LUGANO, Switzerland and
SAN DIEGO, Dec. 3, 2018 /PRNewswire/ -- Helsinn Group,
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 interim data from a Phase 2 study
evaluating pracinostat, a histone deacetylase inhibitor, in
combination with azacitidine for the treatment of patients
with IPSS-R high/very high-risk of Myelodysplastic Syndrome (MDS).
The data demonstrate a 9% discontinuation rate due to adverse
events, a substantially lower rate than observed in an earlier
study, as well as an encouraging 36% complete response rate among
patients receiving at least 6 cycles of treatment. These data are
being presented today at the 2018 American Society of Hematology
(ASH) Annual Meeting.
The ongoing Phase 2 open-label study is evaluating a 45 mg dose
of pracinostat in combination with azacitidine in order to improve
safety/tolerability and retain patients in study longer than in an
earlier Phase 2 study evaluating a 60 mg dose. Prolonged treatment
is envisaged to result in a systemic exposure to pracinostat
sufficient to achieve the desired treatment effect. The data
reported today reinforce results from a planned May 2018 interim analysis meeting a predefined
discontinuation threshold and suggest a reduced dose of pracinostat
may allow MDS patients to remain on treatment longer and thereby
increase the likelihood of a treatment response. If the current
Phase 2 open-label study is successful, Helsinn intends to initiate
a global registration study.
Ehab Atallah, M.D., Study
Chair, Associate Professor of Medicine, Medical College of Wisconsin, said:
"Treatment options for patients with a higher risk of MDS
are still limited and following diagnosis the survival rate is less
than 18 months with the current standard of care. At the time of
the Phase 2 data announced this year in May, I was
excited to see that this treatment demonstrated that it can be
offered to patients as a combination therapy and potentially
improve outcomes. We're pleased that the threshold for expansion of
this study has been met, and I look forward to continuing to
observe the progress of this combination treatment."
Ruben Giorgino, M.D.
Ph.D. Helsinn Group Head of Clinical Development at Helsinn,
commented: "Helsinn bolsters its commitment in developing
pracinostat in combination with hypomethylating agents in patients
with AML and with high risk MDS. Moving forward to the second stage
of this really important Phase 2 clinical trial in MDS patients
represents an important next step in our efforts to understand the
potential benefit of pracinostat in these patients with poor
prognosis and modest response to hypomethylating
monotherapy".
Richard Ghalie, M.D., Senior Vice President, Clinical
Development at MEI Pharma, commented: "The interim data
demonstrating a 9% discontinuation rate due to adverse events, a
substantially lower rate than observed in the earlier study, as
well as an encouraging complete response rate to date of 36% of
patients reaching the first disease assessment at 6 months,
represents an opportunity to advance a promising new treatment for
patients with high/very high-risk disease that currently have
limited options."
The Phase 2 Study
The ongoing Phase 2 study is open-label and is investigating a 45
mg dose of pracinostat in combination with the standard dose of
azacitidine in up to 60 patients with high and very high-risk MDS
previously untreated with hypomethylating agents. The primary
endpoints of the study are 1) safety and tolerability and 2)
overall response rate, defined as complete remission (CR), partial
remission (PR) and marrow CR. Secondary endpoints include CR rate,
overall hematologic improvement (HI) progression-free survival and
overall survival, among others.
As of the end of October 2018, 55
patients have completed at least one cycle of therapy. The data
demonstrate a 9% discontinuation rate due to adverse events, 4% of
which were early discontinuations (within the first 3 treatment
cycles). Of note, 15% of patients discontinued because they
advanced to Stem Cell Transplantation. The discontinuation rate
reported today continues to meet the pre-defined threshold from the
planned interim analysis conducted in May
2018 and is consistent with the discontinuation rate for
azacitidine administered as a single agent.
In the group patients receiving at least 6 cycles of treatment,
the complete response rate is 36%. The median duration on therapy
is 4.7 months (range 0.5-13 months).
The 45 mg dose of pracinostat being evaluated in the Phase 2 is
better tolerated than the 60 mg dose evaluated in a prior Phase 2
study. Treatment in the current Phase 2 study was generally
well-tolerated: adverse events ≥ Grade 3 reported in 20% or more of
patients are febrile neutropenia, anemia, neutropenia and
thrombocytopenia. It is notable that patients in the current study
were diagnosed with higher-risk MDS than in the prior study.
The study was initially designed with two stages: the completed
first stage that met the predefined discontinuation rate threshold,
and a randomized and placebo-controlled second stage triggered upon
meeting the pre-defined discontinuation threshold in the first
stage. Based on the discontinuation rate meeting the pre-defined
threshold in a planned interim analysis in May 2018, the study design was amended by
substituting stage 2 with an expanded open-label portion to enroll
up to 60 patients to obtain data to support the design of a
registration study upon successful completion of the Phase 2
study.
About Higher Risk MDS
Higher risk MDS (high and very high risk in the IPSS-R
classification) is a serious medical condition, with median
survival of less than 18 months. The high and very high-risk groups
represent the highest unmet need in MDS, with median survival
estimates of only 1.6 years and 0.8 years, respectively.
The only curative therapy is allogeneic stem cell
transplantation (SCT), however most patients with MDS are not
candidates for SCT given their typically advanced age,
comorbidities and lack of a suitable donor. Standard therapy with
HMAs in higher risk MDS provides modest responses, though
azacitidine has been shown to improve survival when compared to
conventional care regimens. Patients who do not respond to HMAs or
progress after therapy with HMAs have a very poor outcome, with a
median survival of less than one year.
About Pracinostat
Pracinostat is an oral histone
deacetylase ("HDAC") inhibitor that is in a pivotal Phase 3 study
in combination with azacitidine for the treatment of adults with
newly diagnosed acute myeloid leukemia ("AML") who are unfit for
intensive chemotherapy. It is also being evaluated in a Phase 2
study in patients with high or very high-risk myelodysplastic
syndrome ("MDS"). 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 agreement provides that Helsinn is primarily responsible for
development and commercialization costs for pracinostat in AML and
other indications, including MDS. Pracinostat is an investigational
agent and is not approved for commercial use in the U.S. and any
country worldwide.
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, the
U.S., Monaco and China, as well as a product
presence in approximately 190 countries globally.
To learn more about Helsinn Group please visit
www.helsinn.com
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San
Diego-based pharmaceutical company focused on leveraging its
extensive development and oncology expertise to identify and
advance new 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 acute myeloid leukemia
(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
(MDS). MEI Pharma's clinical development pipeline also includes
ME-401, a highly differentiated oral PI3K delta inhibitor currently
in a Phase 1b study in patients with
relapsed/refractory CLL or follicular lymphoma, and voruciclib, an
oral, selective CDK inhibitor shown to suppress MCL1, a known
mechanism of resistance to BCL2 inhibitors. The Company is also
developing ME-344, a novel mitochondrial inhibitor currently in an
investigator-initiated study in combination with bevacizumab for
the treatment of HER2-negative breast cancer. Pracinostat, ME-401,
ME-344 and voruciclib are investigational agents and are not
approved for use in the U.S. For more information, please visit
www.meipharma.com
MEI Pharma and Helsinn Group 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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