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 Treatment with the Australian company's mesenchymal precursor cell (MPC)
product, MPC-300-IV, was deemed well tolerated with no serious side
effects or infusion-related adverse events in the 48-patient,
12-week Phase II study, the company said.
Among patients previously treated with at least one biologic drug,
the common measure of 20 percent relief of signs and symptoms of the
arthritis, known as ACR20, was achieved by 55 percent of those who
received an infusion of 2 million cells per kilogram of weight. That
compared with 33 percent in the placebo group who achieved ACR20.
The higher bar of ACR70, or 70 percent improvement, was achieved by
36 percent after one infusion of the Mesoblast treatment, compared
with no patients in the placebo group who reported such an
improvement.
The cell treatment also led to improvements in measures of physical
function and overall disease activity versus placebo, the company
said.
"The safety and efficacy results of this study are very encouraging
and suggest that Mesoblast’s cell therapy has the potential to fill
the major unmet medical need" for patients who cannot take biologic
treatments, Dr. Allan Gibofsky, rheumatologist at Hospital for
Special Surgery in New York, said in a statement.
Rheumatoid arthritis is a chronic, often painful autoimmune disease
affecting about 1 percent of the global population. It causes
inflammation and potentially destruction of multiple joints.
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Mesoblast, which is 14.6-percent owned by Teva Pharmaceutical
Industries, said it plans to line up a partner to help it move the
treatment into larger Phase III trials.
About one third of patients either do not respond sufficiently or
cannot tolerate popular biologic treatments for rheumatoid
arthritis, such as AbbVie's Humira, the world's top-selling
prescription medicine, creating a need for new therapy options.
To be competitive with current medicines, new treatments must
address both pain and disease progression.
(Reporting by Bill Berkrot; Editing by Leslie Adler)
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