LUGANO, Switzerland and
SAN DIEGO, June 14, 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 a Phase 2
dose-optimization study of pracinostat in combination with
azacitidine in patients with higher risk myelodysplastic syndromes
(MDS) who are previously untreated with hypomethylating agents
(HMAs).
The two-stage study will be conducted at approximately 25 sites
and is expected to enroll up to 120 patients with high and very
high risk MDS per the Revised International Prognostic Scoring
System (IPSS-R). 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, respectively1. The cost of this
study will be shared by Helsinn and MEI Pharma. Data from the first
stage is expected in the first quarter of 2018.
"Based on our clinical experience with the combination, we
believe that a reduced dose of pracinostat has the potential to
improve tolerability in patients with higher risk MDS, thereby
improving efficacy of the combination compared to azacitidine
alone," said Robert D.
Mass, MD, Chief Medical Officer of MEI Pharma. "We
look forward to working with the study's investigators and Helsinn
to evaluate this hypothesis in the clinic while we await the
outcome of our pivotal Phase 3 study of the combination in acute
myeloid leukemia (AML)."
Sergio Cantoreggi, PhD.,
Helsinn Group Chief Scientific Officer said, "We are pleased
to announce that the first patient with higher risk myelodysplastic
syndromes has been dosed in this Phase 2 dose-optimization study of
pracinostat in combination with azacitidine. Pracinostat is a
promising late-stage asset and a key part of Helsinn's broadened
focus into therapeutic clinical development and we look forward to
seeing the results in early 2018."
In a recently published, placebo-controlled Phase 2 study
(MEI-003) conducted in 102 patients with intermediate-2 and high
risk MDS, pracinostat (60mg) and azacitidine failed to increase the
complete response rate, the study's primary endpoint, compared to
azacitidine and placebo2. Drug discontinuation within
the first two months of treatment, due to poor tolerability
(primarily fatigue and myelosuppression), occurred twice as
frequently in the pracinostat group compared to placebo. A
sensitivity analysis, including 54 patients who received at least
four cycles of study therapy (pracinostat or placebo) and
azacitidine showed a trend for better progression-free survival and
overall survival (hazard ratio = 0.37 and 0.59, respectively)
compared to the control group. These data suggest that insufficient
exposure to treatment may have limited the overall efficacy of the
combination and are consistent with recently presented findings
from an analysis of patients in a Phase 2 study of pracinostat and
azacitidine in AML which showed that continued treatment increases
the rate of minimal residual disease clearance3.
This two-stage, Phase 2 study will investigate a pracinostat
dose of 45 mg, 25% lower than the dose used in study MEI-003, in
combination with the standard dose of azacitidine to determine
whether lowering the pracinostat dose in a higher risk patient
population can improve the tolerance of the combination while
achieving a clinically meaningful improvement in efficacy.
The first stage of the study will be open-label, single arm in
up to 40 patients to assess if the lower pracinostat dose will
result in a discontinuation rate that approximates the rate that
was observed with azacitidine alone in study MEI-003 (10%). If
results from the first stage support expansion of enrollment, the
second stage will be randomized and placebo-controlled to confirm
the discontinuation rate in a blinded setting and to provide data
on safety and efficacy.
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)
response rate, clinical benefit rate (defined as rate of CR + PR +
HI + Marrow CR), rate of cytogenetic complete response/remission,
duration of response, rate of leukemic transformation, event-free
survival, progression-free survival and overall survival.
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 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 regimens4.
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 year5.
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. The deal provides the complementary
resources from both organizations to advance pracinostat into Phase
III clinical development in AML and expand into additional areas of
clinical development, including MDS. 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, an
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 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.
1 Blood. 2012 Sep 20;120(12):2454-65
2 Cancer. 2017 May 15;123(6):994-1002
3 J Clin Oncol 35, 2017 (suppl; abstr 7034)
4 Lancet Oncol. 2009 Mar;10(3):223-32
5 J Clin Oncol. 2011 Aug 20;29(24):3322-7
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