follow-up. The interim analysis, conducted by independent statisticians, showed that CLBS03 continues to be well-tolerated and led to the conclusion that the study was non-futile as determined by predefined futility criteria for therapeutic effect.

CLBS03 is a personalised autologous cell therapy consisting of each patient's own regulatory T cells (Tregs) which have been expanded in number and functionally enhanced by a proprietary method developed through a collaboration with Jeffrey Bluestone and researchers at the University of California, San Francisco (UCSF). Caladrius holds exclusive rights to an international portfolio of issued and pending patents related to this product. CLBS03 as a treatment for Type I diabetes has FDA orphan drug designation, EMA Advanced Therapeutic Medicinal Product classification and FDA fast track designation, which represents the first Type I diabetes programme to receive this distinction.

Caladrius's Revenue Potential Hinges On CLBS03
Caladrius's Annual Results (USD000s)
Source: Caladrius Biosciences, BMI

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