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MEIP Starts Phase II Study on Pracinostat

MEIP ESALY

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MEI Pharma, Inc. (MEIP - Snapshot Report) 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 Vidaza.

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 / (ESALY) 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 89%.

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 now, Santarus, Inc. looks more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).

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