News | December 2, 2014
MEI Pharma Completes Enrollment in Phase II Study of Pracinostat in Front Line Acute Myeloid Leukemia
Interim Data from 33 Evaluable Patients to be Presented at ASH on Saturday
SAN DIEGO, Dec. 2, 2014 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that it has completed enrollment in a Phase II clinical study of its investigational drug candidate Pracinostat in combination with azacitidine (marketed as Vidaza®) in elderly patients with newly diagnosed acute myeloid leukemia. The open-label study enrolled a total of 50 patients at 15 clinical sites in the U.S.
Interim data from the 33 patients evaluable for efficacy will be presented at the American Society of Hematology (ASH) Annual Meeting 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. A copy of the poster, 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),” will also be available at www.meipharma.com.
As reported in an abstract of the presentation, submitted in August 2014, three of the first 14 patients evaluable for efficacy in the study achieved a complete response (CR) and five achieved a complete response with incomplete blood count recovery (CRi). Notably, all eight of these patients have now improved to CR and none have progressed to date.
“The enthusiasm surrounding this open-label study continues to mount, as evidenced by the rapid rate of enrollment over the past six months,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. “Not only are we seeing a higher initial response rate than expected from azacitidine alone, often within the first two cycles, but these patients are continuing to improve with subsequent treatment. We look forward to reporting additional interim data, including duration of response, at ASH on Saturday.”
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 are neutropenia/neutropenic fever, thrombocytopenia, nausea, fatigue and anemia.
Pracinostat is an oral histone deacetylase (HDAC) inhibitor that has been tested in a number of Phase I and Phase II clinical trials in advanced hematologic disorders and solid tumor indications in both adult and pediatric patients. Pracinostat has been generally well tolerated in more than 300 patients to date, with manageable side effects often associated with drugs of this class, including fatigue, myelosuppresion and gastrointestinal toxicity. In a Phase I dose-escalation trial, Pracinostat demonstrated evidence of single-agent activity in elderly AML patients, including two out of 14 (14%) who achieved a CR, with durable responses persisting 206+ and 362 days, respectively. In addition, results from a pilot study of Pracinostat in combination with Vidaza in patients with advanced myelodysplastic syndrome (MDS) showed an overall response rate of 90% (nine out of 10), including eight patients who achieved either a CR or a CRi.
MEI Pharma owns exclusive worldwide rights to Pracinostat.
Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most common acute leukemia affecting adults, and its incidence is expected to increase as the population ages. The American Cancer Society estimates about 14,590 new cases of AML per year in the U.S., with an average age of about 66. Treatment options for AML remain virtually unchanged over the past 30 years. Front line treatment consists primarily of chemotherapy, while the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend azacitidine or decitabine (marketed as Dacogen®) as low intensity treatment options for AML patients over the age of 60 who are unsuitable for induction chemotherapy.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company’s lead drug candidate is Pracinostat, a potential best-in-class, oral HDAC inhibitor currently being developed for MDS and AML. In August 2014, the Company completed enrollment in a randomized, placebo-controlled Phase II study of Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk MDS. The Company plans to unblind the study and report topline data in Q1 2015. MEI Pharma is also developing ME-344, a mitochondrial inhibitor currently in a Phase Ib study in combination with topotecan in patients with small cell lung or ovarian cancer who failed initial therapy. In September 2013, the Company further expanded its pipeline of drug candidates with the acquisition of PWT143, a highly selective PI3K delta inhibitor. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
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Pete De Spain
Vice President, Investor Relations & Corporate Communications