NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement
NeoStem, Inc. (NYSE: NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized Contract Development and Manufacturing Organization (CDMO), and SOTIO, LLC, a Delaware limited liability company that is responsible for organizing the U.S. part of a global pivotal Phase 3 clinical trial of SOTIO, LLC's affiliate, SOTIO a.s. ("SOTIO"), announced today that SOTIO, LLC has retained the services of PCT to manufacture clinical products for SOTIO's U.S. part of a global pivotal Phase 3 clinical trial. SOTIO, LLC is an affiliate of a Czech Republic-based biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. SOTIO, LLC will use the services of PCT to transfer and qualify at PCT's Allendale, New Jersey facility, SOTIO's GMP manufacturing process for the U.S. part of a global pivotal Phase 3 clinical trial for SOTIO's autologous dendritic cell vaccine expected to launch in early 2013, subject to FDA approval.
As part of this agreement, PCT will complete a technology transfer of SOTIO's current product manufacturing and analytical procedures into PCT's ongoing CDMO operations. PCT will then implement and perform process qualification at the Allendale facility, and manufacture, store, and release the product for SOTIO's U.S. part of its global pivotal Phase 3 trial. The U.S. part of this double-blinded, randomized trial will enroll up to 250 patients and will be SOTIO's first trial in the U.S.
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