MEI Pharma Inc (NASDAQ:MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced 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). Results from these studies were recently selected for oral presentation at the upcoming American Society of Hematology (ASH) Annual Meeting in Orlando on December 7, 2015.
“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 next month.”
The data contained within the abstracts listed below are as of the ASH submission deadline on August 4, 2015. In accordance with ASH policies, information that goes beyond that which is contained within these abstracts is embargoed until their presentation on December 7, 2015. (Original Source)
Shares of MEI Pharma are up 7.66% to $2.25 in pre-market trading. MEIP has a 1-year high of $8.30 and a 1-year low of $1.47. The stock’s 50-day moving average is $1.74 and its 200-day moving average is $1.81.
On the ratings front, MEI Pharma has been the subject of a number of recent research reports. In a report issued on October 7, Cowen analyst Boris Peaker reiterated a Buy rating on MEIP. Separately, on September 3, Wedbush’s David Nierengarten reiterated a Hold rating on the stock and has a price target of $3.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and David Nierengarten have a total average return of 22.5% and 50.6% respectively. Peaker has a success rate of 47.6% and is ranked #109 out of 3824 analysts, while Nierengarten has a success rate of 51.1% and is ranked #9.
MEI Pharma Inc is an oncology company focused on the clinical development of novel therapeutics for cancer.