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MEI Pharma Initiates Phase II Clinical Trial Of Pracinostat In Refractory Myelodysplastic Syndrome
Date:1/14/2014

SAN DIEGO, Jan. 14, 2014 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patient has been dosed in a Phase II clinical trial of Pracinostat, the Company's investigational oral histone deacetylase (HDAC) inhibitor, in patients with myelodysplastic syndrome (MDS) who either failed to respond or maintain a response to a hypomethylating agent (HMA) alone.

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"We are very excited about getting this study underway," said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. "This represents the third in a series of Phase II clinical trials we are conducting with Pracinostat in combination with HMAs in an attempt to establish the clinical benefit of selectively combining two epigenetic modifiers. The primary objective in this refractory MDS trial is to determine if the addition of Pracinostat to Vidaza® or Dacogen® can improve clinical responses or rescue previous responses achieved with a HMA alone. We look forward to reporting preliminary data from all three Phase II trials of Pracinostat later this year."

This two-stage trial of Pracinostat is expected to enroll up to a total of 76 patients into two groups: 1) patients who have had disease progression or have relapsed following a clinical response to either Vidaza or Dacogen therapy and 2) patients with stable disease who failed to respond to their initial HMA therapy. If at any time two or more responses are observed in the first 29 patients of each group, that group will continue to enroll an additional nine patients in the second stage, for a total of up to 38 evaluable patien
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SOURCE MEI Pharma, Inc.
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