Helsinn Group and MEI Pharma Announce Upcoming Presentations of Gene Mutation and Clinical Response Data from Phase II Study of Pracinostat and Azacitidine in Acute Myeloid Leukemia

On May 18, 2017 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that data on the correlation between gene mutation clearance and clinical response from a Phase II clinical study of Pracinostat and azacitidine in older patients with acute myeloid leukemia (AML) have been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on Monday, June 5, 2017, and the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Madrid on Friday, June 23, 2017 (Press release, MEI Pharma, MAY 18, 2017, View Source [SID1234519214]). Abstracts of the presentations are now available at abstracts.asco.org and www.ehaweb.org.

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ASCO
Title: Correlation between Mutation Clearance and Clinical Response in Elderly Patients with Acute Myeloid Leukemia (AML) Treated with Azacitidine and Pracinostat
Abstract Number: 7034
Session Title: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes and Allotransplant
Date and Time: Monday, June 5, 2017, 8:00 a.m. – 11:30 a.m. CDT (9:00 a.m. – 12:30 p.m. EDT)

EHA
Title: Treatment of Pracinostat and Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML): Correlation between Mutation Clearance and Clinical Response
Abstract Code: P207
Session Title: Acute Myeloid Leukemia – Clinical 2
Date and Time: Friday, June 23, 17:15 – 18:45 CEST (1:15 p.m. – 2:45 p.m. EDT)

About Pracinostat
Pracinostat is a potential best-in-class, oral histone deacetylase (HDAC) inhibitor that is in late stage clinical development. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. In August 2016, Helsinn and MEI Pharma entered into an exclusive license, development and commercialization agreement for Pracinostat in AML and other potential indications. The deal provides the complementary resources from both organizations to rapidly advance Pracinostat into Phase III clinical development and expand into additional areas of clinical development, including high-risk myelodysplastic syndrome (MDS). Pracinostat is an investigational agent and is not approved for use in the U.S.

About AML
Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most common acute leukemia affecting adults, and its incidence is expected to continue to increase as the population ages. The American Cancer Society estimates about 21,380 new cases of AML per year in the U.S., with an average age of about 67 years. Front line treatment consists primarily of induction chemotherapy, while the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology recommend hypomethylating agents azacitidine or decitabine as low intensity treatment options for AML patients over the age of 60 who are unsuitable for induction chemotherapy.