On November 3, 2016 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 long-term survival and response data from a Phase II clinical study of Pracinostat and azacitidine in older patients with acute myeloid leukemia have been selected for oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego on December 3-6, 2016 (Press release, MEI Pharma, NOV 3, 2016, View Source [SID1234516228]). Schedule your 30 min Free 1stOncology Demo! An abstract of the presentation was published today on the ASH (Free ASH Whitepaper) website at www.hematology.org. In accordance with ASH (Free ASH Whitepaper) policies, information that goes beyond that which is contained within the abstract is embargoed until the Annual Meeting.
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Title: A Phase 2 Study of Pracinostat and Azacitidine in Older Patients with Acute Myeloid Leukemia (AML) Not Eligible for Induction Chemotherapy: Response and Long-Term Survival Benefit
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Agents in AML Therapy
Session Date: Saturday, December 3, 2016
Session Time: 9:30 AM – 11:00 AM
Presentation Time: 10:15 AM
Room: Marriott Marquis San Diego Marina, San Diego Ballroom AB
About Pracinostat
Pracinostat is a potential best-in-class, oral histone deacetylase (HDAC) inhibitor. 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 licensing, 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 indications, including high-risk myelodysplastic syndrome (MDS).
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 20,830 new cases of AML per year in the U.S., with an average age of about 67 years. Treatment options for AML remain virtually unchanged for nearly 40 years. Front line treatment consists primarily of 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.