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
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
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.
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
"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
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.