We begin our new fiscal year with strong momentum, a deep pipeline of clinical-stage oncology drug candidates and a healthy cash balance. One of our core strengths at MEI is identifying promising, differentiated oncology drug candidates, applying our drug development expertise to optimize their potential and, ultimately, making a meaningful impact on the lives of cancer patients. We are making great headway with this approach.
First patient was dosed in a pivotal Phase 3 study of our most advanced investigational drug candidate, pracinostat.
We are investigating pracinostat, in combination with azacitidine, in adults with newly diagnosed acute myeloid leukemia (AML) who are unfit to receive intensive induction chemotherapy. The randomized, double-blind, placebo-controlled study will enroll approximately 500 eligible patients worldwide. The primary endpoint of the study is overall survival. Helsinn Healthcare, has an exclusive license to develop, manufacture and commercialize pracinostat and is responsible for the conduct and funding of this Phase 3 study.
First patient dosed in Phase 2 dose-optimization study of pracinostat in myelodysplastic syndrome.
The first patient was dosed in combination with azacitidine in patients with high and very high risk myelodysplastic syndrome (MDS) who are previously untreated with hypomethylating agents. Based on our clinical experience with the combination, we believe that a reduced dose of pracinostat has the potential to improve tolerability in patients with higher risk MDS. Our experience suggests that prolonged exposure to the combination may translate to greater efficacy compared to azacitidine alone. The two-stage study will be conducted at approximately 25 sites and is expected to enroll up to 120 patients. While we are responsible for the conduct of this study, the cost is being be shared with Helsinn and Helsinn will be responsible for funding any further studies. Data from the first stage is expected in the first quarter of 2018.
Emerging data from Phase 1b study of ME-401 in chronic lymphocytic leukemia and follicular lymphoma and expanding study to evaluate combination with anti-CD20.
An independent safety review committee has now completed its review of the first 2 cohorts of twelve evaluable patients in an ongoing Phase 1b dose-escalation study of the Company's oral PI3K delta inhibitor ME-401 in relapsed or refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). The safety review committee found no dose-limiting toxicities at 60 and 120 mg, declared a minimum biologically effective dose (response rate > 50%) at the starting dose of 60 mg, and recommended escalation to the 180 mg dose cohort. We are very excited by the response and safety data that continue to emerge from this open-label study and await the opportunity to present detailed results at an upcoming scientific meeting.
We are also expanding the study to evaluate the combination of ME-401 with an anti-CD20 such as Rituxan and plan to submit a briefing package to the FDA regarding our registrational plans for MEI-401 during the first quarter of 2018.
Addition of voruciclib complements our existing pipeline and further leverages our core strength in oncology drug development.
Voruciclib, a selective cyclin-dependent kinase (CDK) inhibitor, has an established clinical safety profile, along with compelling pre-clinical data showing suppression of MCL1, a known mechanism of resistance to BCL2 inhibitors, and synergy with the FDA-approved BCL2 inhibitor venetoclax. We believe this provides a clear and efficient clinical development path forward in combination with venetoclax. We entered into a license agreement with Presage Biosciences granting us exclusive worldwide rights.
Remain very excited by our clinical-stage mitochondrial drug candidate, ME-344.
We are looking forward to the results of the hypothesis-testing randomized study evaluating ME-344 in combination with Avastin in women recently diagnosed with HER2- breast cancer. This study is now actively dosing patients and interim data are expected in December 2017.
On behalf of the entire board and management team of MEI Pharma, I’d like to thank our employees, clinical investigators and shareholders for their continued support. I would also like to thank Helsinn for our Pracinostat program as well as Presage Biosciences for rights to voruciclib. We are more excited about our prospects than ever and look forward to progressing our programs for patients in need.
Daniel P. Gold, Ph.D.