Caladrius bags exclusive license to Shire’s cell therapy program for refractory angina

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New Jersey-based Caladrius Biosciences has announced that it has acquired exclusive worldwide rights to Shire’s CD34+ cell therapy program developed for the treatment of chronic myocardial ischemia targeting refractory angina.

Under the terms of the agreement, Caladrius has received global rights to the data sets, including preclinical, Phase 1, Phase 2 and Phase 3 clinical study data, and all the regulatory filings for Shire’s CD34+ cell therapy program for the treatment of no-option refractory angina. In return, Shire will receive undisclosed up-front consideration, milestones and a royalty on product sales.

Data supporting the use of autologous CD34+ cell therapy for refractory angina comes from a pooled analysis of three randomized placebo-controlled clinical trials. Tested in over 300 patients, the study published in European Heart Journal reveals clinically meaningful improvement in exercise capacity, chest pain frequency and mortality.

Dr David J. Mazzo, Caladrius’ President and CEO commented: “This transaction offers an ideal opportunity for Caladrius to obtain a promising late-stage development asset complementary to our existing pipeline of CD34+ cell therapy development programs in ischemic repair. This program represents a large potential commercial opportunity as refractory angina afflicts approximately one million people in the U.S. alone, with an incidence rate of 50,000 to 100,000 annually.

Source: Caladrius snags heart disease stem cell therapy from Shire; Press Release