MEI Pharama Reports Improved Response Rates In Phase II Study of Pracinostat In Front Line Acute Myeloid Leukemia

MEI Pharma, Inc. MEIP, an oncology company focused on the clinical development of novel therapies for cancer, today announced that data from a Phase II clinical study of its investigational drug candidate Pracinostat in combination with the hypomethylating agent azacitidine (marketed as Vidaza^®) in elderly patients with newly diagnosed acute myeloid leukemia has been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting in San Francisco. An abstract of the presentation, entitled "Pracinostat in Combination with Azacitidine Produces a High Rate and Rapid Onset of Disease Remission in Patients with Previously Untreated Acute Myeloid Leukemia (AML)," is now available at www.hematology.org and www.meipharma.com. As reported in the abstract (as of August 1, 2014), eight of the 14 patients evaluable for efficacy achieved a complete response (CR) or a complete response with incomplete blood count recovery (CRi). The authors conclude that this CR/CRi rate of 57% is high compared to historical results with hypomethylating agents alone in this population, noting that the responses occur rapidly, most within the first two cycles. No responders have progressed to date. The combination of Pracinostat and azacitidine has been generally well-tolerated in the study, with no unexpected toxicities. The most common treatment emergent adverse events were neutropenia/neutropenic fever, thrombocytopenia, nausea, fatigue and anemia. In June 2014, the Company reported a CR/CRi rate of 33% in the first nine patients enrolled, meeting the pre-specified CR/CRi rate required to advance to the second stage of the study. The open-label study is enrolling a total of 40 patients to further define the tolerability and efficacy of the regimen, including remission duration. Interim data from up to 30 evaluable patients from 14 clinical sites will be presented by Dr. Guillermo Garcia-Manero of the MD Anderson Cancer Center, lead author and principal investigator of the study, in a poster presentation on Saturday, December 6, 2014 at 5:30 p.m. Pacific time from Hall E in the North Building of the Moscone Center in San Francisco. In addition, the Company's management team will be hosting its 2^nd Annual Analyst and Investor Day in the evening on Monday, December 8, 2014 at the Westin St. Francis in San Francisco. The event will feature updates by Daniel P. Gold, Ph.D., President and Chief Executive Officer, and Robert D. Mass, MD, Chief Medical Officer, along with a presentation by Dr. Garcia-Manero.