On November 5, 2015 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported the publication of new data from the Company’s Phase II clinical studies of the investigational drug Pracinostat in patients with previously untreated myelodysplastic syndrome (MDS) and elderly patients with acute myeloid leukemia (AML) (Press release, MEI Pharma, NOV 5, 2015, View Source [SID:1234508012]). Results from these studies were recently selected for oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando on December 7, 2015. The abstracts are now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

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"The data contained within the abstracts released this morning point to certain trends worth highlighting," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "Since the unblinding of our randomized study in front-line MDS, we have learned that the combination of Pracinostat and azacitidine resulted in a high rate of discontinuations due to adverse events compared to azacitidine alone. These discontinuations occurred predominantly within the first two cycles of treatment and often before a response assessment could be performed, leading to a higher complete response (CR) rate overall with azacitidine alone. However, exploratory sensitivity analyses among patients who were able to tolerate treatment for at least four cycles (n=54) suggest that patients treated with Pracinostat plus azacitidine appear to derive benefit compared to azacitidine alone, with hazard ratios for progression progression-free survival (0.37), event-free survival (0.33) and overall survival (0.59) all favoring the Pracinostat plus azacitidine arm.

"The data from our open-label study in elderly patients with newly diagnosed AML," continued Dr. Gold, "demonstrate that many patients are achieving responses within the first two cycles and continue to improve with ongoing therapy, with fewer discontinuations due to adverse events than in our MDS study. Overall, 54% of patients (27 of 50) have achieved a clinical response with 42% (21 of 50) achieving a CR. The 60-day mortality rate in the study is 10% (5 of 50) and the one-year survival rate is estimated at 60%. All of these data points compare favorably to a recent study of azacitidine alone in this population1. Median overall survival, the most important measure in determining the development path forward for this combination, still has not been reached. We will continue to follow these patients and look forward to the presentation of updated overall survival data at ASH (Free ASH Whitepaper) next month."

The data contained within the abstracts listed below are as of the ASH (Free ASH Whitepaper) submission deadline on August 4, 2015. In accordance with ASH (Free ASH Whitepaper) policies, information that goes beyond that which is contained within these abstracts is embargoed until their presentation on December 7, 2015.

Title: Final Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (Abstract #453)
Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Advances in Therapy
Session Date: Monday, December 7, 2015
Session Time: 7:00 AM – 8:30 AM
Presentation Time: 7:30 AM

Title: A Randomized, Placebo-Controlled, Phase II Study of Pracinostat in Combination with Azacitidine in Patients with Previously Untreated Myelodysplastic Syndrome (Abstract #911)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies I
Session Date: Monday, December 7, 2015
Session Time: 6:15 PM – 7:45 PM
Presentation Time: 7:15 PM

About Pracinostat

Pracinostat is an orally available inhibitor of a group of enzymes called histone deacetylases, or HDACs. HDACs 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. Abnormal activity of these regulators is believed to play an important role in cancer and other diseases. Pracinostat has been tested in multiple Phase I and Phase II clinical studies in advanced hematologic diseases and solid tumor indications. The results of these studies suggest that Pracinostat has potential best-in-class pharmacokinetic properties when compared to other oral HDAC inhibitors, with side effects often associated with drugs of this class, including fatigue and myelofibrosis. Pracinostat has not been approved for commercial distribution in the U.S.