MEI Pharma, Inc.
) announced that it has dosed the first patient in its phase II
study on its pipeline candidate pracinostat, an oral histone
deacetylase (HDAC) inhibitor, for the treatment of patients with
myelodysplastic syndrome (MDS). The patients have either failed
to respond or maintain a response to a hypomethylating agent
(HMA) alone. MEI Pharma intends to evaluate the candidate in
combination with Vidaza or Dacogen.
The primary endpoint of this study is the proportion of
patients with complete remission (CR), partial remission and
hematologic improvement (HI), while the secondary endpoints
include overall response rate, CR rate, HI rate, duration of
response, progression free survival, and overall survival.
Top-line data from the study is expected in Dec 2014.
This is the third open-label phase II study on pracinostat.
MEI Pharma continues to enroll patients in another phase II study
of pracinostat in combination with Vidaza in frontline acute
myeloid leukemia (AML). The top-line data is also expected in Dec
We note that in Jun 2013, MEI Pharma initiated a phase II
study on pracinostat in combination with Vidaza for the treatment
of MDS. MEI Pharma is on track to complete patient enrollment in
this study in Jun 2014, with top-line data expected in Dec
We note that in Aug 2012, MEI Pharma acquired exclusive global
rights to Pracinostat from S*BIO Pte Ltd, which is a
privately-held biotechnology company.
MEI Pharma carries a Zacks Rank #4 (Sell). Better-ranked
stocks include include
Lannett Company, Inc.
WuXi PharmaTech (Cayman) Inc.
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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