MEI Pharma, Inc.
) recently commenced a phase II study of Pracinostat in
combination with Vidaza (azacitidine) for the treatment of
myelodysplastic syndrome (MDS).
The multicenter, randomized, placebo-controlled phase II study
is being performed in patients with previously untreated
intermediate-2 or high-risk MDS to evaluate the safety and
efficacy of Pracinostat compared to placebo when combined with
MEI Pharma expects to complete patient enrollment in this
study in Jun 2014, with top-line data expected in Dec 2014.
The primary endpoint of this study is the achievement of
complete remission (CR), while secondary endpoints include
overall response rate, hematologic improvement, duration of
response, progression free survival (PFS), rate of leukemic
transformation, overall survival (OS) and safety.
MEI Pharma will start two open-label phase II studies of
Pracinostat around Sep 2013: one in combination with Vidaza in
frontline acute myeloid leukemia (AML) and the other in
combination with Vidaza or
Astex Pharmaceuticals, Inc. / Eisai Co., Ltd.' s
) Dacogen in patients with refractory MDS.
In Dec 2012, MEI Pharma had presented results from a study on
Pracinostat plus Vidaza in patients with intermediate-2 or
high-risk MDS. The study showed an overall response rate of
Many candidates are being developed for the treatment of MDS,
like Astex's SGI-110, to treat patients with intermediate or high
risk relapsed or refractory MDS. Another candidate, Telintra, is
being developed for MDS.
MEI Pharma currently carries a Zacks Rank #3 (Hold). Right
) looks more attractive in the pharma space with a Zacks Rank #1
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