Teva To Begin Trial Of Mesoblast Cells in CHF

The FDA has cleared the IND filing made by Teva to begin a Phase III trial in patients with chronic congestive heart failure (CHF) using proprietary Mesenchymal Precursor Cells (MPCs) from development partner Mesoblast. The IND was cleared by the FDA within the minimum 30-day period following submission, and patient recruitment is expected to begin shortly.

The multi-center trial, which will be conducted by Teva, is planned to enroll approximately 1,700 patients and includes two interim analyses of efficacy and/or safety. The clinical protocol was designed after initial consultation with both the FDA and the EMA.

Thetrial design is a double-blinded, 1:1 randomized, placebo-controlled study evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of heart failure patients with New York Heart Association (NYHA) class II or III disease and an ejection fraction. The MPC dose for the trial was chosen on the basis of results from a 60-patient Phase II trial which has shown that heart failure patients treated with the 150 million MPC dose have not experienced any HF-MACE during the three-year follow-up period compared with an HF-MACE incidence of approximately 30% for the control group over the same period.