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.
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.
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.
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SOURCE MEI Pharma, Inc.