LUGANO, Switzerland and
SAN DIEGO, Aug. 2, 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 the first patient has been dosed in the
pivotal Phase 3 study of the investigational agent pracinostat in
combination with azacitidine in adults with newly diagnosed acute
myeloid leukemia (AML) who are unfit to receive intensive induction
chemotherapy.
The randomized, double-blind, placebo-controlled study will
enroll approximately 500 eligible patients worldwide. Patients will
be randomized 1:1 to receive pracinostat or placebo with
azacitidine as background therapy. The primary endpoint of the
study is overall survival. Secondary endpoints include, among
others, morphologic complete remission (CR) rate, event free
survival (EFS) and duration of CR.
Riccardo Braglia, Helsinn Group
Vice Chairman and CEO, said: "Helsinn was delighted to be able to
announce our strategic partnership with MEI Pharma last year,
leveraging on the potential of pracinostat, which was demonstrated
in the Phase 2 study. We are very pleased that pracinostat is
moving into Phase 3, showing the continued momentum of the clinical
programme. As Helsinn broadens its focus beyond cancer supportive
care and into cancer therapeutics, high quality partnerships such
as our collaboration with MEI Pharma are key for Helsinn to create
value and benefit more people with cancer."
"The initiation of this highly anticipated study is the
culmination of diligent preparation in collaboration with our
partners at Helsinn," said Daniel P.
Gold, Ph.D., President and Chief Executive Officer of MEI
Pharma. "AML is a rapidly progressing, often fatal disease, and
patients who are unable to undergo intensive therapies are in
urgent need of new treatment options. We believe that with the
well-powered, rigorously designed Phase 3 study underway,
pracinostat is now one pivotal step closer to serving this need.
Meanwhile, enrollment in our Phase 2 dose-optimization study of
pracinostat and azacitidine in myelodysplastic syndrome (MDS)
continues as planned and we look forward to reporting interim data
from the MDS study early next year."
The Phase 3 study of pracinostat in combination with azacitidine
is open to adult patients with newly diagnosed AML who are unfit to
receive standard induction chemotherapy due to age ≥ 75 years or
predefined co-morbidities. Treatments will be administered based on
28-day cycles, with pracinostat or placebo administered orally once
every other day, 3 times a week for 3 weeks, followed by one week
of no treatment and azacitidine administered for 7 days of each
cycle. Additional information regarding the study, including
detailed inclusion and exclusion criteria, is available at
ClinicalTrials.gov (identifier: NCT03151408).
Results from a Phase 2 open-label, single-arm, multicenter study
of pracinostat and azacitidine in 50 patients aged ≥ 65 years with
newly diagnosed AML not eligible for induction chemotherapy showed
a median overall survival of 19.1 (95%CI: 10.0-26.5) months,
one-year survival of 62% and a CR rate of 42%. Responses were
durable (median CR+CRi 17.2 months). Blast clearance was rapid
(median 8 weeks) while CR required prolonged therapy (>6 months)
in some patients. 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. These results were presented at
the American Society of Hematology (ASH) Annual Meeting in
December 2016.
About AML
AML 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 and 10,590 deaths from AML in the
U.S. for 2017; the average age of a patient with AML is about 67
years. According to the Surveillance of Rare Cancers in
Europe project, the incidence of
AML in Europe is 3.7 per 100,000.
There are currently no drugs approved in the U.S. to treat AML in
patients who are unfit for intensive induction chemotherapy, though
hypomethylating agents are recommended by the National
Comprehensive Cancer Network (NCCN) guidelines. In the EU,
azacitidine is approved for the treatment of adult patients aged 65
years or older who are not eligible for hematopoietic stem cell
transplant (HSCT) with AML with >30% marrow blasts according to
the World Health Organization (WHO) classification.
About Pracinostat
Pracinostat is an 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. Under the terms of the agreement, Helsinn is
granted a worldwide exclusive license to develop, manufacture and
commercialize pracinostat, and is primarily responsible for funding
its global development and commercialization. Pracinostat is an
investigational agent and is not approved for commercial use in the
U.S.
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.
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, a
late-stage oral HDAC inhibitor that is partnered with Helsinn
Healthcare, SA. 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 chronic lymphocytic leukemia (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.