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
Data to be presented at ASCO and EHA in June; Abstracts now available online
May 18, 2017
LUGANO, Switzerland and SAN DIEGO, May 18, 2017 /PRNewswire/ -- 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, today announced 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) Annual Meeting in Chicago on Monday, June 5, 2017, and the European Hematology Association (EHA) Annual Congress in Madrid on Friday, June 23, 2017. Abstracts of the presentations are now available at abstracts.asco.org and www.ehaweb.org.
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)
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)
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.
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.
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland and the US, a representative office in China as well as a product presence in approximately 190 countries globally.
For more information, please visit www.helsinn.com
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 portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA. Pracinostat has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for use in combination with azacitidine for the treatment of patients with newly diagnosed AML who are unfit for intensive chemotherapy. Pracinostat is also being developed in combination with azacitidine for the treatment of patients with high and very high-risk myelodysplastic syndrome. MEI Pharma's clinical development pipeline also includes ME-401, a potent and highly selective oral PI3K delta inhibitor currently in a Phase Ib study in patients with relapsed/refractory CLL or follicular lymphoma. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-sponsored study in combination with bevacizumab for the treatment of HER2-negative breast cancer. For more information, please visit www.meipharma.com.
MEI Pharma Forward-Looking Statements
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies 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.
SOURCE MEI Pharma, Inc.
For further information: Helsinn Group, Paola Bonvicini, Group Head of Communication, Lugano, Switzerland, Tel: +41 (0) 91 985 21 21, [email protected], MEI Pharma Contacts, Investors: Pete De Spain, Vice President, Investor Relations, (858) 792-3729, [email protected], Media: Jason Spark, Canale Communications, (619) 849-6005, [email protected]