LUGANO, Switzerland and
SAN DIEGO, December 5, 2016 /PRNewswire/ --
Phase 2 study results presented at
American Society of Hematology Annual Meeting on
Saturday, December 3,
2016
Global Phase 3 study
site recruitment is ongoing
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
http://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 http://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 http://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.
MEI Pharma Contacts
Investors:
Pete De Spain
Vice President, Investor Relations
+1(858) 792-3729
pdespain@meipharma.com
Media:
Jason Spark
Canale Communications
+1(619) 849-6005
jason@canalecomm.com
Helsinn Group Contact:
Paola Bonvicini
Head of Communication & Press Office
+41-91-985-21-70
info-hhc@helsinn.com