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

ts per group. Preliminary data from this open-label trial is anticipated by December 2014.

The primary endpoint of the trial is clinical improvement rate, defined as the proportion of patients with complete remission (CR), partial remission (PR) and hematologic improvement (HI). Secondary endpoints include overall response rate, CR rate, HI rate, duration of response, progression-free survival, time to progression and overall survival. Dr. Guillermo Garcia-Manero of the MD Anderson Cancer Center is the study's Principal Investigator. Additional information regarding the trial is available at www.clinicaltrials.gov.

Meanwhile, MEI Pharma remains on track to fully enroll its randomized, placebo-controlled Phase II trial of Pracinostat in combination with Vidaza in patients with previously untreated intermediate-2 or high-risk MDS by June 2014, with topline data expected by December 2014.

In addition, the Company continues to enroll patients in a two-stage Phase II trial of Pracinostat in combination with Vidaza in elderly patients with newly diagnosed acute myeloid leukemia (AML). If at any time three or more responses are observed in the first 27 patients, the trial will continue to enroll an additional 13 patients in the second stage, for a total of up to 40 evaluable patients. Preliminary data from this open-label trial is also anticipated by December 2014.

About Pracinostat

Pracinostat is an orally available HDAC inhibitor that has been tested in a number of Phase I and Phase II clinical trials in advanced hematologic disorders and solid tumor indications. Pracinostat has been generally well tolerated in more than 200 adult and pediatric patients to date, with readily manageable side effects that are often associated with drugs of this class, including fatigue. In a Phase I dose-escalation trial, Pracinostat demonstrated evidence of single-agent activity in
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SOURCE MEI Pharma, Inc.
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