Osiris Therapeutics, Inc.
) shares shot up more than 138% with the company reporting
positive data on Grafix, a regenerative wound care product.
Results were presented from Protocol 302, a multi-center,
randomized, controlled study that was conducted to compare the
safety and effectiveness of Grafix to standard of care in
patients with chronic diabetic foot ulcers.
Osiris said that a planned interim analysis showed that Grafix
had met pre-specified stopping rules for overwhelming
While 62% of patients on Grafix met the primary end point of
complete wound closure compared to 21% of patients in the
standard of care arm, statistical significance was also achieved
by Grafix on all top-line secondary endpoints. Grafix was
associated with faster wound closure and a reduction in the
number of treatments needed to achieve wound closure.
Meanwhile, patients whose wounds failed to close 12 weeks
after standard of care experienced an 80% closure rate on
switching to Grafix.
Moreover, Osiris reported that patients in the standard of
care arm were 74% more likely to suffer from an adverse event
compared to patients in the Grafix arm. Given these strong
results, Osiris said that the blinded phase of the trial would be
discontinued and all patients would be offered to continue on
The Grafix study results are a major positive for Osiris. The
market for diabetic foot ulcers is huge as about 25% of all
diabetics suffer from the same and there are more than 25 million
diabetics in the U.S.
The company estimates that the diabetic foot ulcers market in
the U.S. is about $2 billion. Grafix has a presence in the
in-patient market which along with the VA market accounts for
about 20% of the total diabetic foot ulcers market in the U.S.
However, the company can now seek full reimbursement in the
out-patient setting given the positive results from Protocol
Coverage in the out-patient market would expand Grafix' market
five-fold. This would lead to a significant increase in the
number of wound care centers that can be covered by the company
and the number of wounds that can be covered.
Osiris currently carries a Zacks Rank #4 (Sell). Companies
that currently look well positioned include
) with all three being Zacks Rank #1 (Strong Buy) stocks.
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