MEI Pharma, Inc. (MEIP) Reports Preliminary Data from Pilot Phase II Clinical Trial of Pracinostat Combined with Azacitidine

Oncology company MEI Pharma announced that preliminary data from the pilot Phase II clinical trial of its investigational oral histone deacetylase (HDAC) inhibitor Pracinostat, combined with azacitidine, in patients with advanced myelodysplastic syndrome (MDS) has been accepted for poster presentation at the American Society of Hematology annual meeting on Dec. 10.

An abstract of the presentation, called “Very high rates of clinical and cytogenetic response with the combination of the histone deacetylase inhibitor Pracinostat (SB939) and 5-azacitidine in high-risk myelodysplastic syndrome,” is currently available online at www.hematology.org. The abstract was submitted by Dr. Quintas-Cardama and Dr. Gracia-Manero of the MD Anderson Cancer Center. The poster presentation is scheduled to take place at 6 p.m. EST on Dec. 10 in the Georgia World Congress Center in Atlanta, Hall B1-B2, level 1, building B.

MEI Pharma is encouraged by both the reported response rates of Pracinostat combined with azacitidine and the rapid appearance of these responses. The fact that most patients in the study had treatment-related MDS and expressed high-risk cytogenetic abnormalities – both carrying a poor prognosis – makes the data especially compelling. Armed with these data and combined with the capital raise announced by MEI Pharma on Nov. 5, the company expects to be in a position to quickly advance to the next stage of development and initiate a randomized Phase II trial of Pracinostat in combination with azacitidine in MDS patients by the second quarter of 2013.

Pracinostat is a selective inhibitor of a group of enzymes called histone deacetylases (HDAC). Currently, two HDAC inhibitors are approved by the FDA for treating cutaneous T-cell lymphoma – one of which is additionally approved to treat peripheral T-cell lymphoma. Pracinostat has shown evidence of single-agent activity in multiple clinical trials, including advanced hematologic malignancies like MDS, acute myeloid leukemia, and myelofibrosis. Pracinostat has additionally demonstrated pre-clinical activity in hematologic disorders and solid tumors when used alone or in combination with various therapies in laboratory studies. In clinical testing of more than 150 patients, Pracinostat has generally been well tolerated, with readily manageable side effects that are often associated with drugs of this class. Fatigue is the most common adverse event in all grades. Pracinostat has not received FDA approval for commercial distribution.

MEI Pharma is an oncology company engaged in the clinical development of novel therapies for cancer. Based in San Diego, Calif., the company has a clinical development pipeline that includes lead drug candidate Pracinostat, which is a potential best-in-class HDAC inhibitor that has been tested in multiple Phase I and exploratory Phase II clinical trials, including advanced hematologic malignancies like MDS, acute myeloid leukemia, and myelofibrosis. MEI Pharma intends to initiate a randomized Phase II trial of Pracinostat in combination with azacitidine in patients with MDS by the second quarter of 2013. Additionally, the company is developing two drug candidates derived from its isoflavone-based technology platform ME-143 and ME-344.

For more information, visit www.meipharma.com

About MissionIR 

MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.

Sign up for “The Mission Report” at www.MissionIR.com

Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html