MEI Pharma's Pracinostat Gets Breakthrough Therapy Status for Its Pracinostat in Combination with Azacitidine

MEI Pharma, Inc.

disclosed Monday that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Status for its investigational drug Pracinostat in combination with azacitidine. This regulator designation is for the treatment of patients with newly diagnosed acute myeloid leukemia (AML), who are above 75 years of age or unfit for intensive chemotherapy. MEI Pharma also indicated that it struck a deal with the FDA to commence its planed final phase trial design. The company indicated that the regulator's decision was helped by data from a Phase II trial of Pracinostat plus azacitidine in elderly patients with newly diagnosed AML, not candidates for induction chemotherapy that demonstrated a median overall survival of 19.1 months and a complete response (CR) rate of 42 percent, i.e. 21 of 50 patients. The company said that these data compare favorably to a final stage trial of azacitidine (AZA-AML-0011), which demonstrated a median overall survival of 10.4 months with azacitidine alone and a CR rate of 19.5 percent in a similar patient population. The drug developer indicated that the combination of Pracinostat and azacitidine was generally well tolerated, with no unexpected toxicities. Its president and CEO, Daniel Gold, said, "With this designation, the FDA recognizes that our preliminary clinical data demonstrate that Pracinostat may result in a substantial improvement in the lives of AML patients over available therapy. We have worked closely with the FDA to get to this point and now focus on executing our Phase III study and bringing Pracinostat to market as quickly and efficiently as possible." Following the news, shares of the company traded $0.14 or 10.29 percent higher at $1.50 on Monday at the time of writing this.