MEI Pharma Inc. (NASDAQ: MEIP) was leading the bulls in the broad markets Monday on news of positive Phase 2 results. The company announced positive results from a study of its investigational drug candidate Pracinostat in combination with azacitidine in elderly patients with newly diagnosed acute myeloid leukemia (AML). The results were presented earlier in the day at the American Society of Hematology Annual Meeting in Orlando.
Roughly 56% patients in the study achieved the primary endpoint of complete response (CR) plus complete response with incomplete blood count recovery (CRi) plus morphologic leukemia-free state, including 42% of patients who achieved a CR. Notably, patients who achieved a CR are still alive with a 100% one-year survival rate among all CR patients, indicating a correlation between CR and survival with this low intensity therapy.
For some background: Pracinostat is a potent oral inhibitor of a group of enzymes called histone deacetylases. These enzymes belong to a larger set of proteins collectively known as epigenetic regulators that can alter gene expression by chemically modifying DNA or its associated chromosomal proteins.
Dr. Guillermo Garcia-Manero, of the M.D. Anderson Cancer Center, said:
These are impressive results by virtually any measure for a group of patients in dire need of effective new treatment options. Not only did we observe a high rate of responses, but many occurred rapidly and continued to improve with ongoing therapy. Most importantly, we are seeing an encouraging trend in overall survival, particularly among patients who achieved a complete response. These data clearly support further development of Pracinostat in combination with azacitidine for the treatment of elderly patients with AML.
Daniel P. Gold, Ph.D., president and CEO of MEI Pharma, added:
We will now begin to prepare for a Phase III registration study of Pracinostat and azacitidine in elderly patients with newly diagnosed AML, which we plan to initiate in the second half of 2016. We look forward to sharing more information regarding the design of this study in the months ahead.
Shares of MEI Pharma were last seen trading up 14.3% at $1.76, with a consensus analyst price target of $5.00 and a 52-week trading range of $1.47 to $6.82.