LUGANO, Switzerland, and
SAN DIEGO, Dec. 5, 2016 /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,
announced final results from a Phase 2 clinical study of the
investigational drug candidate Pracinostat and azacitidine in
elderly patients with acute myeloid leukemia (AML) who were not
eligible for induction chemotherapy, including evidence of
prolongation of survival in the overall population and across a
number of patient subgroups.
In an oral presentation at the American Society of Hematology
(ASH) Annual Meeting on Saturday, Dr. Guillermo Garcia-Manero, MD Anderson Cancer
Center, principal investigator of the study, reported a median
overall survival of 19.1 (95%CI: 10.7-26.5) months, one-year
survival of 62% and a complete response (CR) rate of 42%.
"The results from this study of Pracinostat and azacitidine in
elderly patients deemed unfit for intensive therapy are
particularly encouraging," said Dr. Garcia-Manero. "Despite recent
advances in the treatment of AML, options for these elderly unfit
patients remain limited. The combination of Pracinostat and
azacitidine appears to show a long-term survival benefit in this
population, including an unprecedented two-year survival rate of
41% in this study. Furthermore, the prolongation of survival over
what is generally expected for azacitidine alone is observed not
only in the overall population, but across virtually every defined
patient subset, including cytogenetic risk group, de novo or
secondary AML, age and ECOG performance status."
A copy of the presentation, entitled "A Phase 2 Study of
Pracinostat and Azacitidine in Elderly Patients with Acute Myeloid
Leukemia (AML) Not Eligible for Induction Chemotherapy: Response
and Long-Term Survival Benefit," is available at
www.meipharma.com.
The open-label Phase 2 study enrolled a total of 50 patients at
15 centers across the U.S. Median age in the study was 75 years.
Patients received 60 mg of Pracinostat orally three times a week
for three weeks followed by one week of rest and 75 mg/m2 of
azacitidine via subcutaneous injection or intravenous infusion for
the first seven days of each 28-day cycle. The combination of
Pracinostat and azacitidine had no unexpected toxicities. The most
common grade 3/4 treatment-emergent adverse events reported in
>10% of all patients included thrombocytopenia, febrile
neutropenia, neutropenia, fatigue and anemia.
Site recruitment is ongoing for the global Phase 3 study of
Pracinostat and azacitidine in newly diagnosed AML patients who are
≥75 years of age or unfit for intensive induction chemotherapy.
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 3 clinical development and
expand into additional indications, including high and very 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
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.
About the Helsinn Group
Helsinn is a privately owned
cancer care pharmaceutical group with an extensive portfolio of
marketed products and a broad development pipeline. Since 1976,
Helsinn has been improving the everyday lives of patients, guided
by core family values of respect, integrity and quality, through a
unique integrated licensing business model working with long
standing partners in pharmaceuticals, medical devices and
nutritional supplement products. Helsinn is headquartered in
Lugano, Switzerland, with
operating subsidiaries in Ireland
and the US, a representative office in China, as well as a product presence in about
90 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
for its development and commercialization in AML and other
potential indications, including MDS. The Company's clinical
development pipeline also includes ME-401, an oral PI3K delta
inhibitor currently in a Phase Ib study in patients with recurrent
chronic lymphocytic leukemia or follicular non-Hodgkin's lymphoma,
and ME-344, a 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.