Monday, 16 July 2012

NeoStem's PCT unit pegs manufacturing services deal for Sotio's phase 3 US trial

NeoStem (NYSE MKT:NBS) said Monday that its cell processing and manufacturing unit, Progenitor Cell Therapy (PCT), has inked a deal to manufacture clinical products for the US part of Sotio's global phase 3 clinical trial.
Sotio LLC is the US affiliate of the Czech Republic-based biotech company Sotio Group, which develops new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases.
The Czech company will use the services of PCT to transfer and qualify its GMP (Good Manufacturing Practices) manufacturing process for the US part of a global phase 3 trial testing Sotio's autologous dendritic cell vaccine - expected to launch in early 2013 subject to FDA approval.
As part of the agreement, PCT said it will complete a technology transfer of Sotio's current product manufacturing and analytical procedures, into PCT's ongoing operations.
PCT will then implement process qualification at its Allendale facility in New Jersey, and manufacture, store, and release the product for Sotio's US part of the phase 3 trial.
The U.S. portion of the double-blinded, randomized trial will enroll up to 250 patients, representing Sotio's first trial in the U.S.
"We are very excited to enter into this agreement to continue and to expand on our relationship with Sotio, LLC, an innovator for cellular immunotherapies to treat prostate cancer," said president and chief scientific officer of PCT, Dr. Robert A. Preti.
"Given our best in class capabilities in the manufacture and distribution of cell-based immunotherapies, we are pleased to work with Sotio, LLC to assist with bringing this exciting therapy and its potential to the U.S.
"PCT will offer SOTIO, LLC the same expertise and dedicated service it has offered past clients like the Dendreon Corporation (Nasdaq:DNDN), for whom we were the primary manufacturer for PROVENGE for more than seven years during its clinical trials," added Preti.
NeoStem is focused on cell therapies, with its PCT unit's manufacturing base being one of the few current GMP facilities available for contracting in the burgeoning cell therapy industry.
"This agreement with PCT represents a major risk mitigation step in conducting the U.S. part of our global pivotal Phase 3 clinical trial," said chairman and CEO of Sotio, Karel Nohejl.
"PCT has significant experience in manufacturing patient-specific products and capabilities to provide the scale-up needed for late-stage clinical trials.
"PCT's competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for SOTIO, LLC as we look forward to launching this trial in anticipation of entering the U.S. market."
Manufacturing contracts for cell therapy products can generate millions of dollars of revenue for the manufacturing partner over the span of a late stage clinical trial, said NeoStem's CEO, Dr. Robin Smith.
Smith foresees "meaningful client base growth as therapeutic development companies from Europe and Asia seek access to the American market and look for a U.S. contract development and manufacturing partner."
NeoStem is also focused on developing cell therapies with Amorcyte, which NeoStem acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease, with the company's lead compound designed to preserve heart function after a heart attack. The drug is now in phase 2 trials, and represents NeoStem's most advanced therapeutic.

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